Guideline on the Integrated Management of Pediatric HIV and AIDS by REDHOT

Guideline on the Integrated Management of Pediatric HIV and AIDS

Guideline on the Integrated Management of Pediatric HIV and AIDS I

Guideline on the Integrated Management of Pediatric HIV and AIDS Writers:

Melecia Velmonte, MD Professor Emeritus, UP College of Medicine-Philippine General Hospital, Manila Lorraine Anderson Executive Director, Precious Jewels Ministry, Manila Annie Ditangco, MD, MS III Head HIV/AIDS Study Group, Research Institute for Tropical Medicine, Alabang Metro Manila Thelma Laot, MD, MS III Research Institute for Tropical Medicine, Alabang, Metro Manila Rosario Abrenica, MD, MS III Head H-4/Bahay Lingap Pavillion, San Lazaro Hospital, Manila Ma. Olivia Dizon, MD, MS II H-4/Bahay Lingap Pavillion, San Lazaro Hospital, Manila Dominga Gomez, Nurse 6 – Chief Nurse Department of Rehabilitation, Infection Control Nurse – Philippine General Hospital, Manila Ann Joy Aguadera, MD Psychiatrist, H-4/Bahay Lingap Pavillion, San Lazaro Hospital, Manila

Style Writer: Eric E. Camacho, RMT, MPH Layout:

Marilyn S.P. Mirando

Artists:

Precious Jewels Ministry children living with HIV and AIDS Judith Picardal

Department of Health San Lazaro Compound, Rizal Avenue, Bldg. 13, 3/F San Lazaro Compound Sta. Cruz, Manila

Precious Jewels Ministry P.O. Box 3356, 1099 Manila Tel/Fax: 0063 2 921 5860 E-mail: philcrossingborders@yahoo.com pjewels87@gmail.com

Guideline on the Integrated Management of Pediatric HIV and AIDS

United Nations Children’s Fund Philippine Country Office HIV Programme, Health and Nutrition Section 31st Floor, Yuchengco Tower, RCBC Plaza 6819 Ayala Avenue, 1200 Makati City Tel: 0063 2 901 0100

Table of Contents Acknowledgements Message from DOH Message from UNICEF Message from WHO Message from the Core Group Foreword About the Guideline Introduction Section 1: Section 2: Section 3: Section 4: Section 5: Section 6: Section 7: Section 8: Section 9:

IV V VI VII VIII IX X XI

HIV and AIDS through the Eyes of the Child 1 Counseling, Disclosure and Seeking Informed Consent 7 Diagnosis of HIV Infection 11 Management of Children with HIV and AIDS 19 Adherence to ART 41 Monitoring for ARV Treatment 49 Special Considerations 59 ART in Adolescents 71 Treatment Failure 77

Annexes A – Interactive Consent Form B – WHO Clinical Staging for Infants and Children C – Drug Formulations and Dosages D – Management of Specific Adverse Reactions E – Sexual Maturity Rating in Adolescents

87 89 94 98 103

Glossary of Abbreviations References Training Course

104 105 107

III Guideline on the Integrated Management of Pediatric HIV and AIDS

Acknowledgements It takes many hands to care for each child to ensure their safety and well-being. This guideline is a first of its kind in the Philippines and would not have been possible without the invaluable support of many organizations and individuals. Thus, we would like to express our heart felt gratitude to:

. . . Our “inspiration” The children living with HIV and AIDS, who unselfishly shared their artwork and life-stories for this guideline;

. . . Our “partners” Those individuals and organizations who shared their thoughts and recommendations through a series of consultative sessions namely: Dr. Nicholas Alipui, Dr. Aye Aye Mon and Ms. Gudrun Nadoll (UNICEF), Dr. Jean Marc Olivé, Dr. Nerissa Dominguez and Dr. Madeline Salva (WHO), Dr. Marlene Borromeo (UNAIDS), Bing Baguiorro (Children’s Laboratory Foundation), Usec Ethelyn Nieto, Dr. Yolanda E. Oliveros, Dr. Gerard Belimac and Dr. Ethel Daño (DOH), Dr. Perla Alban (Order of Malta), Manila Doctors Hospital, Pinoy Plus Association, Positive Action Foundation Philippines Incorporated (PAFPI), DOH-NASPCP, Philippine National AIDS Council (PNAC), Caritas Manila, PIDSP Pediatric Infectious Disease Society of the Phillipines, Department of Social Welfare and Development (DSWD-CO) and the Hospital Directors Dr. Carmelo Alfiler (PGH), Dr. Remigio Olveda (RITM) and Dr. Arturo Cabanban (SLH); . . . Our “think tank” Also known as the Crossing Borders Task Force on the Interim Guideline and Core Group chaired by Dr. Melecia Velmonte (PGH), Dr. Annie Ditangco and Dr. Thelma Laot (RITM), Dr. Rosario Abrenica and Dr. Olivia Dizon (SLH), Ms. Dominga Gomez (PGH) and Ms. Lorraine Anderson (PJM), Dr. Joy Ann Aguadera (SLH).

. . . Our “hands” Those individuals who endured translating the core group’s ideas into such a beautiful and heart-felt manual: Mr. Eric E. Camacho (Technical and Style Writer), Ms. Judith Picardal (PJM Artist), Ms. Marilyn SP Mirando (Graphic Artist and Layout) and Ms. Lolita Bungayong, Ms. Kathleen R. Ritual (clerical assistance).

. . . And our “convenor” Who painstakingly brought everything together, The Precious Jewels Ministry headed by their President, Dr. Lynn Panganiban and Executive Director, Ms. Lorraine Anderson, Program Coordinator, Ms. Johanna Bergink and their hardworking staff namely: Jem, Charity, Joyce, Eve, Joven and Dess.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Message from DOH

Since 1984, the Department of Health has wielded effective leadership to make sure that the country is prepared to respond in the event of a fullblown HIV / AIDS epidemic. The multi-pronged and multi-sectoral program to prevent and control HIV infection became operational in the 1990â&#x20AC;&#x2122;s with the organization of the Philippine National AIDS Council composed of members coming from different government agencies, NGOs, health provider organizations and patient advocacy groups. Since then, the Philippines has managed to keep HIV / AIDS at bay and has maintained the lowest prevalence of HIV at less than 1%. Through the years, surveillance data have shown that heterosexual intercourse is the predominant mode of transmission for majority of Filipinos found to be HIV positive. However, the risk of mother-to-child transmission has been present all along. Of the more than 3,000 cumulative cases of HIV positive patients diagnosed from 1984 to the last quarter of 2008, 2% were transmitted through vertical transmission (i.e. mother-to-child route). This year we saw an upsurge of positive cases among adults, which could mean a corresponding increase in the risk of mother-to-child transmission. It is timely, thus, that the Interim Guideline on the Integrated Management of Pediatric HIV and AIDS was designed and it is now being published as a ready reference for health service providers all over the country. This Guideline is a result of the collaborative efforts of the Department of Health and its hospitals, San Lazaro Hospital and the Research Institute of Tropical Medicine, the UP College of Medicine-Philippine General Hospital, Precious Jewels Ministry - Crossing Borders Project, the United Nations Childrenâ&#x20AC;&#x2122;s Fund (UNICEF), the World Health Organization (WHO) and our other development partners who uphold the right of every child to health, development and a full life. Congratulations to everyone who worked hard to ensure that every child affected with HIV - AIDS would be adequately cared for by committing to the drafting and completion of this Interim Guideline. Indeed every child is special!

Francisco T. Duque III, MD, MSc. Secretary of Health

Guideline on the Integrated Management of Pediatric HIV and AIDS V

Message from UNICEF AIDS continues to devastate families, communities and societies in many parts of the world, affecting populations who are poor, vulnerable and socially marginalized. In 2007, there were an estimated 33 million people living with HIV globally, half of them women. An estimated 2.1 million children younger than 15 years were living with HIV in 2007, and more than 90% of them were infected through mother-tochild transmission. Children account for 6% of all HIV infections, 17% of new infections and 14% of all HIV-related mortality. The Philippines is so far experiencing a very limited epidemic, with national adult HIV prevalence of under 0.1% and estimated 7,490 adults and children living with HIV in 2007. However the trend is clearly upward, with urban areas seeing significant increases in cases of HIV. The number of children affected by AIDS in the Philippines is small, but like other children affected by AIDS everywhere, they suffer a multiple burden of loss, stigma and discrimination. Should AIDS reach epidemic proportions in this country, the effect on children would be devastating. Now is the time to act. Now is the time to establish a system to help our Filipino children who are infected with HIV. Pediatric HIV management is new in the Philippines. Therefore, I hope that this â&#x20AC;&#x153;Guideline on the Integrated Management of Pediatric HIV and AIDSâ&#x20AC;? will serve as a tool for health care professionals to be able to provide comprehensive care, treatment and support for children affected by AIDS. By ensuring access to anti-retroviral therapy, children who are living with HIV have a much greater chance to fulfill their potential and live healthier, longer lives.

Vanessa Tobin UNICEF Representative in the Philippines

Guideline on the Integrated Management of Pediatric HIV and AIDS

Message from WHO Guideline on the Integrated Management of Pediatric HIV and AIDS I would like to congratulate the Department of Health and its treatment hubs, Precious Jewels Ministry, UNICEF and WHO for putting their efforts together in the development of this Guideline for the Integrated Management of Pediatric HIV and AIDS. This manual, which adopts child-based approach, is a resource that can be used to address specific targeted supportive services for children and the adolescents. These children and youth, usually missing in many ways from HIV and AIDS picture, will need immediate access to on-going medical and psychosocial care. The facts are clear, globally, children under 15 accounted for 2.1 million of the estimated 33.2 million people living with HIV in 2007, 420,000 were newly infected and 290,000 died of AIDS. Most children are infected with the virus during pregnancy, delivery or while breastfeeding. About fifty percent of infants who get HIV from their mothers die before their second birthday. We know there is no cure for HIV, but we can give these children the chance to make the most of their lives. We can help them live with dignity by ensuring that they receive the services they need from trained health care workers and service providers. It is important that this Guideline, which provides reliable and practical guidance on how to diagnose and treat children with HIV to be implemented immediately. This is a step towards ensuring the protection of the children and will ameliorate the devastating impact of AIDS in them. The only time when we can secure their TOMORROW is ... TODAY.

Dr Soe Nyunt-U WHO Representative for the Philippines

Guideline on the Integrated Management of Pediatric HIV and AIDS VII

Message from Crossing Borders Core Group

In March 2004, we first met to discuss how we could work together to develop a comprehensive model of care for children affected by HIV and AIDS. We came from such diverse backgrounds: infectious disease specialists, pediatricians, social workers and nurses and yet our combined experience presented a rich resource to grow this idea into the project Crossing Borders â&#x20AC;&#x201C; Towards the Integrated Care of HIV and AIDS Affected Children. This Interim Guideline on the Integrated Management of Children with HIV and AIDS has been prepared for the Crossing Borders project in cooperation with many vital partners. The collaborative effort of the Core Group has been tremendous as they worked long and hard to develop material that is not only informative but acceptable, feasible and practical in resource practical setting and practical. The delightful artwork and poignant stories remind us that this guide is ultimately for the ones most affected by HIV and AIDS â&#x20AC;&#x201C; the children. This manual is accompanied by a Training Course for health care workers. We hope it will be a useful tool in providing optimum quality care for all HIV and AIDS affected children and their families.

Melecia Velmonte, MD (UPCM-PGH) Chair Task Force on Interim Guideline Crossing Borders Project Members: Lorraine Anderson (PJM) Annie Ditangco, MD (RITM) Thelma Laot, MD (RITM) Rosario Abrenica, MD (SLH) Dr. Olivia Dizon Ms. Dominga Gomez

VIII

Guideline on the Integrated Management of Pediatric HIV and AIDS

Foreword

The HIV epidemic remains to pose a significant threat to public health today. Although much efforts have been undertaken by the country through its multi-sectoral approach in programme implementation to control and prevent HIV, much more need to be done. Children continue to be one of the most vulnerable populations to HIV infection. The DOH AIDS Registry reveals that there are almost 50 children reported with HIV infection through mother to child transmission (MTCT) since 1984. As we carefully undertake the right approach to MTCT prevention, we need to ensure that diagnosis, treatment, care and support to children living with HIV should be in place. As children altogether have different sets of needs, service providers at any health care setting should completely understand, be armed with knowledge, skills and compassion in providing the physical, mental and social needs of children infected with HIV to achieve their state of well-being and live a normal life. This manual provides guidance on the diagnosis, treatment, care and support for children living with HIV using the client – centered approach. After almost 2 years of pilot implementation by the Crossing Borders Project as supported by UNICEF in 3-DoH designated Treatment Hubs, we are now ready to expand this guideline on a national scale so as ALL Filipino children with HIV receive the appropriate health care and services. Kids can’t wait! Let’s keep the promise!

YOLANDA E. OLIVEROS, MD, MPH, MHSA Director IV National Center for Disease Prevention and Control

Guideline on the Integrated Management of Pediatric HIV and AIDS IX

About the Guideline Background and Rationale It was in 1995 when the 1st Filipino child living with AIDS died at age seven. The absence of appropriate treatment and our limited understanding and capacity to manage the disease was clearly evident. In recent years however, integrated models of care and the emergence of life-saving treatment for HIV and AIDS has provided an opportunity for proper management of children living with HIV and AIDS in several countries worldwide. And now, after 11 years, antiretroviral drugs for Filipino children living with HIV and AIDS are beginning to be available. In 1995, the Department of Health (DOH), Department of Social Welfare and Development (DSWD) and the Precious Jewels Ministry (PJM) hosted the 1st National Consultation on Children Living in Families Affected by HIV/AIDS. Through the years that followed, PJM along with its various donors, government and non-government partners painstakingly worked towards mainstreaming key strategies and programs to integrate child welfare and health care in the management of HIV and AIDS in the country. One of the realizations of these efforts is the current Crossing Borders Project. Precious Jewels Ministry spearheaded the Crossing Borders Project with funding support from UNICEF. This project forges new partnerships as medical practitioners and child-welfare advocates join together in the provision of optimum quality care for children affected by HIV and AIDS. Beyond defining the roles and responsibilities of forged partnerships, Crossing Borders aims to develop the capacity of health care workers in using revised protocols for the care and treatment of children with HIV and AIDS utilizing the Convention on the Rights of the Child as the framework. Representatives from San Lazaro Hospital (SLH), Research Institute for Tropical Medicine (RITM), Philippine General Hospital (PGH), DOH, UNICEF, WHO, and PJM formed the core group for the Crossing Borders Project. They worked closely together to develop a protocol entitled “Interim Guideline on the Integrated Management of Pediatric HIV and AIDS” to be initially implemented in the above mentioned hospitals. In June 2008, a review of the guideline was conducted by the core group to improve its over-all content and responsiveness to present needs. The guideline was subsequently adapted by the DOH for utilization at the country level.

Content This pioneering guideline has been developed for San Lazaro Hospital, Research Institute for Tropical Medicine and Philippine General Hospital under the Crossing Borders Project. The protocols are based on the existing standard operating procedures of the participating hospitals and results from agreements and consultations made among various stakeholders of the Crossing Borders Project, along with review of related literature from WHO and other countries. This nine section document serves as a reference material in applying a multidisciplinary approach in providing quality diagnosis, treatment, care and support to children diagnosed with HIV infection. It characterizes medical, clinical and psycho-social interventions applied to an HIV infected child from the womb to adolescence. This document will be regularly reviewed and updated by NASPCP – NCDPC in consultation with the core group and other relevant stakeholders.

End Users The end-users of this manual include doctors, nurses, pharmacists, medical technologists, social workers and other members of the Hospital AIDS Core Teams involved in the provision of multi-disciplinary services to PLHIV.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Introduction The Convention on the Rights of the Child or CRC recognizes the rights of the child to the enjoyment of the highest attainable standard of health including facilities for diagnosis, treatment and rehabilitation. The emergence and continuous development of antiretroviral therapy has positively curbed the fate of those infected by HIV. It has enhanced survival of infected individuals in parts of the world where it has been successfully introduced. Infants diagnosed with HIV infection can now survive to adolescence and adulthood. Taking into account the rights of an HIV infected child to survival, protection, development and participation, the benefit of antiretroviral therapy must be optimized by ensuring availability and access to ARV and acceptance of quality management protocols in diagnosis, treatment monitoring, and maintenance of a supportive environment that would enhance adherence. Furthermore, in considering the evolving capacities of the child, his/her participation in the whole process of treatment must be guaranteed at all times. While the benefits of ARV in children are hopeful, much consideration should be given to treatment monitoring and adherence. This is particularly important since this therapy is closely associated with potential short and long-term toxicities so much more in children than in adults. On the other hand, higher levels of adherence are associated with improved outcomes (more than 90%), therefore maximizing adherence ensures the effectiveness of the ARV and ultimately avoids the emergence of drug resistance. In the Philippines, HIV treatment in children is practically a new specialty in Pediatrics. More than making the drugs accessible, the challenge is ensuring that the treatment protocols will be applicable to the Filipino child and his/her local environment. This is also supported by Republic Act 8504, known as, Philippine AIDS Prevention and Control Act of 1998. This pioneering manual took into consideration all materials available in managing HIV in children and streamlined the processes into a child-centered approach.

Guideline on the Integrated Management of Pediatric HIV and AIDS XI

Section 1 HIV and AIDS through the eyes of the child â&#x20AC;&#x153;I want to color my heart like this. My heart is green - my mother is color yellow and my sister is the red. I miss themâ&#x20AC;?. -Mon, 6 years old

Guideline on the Integrated Management of Pediatric HIV and AIDS

“The Child’s Name is Today” We are guilty of many errors and faults... But the worst crime is abandoning the children. Neglecting the fountain of life Many of the things we need can wait.... The children cannot. Right now is the time their bones are being formed, Their blood is being made and Their senses are being developed. To them, we cannot answer “Tomorrow” The child’s name is “Today” Guideline on the Integrated Management of Pediatric HIV and AIDS

Every child has a right to... Be born well, to have a name and a nationality Be free, have a family, have a good education have enough food, healthy and active body, Be given opportunity for play and leisure Be given protection against abuse, danger and violence Live in a peaceful community, Be assisted and defended by the government, Be able to express their own views Reference: The Convention on the Rights of the Child Philippines 1990

The Convention on the Rights of the Child or CRC recognizes the rights of the child to the enjoyment of the highest attainable standard of health including facilities for diagnosis, treatment and rehabilitation. The emergence and continuous development of antiretroviral drugs have positively curbed the fate of those infected by HIV. It has enhanced survival of infected individuals in parts of the world where it has been successfully introduced. Individuals diagnosed with HIV infection as infants can now survive to adolescence and adulthood. A child has the right not only to SURVIVE but also to ENJOY LIFE and GROW. The cornerstone of the CRC is for every child to LIVE and to live his or her life FULLY. This â&#x20AC;&#x153;fullness of lifeâ&#x20AC;? defines health and development for children.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Child’s Health = Fullness of Life

Life (Survival and Protection of Rights)

Fullness (Development and Participation Rights)

Ensuring, Protecting, Preventing and Responding to Threats

Nurturing, Engaging and Helping

Children’s rights are not given, but are protected. Anything anyone does for any child must be for the child’s survival and development. Child’s participation is about being informed with adequate, correct and appropriate information about anything that affects his/her life, based on his/her evolving capacity. Child Friendliness is neither a program nor a policy, but a lifestyle and culture.

As a matter of right and responsibility, health care workers should support the CRC and in the care of children with HIV and AIDS, the benefit of antiretroviral therapy must be optimized. This means ensuring availability and access to antiretroviral drugs (ARVs) and acceptance of quality management protocols in diagnosis, treatment monitoring and maintenance of a supportive environment that would enhance adherence.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Section 2

Guideline on the Integrated Management of Pediatric HIV and AIDS

Section 2:

Counseling, Disclosure & Seeking for Informed Consent Disclosure: A Psycho-Social Issue One of the most difficult areas of HIV management in children is disclosure. Many parents wish to keep the diagnosis from their children for as long as possible. This poses ethical dilemmas for professionals, who are aware that children and young people need to be able to talk about their infection and to be involved in decisions about their treatment (Gibb et al., 1977). Parents fear that children are unable to keep secrets, therefore telling them about their diagnosis potentially means telling it the world. Parents also desire to protect the child from the knowledge that parents and/or child has the infection. However, children very often know a great deal of their infection even when families and caregivers have gone to great lengths to conceal such information. Children are very sensitive to discrepancies between verbal and non-verbal information. They readily sense distress in those around them and may feel anxious and isolated as a result (Psychosocial Issues, 2006). A large body of literature in pediatric psychology has established that children have better emotional and social adjustment if they are told of their diagnosis and allowed to discuss their conditions openly with their family and medical care givers. (Lewis,1999). Children not only need to be repeatedly told, but also helped to understand that they are not to be blamed for the infection. At present, the role of the medical professional is to provide parents/guardians with enough information, so that they can make informed decisions when it comes to disclosing the HIV status to a child. Disclosure of a childâ&#x20AC;&#x2122;s HIV status needs a very supportive environment, where adults are ready to provide appropriate information and reassurance and the community is there to help parents/guardians face this difficult situation. It is important to understand that disclosure is a process rather than a one time event that begins and ends with telling the child his/her illness. Issues surrounding disclosure mandate that families have time and opportunities for discussion of issues such as preparing the child, finding the right words to say, deciding whom to tell and when to tell them and defining and considering how to manage any risks (New York State Department of Health, 2006).

Source: The Impact of Psycho-Social Support and Disclosure in ARV Therapy, Brighton Guezera (The CRIS-CABA Journal, Mar. 2006. Vol. 4, No. 1)

Guideline on the Integrated Management of Pediatric HIV and AIDS

Recommended topics covered in the counseling session Pre-Test • • • • • • •

Basic HIV/AIDS Information HIV Risk factors in Children HIV Testing in Children Benefits of Testing Need for Informed Consent Readiness of caretakers The Crossing Borders initiative

Post Test for HIV + Child • • • • • • • • •

Goal of ARV treatment Treatment and Monitoring Adherence ARVs and Side Effects Care and Support Options Nutritional Assessment/ counseling Infant feeding counseling Routine childhood care Psychological prep includes psychosocial support • List of other treatment centers • What to do next (referral from management) • PJM and other available services

Post Test for HIV - Child • Prevention • Monitoring & Confirmation of HIV status at age 18 months and for children seen @ more than this age should be advised when to have repeat examination • Explain project • PJM and other available services especially for the children with parents • Other services available • Nutritional Assessment/ counseling • Infant feeding counseling

Under the Crossing Borders initiative, HIV testing in children can only be done after pre-test counseling has been provided to the parent(s) or legal guardian and the child considering his/her evolving capacity to understand their health condition. Post test counseling should also be provided once the results are available. Both counseling processes shall be facilitated by health care workers trained in HIV and AIDS counseling. Furthermore, a written informed consent provided by the hospital and signed by the parents or legal guardian is required before HIV testing, diagnosis and treatment initiation of a child 0 – 18 years old. In addition, the child should understand his/her health status using an interactive consent form.

(See Annex A: Interactive Consent Form)

Guideline on the Integrated Management of Pediatric HIV and AIDS

Section 3 Diagnosis of HIV infection

“He is confined in the hospital” -Jude, 7 years old

Guideline on the Integrated Management of Pediatric HIV and AIDS

Section 3

Diagnosis of HIV infection What’s the Difference? What’s the difference between 6 months and 18 months? The answer is obvious - 12 months. Not many months in a lifetime but a lot of days if you are an infant infected with HIV. In October 2005, doctors specializing in HIV and AIDS and child welfare advocates met for three long days and nights to draft a guideline for the management of children affected by HIV and AIDS. In considering testing of infants, the doctors were unanimous in advocating for early diagnosis of child less than 18 months old. Why? A CHILD CANNOT WAIT! The early diagnosis of a child lessens the stress, anxiety and fear of the mother and assures the treatment and care of an infected child at the earliest time possible. There’s a lot of life and development in a child between the ages of 6 - 18 months. Let’s give them a chance to live a full life!

Guideline on the Integrated Management of Pediatric HIV and AIDS

13 13

A. Laboratory Diagnosis Accurate diagnosis of HIV infection in children at any age requires laboratory testing. Since maternal HIV antibody crosses the placenta and persists until 18 months, infants born to HIV infected mothers may test (+) up to this age. Persistence of HIV antibody after 18 months of age indicates HIV infection. For children under 18 months old, HIV diagnosis may be done by detecting the virus or its components in the childâ&#x20AC;&#x2122;s blood as presented below:

Algorithm A - Infant less than 18 months; virologic test available

Infant born to HIV-infected mother

Do virologic test

Breastfeeding (BF)? yes Do virologictest 6 weeks after discontinuation of BF

no Positive test?

HIV negative

yes Repeat virologictest

Positive test?

Not HIV infected

yes

HIV-infected

Guideline on the Integrated Management of Pediatric HIV and AIDS

Cotrimoxazole prophylaxis should be initiated from 4-6 weeks to 18 months until testing confirm a negative result

Algorithm B - Infant less than 18 months; virologic test NOT available

Infant born to HIV-infected mother

Breastfeeding (BF) during past 6 wks?

Do HIV antibody test At 9-12 months

yes

Do HIV antibody test at 9-12 months 6 weeks after discontinuation of BF

Positive antibody test?

yes

HIV antibody test can be used to exclude HIV infection in children 9-12 months of age. At 9 months, 74% and at 12 months 96% of HIV uninfected children have a negative Ab test result.

Likely to be HIV infected. Repeat antibody test at >18 months.

Positive antibody test? + Confirmatory test?

Not HIV infected

yes

HIV - infected

Cotrimoxazole prophylaxis should be initiated from 4-6 weeks to 18 months until testing confirm a negative result

Guideline on the Integrated Management of Pediatric HIV and AIDS

Algorithm C - Child more than 18 months; Antibody test available

Infant born to HIV-infected mother

Do HIV antibody test Counsel mother not to breastfeed 6 wks before doing the test

Positive antibody test? yes

Confirmed at SACCL? yes

HIV-infected

Guideline on the Integrated Management of Pediatric HIV and AIDS

Not HIV-infected

The table below summarizes the types and schedules of tests that may be performed on the child’s blood:

Age of Child

Type of Test

Test Schedules

Child under 18 months Newborn infants / neonate

PCR (DNA)

At 6 weeks Repeat 3-6 months if initial tests are negative

PCR (DNA)

6 weeks or longer after complete cessation of breastfeeding

Mother or infant has received antiretroviral Prophylaxis of MTCT

PCR (DNA)

Anytime

When mother is on ART at delivery

PCR (DNA)

Anytime

Children 18 months or older

HIV antibody test

On or after 18 months

Breast feeding infants

B. Presumptive Diagnosis A presumptive diagnosis of severe HIV disease in infants under 18 months should be made if: o Infant is born to a confirmed HIV antibody positive mother o Infant is confirmed HIV antibody positive o Aged under 18 months o Diagnosis of clinical stage 4 or positive AIDS indicator conditions o Other Factors • Recent HIV-related maternal death • Advanced HIV disease in mother • CD4 less than 20% Confirmation of presumptive diagnosis at the latest with HIV Virological test (PCR) for < 18 months or with HIV antibody testing at age 18 months.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Section 4 Management of children with HIV and AIDS

â&#x20AC;&#x153;I want to go home and play wth my cousins in our farmâ&#x20AC;? -Mon, 6 years old

Guideline on the Integrated Management of Pediatric HIV and AIDS

Section 4

Management of children with HIV and AIDS Clinicians should be familiar with side effects, adverse reactions and unpleasant qualities of antiretroviral medications being prescribed and should make parents and children aware of this information before initiating a treatment plan. Establishing partnership with the family is one of the best strategies for fostering adherence. A clinician prescribing a complicated antiretroviral medication plan should be available for continuing support and education. To encourage adherence, clinicians should provide the child and family with visual aids and educational materials and instructions on exact doses and frequencies of ARVs (New York State Department of Health, 2006). The decision to start ARV therapy in children is much more complex than in adults. Data of specific outcome in children is limited. Natural history, studies in children and extrapolation from adults studies are used to derive guidelines. In older children, the guidelines favor treatment when the child reaches a more advanced stage. All emphasize the need for education to ensure adherence and routine monitoring of efficacy and safety.

Guideline on the Integrated Management of Pediatric HIV and AIDS

The goals of Management and Care of the HIV infected child are to promote health and well being, prevent opportunistic infection and prevent disease progression A. Baseline Assessment 1. Clinical Assessment 1.a. Get complete medical history of the child appropriate for age including maternal, perinatal and immunization history. 1.b. Perform complete physical examination appropriate for age. 1.c. Assess nutritional status including feeding history. 1.d. Note HIV status of the mother and whether breastfeeding or not. Note: Refer to discussion on Section 7: Special considerations

2. Laboratory Tests 2.a. CD4 percentage (up to 6 years old) or CD4 Count 2.b. Blood count with platelet count and Total Lymphocyte Count (TLC) 2.c. HBsAg, HCV, SGPT, SGOT, DBIB 2.d. Other Tests: urinalysis, TB screening, Glucose, Lipids, Amylase, Serum Electrolytes and other tests when indicated 3. Psychosocial Evaluation and Counseling 3.a. Assess knowledge and understanding of the disease as appropriate for age and if disclosure is an option 3.b. Assess knowledge and understanding of ARV therapy including the importance of adherence on the part of the child and caregiver. 3.c Identify possible barriers to adherence and strategies to overcome such barriers 3.d. Assess willingness of the care giver/guardian and child to participate in the treatment program 3.e. Assess family and psychosocial environment for continuum of care which includes infant feeding, hygienic practices, household contacts, appropriate activities in school, appropriate support system (roles of the family, caregiver & community, etc.)

Guideline on the Integrated Management of Pediatric HIV and AIDS

B. Clinical and Immunologic Staging Clinical Staging Clinical Staging is done once HIV infection has been confirmed. WHO classifies HIV-associated clinical disease in infants and children as presented in the table below. (See also Annex B: Presumptive and Definitive Criteria) Table 1. WHO Clinical Staging of HIV in Infants and Children

Clinical Stage

Classification of HIV-Associated Clinical Disease

Asymptomatic

Mild

III

Advance

Severe

Note: A continuous support system for the affected child and family is essential to ensure adherence to treatment including regular assessment and evaluation.

Clinical staging is useful in: 1) assessment at baseline or entry into HIV and AIDS care, 2) predicting mortality in HIV-infected children not yet on ARV, and 3) can also be used to guide decision-making on when to start contrimoxazole prophylaxis and other related HIV and AIDS interventions, including when to start and when to stop

Guideline on the Integrated Management of Pediatric HIV and AIDS

Immunologic Staging CD4 testing is very valuable to guide initiation of ART and wherever possible should be in conjunction with clinical assessment. It can also be used to monitor treatment response. In children less than 5 years old, the absolute CD4 count tends to vary from within an individual child more than the CD4 percentage. Therefore, measurement of the CD4 percentage is preferred in younger children <5 years. Children with opportunistic infection may have low CD4/TLC values which may improve after acute illness. Since CD4 and TLC are subject to considerable variability, to values before threshold should be obtained particularly before starting a child with clinical stage 1 disease or ARV

Table 2: WHO Classification of Age-related CD4 Values in HIV–Associated Immunodeficiency

<11 months (CD4%)

12-35 months (CD4%)

36-59 months (CD4%)

5 years (cells/mm3 or CD4%)

Asymptomatic or Non significant

> 35

>30

>25

>500

Mild

30 – 35

25 – 30

20 – 25

350 - 499

Advanced

25- 29

20 - 24

15 - 19

200 - 349

Severe

<25

<20

<15

<200 or <15%

Classification

Guideline on the Integrated Management of Pediatric HIV and AIDS

Using Total Lymphocyte Count (TLC) The TLC is an option that is used only if CD4 measurement is not available in children with WHO clinical stage 2 disease. It cannot be used in asymptomatic children. The TLC is also not useful for monitoring ART. As in HIV infected adults, the TLC significantly predicts the risk of mortality in HIV infected children. The 12 month risk of mortality is greater than 20% for children aged <11 months with a TLC of <4000 cells/mm3, for children aged 12-35 months with a TLC of <3000 cells/ mm3, for children 3-5 years old with a TLC of <2500 cells/mm3 and in children older than 5 years of age with a TLC of < 1500/mm3 (32). Therefore, in situations where CD4 assays are not available, TLC may be used as an indication for the need to initiate ART in infants or children with WHO Pediatric Clinical Stage II disease. As stated above, it is desirable that an abnormal TLC or CD4 cell/count percentage be confirmed with a second test before therapeutic decisions are made but it is recognized that this may not always be possible. Table 3: Diagnosing severe immunodeficiency using TLC (optional if CD4 is not available)

Calculation of TLC = % lymphocytes x total white blood cells (WBC) count.

Classification of HIV-associated immunodeficiency

TLC

CD4 count

Age-related TLC values (cells/mm3)

11 months

12-35 months

36-59 months

>5 years

<4000

<3000

<2500

<2000

<1500

<750

<350

<200

Guideline on the Integrated Management of Pediatric HIV and AIDS

C. Initiation of Co-trimoxazole prophylaxis for HIV positive children

Table 4: Indications for co-trimoxazole (CTX) prophylaxis

HIV-exposed infants and children

Confirmed HIV-infected infants and children <1 year

1-5 years

CTX prophylaxis is universallya CTX prophylaxis indicated WHO stages 2, 3 and 4 regardless indicated, starting at 4-6 weeks regardless of CD4% or clinical of CD4%b after birth and maintained until status cessation of risk of HIV transmission Or and exclusion of HIV infection Any WHO stage and CD4 <25%b

>6 years Any WHO clinical stage and CD4 <350a Or WHO stage 3 or 4 and any CD4 levelc

Universal option: This strategy may be considered in settings such as in TB programmes with a high prevalence of HIV and limited health infrastructure

Notes: a All HIV exposed infants starting at 4-6 weeks and all infants with presumptive clinical diagnosis of severe symptomatic HIV until no longer breastfeeding and HIV has been excluded. b. In resource-limited settings, co-trimoxazole may be started when the CD4 count has dropped to <25% at age <5 years or is <350 cells/mm3 at >6 years. The aim is to reduce the morbidity and mortality associated with malaria, bacterial diarrheal diseases and pneumonia, in addition to the prevention of PCP and toxoplasmosis.

In other settings where the use of co-trimoxazole is limited to preventing PCP, co-trimoxazole may be started when the CD4 count has dropped to <20% at age <5 years or is <200 cells/mm3 at >6 years. Asymptomatic children in WHO clinical stage 1 do not require co-trimoxazole prophylaxis. However, it is strongly recommended to measure the CD4 count as asymptomatic children may also have laboratory signs of immunodeficiency.

Guideline on the Integrated Management of Pediatric HIV and AIDS

D. Initiating ART in Infants and Children ART initiation in infants and children with proven HIV infection should be started: 1. In infants less than 12 months of age regardless of clinical stage and CD4 values Initiate ART regardless of clinical stage or laboratory immunoligical values. 2. In children 12 months of age or older 2.1 If CD4 is not available Initiate ART if WHO Pediatric Clinical Stage III and IV disease 2.2 If CD4 is available 2.2 a WHO Pediatric Clinical stage II disease AND CD4 count or percentage or Total Lymphocyte Count at or below threshold; 2.2 b WHO Pediatric Clinical Stage I disease AND CD4 count or percentage at or below threshold. Initiating ART for Infants and Children Infant/Child with confirmed HIV Infection Confirmation = serologic or virologic depending on age

Treat and stabilize Acute conditions and opportunistic infections No

>12 months of age

Less than 12 months

Yes Assess clinical stage WHO Paediatric Clinical Staging

No Stage 4

Stages 1,2,3

Yes CD4 Assessment Available?

Stage 1 & 2 - Do not start

Stage 3 Yes

>12 months - 35 months: %CD4 <25 or CD4 count <750/mm3 >36 months - 59 months : %CD4 <20 or CD4 count <350/mm3

Initiate First Line ART

>5 years: %CD4 <15 or CD4 count <200/mm3

Guideline on the Integrated Management of Pediatric HIV and AIDS

E. Preparing to start ART Prepare the Caregiver

Prepare the Child

The caregiver should be able to: • understand the natural history of HIV infection in children, and the benefits and side-effects of ART. • understand the importance of taking ART on time everyday and ensure adherence to treatment. • assume the primary responsibility to directly observe the daily ARV intakes of the child. • assume the primary responsibility to ensure compliance in adolescents. Direct observation of drug intake may not be needed in adolescents. The caregiver may allow the adolescent to be responsible for taking ART. • appropriately store ARV drugs. • correctly demonstrate mixing/measuring of the selected ART regimen. • afford ART and necessary laboratory monitoring as well as transportation to the hospitals in a sustainable manner (if self-paid).

Children who know their HIV status (explanation is given by health care worker according to the child’s maturity level) should be able to: • understand the natural history of HIV infection, and the benefits and side-effects of ART. • understand the importance of taking ART on time every day and adhere to treatment. Children who do not know their HIV status should be explained why they need to take ART by using culturally- and age-appropriate explanations and by avoiding the words “HIV” or “AIDS”. They should be: • ready and agree to take ART (depending on their level of maturity but mostly in children >6 years the health care worker can explain according to the child’s maturity level), and • able to understand the importance of taking ART on time every day and of adherence to treatment.

Agree on the treatment plan Caregiver / child and health-care personnel agree on an ART regimen and follow-up appointments that the caregiver / child can adhere to.

Assess treatment preparedness and factors that may affect adherence • • • 28

Assess the caregiver / child’s understanding of the reason for taking ART, anticipated treatment response, side-effects or ART and how ART is taken (dose, time and food requirements). Assess the factors that may affect adherence and work with the caregiver / child in finding solutions for these anticipated problems. Assess the readiness for disclosure of HIV status. Disclosure is not a prerequisite for starting ART but is encouraged when the caregiver is ready and the child is felt to be mature enough and can keep secrets. Preparing for and performing disclosure is a process that takes time. The health- care personnel’s role is to help prepare and support the caregiver and child. Guideline on the Integrated Management of Pediatric HIV and AIDS

F. What to Start STRONG RECOMMENDATION: For HIV infected infants with no exposure to maternal or infant non-nucleoside reverse transcriptase inhibitors, or whose exposure to maternal or infant antiretrovirals is unknown, standard nevirapine-containing triple therapy should be started. CONDITIONAL RECOMMENDATION (Context specific and time limited) For HIV infected infants with a history of exposure to single dose nevirapine or non-nucleoside reverse transcriptase inhibitor containing maternal antiretroviral therapy or preventive antiretroviral regimens, a protease inhibitor-based triple antiretroviral therapy regimen should be started. Where protease inhibitors are not available, affordable or feasible, nevirapine-based therapy should be used.

Currently Available Drugs in the Philippines First Line Regimens Normal Hemoglobin AZT + 3TC + NVP AZT + 3TC + EFV Hemoglobin Below 7.5 gm/dl d4T + 3TC + NVP d4T + 3TC + EFV

Guideline on the Integrated Management of Pediatric HIV and AIDS

G. When do side-effects and toxicities occur with ARVs? Time Within the first few weeks

From 14 weeks onwards

Side-effects and toxicities • •

GI toxicities include nausea, vomiting and diarrhea. These side-effects are usually self-limiting and require symptomatic treatment only. Rash and liver toxicity are more common with the NNRTI drugs but are also seen with certain NRTI drugs such as ABC and some protease inhibitors (PIs).

• • • • • •

A lead-on dose is used for NVP. To lower the risk of toxicity. In case of mild-to-moderate rash and liver toxicity, ARV can be continued under close follow-up, and symptomatic treatment and supportive care given. Severe rash and liver toxicity (ALT >5 ULN) can be life-threatening and NVP should be substituted with another drug. CNS toxicity from EFV can be self-limiting. Because EFV can cause dizziness, most physicians advise that it should be taken at night. ABC hypersensitivity usually occurs within the first 6 weeks and can be life-threatening. ABC must be stopped and re- challenge never attempted.

• Drug-induced bone-marrow suppression such as anaemia and neutropenia are most commonly seen with AZT. • Other causes of anaemia should be looked for and treated. • Asymptomatic mild anaemmia is common. • If there is severe anaemia (Hb <7.5 g/dl) and neutropenia (neutrophil count <500/mm3) AZT should be stopped and either ABC or d4T given.

6-18 months

• • • •

Mitochondrial dysfunction is primarily seen with the NRTI drugs; these include lactic acidosis, hepatic toxicity, pancreatitis, peripheral neuropathy, lipoatrophy and myopathy. Lipodystrophy is frequently associated with d4T use and can cause permanent disfigurement. Lactic acidosis is rare and can occur at any time. It is particularly associated with d4T use. Severe lactic acidosis can be life-threatening. Metabolic disorders are more common with PIs and include hyperlipidaemia, fat accumulation, insulin resistance, diabetes and osteopenia.

• Stop the NRTI and switch to another drug with a different toxicity profile. After 1 year

• Nephrolithiasis is commonly seen with indinavir (IDV). • Renal tubular dysfunction is associated with renofovir disoproxil fumarate (TDF). • Stop the PI and switch to another drug with a different toxicity profile.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Choosing the Initial ARV Regimen 1. Factors to consider when selecting appropriate ARV regimen 1.a. Age of infant/child 1.b. Suitability of drug formulation 1.c. Side effects profile (See Annex C: Drug Profiles) 1.d. Laboratory monitoring requirements 1.e. Potential for maintenance of future treatment options 1.f. Anticipated patient adherence (including considerations of drug regimens taken by parents/caretakers, as appropriate) 1.g. Coexisting conditions 1.h. Pregnancy or the risk thereof 1.i. Use of concomitant medications 1.j. Potential for infection with a virus strain with diminished susceptibility to one or more ARVs, including that resulting from prior exposure to As given for prophylaxis or treatment 1.k. Availability and cost-effectiveness 2. Considerations for drug formulation and doses for children

2.a. Syrups and solutions for infants and very young children. As they get older, solid formulations should be given 2.b. Dosage is based on body surface area or weight (weight bands)

3. Consideration for choice of first line regimen 3.a. Use of 3 antiretroviral medication is currently the standard in treatment of HIV infection 3.b. Preferred option in children: NNRTI-based regimen consisting of 2 NRTIs and 1 NNRTI 3.c. Triple NRTI is an option, especially for those children who are receiving treatment for tuberculosis

Guideline on the Integrated Management of Pediatric HIV and AIDS

First Line ARV Treatment Regimen for HIV + Infants <12 Infant (<12 months) Needs ART

Expedite treatment readiness for child and the caregiver

No exposure to NNRTIs OR Unknown exposure to maternal or infant ARVs

History of any exposure to nevirapine*

Protease inhibitors not available or feasible

Start two NRTIâ&#x20AC;&#x2122;s plus one NNRTI

One of these NRTIs: AZT or ABC or d4T

*includes exposure to: 1. Single dose nevirapine OR (mother or infants) 2. NNRTI-containing maternal ART

Protease inhibitors available or feasible

Start two NRTIâ&#x20AC;&#x2122;s plus Lopinavir / ritonavir

plus

(NRTI)

plus

3TC*

(NNRTI)

One of these NRTIs: AZT or ABC or d4T

NVP

plus

(NRTI)

plus

3TC

(PI) LPV/r

Does the infant/child have any conditions requiring regimen or dosing modifications?

Yes

Acute hepatitis: Do not start ARVs until symptoms resole, then avoid NVP

Renal disease: Refer

Provide ongoing guidelines & support to ensure ART adherence

Modify dose / regimen

Follow-up with routine monitoring visits

Guideline on the Integrated Management of Pediatric HIV and AIDS

Severe anaemia: Avoid AZT

Severe neutropenia: Avoid AZT

Follow these cases with intensive monitoring

TB: Stabilize on TB therapy 2-8 weeks prior to starting ART

Pediatric Dose and Method of Administration of Currently Available Antiretroviral Drugs Under the Crossing Borders Project Drug

Dose and Method of Administration

Nevirapine NVP (oral suspension: 10 mg/ml)

15-30 days (5mg/kg dose â&#x20AC;&#x201C; 1xDx2 weeks) Add revised dosing guidance with step down at 8 years (15-30 days; 5mg/m2/dose: 1Dx2weeks; then 120mg/m2/dose 2Dx2weeks, then 200mg/m2/dose 2D

Can be taken with food

Zidovudine AZT(syrup: 10 mg/ml)

>4 weeks to 13 years: 180 mg/m2/dose 2xD

Can be taken with food

Stavudine D4T (oral solution:1mg/ml)

>30-60-kg : 30 mg/dose 2xD

Can be taken with food

Lamivudine 3TC (oral solution: 10 mg/ml; tablet 150g)

<30 days 2 mg/kg/dose 2xD >30 days or < 50 kgs: 4mg/kg/dose 2xD > 50kg: 1 tablet 2xD

Can be taken with food

Efavirenz EFV (syrup: 30mg/ml)

Only for children more than 3 years old 10-15kg: 200mg or 9ml daily 15-20+ kg: 250 mg or 10 ml daily

Can be taken with food

Absorption and Meal

Computation of Body Surface Area (BSA)

Weight in kilo x height in cm

BSA m2 = 3,600

Guideline on the Integrated Management of Pediatric HIV and AIDS

H. Managing Adverse Events and Toxicities with ARV Side effects of ARVs may become intolerable for some children as it affects their ability to play, go to school and eat. It is important to provide helpful tips to the caregiver as well as the child on how to cope with nausea, loss of appetite, diarrhea and dizziness. Effective management of side effects will encourage the child to continue with the regimen and enables them to participate in their ongoing treatment. (See Annex D: Management of Specific Adverse Reactions).

Medical 1) Determine the seriousness of the adverse effect; 2) Establish whether the adverse event is due to ARV agent or to other medication taken at the same time; 3) Consider other disease processes (e.g., viral hepatitis in a child who develops jaundice on ARV drugs) because not all problems that arise during treatment are due to ARV drugs; 4) Never stop only one ARV (patient should always be on 3 drugs). If ART needs to be discontinued, all drugs should be stopped altogether.

Psycho-Social Side effects of ARVs may become intolerable for some children, especially when toxicities and adverse reactions occur. Effective management of these will encourage the child to adhere to treatment, thus increasing the child’s active participation in the treatment process. Some tips in providing psychosocial support includes: 1.

Teach the child’s parent / guardian/ care giver on how to determine when adverse events or toxicities occur in the child and what to do including how to respond to the child’s Inquiries. Annex D details the management of common adverse reactions in children.

5) Manage the adverse event according to severity: a. Severe life- threatening reactions: Immediately discontinue ARV’s manage the medical event (i.e. symptomatic and supportive therapy); reintroduce ARV drugs using a modified regimen ( i.e. substitute the offending drug) when patient is stabilized b. Severe reactions: Substitute the offending drug without stopping ART c. Moderate reactions: Consider continuation of ART as long as feasible; if patient does not improve on symptomatic therapy, consider single drug substitutions d. Mild reactions are bothersome but they do not require change in therapy

2. Determine if the child understands why adverse events occur and how s/he should perceive and respond to it. 3. Assess the child’s quality of life based on his/her attitude towards:  eating  schooling  playing  having friends  feeling well/sick

4. 6) If there is a need to discontinue ART because of life-threatening toxicity, all ARV drugs should be stopped until the patient is stabilized. The NNRTI drugs have a long half-life, and if a child is on an NNRTI-based regimen and drugs are discontinued for non-life-threatening reasons, some clinicians may want to continue the NRTI dual backbone for 7 days after discontinuation of the NNRTI drug. However, in situations of life- threatening toxicity, it is more advisable to discontinue all ARV drugs at once. 34

Guideline on the Integrated Management of Pediatric HIV and AIDS

Assess how the child expresses his/her views and communicate her/his needs related to his/her condition:  testing and counseling  awareness of sickness  diagnosis  treatment  adherence

 Starting ART is not an emergency. But once ART is started the ARV drugs must be given on time every day. Non-adherence to treatment is the main reason for treatment failure.  Starting ART when the child/caregiver is not ready can result in poor adherence to treatment and ART resistance.

The auntie gave the boy his medication every morning after breakfast before school. One day she was cleaning his room and discovered a treasure of white and blue pills hidden under his mattress. When she confronted him, his reply was simple. “I don’t like the feeling of throwing up when I arrive at school!”. Over the next days, she and her 11 year old ‘health advocate’ worked on a medication schedule that was agreeable to both. He never hid the pills again.

Based on local experience, one out of three adult patients had hypersensitivity reaction to Nevirapine. During the first 14 days of treatment, Nevirapine is administered at half its dose given once a day. If there is no sign of hypersensitivity, the full dose is given thereafter. It is still possible that hypersensitivity reaction will appear once the full dose of nevirapine is administered. If there is no reaction after 14 days of the full dose of nevirapine, hypersensitivity is unlikely to appear. The following are signs and symptoms of severe hypersensitivity reaction which are potentially life threatening. Nevirapine should be STOPPED immediately if anyone is observed:

1. fever or feverish sensation 2. flu like symptoms such as muscle or body pains 3. disseminated macular or maculopapular or urticarial rashes

In case mild skin rashes (discreet papular or nodular rashes that are limited in number) appear but not accompanied by other signs, nevirapine may still be continued, but patient should be closely observed for any progression.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Children may experience the same toxicities seen in adults and this would greatly affect treatment adherence. To encourage full participation of the child, she/he together with his/her parent or care giver should be aware of the possible side effects that may result from the treatment regimen prior to initiation of ART. It is important for both the child and the parent or caregiver to be reminded that most mild and moderate adverse events are temporary and will resolve as treatment progresses.

Differentiating between complications of HIV disease and adverse events/toxicities secondary to drugs used for the management of HIV infection can be difficult. Drug related adverse events can be acute, sub-acute (1-2 days), or later. Adverse effects can be mild to life threatening. Some of these distinct side effects include:  Hematologic Adverse Events from drug-induced bone marrow suppression (anemia, neutropenia, thrombocytopenia)  Mitochondrial dysfunction, primarily seen with therapy including NRTI drugs (lactic acidosis, hepatic toxicity, pancreatitis, and peripheral neuropathy)  Metabolic abnormalities, primarily seen with PI therapy but also with certain NRTI drugs, such as d4T.  Lipodystrophy syndrome, with fat maldistribution and body habit changes - hyperlipidaemia - hyperglycemia - insulin resistance - diabetes mellitus - osteopenia - osteoporosis - osteonecrosis  Allergic reactions (skin rashes & hypersensitivity reactions) - Stevens-Johnson Syndrome

Guideline on the Integrated Management of Pediatric HIV and AIDS

What’s YOUR advice? Caregiver: What would you like to say to this younger boy in the hospital who is going to start taking medicine? Chito: Don’t be afraid. Don’t worry if you feel weird when you take the medicine. Just pray... God will be with you. One day you’ll be able to do things you used to do (laughs) and even more! (pauses - thinking what else to say) And one day... you’ll become just like me!

Chito is an HIV+ Filipino youth who has been taking ARV’s for 6 years

Guideline on the Integrated Management of Pediatric HIV and AIDS

I. Substituting within an ARV regimen in Infants and children When the adverse event is related to an identifiable drug in the regimen, the offending drug can generally be replaced with another drug from the same class that does not have the same adverse effect, e.g. substitution of d4T for AZT (for anemia) or NVP for EFV (for CNS toxicity or in the event of pregnancy in adolescent girls). Given the limited number of ARV combination options available in resource-limited settings, it is preferable to pursue drug substitutions where feasible so that the premature switching to completely new alternative regimens is minimized.

J. Drug Interactions Effective management of side effects will encourage the child to continue with the regimen and enables them to participate in their ongoing treatment. (See Annex D Management of Specific Adverse Reactions)

Protease Inhibitors and NNRTIs can interact with a number of other drugs through changes in drug metabolism in the liver. Traditional remedies, phytotherapeutics, as well as other complimentary medicines, when used together with ARV, could cause liver enzyme induction. They could also bind the drug in the gut, leading to decreased blood levels of ARV drugs and ultimately resistance. The table below presents some examples of these drugs:

Guideline on the Integrated Management of Pediatric HIV and AIDS

Table 5: Prohibited Drug Combinations with Specific ART

Agents by Class

Agents Prohibited with NVP and EFV

Anti-arrhythmic agents Anti-histaminics

Astemizole Terfenadine

Anti-infectives

Systemic Ketoconazole

Cholesterol Lowering Agents GI Motility

Cisapride

Psychiatric Medications

St. Johns Wort (Hypericum perforatum)

Sedatives/Hypnotics

Midazolam Triazolam

Others

Dihydroergotamine Ergotamine Methylergonovine

Guideline on the Integrated Management of Pediatric HIV and AIDS

Section 5 Adherence to antiretroviral treatment [ART]

â&#x20AC;&#x153;I will send these balloons to my mother, sister and brother who are far away. We will see each other soonâ&#x20AC;? -Mon, 6 years old

Guideline on the Integrated Management of Pediatric HIV and AIDS

Section 5:

Adherence to ART I Want To...

The boy was sick and very tired of being sick. He would tell the doctors “I

want to die”. Nothing seemed to work in his treatment. Then one day his uncle told him about the Family Camp. “Too bad you won’t be able to go... you’re just too sick.” The little soldier stuck out his lip in defiance and replied “I want to go!” And that became his focus, every day he would remind the doctors that he wanted to go to the camp. They smiled but knew it was impossible with his Continuous bouts of diarrhea and fevers. But the boy was insistent and so the doctors finally relented. “Physically he is not strong enough, but we must let him go to camp!” When the boy returned, his cheeks a little chubbier and his face kissed by the sun, he walked into the hospital and in a loud voice declared “I am strong! I will fight this sickness!” Now, he wants to live.

Guideline on the Integrated Management of Pediatric HIV and AIDS

While the benefits of ARV in children are hopeful, much consideration should be given to treatment monitoring and adherence. This is particularly important since this therapy is closely associated with potential short-and long-term toxicities so much more in children than those in adults. On the other hand, higher levels of adherence are associated with improved outcomes (more than 90%), thus maximizing adherence ensures the durability of the effect of the ARV and ultimately avoids emergence of drug resistance. Adherence is related to virological and clinical response to treatment. As ART becomes increasingly available to children in resource limited setting, attention to treatment and monitoring adherence are important to maintain long term health benefits and to notice development of drug resistance. Adherence in children is a special challenge because of a variety of complex factors concerning the child, the caregiver, the medication and their interrelationships. It is therefore essential to provide all patients with a comprehensive plan to support adherence. This plan must include the health care provider, the family, the child welfare advocates and the community with the child at the center focus of all activities. It is most essential for each child undergoing ARV therapy to have a comprehensive plan to support treatment adherence. This plan should contain various strategies all linked up to motivate the child to adhere to his/her treatment regimen. A framework of roles and strategies that can be performed by all members of an ideal support structure is presented. References: 1. Building Trust and Building Bridges. A Workshop and Training Guide: Ang Tulay â&#x20AC;&#x201C; A Journey with Children in Grief (PJM). 2. Red Flags in conducting Family Home Assessments by PJM. 3. Feedback Mechanisms for children who are being treated with ARV-Precious Jewels Ministry.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Reasons for non-adherence:

a. Missed doses The health-care worker should ask about missed doses at every visit: • Ask whether the child has missed any dose in the past 3 days and since the last visit. • Ask when the child takes ART. • Ask for reasons for non-adherence. • Missed doses may occur:  If the dosing time is inconvenient / does not fit in with caregiver ; child’s lifestyle.  If the regimen is hard to take because of a high pill / liquid load and bad taste.  If there are ART supply issues (lack of money, inadequate ART prescribed).  If the child refuses to take the medicines (especially an older child who is tired of taking medications or who does not know his/her HIV status. b. Incorrect dosing • At every visit, the health-care worker should check:  The dose of each ARV.  The preparation of each ARV.  The storage of each ARV. c. Side-effects • Severe side-effects should be taken seriously and treated promptly. • Minor side-effects that are non-life threatening can be easily overlooked and may be the reason for non-adherence, • Lipodystrophy can cause adolescents to discontinue ART. d. Others • There are many possible reasons why a child does not adhere to treatment. Examples are a bad relationship between health-care personnel and the family, OIs/other conditions and their treatments which cause the child to feel ill, a large pill burden, and social issues such as change of caregiver, illness of primary caregiver, etc.

Guideline on the Integrated Management of Pediatric HIV and AIDS

A. Basic Adherence Package 1. Pre-treatment 1.a. Patient and caregiver information and education on HIV and its natural history, benefits and side effects of ARV medication. How it is taken, and the importance of NOT missing doses. 1.b. Child is introduced to treatment counselor and patient advocate if available and chosen by the child. The home visit is also arranged. 1.c. Co-trimoxazole count is undertaken for one month prior to initiating therapy. This is not to be used to exclude people from ART. It is meant to reinforce daily medication-taking behavior from the beginning. It is also meant to identify potential problems before starting ART. 1.d. Continuous access to supply of free ARV treatment: (To be done at each visit) 1.e. Syrup preparations to be tasted by parent/guardian with the child prior to start of treatment.

2. During Treatment (To be done at each visit)

2.a. Quantitative measurement of adherence is particularly difficult in children. Ask children or caregivers how many doses were missed during the past 3, 7 or 30 days.

Quantitative evaluation can more effectively identify barriers but can be more difficult and time consuming for the healthcare provider as well as the children and their caregiver. ART pill-return count (% doses missed) or syrup bottles would be ideal. Adherence goal is >95% doses taken. Patients with adherence <80% require increased adherence support.

2.b. Tablet count may be done before the patient sees the doctor and reviewed by the doctor during the early/initial visit to evaluate adherence. 2.c. Missed/late clinic visit should trigger concern about adherence. 2.d. Routine adherence-discussion (education) with counselor is of value. This should be an openended discussion, with time for questions and clarification of treatment. 2.e. Feedback from treatment counselors to the rest of the team is important to get a better profile of the patient and their environment. 2.f. Encourage participation in a support group. 2.g. Continue monthly visit with treatment counselors for first three months and quarterly thereafter. 2.h. Arrange regular community visit by patient advocates.

Guideline on the Integrated Management of Pediatric HIV and AIDS

B. Package for Patients with Reduced Adherence This is necessary when the adherence assessment is <80% at any visit, with or without viral or clinical failure 1. The treatment counselor/nurse or doctor needs to re-educate the child and their caregiver about the importance of adherence. The long term benefits need to be re-emphasized. 2. Evaluate the support structures in place 2.a. Are they appropriate? 2.b. How can they be improved? 2.c. What alternatives are there? 3. Consider doing a psychological profile and provide psychological support to caregiver, children and support groups. 4. Conduct a case assessment of the family. 5. Consider daily dosing diary. 6. Increase home visits by treatment counselors/patient advocates to daily or weekly, at a minimum (spot pill count to be done at home) 7. Consider directly-observed therapy for an agreed period 8. Promote Parent Effectiveness Training 9. Insist on participation in a support group or link with a patient advocate

Guideline on the Integrated Management of Pediatric HIV and AIDS

Health Care Provider Explain to child and treatment partner potential side effects and its management Establish â&#x20AC;&#x153;readinessâ&#x20AC;? to take medication before initiating treatment Develop treatment plan together with child and his/her treatment partner Anticipate, monitor and treat side effects, OI, etc. Educate and motivate the treatment partner Do house visitations Evaluate support structures in place

Family

Community

Spend time with the child and serve as treatment partner and motivator Oversee childâ&#x20AC;&#x2122;s drug intake (directly observed treatment) Observe onset of adverse reactions, toxicities, or other interim illnesses that may develop. Provide a safe place to express feelings of fear and worries

Organize support groups and patient advocates Provide a safe place for family activity and generous time to process feelings Organize community visits by patient advocates Provide other treatment support services (day care, special education, provision of OI medication, etc)

A child should know about his/her HIV status. Disclosure positively supports treatment adherence in children undergoing ART.

Child Welfare Advocate Encourage disclosure to family, friends and significant others who can support the treatment plan Provide adherence services like counseling and tools such as written calendar, pill boxes, etc Develop links with community-based organizations to support adherence Encourage links with support groups Evaluate support structures are in place House visitations Educate community to prepare an accepting environment 48

Guideline on the Integrated Management of Pediatric HIV and AIDS

Section 6 Monitoring for ARV treatment â&#x20AC;&#x153;This is my heart. Even if my baby sister and mother are gone, they are still in my heart.â&#x20AC;? Lito, 7 years old

Guideline on the Integrated Management of Pediatric HIV and AIDS

Section 6:

Monitoring for ARV treatment My Blood is Fat!

The first time the little girl had her blood taken she was very sickly. Sitting in the clinic with so many adults watching made her feel uncomfortable but she put on her brave “older sister face” for her 2 year old brother who was next in line. Three months later she came back for another blood test but this time she was at the child care center. As she walked into the clinic, she thrust our her arm toward the laboratory technician. “Last time you did this I was really skinny, but now my blood is fat!” This wise four year old understands that having her blood checked is not because she is sick, but helps her stay healthy.

-Story of a child patient in San Lazaro

Guideline on the Integrated Management of Pediatric HIV and AIDS

A. Clinical and Laboratory Monitoring Clinical and laboratory assessment are required at baseline (at entry into treatment), during care of patients who are not yet eligible for ART and for starting and monitoring ART. In resource limited settings, clinical parameters is recommended for monitoring. However, laboratory monitoring will improve efficient therapeutic intervention and will ensure the maximum level of safety of patients on ARV.

Parameters At baseline  Staging of HIV disease  Determination of concomitant medical conditions (e.g. TB, malnutrition, pregnancy (among adolescent girls)  Detailing of concomitant medications, including traditional and herbal therapies  Weight, height, head circumference  Development status  Nutritional status  Patient’s and caregiver’s readiness for therapy  Confirmation of HIV infection status (as per recommendation in Section III)  CD4 cell% or count  Hemoglobin  CBC and differential  Full chemistry (including but not restricted to: liver enzymes, renal function, glucose, lipids, amylase, serum electrolytes, etc.)  Other laboratory parameters as per indication

Guideline on the Integrated Management of Pediatric HIV and AIDS

During therapy  Assessment for potential drug toxicities, including staging of HIV disease  Determination of concomitant medical conditions (e.g. TB, malnutrition, pregnancy (among adolescent girls)  Detailing of concomitant medications, including traditional and herbal therapies  Weight and height  Development status  Nutritional status  Adherence to therapy  Confirmation of HIV infection status (for those with presumptive diagnosis of severe HIV disease)  CD4 cell% or count (every six months)  Hemoglobin (monthly during first 3 months of ART, then symptom-directed)  CBC and differential ( monthly during the first 3 months of ART, then symptom directed)  Full chemistry (including but not restricted to: liver enzymes, renal function, glucose, lipids, amylase, serum electrolytes, etc.; every 6 months)  ALT (symptom-directed)  Other laboratory parameters as per indication

B. Laboratory Assessment 1. Confirmatory HIV antibody testing should be done to resolve an indeterminate HIV status of the child 2. Assessment of symptoms of potential drug toxicities is complemented by the re-assessment of the clinical stages of HIV disease 3. Assessment of CD4 level every 6 months for all patients 4. Hemoglobin monitoring during the 1st weeks of treatment recommended. 5. The regular monitoring of full chemistry tests, particularly lipids, liver tests, renal function and glucose, has been considered for patients using 2nd line drugs 6. Regular ALT monitoring should be done monthly during the first three months and every three months thereafter. 7. Other laboratory parameters that are suggested if indicated may include: 7.a. 7.b. 7.c.

sputum smear for TB; pregnancy test in adolescent girls; diagnostic test for treatable AIDS-related OIâ&#x20AC;&#x2122;s (e.g. Cryptococcosis, Toxoplasmosis, Pneumocystis carinii pneumonia (PCP) and viral load measurement.

Guideline on the Integrated Management of Pediatric HIV and AIDS

C. Monitoring Treatment Clinical and Laboratory Examinations Required Regimen

Lab Work-up requirements

Children on ARV should be followed up at regular intervals initially after 1 month then every 3 months

A. Weight, height growth B. Nutritional status C. Developmental milestones and neurological symptoms

For Patients zidovudine (AZT) + lamivudine (3TC) + (nevirapine (NVP) or efavirenz (EFV))

1. CBC – after 1 month, 3 months thereafter if stable 2. SGPT, SGOT, Alkaline phosphatase, amylase, glucose, electrolytes, creatinine, total cholesterol – after 1 month , 3 months thereafter Note: In case of decreasing hemoglobin, change zidovudine to stavudine. It is possible to shift back to zidovudine at least 6 months after the hemoglobin returns to normal level.

Stavudine (d4T) + lamivudine (3TC) + (nevirapine (NVP) or efavirenz (EFV))

1. CBC – after 1 month, every 3 months thereafter if stable 2. SGPT, SGOT, Alkaline phosphatase, amylase – after 1 month, 3 months thereafter 3. Cholesterol, triglyceride, LDL-after 1 month, 3 months thereafter if stable Note: Change stavudine to zidovudine at least 6 months after the hemoglobin returns to normal level.

PI containing regimen

Some patients may not be able to tolerate NNRTI side effects and would be shifted to a PI containing regimen. The recommended PI is lopinavir/ritonavir.

(Zidovudine (AZT) or Stavudine (d4T) + lamivudine (3TC) + (lopinavir/ritonavir)

1. CBC - after 1 month, every 3 months thereafter 2. SGPT, SGOT, Alkaline phosphatase, amylase – after 1 month, every 3months thereafter 3. Cholesterol, triglyceride, LDL-after 1 month, every 3months thereafter 4. FBS – after 1 month, every 3 months thereafter

Guideline on the Integrated Management of Pediatric HIV and AIDS

Monitoring of HIV-infected children Baseline

Month 1

Month 2

Month 3

Month 6

Every 6 months

Clinical evaluationa

Weight, height

Nutritional status and needs

Co-trimoxazole need and adherenceb

Counseling for prevention of STIs and pregnancyc

OI prevention and treatment needsd

Items Clinical

Laboratory Hb and WBC count

ALTe

CD4% or countf

STI – sexually transmitted infection ALT – alanine aminotransferase OI – opportunistic infection Notes: Includes history-taking, physical examination and assessment of neurodevelopment. Children <12 months of age have a higher risk of HIV disease progression and should be followed more frequently than older children. b See page 26 for co-trimoxazole prophylaxis. c In teenage girls in the reproductive age group provide counseling on family planning and prevention of STIs. Counseling should also include prevention of transmission of HIV to others and the risk of transmitting HIV to their infants. d Exposure to TB should be assessed. e ALT at baseline is the minimum monitoring required for possible liver impairment. Children with a high ALT (>5 times upper limit of normal [ULN]) should undergo a complete assessment of liver functions as well as for hepatitis B, hepatitis C or other hepatic disease. Other biochemical tests are performed if indicated by the symptoms. f CD4% is used in children <5 years of age. For children >5 years of age, CD4 count is mainly used. TLC can be used when CD4 assessment is not available to classify severe immunodeficiency, which is a criterion for starting ART. a

Guideline on the Integrated Management of Pediatric HIV and AIDS

D. Immune Reconstitution Inflammatory Syndrome (IRIS) Definition

• A collection of signs and symptoms resulting from the ability to mount an immune response to antigens or organisms associated with immune recovery while on ART1

Frequency

• 10% of all adult patients starting ART • Up to 25% of patients starting ART with a CD4 cell count <50 cells/mm3 or severe clinical disease (WHO clinical stage 3 or 4)2,3

Timing

• Typically within 2-12 weeks of starting ART but may present later

Signs and Symptoms

• Unexpected deterioration of clinical status soon after commencing ART • Unmasking of subclinical infection such as TB, which may present as new active disease or development of abscess at the BCG vaccination site • Worsening of co-existing infections such as a flare-up of hepatitis B or C

Most common IRIS events

• Mycobacterium tuberculosis, M. avium complex (MAC) and cryptococcal disease

Management

• Continue ART if the patient can tolerate it • Treat unmasked active OI • In most cases the symptoms of IRIS resolve after a few weeks; however, some reactions can be severe or lifethreatening and may require a short course of corticosteroid treatment to suppress exaggerated inflammatory responses • Prednisone 0.5-1 mg/kg/day for 5-10 days is suggested in moderate-to-severe cases of IRIS4

Robertson J, Meier M, Wall J, Fichtenbaum C. Immune reconstitution syndrome in HIV: validating a case definition and identifying clinical predictors in persons initiating antiretroviral therapy. Clin Infect Dis 2006, 42:1639-46. 2 French MA, Lenzo N, John M, et al. Immune restoration disease after the treatment of immunodeficient HIV-infected patients with highly active antiretroviral therapy. HIV Med 2000, 1:107-15. 3 Breen RAM, Smith CJ, Bettinson H, et al. Paradoxical reactions during tuberculosis treatment in patients with and without HIV co-infection. Thorax 2004, 59:704-7. 4 McComsey G, Whalen C. Mawhorter S, et al. Placebo-controlled trial of prednisone in advanced HIV-1 infection. AIDS 2001, 15:321-7. 1

Guideline on the Integrated Management of Pediatric HIV and AIDS

E. Family Assessment / Social Environment Assessment Scoring Instructions: If NO = 0, if YES = 1, if NOT SURE = 2 Score

Area of Observation Schooling:

Remarks

Is the child attending school? Does the child have adequate school supplies?

Safety: Who is supervising the child? No one = 0, Parent = 1, Sibling = 2, Relative = 3 Are parents or guardians working away from the home? Where does the child sleep and with whom? Are there any signs of neglect? Are there any observable negative changes of behavior? Are there any observable negative changes of behavior? Is the home environment safe, healthy and hygienic? Is the child working? Are other sibling minors working?

Economic Resource: Is any parent or guardian working? What work do the parents or guardians do?

Health Condition: Has the child lost weight? Is the child sick? Is any other family member sick? Is the child eating nutritious food? Is the child eating sufficient amount of nutritious food? Is the child well provided with clothing? Is the child well cared for in terms of personal hygiene? Is the child well provided with shoes? Has the child recently had significant loss, death or separation in family?

Behavior: Does the child have friends? Are there negative influences? (e.g. drugs, gangs, promiscuity) Where does the child play?

How well is the child doing overall? Very Unwell

Unwell

Average

Well

Very Well

Comments. Guideline on the Integrated Management of Pediatric HIV and AIDS

Guideline on the Integrated Management of Pediatric HIV and AIDS

Section 7 Special considerations

â&#x20AC;&#x153;I am looking forward to going to schools this year.â&#x20AC;? -Carlos, 10 years old

Guideline on the Integrated Management of Pediatric HIV and AIDS

Section 7

Special considerations LETTING GO... LETTING GOD The boy approached his father and said “Can you call my Dad through your cellular phone?” Dementia caused this heart-breaking situation. He could not recognize his Dad but he could not ignore the gnawing pain in his stomach and lightning pain on his legs. Seeing that patient of mine each day battling with the disease caused me so many sleepless nights. I kept on thinking what I could do to help; after all I am a doctor and I should be saving lives. Starting ARV medications posed a promise for him, most especially for his Dad. As days passed, I saw his condition getting worse. The abdominal pain was more frequent and the fever would not go away. I had to stop the medication. And the worst part was I had to leave him in that state for a much-needed training on HIV/AIDS. As I endorsed the child to the NGO, I could not help but cry. My mind was wondering if I would be seeing him again when I return. Half of me wanted to stay while the other half wanted to go... Struggling inside of me, the only thing I could do was to pray for him. God responded to me with a still small voice saying, “let go.” It was as if He was telling me that He knows what He was doing and that He was in control. I realized that God’s concern for this child was even greater than mine... So I gave him up to the Lord and then, I felt the heavy load was taken off my shoulders. I went to the training with full assurance that God would take care of him. He was still alive when I got back, though he had grown extremely irritable because of his pains. Again, there was nothing I could do but to plead to God to make it easy for him in the end. When he died months later, he carried a part of me: it was my helplessness and the attitude of trying to play God with my patients. His death brought the challenge of giving hope to other people, reminding them that God has a plan for them. I have seen his father go through all the mourning stages... I have seen him having moved on and still moving on... dreaming again... believing that he still has a purpose in this world. It is by letting go of our pride in our abilities as doctors that God can really move in the lives of our patients. In the end it is not the difference that we can make in our patients’ lives but the difference that God can make out of their lives.

by: Dr. Maria Olivia M. Dizon, MD

Guideline on the Integrated Management of Pediatric HIV and AIDS

Considerations for Infants and Children Coinfected with Tuberculosis and HIV A. Concomitant TB in Children Tuberculosis is a common co-morbid illness with HIV. In HIV-infected children with confirmed and presumptive TB disease, initiation of TB treatment is a priority. The decision on when to start ART after starting TB treatment involves a balance between the child’s age, pill burden, potential drug interactions, overlapping toxicities and possible immune reconstitution syndrome versus the risk of further progression of immune suppression with its associated increased mortality and morbidity. Considerations in initiating ART in HIV infected Children: Scenario 1: Child Present with TB before commencing ART

• For all WHO Pediatric Clinical Stage III (no pulmonary TB) and Clinical Stage IV with extrapulmonary TB except lymph node TB, ART is indicated.

• Earlier initiation is more critical in co-infected children with low CD4 count or who have clinical AIDS

• For all children with WHO Pediatric Clinical Stage IV regardless of immunological criteria and in children with WHO Pediatric Clinical Stage III and concurrent severe immunodeficiency, it is recommended that ART shall be started between 2 and 8 weeks after start of TB therapy, after the patient has been stabilized on TB therapy

•• Children in Clinical Stage III with higher CD4 values or mild immunodeficiency have lower short term risk of HIV disease progression or death, and response to TB therapy can guide decision whether ART needs to be initiated. If an appropriate clinical response is not observed, ART treatment can be initiated earlier (before 2 month induction phase. If clinical response is observed, then ART could be deferred until TB treatment is completed.

•• In situations where CD4 measurements are not available, children with Pediatric Clinical Stage III should be started on ART with the same urgency as children with Pediatric Clinical Stage IV except those with lymph node TB (See table on p. 62 WHO 2006)

Guideline on the Integrated Management of Pediatric HIV and AIDS

Scenario 2: Child on First Line ARV Regimen Diagnosed with TB

• •ART should be continued. However, it should be reviewed and altered, if needed, to ensure optimal treatment of both TB and HIV and to decrease the potential for toxicities and drug interactions.

• For children receiving NNRTI-based regimens, a change in triple NRTI regimen for the period during which rifampicin is administered can be considered, or the child can remain on their NNRTI regimen (however, this is more optimal for children on EFV-based regimens than NVP- based regimens)

Scenario 3: Child on Second Line ARV Regimen Develops TB • For children who failed NNRTI first-line regimen and are receiving RTV-boosted PIs, the choice is more difficult because of likely resistance to first line NRTI drugs and TFV, which could be an alternative for older children with a weight that would allow adult dosing. It should be given with ddl, one of the second line NRTI drugs.

• Children with a weight over 25 kg who are receiving SQV/RTV could be continued on the therapy with monitoring of liver enzymes

• Children weighing less than 25 kg who are receiving LPV/RTV could be administered with additional RTV dosing to provide standard therapeutic doses of RTV. Scenario 4: Immune Reconstitution in HIV/TB Co-management • This has been initially seen in adults. This syndrome is characterized by worsening of the disease after initial clinical improvement, with new onset of systemic symptoms, especially of ever, worsening of pulmonary infiltrates, development of peripheral and mediastinal adenopathy and expanding CNS lesions in patients with tuberculomas. • These reactions are generally self-limiting and last between 10-40 days. Some severe reactions may require short course of treatment with glucocorticoid.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Recommendations for the Management of TB/HIV Co-infection ART Status/ Clinical Criteria Child with TB, Not on ART: WHO Pediatric Clinical Stage IV (b)

Recommended Management (a) • Start TB Treatment • Start ART as soon as the TB Treatment is tolerated (between 2 and 8 weeks following start of TB treatment)

Recommended ARV Regimen In children <3 years: • Triple NTRI regimen (d4T or AZT + 3TC + ABC) In children>3 years: • d4T or AZT + 3TC + EFV (c) • Alternative : d4T or AZT + 3TC + NV

Child with TB, Not on ART: WHO Pediatric Clinical Stage III

Where CD4 not available: • Start TB treatment • Start ART as soon as the TB Treatment is tolerated (between 2 and 8 weeks following start of TB treatment) Where CD 4 is available: • Start TB Treatment • Defer initiation of ART depending on clinical and CD4 response to TB therapy: o Severe immunodepression: initiate ART as soon as tolerated (between 2 and 8 weeks following start of TB treatment) o Advance Immunodepression: Initiation of ART can be deferred; monitor closely response to TB therapy over the 1st 8 weeks of treatment; if no improvement, start ART o Mild Immunodepression: Initiation of ART may be deferred until after completion f TB therapy; monitor closely response to TB therapy and re-assess for ART after TB therapy; if no improvement, consider starting ART

In children <3 years: • Triple NTRI regimen (d4T or AZT + 3TC + ABC) In children>3 years: • d4T or AZT + 3TC + EFV • Alternative : d4T or AZT + 3TC + NV

Child on First Line ART developing TB

• •

Start TB treatment Continue ART but assess for need for change in ART regimen

If on NNRTI-based regimen: • Recommended: change to triple NRT regimen (d4T or AZT + 3TC + ABC) • vAlternative: d4T or AZT + 3TC + NNRTI: o If age > 3 years- remain on EFV-based regimen o If age < 3 years – consider NVP-based regimen (d)

Child on Second Line ART developing TB

• • •

Start TB treatment Continue ART but assess for need for change of ART regimen Consider rifampicin-free TB continuation phase if appropriate drugs are available. This is very risky at present and must be used for longer period – probably use 3 drugs for 7 to 10 months (ex. Ethion, PZA,emb) – suggest further consultation with TB experts

If on RTV-boosted PIs, expert opinion suggests (e): • Change to 2 NRTIs (AZT or ABC + d4T plus SQV/RTV if >25 kg, with liver enzyme monitoring; or • Change 2 NRTIs (AZT or ABC + d4T plus LPV/RTV with additional RTV to achieve standard therapeutic RTV dosage if <25 kg

Notes: a. While cotrimoxazole prophylaxis should be part of the clinical management of all HIV-exposed children, administration is particularly important in those children with TB/HIV co-infection. b. All children with pediatric clinical stage IV should be initiated on ART regardless of immunological criteria c. EFV is contraindicated in adolescent girls of child bearing potential without effective contraception and in the 1st trimester of pregnancy d. Cautious NVP dose increases by 10% per week for 3 weeks can be considered or add ABC to 1st line of NVP or switch NVP to RTV e. No data is available for evidence-based ART recommendations, research is urgently needed f. May be safer to use RTV alone if tolerated

Guideline on the Integrated Management of Pediatric HIV and AIDS

B. Infant Feeding Background Only few children will get infected with HIV through breastfeeding. The risk of HIV-transmission during the first six months is 5-10% if the infant is exclusively breastfed; even with extended breastfeeding for 18-24 months, the transmission risk is 15-20%. Commercial formula poses no risk of transmitting HIV to the infant. However, commercial formula does not contain antibodies, which protect infants from infection. An infant who is fed commercial formula exclusively is more likely to get diarrhea and pneumonia and may develop malnutrition. Diarrhea and pneumonia are the main causes of infant mortality in the Philippines. Counseling of HIV-infected mothers should include information about the risks and benefits of exclusive breastfeeding and exclusive replacement feeding and guidance in selecting the most suitable option in their circumstances. Recommendations: The most appropriate infant feeding option for an HIV-infected mother should continue to depend on her individual circumstances, including her health status and the local situation, but should take greater consideration of the health services available and the counseling and support she is likely to receive. Exclusive breastfeeding is recommended for HIV-infected women for the first 6 months of life unless replacement feeding is acceptable, feasible, affordable, sustainable and safe (AFASS) for them and their infants before that time. Mixed feeding must be avoided. When replacement feeding AFASS, avoidance of all breastfeeding by HIV-infected women is recommended. At six months, if replacement feeding is still not AFASS, continuation of breastfeeding with additional complementary food is recommended, while the mother and baby continue to be regularly assessed. All breastfeeding should stop once a nutritionally adequate and safe diet without breastmilk can be provided. Whatever the feeding decision, health services should follow-up all HIV-exposed infants, and continue to offer infant feeding counseling and support, particularly at key points when feeding decisions may be reconsidered, such as the time of early infant diagnosis and at six months of age. Breastfeeding mothers of infants and young children who are known to be HIV-infected should be strongly encouraged to continue breastfeeding.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Definitions:

• Exclusive breastfeeding: The mother gives her infant only breastmilk except for drops or syrups consisting of vitamins, mineral supplements, or medicine. The exclusively breastfed child received no food or drink other than breastmilk – not even water. • Acceptable: The mother perceives no significant barrier(s) to choosing a feeding option for cultural or social reasons or for fear of stigma and discrimination. • Feasible: The mother (or other family member) has adequate time, knowledge, skills, and other resources to prepare feeds and to feed the infant as well as the support to cope with family, community, and social pressures. • Affordable: The mother and family, with available community and/or health system support, can pay for the costs of the replacement feeds – including all ingredients fuel and clean water – without compromising the family’s health and nutrition spending. • Sustainable: The mother has access to a continuous and uninterrupted supply of all ingredients and products needed to implement the feeding option safely for as long as the infant needs it. • Safe: Replacement foods are correctly and hygienically stored, prepared, and fed in nutritionally adequate quantities; infants are fed with clean hands using clean utensils, preferably by cups.

Rapid Weaning

1. Express breast milk and give to baby using a cup, especially during the day. Helpful Hint: Let a close relative or other responsible person staying with you give the baby your expressed breast milk in a cup. 2. At first, continue to breast-feed during the night, to assure adequate rest for mother and baby. 3. Increase the number of expressed breast milk feeds from the cup, while decreasing the number of feeds directly from the breast gradually over a 2-week period. 4. Stop breast-feeding as soon as possible when the baby is used to feeding from the cup. Helpful Hint: Hold the baby more often for comfort when you stop breast-feeding. 5. Introduce complementary foods when baby is 6 months old.

After stopping breastfeeding, mother should be provided with specific guidance and support for at least the 1st 2 years of the child’s life to ensure adequate replacement feeding, nutrition and growth of infant. The following is recommended for mothers who choose replacement feeding or when replacement is AFASS. Replacement feeding means the process of feeding a child who is not receiving any breast milk with a diet that provides all the nutrients the child needs.

1. During the first 6 months this should be with a suitable commercial milk formula with micronutrient supplements. 2. After 6 months, preferably feed a suitable milk formula, and complementary foods made from appropriately prepared and nutrient– enriched family foods, given four times a day. If suitable milk formulas are not available, feed appropriately prepared family foods that are further enriched, given four to six times a day and ensure adequate nutrition and growth of the child.

Adapted from: Counseling Mothers on Infant Feeding for the Prevention of Mother-to-Child Transmission of HIV; A Job for Primary Health Care Workers. USAID Regional Centre for Quality Health Care, 2003) 66

Guideline on the Integrated Management of Pediatric HIV and AIDS

C. Nutrition Malnutrition is a common condition in HIV infected children and is the leading cause of immunodefficiency and greatest contributor to mortality in both HIV and non-HIV infected children. In combination with HIV infection, malnutrition further impairs the immune function. Thus, early nutritional intervention should be an integral part of the care plan of HIV infected children. 1. Nutritional Effects of ART 1.a. 1.b.

ARV drugs may have adverse effects that affect food intake and nutrition in general and thus limit adherence to therapy Health care workers should be aware of the most common G.I. side effects of ARVs and consider them during nutritional assessment.

2. Nutritional Assessment and Support 2.a. Conducting systematic evaluation of current nutritional status on a monthly basis, followed by appropriate support and ongoing monitoring are essential components of nutritional interventions both prior to and while on ART.

2.b. Poor growth should be part of the nutritional monitoring. In HIV-infected children, severe growth problems not attributable to inadequate nutrient intake may indicate the need for initiation of ART and maybe useful in the evaluation of response to ARV therapy.

3. For Severe Malnutrition 3.a. Severe malnutrition is defined as severe wasting or edema on both feet. All children with malnutrition urgently require nutritional build-up and management. 3.b. In an HIV-infected and severely malnourished child who does not respond to standard nutritional therapy, ART should be considered. The phase of malnutrition at which ARV therapy should start is not known. Expert opinion suggests stabilization of the condition first prior to ART initiation. Once a response to the initial treatment of severe malnutrition is seen (5-10 days), ART may be deferred until the child condition stabilizes. If no response is observed after more than 10 days, TB and other OIs should be ruled out and ART can be initiated.

BREAKING THE SILENCE

Tears are quickly brushed aside as he turns his head away, embarrassed by this show of emotion. The headache is back and now we are talking about another IV. Long silence. As I stroke his temples, his body curls into a fetal position. Finally he speaks. “I feel sad.” “Why?”. “I can’t go out and do what others do.” More silence - my words are too small for this conversation. “I’m so bony. People always stare at me all the time.” The words tumble out now, needing to be released. “The other day at school a kid grabbed my arm and laughed at me. Later, I found a drawing of skeleton taped on my notebook.” He turns over and we look at each other - silent knowing. Sleep overtakes him as his body relaxes. The burden is removed. (A conversation with HIV+Filipino youth)

Guideline on the Integrated Management of Pediatric HIV and AIDS

D. Immunization Children with asymptomatic HIV infection should be immunized with inactivated vaccines (diphtheria and tetanus toxoid and accellular persussis, inactivated polio virus, H. influenza tybe b, hepatitis B and pneumococcal conjugate vaccine) at the appropriate age according to national policies. Measlesmumps-rubella vaccine should be administered to HIV infected children at 8-9 months of age unless the children are severely immunocompromised. The 2nd dose may be administered 4 weeks after the first rather than waiting until school entry. During the outbreak of measles, when exposure is likely, immunization should begin as early as 6 to 9 months. In general, children with symptomatic HIV infection have poor immunologic responses to vaccines. Hence, these children, when exposed to a vaccine-preventable disease, should be considered susceptible regardless of the history of immunization and should receive, if indicated, passive immunoprophylaxis. Immune Globulin (Ig) should also be given to any unimmunized household member who is exposed to measles infection to decrease likelihood that the HIV-infected child will be exposed. Children infected with HIV may be at increased risk of morbidity from varicella and herpes zoster. Weighing potential risk, varicella vaccines should be considered for HIV-infected children. Hepatitis A vaccine is recommended for children living in regions with consistently increased hepatitis A rates. In developing countries where the prevalence of tuberculosis is high, the WHO recommends that BCG vaccine be given to all infants at birth if they are asymptomatic, regardless of maternal HIV infection. Note however that disseminated BCG infection has occurred in HIV-infected infants immunized with BCG vaccine. Seronegative Children Residing in the Household of Patient with Symptomatic HIV Infection In households where an adult or child is immuno compromised as the result of HIV infection, all children should receive IPV vaccine. To decrease risk of transmission of influenza, all household members 6 months and older should receive yearly influenza immunization. Varicella immunization of siblings and susceptible adult caregivers of patients with HIV infection is encouraged to prevent acquisition of wild type of varicella-zoster infection.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Passive Immunization of Children with HIV Infection Symptomatic HIV-infected children who are exposed to measles should receive Intramuscular IG prophylaxis (0.5mL/kg, maximum 15 ml), regardless of immunization status. Exposed, asymptomatic HIV-infected patients should also receive IG, the recommended dose is 0.25 mL/kg intramuscularly. Children who receive IVIG within 2 weeks of exposure do not require additional passive immunization. In the management of wounds classified as tetanus prone, children with HIV infection should receive Tetanus Immune Globulin regardless of immunization status. Children infected with HIV who are exposed to varicella or zoster should receive Varicella-Zoster Immune Globulin . Children who have received IVIG or Varicella-Zoster Immune Globulin within 2 weeks of exposure do not require additional passive immunization. Recommendations for Routine Immunization of an HIV infected Child World Health Organization / United Nations Childrenâ&#x20AC;&#x2122;s Fund recommendations for the immunization of HIV-infected children in developing countries, along with estimated vaccine efficacy and safety profile. Adapted with permission from the World Health Organization

Guideline on the Integrated Management of Pediatric HIV and AIDS

Vaccine

Asymptomatic HIV Infection

Symptomatic HIV Infection

Timing of vaccine

Vaccine safety

Estimated efficacy of HIVinfected children

BCG

Yes

Birth

Risk of BCG-related disseminated disease; immuno-suppression may lead to reactivation of latent BCG

Varies from 0% to 80% effective in preventing disseminated disease; however, immune response following BCG is poorly defined; tuberculin skin test often negative

DTPwa

Yes

6, 10 and 14 weeks

Few adverse effects when administered early in infancy

Protective serological response in >40% of HIV-infected children

IPVb

Yes

Birth, 6, 10 and 14 weeks

Vaccine-related paralytic polio very rare; prolonged shedding of vaccine strain virus

Estimated 90% of HIV-infected children respond to three doses of IPV

Yes

6, 10 and 14 weeks (in South East Asia, first dose at birth) Infants of HbsAg â&#x20AC;&#x201C; positive mother should receive a dose of immunoglobulin at birth

No reported data on adverse events related to vaccine

Adequate serological response in 25-50% of HIVinfected children; rapid decline in antibody titers.

Hepatitis B

a Acellular pertussis vaccine has fewer adverse effects than the whole-cell vaccine but is not widely available in most developing countries due to high cost. b Some developed countries recommend the use of inactivated poliomyelitis vaccine (IPV); IPV may also be used for symptomatic children. Abbreviations:

DTPw - diphtheria, tetanus and whole cell pertussis vaccine; HbsAg - hepatitis B surface antigen; OPV - oral poliomyelitis vaccine.

Notes: 1 Only IPV vaccine should be used for HIV-infected children, HIV-exposed infants whose status is indeterminate, and household contacts of HIV-infected people. 2 Severely immunocompromised HIV-infected children should not receive MMR vaccine. 3 Pneumococcal vaccine should be administered to all age-appropriate HIV-infected children. Children who are older than 2 months of age should receive pneumococcal vaccine at the time of diagnosis. Reimmunization after 3 to 5 years is recommended in either circumstance. 4 Influenza vaccine should be provided each summer for HIV-exposed infants 6 months of age and older, HIV-infected children and adolescents, and household contacts of HIV-infected people. 5 Consider for HIV-infected children in CDC and prevention class N1 and A1. 6 In developing countries where the prevalence of tuberculosis is high, the World Health Organization recommends tha BCG vaccine be given to all infants at birth if they are asymptomatic, regardless of maternal HIV infection. 70

Guideline on the Integrated Management of Pediatric HIV and AIDS

Section 8 ART in adolescents

â&#x20AC;&#x153;Together, we will overcome any challengeâ&#x20AC;? PJM youth leaders

Guideline on the Integrated Management of Pediatric HIV and AIDS

Section 8

ART in adolescents TIRED IS TIRED I lay down ... I get tired I sit up ... I get tired I go out ... I get tired So Better to go out See a movie Be with my friends So what if I get tired Tired is tired (Conversation with HIV+Filipino youth) Guideline on the Integrated Management of Pediatric HIV and AIDS

Considerations of ART for Adolescents A. Adolescence and Development Adolescence covers the period within 10-18 years old. During this time, an adolescent passes through different stages of physical, psychological and sexual maturation that have implications for providing treatment and care. The principles of helping young people gain knowledge, independence and maintain good self-esteem can be applied to all adolescents with or without chronic disease. However, the presence of HIV infection makes this process more difficult.

Experience in the management of HIV and AIDS among adolescents is very limited in the Philippines. This section shall discuss only basic points for consideration on adolescents and ART adherence. Further discussions on the management of HIV-infected adolescents will be integrated in this material as soon as evidence-based data have been gathered.

Adolescents infected with HIV often face considerable challenges. Stunting and/or wasting caused by progression of HIV is frequently exarcerbated by malnutrition. This further complicates the decision whether to follow child or adult ARV treatment guidelines. WHO recommends using the Tanner Staging (See Annex E: Tanners Staging Based on Sexual Maturity) as the basis for choice of ARV regimens and dosage for adolescents. Children in Tanner Stage I, II and III should begin on a pediatric schedule and monitored particularly carefully because of developmental changes. Children in Tanner Stage IV and V are considered adults and thus require the same recommendations and special considerations as adults.

Guideline on the Integrated Management of Pediatric HIV and AIDS

B. Adherence 1. Adherence to long-term therapy is particularly difficult among adolescents. 2. Health care providers must consider issues relevant to adolescents that may impair adherence to treatment. Such issues may include: 2.a. Perception of being immortal 2.b. Desire for independence 2.c. Lack of disclosure of HIV status 2.d. Stigma and Discrimination 3. Parents may avoid discussing with the child his/her HIV status for fear of stigma and blame 4. The adolescent should be oriented on the ff: 4.a. HIV status 4.b. Understanding of HIV and AIDS 4.c. Treatment and importance of adherence 4.d. Confidence in selective disclosure 4.e. Awareness and understanding of support systems

Guideline on the Integrated Management of Pediatric HIV and AIDS

C. Changing Regimen 1. First line regimen of fixed-dose combination should be considered. This would be more convenient and adherence is more promising. 2. Autonomy for HIV diagnosis and disclosure on the outcome should also be considered. Enabling adolescents to actively participate in their HIV treatment is an important step to ensure timely initiation of ART and access to prevention interventions.

D. Adolescent Education Adolescents who are sexually active or using illicit injection drugs are at risk of HIV infection. All adolescents should be educated about HIV infection and have access to HIV testing and knowledge of their serologic status. Informed consent for testing or release of information about serologic status is necessary. Specific recommendations for those caring for adolescents are as follows: Information about HIV infection and AIDS and availability of HIV testing should be regarded as essential component of anticipatory guidance for adolescent patients. It must also include information on prevention, transmission and implications of infection Preventive guidance should help adolescents understand the responsibilities of becoming sexually active. Information should be provided on abstinence and use of safer sexual practices to decrease risk of unplanned pregnancy and sexually transmitted infections, including HIV infection. Availability of of HIV testing and should be encouraged with consent to those who are sexually active or using drugs. Although parental involvement in adolescent health care is desired, consent of the adolescent alone should be sufficient to provide evaluation and and treatment for suspected and confirmed HIV infection. A negative HIV result can ally anxiety over resulting from high-risk events/behaviors and is a good opportunity to counsel on decreasing high- risk behaviors to decrease future risk. For adolescents with positive HIV test result, it is important to provide support, address medical and psychosocial needs and arrange linkages to appropriate care. Health care providers should help adolescents with HIV infection understand the importance of informing their other sexual partners of their potential exposure to HIV. They should also advocate for the special needs of adolescents for information about HIV, access to HIV testing and counseling and HIV treatment.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Section 9 Treatment failure

â&#x20AC;&#x153;My father is sleeping and he will not wake up anymoreâ&#x20AC;? -John, 5 years old

Guideline on the Integrated Management of Pediatric HIV and AIDS

Section 9

Treatment failure “Children, Sickness and Grief” Adapted from Ang Tulay - A Journey with Children in Grief (Precious Jewels Ministry 2004) Children who are living in families affected by HIV/AIDS may face prolonged periods of loss and grief due to the frequency of illness and separation from the family. Life becomes a roller coaster as there may be extended periods of the child being well and then they succumb to a life-threatening infection which they may recover from after several months of hospitalization. This experience can create tremendous anxiety in a child.

A Few Keys to Help Children in Grief: 1. Be sensitive to the individual needs of each child rather than following a prescribed pattern of ‘how a child should grieve’. 2. Encourage children to express their feelings, remembering that there are no right or wrong feelings. Children experience a wide range of emotions. Their behavior is often a visible expression of their grief. 3. Allow children to ask questions. 4. Be truthful and honest with children. Answer them truthfully and share information depending on their age level and maturity. 5. Allow children a “listening space” in their grief. Some need to be held and comforted while others want to be alone. 6. Take time to let them tell stories about their family using creative materials to make pictures of their memories, hopes and dreams.

Guideline on the Integrated Management of Pediatric HIV and AIDS

ANTIRETROVIRAL TREATMENT FAILURE Step 1. Assess clinical criteria for treatment failure

Child on ART presenting for follow-up visit and no clinical and immunological improvement

Clinical failure criteriaa

Check for immunological failure criteria (see page 81)

Yes

Patient may need to switch to second-line ART (see page 82) Note: a Clinical failure criteria Does the child fulfill any of these clinical failure criteria? • • •

Lack of or decline in growth rate in children who initially respond to treatment Loss of neurodevelopmental milestones or development of encephalopathy Occurrence of new OIs or malignancies or recurrence of infections such as oral candidiasis that is refractory to treatment or esophageal candidiasis.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Step 2. Assess immunological criteria for treatment failure

Child on ART presenting for follow-up visit and no clinical improvement

Immunological failure criteria

CD4

6 mo

12 mo

6 mo

Type 1

Type 2

Yes Patient may need to switch to second-line ART (see page 82)

12 mo

6 mo

12 mo

Type 3

No Continue ART

Note: Type 1 Development of age-related severe immune deficiency after initial immune recovery. Type 2 New progressive age-related severe immune deficiency, confirmed with at least one subsequent CD4 measurement. Type 3 Rapid rate of decline to below threshold of age-related severe immune deficiency.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Switching to a Second-line ART Regimen • The most common reason for failure is poor adherence. Adherence must be investigated and supportive mechanisms reinforced prior to any change in regimen. • Switching to a second-line regimen is not an emergency. • It is important to ensure that the child is on appropriate OI prophylaxis. • A failing regimen usually retains some anti-HIV activity; therefore, in general, a child should continue the failing regimen until he/she is ready to switch to a second-line regimen.

Does the child have good adherence to ART?

• Work with the family to resolve issues causing nonadherence. • Continue the same first-line regimen, give OI prophylaxis and follow closely. • Start second-line therapy only after good adherence can be assured.

Yes

Does the child have clinical treatment failure?

• If the child has CD4 failure alone without clinical failure, switching to second-line therapy is not as urgent. • The child can continue on the same first-line regimen while adherence is enforced, and OI prophylaxis, close follow up and monitoring of CD4 count is performed. • Switching to second-line therapy only if the child/family is ready and CD4 count remains in the severe immune deficiency range.

Yes

Has the caregiver/child fulfilled the items in “Prepare to start ART?”

Work on the items to prepare the caregiver / child to start second-line therapy.

Yes Agreeing on a treatment plan and solving anticipated factors for non-adherence • The caregiver/child and health-care personnel agree on a second-line regimen and follow-up appointments that the caregiver/child can adhere to. • Health-care personnel should assess factors that may affect adherence to treatment and work towards a solution with the caregiver/child.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Recommended Second-line Regimens in Infants and Children Expert consultation is recommended when ART failure is suspected. If the first line regimen is 2 NRTI + 1 NNRTI =2 new NRTIs + 1 PI Step 1: Choose 2 NRTIs

Considerations in Choosing Second Line Regimen First – line NRTI

Second – line NRTI

AZT or d4T + 3TC

ddI + ABC

ABC + 3TC

ddI + AZT

Step 2: Choose 1 PI

Preferred PI

Advantages

Disadvantages

Lopinavir / ritonavir (LPV / r)

• Excellent efficacy especially in PI-naïve children • High threshold for development of drug resistance due to its high drug level from boosting with ritonavir (RTV) • It is the only RTV-boosted PI availale as a liquid formulation and pills • Paediatric dosages are available for all age groups

• • • • • •

Saquinavir / ritonavir (SQV / r)

• Can be used with RTV boosting • Good efficacy

• Can be used only in children who weigh >25 kg and can swallow capsules • The soft-gel capsule formulation is large in size and requires refrigeration • The pill load is high • GI side-effects are frequent

Alternative PI NFV

Advantages

Both liquid and gel capsule formulation require refrigeration The gel capsule is large in size The heat-stable tablet formulation is now available in some countries but cannot be split It is expensive Liquid contains 43% alcohol excipient and capsule contains 12% alcohol The taste is extremely unpleasant

Disadvantages

• Long term data show a good efficacy and safety profile • Causes less hyperlipidaemia and lipodystrophy than RTV – boosted PI

• Data is adults show it to be inferior in efficacy compared to boosted PI or EFV • The pill burden is high • GI side effects are frequent

Guideline on the Integrated Management of Pediatric HIV and AIDS

If the first line regimen is 3 NRTI = NRTIs + NNRTI + 1 PI

First – line NRTI

Second – line NRTI

AZT or d4T + 3TC + ABC

ddI + EFV or NVP + 1 PI (LPV/r or SQV/r preferred. The alternative is NFV)

• Cross-resistance within ART class occurs commonly, especially in those who have had treatment failure based on clinical or CD4 criteria. Resistance occurs when HIV replicates despite ART. If treatment failure occurs while on NNRTI or 3TC, one would expect that resistance has developed to NNRTI and 3TC. Continuing NNRTI in this circumstance is not useful; however, continuing 3TC may lead to decreased HIV viral fitness and lowering of the HIV viral load. • AZT and d4T have the same pattern of resistance and one would expect cross-resistance. Therefore, it is not recommended that one be substituted by the other. • Principle of choosing second-line regimens:  Choose as many new classes as possible.  If the same ARV class has to be used, choose as many new drugs as possible within the same class. • The goal of a second-line regimen is to achieve clinical and CD4 response but this is less likely than with a first-line regimen due to crossresistance among ARV drugs. • Before switching over to a second-line regimen, adherence to treatment needs to be ensured. • For children who fail a second-line regimen, identifying an effective salvage regimen will be difficult. Expert consultation should be sought. • For monitoring after changing over to a second-line regimen, see page 46 section 5, A basic adherence package. For RTV-boosted PIbased regimens, the child should also undergo estimation of serum lipids (triglycerides and cholesterol and, if possible, LDL and HDL) every 6-12 months.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Annexes

Guideline on the Integrated Management of Pediatric HIV and AIDS

Annex A Interactive Consent Form When a child first comes to Precious Jewels Ministry (PJM) they are feeling a little scared, perhaps sad or even sick. During their first visit, the teacher or social worker will interact with the child using a few toys or some crayons and paper. As the child relaxes, the adult will ask him/her how she is feeling today, pointing to the set of colored smiley faces that are either on the wall or spread out on the table. Usually this conversation leads into the topic about sickness and why the child is at PJM.

We then use the pictures of the body to introduce and talk about the role of the immune System using a very simple language. The descriptions of the pictures are posted on the next page: Picture 1 - Ito ang iyong katawan Picture 2 - Inaalagaan ng (WBC) White Blood Cells Picture 3 - ang WBC ay sundalo ng iyong katawan na lumalaban sa mga mikrobyo na nagdadala ng sakit Picture 4 - Kadalasan nananalo ang WBC Picture 5 - Mayroong isang mikrobyo (HIV) Human immuno Deficiency Virus Picture 6 - Ganito pinupuksa ng HIV ang WBC Picture 7 - Tuluyan na silang natatalo Picture 8 - Kaya nagiging mahina at malungkot ang iyong katawan

Guideline on the Integrated Management of Pediatric HIV and AIDS

Picture 1

Picture 2

Picture 3

Picture 4

Picture 5

Picture 6

Picture 7

Picture 8

Guideline on the Integrated Management of Pediatric HIV and AIDS

Annex B Presumptive and Definite Criteria for Recognizing HIV / AIDS Related Clinical Event in Infants and Children with Established HIV Infection For use in children aged less 15 years confirmed HIV infection.

Clinical event

Clinical diagnosis

Definitive diagnosis

No HIV-related symptoms reported and no clinical signs on examination

Clinical diagnosis

Clinical Stage 1 Asymptomatic Persistent generalized lymphadenopathy (PGL)

Painless swollen or enlarged lymphnodes >1 cm at two or more non-contiguous sites (excluding inguinal), without known cause

Clinical diagnosis

Unexplained persistent Hepatosplenomegaly

Enlarged liver or spleen without obvious cause

Clinical diagnosis

Papular pruritic eruptions

Papular pruritic vesicular lesions

Clinical diagnosis

Fungal nail infections

Fungal paronychia (painful, red and swollen nail bed) or onycholysis (painless separation of the nail from the nail bed)l Proximal white subungal onchomycosis is uncommon without immunodeficiency

Clinical diagnosis

Fungal nail infections

Splits or cracks at the angle of the mouth not attributable to iron or vitamin deficiency, and usually responding to antifungal treatment.

Clinical diagnosis

Lineal gingival erythema (LGE)

Erythematous band that follows the contour of the free gingival line; may be associated with spontaneous bleeding.

Clinical diagnosis

Characteristic warty skin lesions: small fleshy grainy bumps, often rough, flat on sole of feet (plantar warts); facial, more than 5% of body area or disfiguring

Clinical diagnosis

Characteristic skin lesions; skin flesh-colored or pink, dome-shaped or umbilicated growths, may be inflamed or red; facial, more than 5% of body area or disfiguring. Giant molluscum may indicate advanced immunodeficiency.

Clinical diagnosis

Clinical Stage 2

Extensive molluscum contagious infection

Note: Highlighted event are still awaiting further data for clarification of definitions Guideline on the Integrated Management of Pediatric HIV and AIDS

Clinical event

Clinical diagnosis

Definitive diagnosis

Recurrent oral ulcerations (two or more in six months)

Current event plus at least one previous episode in past six months. Aphthous ulceration, typically with a halo of inflammation and a yellow-grey pseudomembrace

Clinical diagnosis

Unexplained persistent Parotid enlargement

A symptomatic bilateral swelling that may spontaneously resolve and recur, in absence of other known cause, usually painless.

Clinical diagnosis

Herpes Zoster

Painful rash with fluid-filled blisters, dermatomal distribution, can be haemorrhagic on erythematous background, and can become large and confluent. Does not cross the midlines.

Clinical diagnosis

Recurrent or chronic upper respiratory tract infection (URTI)

Current event with at least one episode in past 6 months. Symptoms complex; fever with unilateral face pain and nasal discharge (sinusitis) or painful swollen eardrum (otitis media), sore throat with productive cough (bronchitis, sore throat (pharyngitis) and barking croup-like cough (LTB). Persistent or recurrent ear discharge.

Clinical diagnosis

Clinical Stage 3

Unexplained moderate malnutrition

Unexplained persistent diarrhoea Unexplained persistent fever (>37.50C intermittent or constant, for longer than one month)

Weight loss; low weight-for-age, up to -2 standard deviations (SDs) from the mean, not explained by poor or inadequate feeding or others infections, and not adequately responding to standard management.

Documented failure to gain weight or weight loss: body weight of -2 SD, failure to gain weight on standard management and no other cause identified during investigation

Unexplained persistent (14 days or more) diarrhoea (loose or watery stool, three or more times daily), not responding to standard treatment.

Stools observed and documented as unformed. Culture and microscopy reveal no pathogens.

Reports of fever or night sweats for longer than one month, either intermittent or constant, with reported lack of response to antibiotics or antimalarials. No other obvious foci of disease reported or found on examination. Malaria must be excluded in malarious areas.

Documented fever >37.50C with negative blood culture, negative malaria slide and normal or uncharged CXR and no other obvious foci of disease.

Persistent oral candidiasis (after 8 weeks of life)

Persistent creamy white to yellow soft small plaques which can be scraped off (psedomembranous), or red patches on tongue, palate or lining of mouth usually painful or tender.

Microscopy or culture

Oral hairy leukoplakia

Fine small linear patches on lateral borders of tongue, generally bilaterally, which do not scrape off.

Clinical diagnosis

Guideline on the Integrated Management of Pediatric HIV and AIDS

Clinical event

Clinical diagnosis

Definitive diagnosis

Acute necrotizing ulcerative gingivitis or stomatitis, or acute necrotizing ulcerative periodontitis

Severe pain, ulcerated gingival papillae, loosening of teeth, spontaneous bleeding, bad odor, and rapid loss of bone / or soft tissue

Lymph node TB

Non-acute, painless â&#x20AC;&#x153;coldâ&#x20AC;? enlargement of peripheral lymph nodes, localized to one region. Response to standard anti TB treatment in one month

Histology or fine needle aspirate positive for Ziehl-Neelsen (ZN) stain or culture

Pulmonary TB

Nonspecific symptoms, such as chronic cough, fever, night sweats, anorexia and weight loss. In the older child, also productive cough and haemoptysis. History of contact with adult with smear positive PTB. No response to standard broad spectrum antibiotic treatment.

One or more sputum smear positive for acid-fast bacilli and/or radiographic abnormalities consistent with active T and/or culture positive for M. tuberculosis

Severe recurrent bacterial pneumonia

Cough with fast breathing, chest indrawing, nasal flaring, wheezing, and grunting. Crackles or consolidation on auscultation. Responds to course of antibiotics. Current episode plus one or more in previous 6 months.

Confirmed by isolation of bacteria from appropriate clinical specimens (induced sputum, BAL, lung aspirate)

Symptomatic lymphocytic interstitial pneumonitis (LIP)

No presumptive clinical diagnosis.

CXR: bilateral reticulonodular interstitial pulmonary infiltrates present for more than two months with no response to antibiotic treatment and no other pathogens found. Oxygen saturation persistently <90%. May present with cor pulmonale and may have increased exercise-induced fatigue. Characteristic histology.

Chronic HIV-associated lung disease (including bronchiectasis)

History of cough productive of copious amounts of purulent sputum (bronchiectasis only), with or without clubbing, halitosis, and crepitations and/or wheezes on auscultation.

CXR may show honeycomb appearance (small cysts) and/or persistent areas of opacification and/or widespread lung destruction, with fibrosis and loss of volume.

Unexplained anemia (<8 g/dl), neutropenia (<0.5 x 109/L3) or chronic thrombocytopenia (<50 x 109/L3)

No presumptive clinical diagnosis

Laboratory testing not explained by other non-HIV conditions, not responding to standard therapy with haematinics, anatimalarials or anthelmintics as outlined in WHO IMCI guidelines.

Clinical diagnosis

Guideline on the Integrated Management of Pediatric HIV and AIDS

Clinical event

Clinical diagnosis

Definitive diagnosis

Clinical Stage 4 Unexplained severe wasting, stunting or severe malnutrition not adequately responding to standard therapy Pneumocystis pneumonia (PCP)

Recurrent bacterial infection, e.g. empyema, pyomyositis, bone or joint infection, meningitis but excluding pneumonia

Persistent weight loss not explained by poor or inadequate feeding, other infections and not adequately responding in two weeks to standard therapy. Characterized by: visible severe wasting of muscles, with or without oedema of both feet, and/or weight-for-height of -3 SDs, as defined by WHO IMCI guidelines.

Documented weight for height weight for age of more than - 3SD from the mean with or without oedema.

Dry cough, progressive difficulty in breathing, cyanosis, tachypnoea and fever; chest indrawing or stridor. (Severe or very severe pneumonia as in IMCI.) Usually of rapid onset especially in infants under 6 months of age. Response to high-dose cotrimoxazole +/-prednisolone. CXR typical bilateral perihilar diffuse infiltrates.

Cytology or immunofluorescent microscopy of induced sputum or bronchoalveolar lavage (BAL), or histology of lung tissue.

Fever accompanied by specific symptoms or signs that localize infection. Responds to antibiotics. Current episode plus one or more in previous six months.

Culture of appropriate clinical specimen.

Chronic herpes simplex infection; (orolabial or cutaneous Severe and progressive painful orolabial, genital, or anorectal lesions caused by HSV infection present for more than one month of more than one monthâ&#x20AC;&#x2122;s duration or visceral at any site)

Culture and/or histology.

Oesophageal candidiasis (or Candida of trachea, bronchi or lungs).

Difficulty in swallowing or pain on swallowing (food and fluids). In young children, suspect particularly if oral Candida observed and food refusal occurs and/or difficulties/crying when feeding.

Macroscopic appearance at endoscopy, microscopy of specimen from tissue or macroscopic appearance at bronchoscopy or histology.

Extrapulmonary TB

Systemic illness usually with prolonged fever, night sweats, weight loss. Clinical features depend on organs involved, such as sterile pyuria, pericarditis, ascites, pleural effusion, meningitis, arthritis, orchitis, pericardial or abdominal

Positive microscopy showing acid-fast bacilli (AFB) or culture of M. tuberculosis from blood or other relevant specimen except sputum or BAL. Biopsy and histology.

Kaposi sarcoma

Typical appearance in skin or oropharynx of persistent, initially flat, patches with a pink or blood-bruise colour, skin lesions that usually develop into nodules.

Not required but may be confirmed by: - typical redpurple lesions seen on bronchoscopy; - dense masses in lymph nodes, viscera or lungs by palpiration or radiology; - histology

CMV retinitis or CMV infection affecting another organ, with onset at age over 1 month.

Retinitis only CMV retinitis may be diagnosed by experienced clinicians: typical eye lesions on serial fundoscopic examination; discrete patches of retinal whitening with distinct borders, spreading centrifugally, often following blood vessels, associated with retinal vasculitis, haemorrhage and necrosis.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Definitive diagnosis required for other sites. Histology. CSF polymerase chair reaction (PCR).

Clinical event

Clinical diagnosis

Definitive diagnosis

CNS toxoplasmosis with onset at age over 1 month.

Fever, headache, focal neurological system signs and convulsions. Usually responds within 10 days to specific therapy.

Computed tomography (CT) scan (or other neuroimaging) showing single/multiple lesions with mass effect/enhancing with contrast.

Extrapulmonary cryptococcosis (including meningitis)

Meningitis: usually subacute, fever with increasing severe headache, meningism, confusion, behavioral changes that respond to cryptococcal therapy.

CSF microscopy (India ink or Gram stain), serum or CSF cryptococcal antigen test or culture

HIV encephalopathy

At least one of the following, progressing over at least two months in the Neuro imaging demonstrating atrophy and basal ganglia absence of another illness: calcification, exclusion of other causes. - failure to attain, or loss of, developmental milestones, loss of intellectual ability; or - progressive impaired brain growth demonstrated by stagnation of head circumference; or - acquired symmetric motor deficit accompanied by two or more of the following: paresis, pathological reflexes, ataxia, gait disturbances.

Disseminated mycosis (coccidiomycosis, histoplasmosis, penicilliosis)

No presumptive clinical diagnosis.

Histology: usually granuloma formation. Isolation: antigen detection from affected tissue; culture or microscopy from clinical specimen or blood culture.

Disseminated nontuberculous mycobacterial infection

No presumptive clinical diagnosis.

Nonspecific clinical symptoms including progressive weight loss, fever, anaemia, night sweats, fatigue or diarrhoea; plus culture of atypical mycobacteria species from stool, blood, body fluid or other body tissue, excluding lung.

Chronic cryptosporidiosis

No presumptive clinical diagnosis.

Cysts identified on modified ZN microscopic examination of unformed stool.

Chronic Isosporiasis

No presumptive clinical diagnosis.

Identification of Isospora.

Cerebral or B cell nonHodgkin lymphoma

No presumptive clinical diagnosis.

Diagnosed by CNS neuro, histology of relevant specimen.

Progressive multifocal leukoencephalopathy (PML)

No presumptive clinical diagnosis.

Progressive neurological disorder (cognitive dysfunction, gait/ speech disorder, visual loss, limb weakness and cranial nerve palsies) together with hypodense white matter lesions on neuroimaging or positive polyomavirus JC (JCV) PCR on CSF.

Symptomatic HIV-associated nephropathy

No presumptive clinical diagnosis.

Renal biospy

Symptomatic HIV-associated cardiomyopathy

No presumptive clinical diagnosis.

Cardiomegaly and evidence of poor left ventricular function confirmed by echocardiography.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Annex C Drug Formulations and Dosages Summary of Formulations and Dosages of ARV Drugs For Children Name of Drugs

Formulation

Pharmacokinetic data available

Age (wt), Dose, Frequency

Other Comments

Nucleoside analogue reverse transcriptase inhibitors Zidovudine (AZT)

Syrup: 10 mg/ml

All ages

<6 weeks: 4 mg/kg/dose twice daily

Large volume of syrup is not well tolerated in older children. Syrup needs to be stored in glass jars and is light-sensitive.

6 weeks to 13 years: 180-240 mg/ m2/dose twice daily

Can be given with food.

Capsules: 100 mg 200 mg Tablet: 300 mg

Doses of 600 mg/m2/dose per day are required for HIV encephalopathy. Maximum dose: > 13 years: 300 mg/dose twice daily

Capsule can be opened and contents dispersed or tablet crushed and contents mixed with a small amount of water or food and taken immediately (solution is stable at room temperature) Do not use with d4T (antagonistic ARV effect).

Lamivudine (3TC)

Oral solution: 10 mg/ml

All ages

Tablet: 150 mg

< 30 days: 2mg/kg/dose twice daily

Well tolerated.

<30 days or <60 kg: 4mg/kg/dose twice daily

Can be with food. Store solution at room temperature (use within one month of opening).

Maximum dose: < 60kg: 150mg/ dose twice daily Fixed dose combination of AZT + 3TC

No liquid preparation available.

Adolescents and adults

Maximum dose: >13 years or >60 kg: 1 tablet / dose twice daily (should not be given if weight <30 kg)

Tablet: 300 mg AZT + 150 mg 3TC

Tablet can be crushed and contents mixed with small amount of water or food and taken immediately. Ideally, the tablet should not be split. Tablet can be crushed and contents mixed with small amount of water or food and taken immediately. At weight <30 kg, the correct dose of AZT and 3TC cannot be given in tablet form.

Stavudine (d4T)

Oral Solution: 1 mg/ml Capsules: 15 mg, 20 mg 30 mg, 40 mg

All ages

<30 kg: 1 mg/kg/dose twice daily

Large volume of solution

30 â&#x20AC;&#x201C; 60 kg: 30 mg/dose twice daily

Keep solution refrigerated; stable for 30 days; must be shaken well. Needs to be stored in glass bottles.

Maximum dose: > 60 kg: 40 mg/dose twice daily. Consider using a maximum dose of 30mg twice daily in order to limit mitochondrial toxicity.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Capsules can be opened and mixed with small amount of food or water (stable in solution for 24 hrs if kept refrigerated). Do not use with AZT (antagonistic antiretroviral effect)

Name of Drugs Fixed dose combination of d4T + 3TC

Formulation No liquid preparation available.

Pharmacokinetic data available Adolescents and adults

Tablet: d4T 30 mg + 3TC 150 mg; d4T 40 mg + 3TC 150 mg Didanosine (ddI, Oral solution: 10 mg/ml dideoxyinosine) Tablet: 150 mg

Age (wt), Dose, Frequency Maximum dose: 30-60kg: one 30mg d4T-based tablet twice daily

Oral solution: 20mg/ml

Ideally the tablet should not be split.

>60 kg: one 40 mg d4T-based tablet twice daily All ages

<3 months: 50mg/m2/dose twice daily.

Keep suspension refrigerated; stable for 30 days; must be shaken well. Administer on empty stomach, at least 30 minutes before or 2 hours after eating.

3 months to <13 years: 90-120 mg/m2/dose twice daily or 240 mg/m2/dose once daily

Abacavir (ABC)

Other Comments

>3 months

It tablets are dispersed in water, at least 2 tablets of appropriate strength should be dissolved for adequate buffering.

Maximum dose: >13 years or >60 kg: 200 mg/dose twice daily or 400 mg once daily.

Enteric-coated beadlets in capsules can be opened and sprinkled on a small amount of food.

<16 years or <37.5 kg: 8 mg/kg/ dose twice daily

Can be given with food.

Tablet: 300 mg Maximum dose: >16 years or >37.5 kg: 300 mg/dose twice daily.

Tablet can be crushed and contents mixed with a small amount of water or food and ingested immediately. MUST WARN PARENTS ABOUT HYPERSENSITIVITY REACTION. ABC should be stopped permanently if hypersensitivity reaction occurs.

Fixed dose combination of AZT + 3TC + ABC

No liquid preparation available.

Adolescents and adults

Maximum dose: >40 kg: 1 tablet/ dose twice daily.

Ideally, the tablet should not be split. At weight <30 kg, AZT/3TC/ABC the correct dose cannot be given in tablet form.

Tablet: AZT 300 mg + 3TC 150 mg + ABC 300 mg

MUST WARN PARENTS ABOUT HYPERSENSITIVITY REACTION. AZT/3TC/ABC should be stopped permanently if hypersensitivity reaction occurs.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Name of Drugs

Formulation

Pharmacokinetic data available

Age (wt), Dose, Frequency

Other Comments

Nucleoside analogue reverse transcriptase inhibitors Nevirapine (NVP)

Oral Suspension: 10 mg/ml

All ages

Tablet: 200 mg

15-30 days: 5mg/kg/ dose once daily for 2 weeks, then 120 mg/m2/ dose twice daily for 2 weeks, then 200 mg/m2/dose twice daily.

Avoid using if rifampicin is being co-administered. Store suspension at room temperature. Must shake well.

>30 days to 13 years: 120 mg/m2/ dose once daily for 2 weeks, then 120-200 mg/m2/dose twice daily. Maximum dose: >13 years: 200 mg/dose once daily for first 2 weeks, then 200 mg/dose twice daily.

Can be given with food. Tablets are scored and can be divided into two equal halves to give a 100 mg dose; can be crushed and combined with a small amount of water or food and immediately administered. PARENTS MUST BE WARNED ABOUT RASH. Do not increase the dose if rash occurs ( if mild/moderate rash, hold drugs; when rash clears, restart dosing from beginning of dose escalation; if severe rash, discontinue drug).

Efavirenz (EFV)

Syrup: 30 mg/ml (note: syrup requires a higher dosage than capsules)

Only for children over 3 years of age or weight >10 kg

Capsule: 50mg, 100mg 200mg

Capsule (liquid) dose: 10-15kg: 200mg (270 mg = 9 ml) once daily

Well tolerated. Can be with food.

15-<20kg: 250mg (300 mg = 10 ml) once daily

Store solution at room temperature (use within one month of opening).

20 - <25kg: 300mg (360 mg = 12 ml) once daily

Tablet can be crushed and contents mixed with small amount of water or food and taken immediately.

25 - <33kg: 350mg (450 mg = 15 ml) once daily 33 - <40 kg: 400mg (510 mg = 17 ml) once daily Maximum dose: >40 kg: 600mg once daily Fixed dose No liquid preparation combination of available. d4T + 3TC + NVP Tablet: 30 mg d4T/150 mg 3TC/ 200 mg NVP

Adolescents and adults

Maximum dose: 30-60 kg: one 30 mg d4T-based tablet twice daily >60 kg: one 40 mg d4T-based tablet twice daily

40 mg d4T/150 3TC/200 mg NVP

Guideline on the Integrated Management of Pediatric HIV and AIDS

Ideally, the tablet should not be splits. At weight <30 kg, d4T/3TC/NVP the correct dose cannot be given in tablet form; If tablets are split, NVP dose requirements will be inadequate for very young children and additional NVP is needed to give a total of at least 150 mg/m2/dose twice daily. Optimum NVP dosage is 200 mg/m2/dose twice daily. Since the fixed dose combination (FDC ) contains NVP, dose escalation is required.

Name of Drugs

Formulation

Pharmacokinetic data available

Age (wt), Dose, Frequency

Other Comments

Nucleoside analogue reverse transcriptase inhibitors Nelfinavir (NFP)

Powder for oral suspension (mix with liquid): 200 mg per level teaspoon (50 mg/1.23 ml scoop): 5 ml Tablet: 250 mg (tablets can be halved; can be crashed and added to food or dissolved in water)

All ages. However, extensive pharmacokinetic variability in infants, with requirement for very high doses in infants <1 year

<1 year: 50mg/kg/ dose three times daily or 75 mg/kg/dose twice daily.

Powder is sweet, faintly bitter, but gritty and hard to dissolve; must be reconstituted immediately prior to administration in water, milk, formula, pudding, etc. Do not use acidic food or juice (increase bitter taste); solution stable for 6 hours.

>1 year to <13 years: 55-65 mg/kg/ dose twice daily.

Because of difficulties with use of powder, use of crushed tablets preferred (even for infants) if appropriate dose can be given.

Maximum dose: >13 years: 1250 mg/dose twice daily.

Powder and tablets can be stored at room temperature. Can be taken with food. Drug interaction (less than ritonavir-containing PIs)

Lopinavir/ ritonavir (LPV/r)

Oral solution: 80 mg/ml lopinavir plus 20 mg/ml ritonavir (Note: oral solution contains 42% alcohol)

6 months of age or older

Capsule: 133.3mg lopinavir plus 33.3mg ritonavir

>6 months to 13 years: 225mg/m2 LPV / 57.5 mg/m2 ritonavir twice daily or weight-based dosages.

Oral solution and capsules should preferably be refrigerated; however, can store at room temperature up to 25.0 C (77.0 F) for 2 months; at temperatures >25.0 C (77.0 F), drug degrades more rapidly.

7-15kg: 12mg/kg LPV / 3 mg/kg ritonavir/dose twice daily.

Liquid formulation has a small volume but bitter taste. Capsules large.

15 - 40kg: 10mg/kg LPV / 5 mg/kg ritonavir twice daily.

Saquinavir/r

Soft-gel capsule: 200 mg Hard-gel capsule: 200 mg and 500 mg

>25 kg

Capsules should not be crushed or opened, but must be swallowed whole.

Maximum dose: >40 kg: 400mg LPV/100 mg ritonavir (3 capsules or 5ml)

Should be taken with food.

Approved dosage in adults: SQV 1000 mg / RTV 100 mg twice daily.

Capsules large. Capsules should not be crushed or opened, but must be swallowed whole.

There are no data in children. For children weighing >25 kg, the approved adult dose can be used.

Should be taken with food.

If possible, monitoring of SQV.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Annex D

Management of Specific Adverse Reaction

Health Care Workers play a vital role in the effective management of side effects in ARV treatment of children. Often the parent/caregiver will want to stop giving ARVâ&#x20AC;&#x2122;s because the child does not feel well.

Participation of the child in expressing his/her feelings and identifying what is really making them feel bad will also greatly enhance the likelihood of compliance.

Guideline on the Integrated Management of Pediatric HIV and AIDS

Stop all therapy if there is severe hepatitis, pancreatitis, lactic acidosis or Steven-Johnson syndrome suspected. Nausea • Nausea due to antiretroviral medication must be actively managed, or adherence will suffer. • Anti-emetics taken half an hour before the antiretroviral dose up to 3 times daily may be helpful. It the nausea does not settle, refer for expert advice. Rashes on First Line Therapy • Do a clinical assessment to rule out any other cause of the rash. Inquire about systemic symptoms, and check the temperature in any patient presenting with a rash. • Do a grading of the rash and refer to tables for management • Both nevirapine and efavirenz may cause skin reaction. This usually occurs within the first 2 months of treatment. Concomitant (simultaneous) TB therapy may confuse the situation as these drugs can cause similar adverse events. Abdominal Pain • • • •

Abdominal pain in a patient on ART can be caused by a number of serious problems and should never be ignored. Important causes include lactic acidosis, pancreatitis, hepatitis, hyperlactataemia (increased serum lactate) and disseminated tuberculosis. Recommended investigation: liver function, lipase and serum lactate Refer for further investigations as needed. Seek expert help if you are unsure of the cause of the pain.

Lactic Acidosis and Hyperlactatemia • Asymptomatic elevation of lactate is common in patients taking antiretroviral drug (up to 20% per year) Routine monitoring of lactate is not recommended if the patient is symptomatic. • Patients on ART can occasionally develop symptomatic hyperlactatamia (1-2% per year and more rarely lactic acidosis (0.1-0.2% per year) • Risk factor acidosis include o female gender o obesity o prolonged ART and excellent adherence o chronic renal failure o pregnancy

Guideline on the Integrated Management of Pediatric HIV and AIDS

• Symptoms are non-specific: o unwellness, generalized fatigue, weakness o gastro-intestinal symptoms (nausea, vomiting, abdominal pain, abdominal distension and bloatedness) o shortness of breath, dyspnoea, tachypnoea o neurologic symptoms (disequilibrium, motor weakness) • Confirmed laboratory test (hyperlactatemia) HyperLactatemia • • • •

Discuss with the treatment expert. ART should be discontinued in the patient with these symptoms Symptoms associated with lactic acidosis discontinuation of ART Therapy is primarily supportive: fluid bicarbonate administration and respiratory support.

Lipodystrophy • HIV- associated lyphodystrophy include fat loss and/ or fat accumulation in district regions of the body. This includes increased fat around abdomen, buffalo hump, breast hypertrophy, and fat loss from limbs, buttocks and face. • Association with antiretrovirals; lipodystrophy more common in individuals taking NRTIs or protease inhibitors. • Management: There are no established methods for treating lypodystrophy, but the following is recommended: o Encourage exercise to reduce fat accumulation. o Some patients improve if switched from a protease inhibitor to an NNRTI o Fibrates are affective at lowering cholesterol and triglyceride levels. o Insulin resistance can be improved with anti-diabetic agents. Hyperlipedemia • Patients on lopinavir/ritonavir who develop hyperlipidaemia should be counseled about lifestyle modification: o Weight loss if obese o Increasing exercise o Stopping smoking o Reducing cholesterol and saturated fat intake

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Guideline on the Integrated Management of Pediatric HIV and AIDS

First Line ARV Regimen in Infants and Children, Adverse Events and Drugs for Potential Substitution First line ARV regimen d4T/3TCa/NVP

AZT/3TCa/NVP

d4T/3TCa/EFVe

AZT/3TCa/EFVe

Major potential toxicities

Drug Substitution

d4Tb – lactic acidosis d4T - peripheral neuropathy or pancreatitis

Switch d4T AZT

d4T - lipoatrophy

Switch d4T ABCd

NVP – severe hepatotoxicity

Switch NVP EFVe

NVP – severe rash but not life threatening

Switch NVP EFVe

NVP – severe life threatening rash (Stevens-Johnson Syndrome)

Switch NVP EFV with close monitoring OR triple NRTI OR PIe,f NRTI(EA2) OR PIc

AZT – anaemia, gastro-intestinal intolerance, neutropenia

Switch AZT d4T or ABC Switch AZT d4T(EA3)

NVP-severe hepatotoxicity

Switch AZT d4T or ABC Switch AZT d4T(EA3)

NVP – severe life threatening rash (Stevens-Johnson Syndrome)

Switch NVP EFV with close monitoring OR triple NRTI OR PIef

d4Tb – lactic acidosis

Switch d4T AZT or ABCd

d4Trelated lipoatrophy

Switch d4T ABCd

EFV – CNS toxicity and potential for teratogenicity

Switch EFV NVP

AZT – anaemia, gastro-intestinal intolerance, neutropenia

Switch AZT d4T or ABC

EFV – CNS toxicity and potential for teratogenicity

Switch EFV NVP

Annotations: a. 3TC has limited toxicity but may cause headache, abdominal pain or rarely, pancreatitis; 3TC can be continued for most toxicity; in the case of life– threatening pancreatitis, all drugs should be discontinued until resolution of toxicity, and restarted with careful monitoring. b. Lactic acidosis associated with NRTI therapy, in particular with d4T or the combination of d4T/ddI. c. Symptomatic NVP-associated hepatic toxicity appears to be very rare in HIV-infected children prior to adolescence d. Switching of d4T typically not reverse lipoatrophy but may slow its progression. In children, ABC can be considered as alternative; in the absence of ABC availability, ddI or AZT are additional alternatives to consider. (TDF can be substituted for d4T in adults; however, TDF is not currently approved for use of children and there is no approved pediatric drug formulation available) e. EFV should not be given where there is risk of pregnancy, and in children <3 years of age. f. In the event of severe rash/Stevens’ Johnson Syndrome, EFV can be substituted for NVP after severe rash has resolved in children over age 3 years ONLY if careful and close monitoring can be conducted during the initial weeks of therapy (37,67-71); if any rash recurs, change to triple NRTI or PIbased regimen is warranted. However, in the rare event of Stevens-Johnson Syndrome/toxic epidermal necrolysis) <1% of children) NVP should never be reinitiated as a recurrence may be more rapid, more severe and even fatal. Where PI is chosen as a substitute drug, LPV/r (in children weighing > 25 kg) can be considered; NFV can be considered as an alternative.

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Confidential Report on Adverse Drug Experience Patientâ&#x20AC;&#x2122;s initial

Age

Sex: Male: Female

Wt. (Kg.)

Ethnic group:

Describe the reaction/s:

Drugs used prior to ADE (grand names). Pls. check the suspect drugs/s. Pls. indicate manuf. If generic names are used. Pls. indicate batch & lot number if applicable

zOnset of Reaction: Date: Mo.DayRoute

Dose

Dosing time

Date/time started

Time

Month

Day

Time: Am-

Yr.-

Date/time stopped

Year

Time

Month

Day

PmIndication/s

Year

Treatment of reaction/s Outcome: __________Recovered: Date: _______/_________/________ __________Not yet recovered __________Unknown __________ Died Date: _______/_________/________ Resulted in prolonged hospitalization? ___________ No _________ Yes Sequelae ___________ No _________ Yes, Please describe: Comments: a, Allergies b. Previous exposure/reaction to suspect drug/s c. Pregnancy with LMP Name of reported Address of reporter MD

d. relevant history e. others Signature

Date reported: _____/______/______ Tel. No.

Nurse

Pharmacist

Patient

Others

Note: Submission of this report does not constitute an admission that the drug caused the adverse reaction. Identities of the reporter, institution and patient will remain confidential. Please mark all appropriate items. 102

Guideline on the Integrated Management of Pediatric HIV and AIDS

Annex E Sexual Maturity Rating in Adolescents (Tanner Staging) Female Stage

III

Age Range

Male Age Range

Breast Growth

Pubic Growth

Other Changes

Pre-Adolescent

None

Pre-Adolescent

0-15

Breast budding; areolar hyperplasia with small amount of breast tissue

Long, downy pubic hairlabia, often appearing with the breast budding or several weeks or months later.

Peak growth velocity often occurs soon after stage II

10-15

Increase in amount and pigmentation of hair

Menarche occurs in 2% of girls late in stage III

10.5-16

10-15

Further enlargement of breast tissue and areola, with no separation of their contours

10-17

Separation of countour, areola and nipple form secondary mound above breast tissue

0-15

8-15

Large breast 12.5 - 18 with single contour

Penis Growth

Pubic Growth

Other Changes

PrePreAdolescent Adolescent ((<or=2.5 cm

None

Pre-Adolescent

Enlargement Minimal or of testes; no pigment of enlargement scrotal sac

Long, downy hair, often appearing several months after testicular growth; variable pattern noted with pubarche

n/a

Further Enlarge

significant enlargement, specially in diameter

Increase in amount; curling

n/a

Adult in the type but not distribution

Menarche variable Further occurs in most 2-17 Enlarge girls in stage IV, 1-3 years after the thelarche

Futher enlargement especially in diameter

Adult in type but not in distribution

Auxiliary hair and some facial hair develop

Adult in distribution

Menarche occurs in 10% of girls in stage V

Adult in size

Adult in distribution (media aspects of thighs and linea alba)

Body hair continues to grow and muscles continue to increase in size for several months to years; 20% of boys reach peak velocity

13-18

Testes Growth

Adult in size

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Glossary of Abbreviations 3TC Ab a.m. ABC AFB AIDS ALT ART ARV AZT Bid BSA CD4+ CNS CPK CPT CRC CTX CXR d4T DNA DOH DOT EFV ELISA HIV IMCI INH LIP

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lamivudine antibody ante meridiem (denotes morning) abacavir acid-fast bacilli acquired immunodeficiency syndrome alanine aminotransferase antiretroviral therapy antiretroviral (drug) zidovudine (also known as ZDV) twice daily body surface area T-lymphocyte bearing CD4 receptor central nervous system creatinine phosphokinase co-trimoxazole preventive therapy Convention on the Rights of the Child co-trimoxazole chest X-ray stavudine deoxyribonucleic acid Department of Health directly observed therapy efavirenz enzyme-linked immunosorbent assay human immunodeficiency virus integrated management of childhood illness isoniazid lymphocytic interstitial pneumonia

Guideline on the Integrated Management of Pediatric HIV and AIDS

LPV MTCT NNRTI NRTI NVP OHL PCP PCR PGH PGL PI PJM p.m. PML PMTCT RITM SJS SLH TB TEN TLC URTI WBC WHO

lopinavir mother-to-child transmission (of HIV) non-nucleoside reverse transcriptase inhibitor nucleoside reverse transcriptase inhibitor nevirapine oral hairy leukoplakia Pheumocystis Carnii pneumonia polymerase chain reaction Philippine General Hospital persistent generalized lymphadenopathy protease inhibitor Precious Jewels Ministry post meridiem (denotes afternoon) progressive multifocal leukoencephalopathy prevention of mother-to-child transmission (of HIV) Research Institute for Tropical Medicine Stevens-Johnson syndrome San Lazaro Hospital tuberculosis toxic epidermal necrolysis total lymphocyte count upper respiratory tract infection white blood cell count World Health Organization

References Antiretroviral Therapy of HIV Infection in Infants and Children in Resource Limited Settings, Towards Universal Access: Recommendations for a Public Health Approach (WHO, Draft 2005) Centre for HIV/AIDS networking (HIVAN); Department of Paediatrics and Child Health, Nelson Mandela School of Medicine, University of KwaZulu-Natal, Congella 4013, South Africa WHO International Collaborating Group for the Study of the WHO Staging System. Proposed “World Health Organization staging system for HIV infection and disease’: preliminary testing by an international collaborative cross-sectional study. AIDS 1993; 7:711-18 National Antiretroviral Treatment Guidelines. (National Department of Health-South Africa, 2004) Centers for Disease Control and Prevention. Recommended childhood and adolescent immunization schedule - United States, January - June 2004. MMWR 2004; 53 (01): Q1-4 24th Edition Red Book: 2003 Report of the Committee on Infectious Diseases. (American Academy of Pediatricians, 2003) UNICEF Website www.unicef.org Philippine AIDS Prevention and Control Act of 1998 (RA 8504) Precious Jewels Ministry Library AIDS Education and Training Center (AETC) National Resource Center Guidelines for the Use of ARV Agents in Pediatric HIV Infection (Nov 2004) INTERIM GUIDELINE ON THE INTEGRATED MANAGEMENT OF PEDIATRIC HIV AND AIDS

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Guideline on the Integrated Management of Pediatric HIV and AIDS

Training Course

How to Use The Guideline on the Integrated Management of Pediatric HIV and AIDS

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Guideline on the Integrated Management of Pediatric HIV and AIDS

Training Workshop on

How to Use the GUIDELINE ON THE INTEGRATED MANAGEMENT OF PEDIATRIC HIV and AIDS Crossing Borders Project

Rationale and Background Under the Crossing Borders Project, a guideline on the integrated management of HIV and AIDS in children has been produced. The guideline shall be used by the 3 participating hospitals for the management of prospective and confirmed HIV positive infants and children. About the Training Course The 3 - day training course shall provide the necessary knowledge, attitude and skill for health care providers for the integrated management of pediatric HIV and AIDS cases in the 3 participating hospitals enrolled under the Crossing Borders Project. One of the major outputs of the course is an integration plan for all the participating hospitals and institutions. Various learning methodologies, based on the adult principles of learning and conditions, will be used in the course. Some of these will be: structured learning exercises, group discussions, simulation exercises, demonstrations and lecture discussions. Course Objectives The training is designed to: 1. Increase appreciation and understanding on the various issues and concerns surrounding HIV and AIDS in children and its management. 2. Understand the use of the Interim Guideline; 3. Articulate and demonstrate standard operating procedures in the integrated management of children with HIV and AIDS under the Crossing Borders Project; and 4. Integrate the guideline in the institutionâ&#x20AC;&#x2122;s service delivery system. Participants The orientation session shall be attended by pre-selected participants from the 3 participating hospitals. The participants should have a comprehensive understanding on HIV and AIDS and the various issues surrounding the disease. Experience in dealing with children infected and affected by HIV and AIDS is also required.

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Training Flow Day

Duration (hours)

Day 1

30 min

1 hr

8 hrs

Day 2

Session Preliminaries

Module 1: Understanding HIV and AIDS

Module 2: HIV through the Eyes of a Child

4 hrs Module 3: Understanding the Guideline

Day 3

4 hrs

Module 4: Health Care Workers Roles, Issues, Concerns and Dilemmas

3 hrs

Module 5: Implementing the Guideline

30 min

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Closing Ceremonies

Input Welcome Remarks Overview of the Crossing Borders Project Leveling of Expectations and Statement of Objectives Basic Facts on Pediatric HIV and AIDS Brief Discussion on RA 8504 Local and Global Magnitude of the Problem Current Management of HIV and AIDS in Children CRC Framework and the Rights of the Child Art Gallery Presentation & Understanding the Child & Their Evolving Capacity Testimonies of Caregivers (Parents, Guardians, Teachers, HCWs) Building Effective Support Systems Ribbon of Hope & Commitments Overview of the Guideline Counseling, Disclosure and Seeking Informed Consent Diagnosis and Management of HIV in Children Adherence to ART Monitoring for ARV Therapy Special Considerations (TB, Immunizations, Infant Feeding and Nutrition Treatment Failure and ART in Adolescents Prevention Group Workshop and Presentation Summary Lecture - Presentation

Action Planning Workshop Awarding of Certificates and Closing Remarks

Guideline on the Integrated Management of Pediatric HIV and AIDS

Session 1: Preliminaries

Objectives:

1. To welcome and introduce the participants;

2. Clarify their expectations and explain the purpose of the orientation session;

3. Introduce and provide an overview of the session flow.

1. Welcome and Introductions 1.1. Registration 1.2. Welcome Remarks 1.3. Introducing of Participants 1.4. Background on the Crossing Borders Project 2. Leveling of Expectations 2.1. What do you expect to learn? 2.2. What activities will help you learn? 2.3. What do you expect from your facilitators? 2.4. What do you expect from your co-participants? 3. Statement of Objectives and Presentation of the Session Flow 3.1. Present the Training Objectives and explain expected outputs 3.2. Present the Session Flow 3.3. Develop the House Rules

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Session 2: Module 1: Understanding HIV and AIDS

Objectives:

1. Review Basic Facts on HIV and AIDS;

2. Discuss the current management of HIV and AIDS in children; and

3. Simulate living with HIV and AIDS

Introduction for the Session: Most of us, if not all have attended an HIV and AIDS orientation session. At the back of our minds, most of us can lecture this topic at any given time. But today, let us look at HIV and AIDS again. This time, let us talk about HIV and AIDS in children. This session will not only discuss the basic facts of HIV and AIDS in children but also provide a closer look on the current fires and responses made available for them.

Topics to be covered: 1. How many children are now living with HIV and AIDS in the world? In the Philippines? 2. How do children get HIV and AIDS? 3. What are the current support systems made available for PLHIV? For children? 4. How does if feel to be infected or have to live with an HIV infected child?

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Guideline on the Integrated Management of Pediatric HIV and AIDS

Session 3: Module 2: HIV and AIDS Through the Eyes of a Child

Objectives:

1. Understanding HIV and AIDS in relation to the CRC Framework;

2. Identity the key roles of health care providers in ART with children

Introduction to the Session: How does a child look at HIV and AIDS? Do they understand it? Do they have to be told of their HIV status? As a healthcare worker, what should you do? How should you manage an HIV infected child? These and many other questions begin to linger in all of us once we begin to talk about HIV and AIDS in children. In these session, we will focus on children. We shall look into their rights and how these rights are to be respected and considered in the management of children who might be infected and those who have diagnosed. Topics to be covered:

1. 2. 3. 4. 5.

The Convention of the rights of a Child as a framework for the Pediatric Guideline. Discussion on Pediatric HIV and AIDS and the Fullness of Life. The childâ&#x20AC;&#x2122;s evolving capacity to understand sickness, separation and death. The impact of HIV and AIDS on the whole family. Building effective support systems.

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Session 4: Module 3: Understanding the Guideline

Objectives:

1. Articulate the guidelines on the integrated management of pediatric HIV and AIDS;

2. Clarify the technical facts and processes discussed in the guideline; and

3. Demonstrate use of the guideline and its recommended tools.

Introduction to the Session: It is now time for us to discuss the guideline. In this session, we shall begin with an orientation on the guideline and later digest its contents in more detail. This guideline is a living document. It has been designed for health care providers, as a guide in the management of pediatric HIV and AIDS with much sensitivity and consideration to the child - their rights and needs. Topics to be covered: 1. Overview of the Guideline a. Format and lay-out b. Contents and utilization c. References and cross references 2. Detailed Discussion of the Sections of the Manual a. Counseling, Disclosure and Seeking Informed Consent i. Disclosure ii. Counseling procedure and contents iii. Seeking informed consent

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b. Diagnosis of HIV infection in Children i. Child less than 18 months ii. Child more than 18 months iii. Procedure / Referral

Guideline on the Integrated Management of Pediatric HIV and AIDS

c. Management of Child with HIV and AIDS i. Baseline evaluation ii. Clinical and immunological staging iii. Initiating ART in children iv. Immunological criteria v. Choosing the initial ARV regimen vi. Managing adverse reactions vii. Drug interactions viii. Substituting ARV regimens d. Adherence to ART i. Define adherence and its significance ii. Basic adherence package iii. Roles framework for the child e. Monitoring for ARV Therapy i. Clinical assessment ii. Laboratory assessment iii. Monitoring treatment iv. Family / Social Environment assessment f. Special Considerations i. TB ii. Infant feeding iii. Nutrition / Malnutrition iv. Immunization g. Treatment Failure h. ART in Adolescents

3. Summarize the steps via a flow chart.

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Session 5: Module 4: Health Care Workers - Roles, Issues, Concerns and Dilemmas

Objectives:

1. Define the roles of the Health Care Workers in the care and support of patients / clients with HIV and AIDS

2. Identity the issues, concerns and dilemmas confronting the Health Care Workers.

3. Develop strategies to address the Health Care Worker’s issues, concerns and dilemmas.

4. Discuss Ethico-legal impications of HIV and AIDS care.

Topics to be covered:

1. Republic Act 8504 in relations to Health Care Workers’ roles, issues and concerns.

2. Interactive session to bring out the Health Care Workers’ strategies on how to address their issues, concerns and dilemmas.

3. Interactive: Ethico - legal Implications

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Guideline on the Integrated Management of Pediatric HIV and AIDS

Session 6: Module 5: Implementing the Guideline

Objectives:

1. To be able to develop a process flow in the management of prospective and diagnosed pediatric HIV and AIDS cases;

2. Identity possible challenges that may be faced, including recommended actions to be undertaken.

3. Develop an integration plan for the institution.

Introduction to the Session: In the previous sessions, we learned everything about the guideline. But how do we do translate this for our use? Do you have an idea on how we should integrate these in your current hospital / institutional - set up? In this session, we shall look into ways and means of integrating the guideline into our current practice. So much so, identify possible challenges we might face and possible solutions to address them:

Workshop Process: (Per Institution)

1. Define your current practice.

2. Define your ideal set-up (integrating the guideline).

3. What are the gaps? Issues?

4. How will you address these gaps?

5. What support do you need to implement the new set-up?

6. Develop your integration plan.

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First Printing, 2009 UNICEF Philippines

Printed with funding support from 118

Guideline on the Integrated Management of Pediatric HIV and AIDS