Post Exposure Management (PEM) for HIV, Hepatitis B & C in Healthcare Settings National AIDS and STI Prevention and Control Program Department of Health
2009
Post Exposure Management (PEM) for HIV, Hepatitis B and C in Healthcare Settings 2009 Produced by the Department of Health in partnership with Health Action Information Network and World Health Organization. Research Team: National AIDS/STI Prevention and Control Program (NASPCP) Dr. Jose Gerard Belimac, Program Manager Dr. Ethel Da単o, Program Officer Health Action Information Network Noemi D. Bayoneta-Leis, Coordinator Emilyne B. de Vera, Project Staff Ross M. Mayor, Researcher/Writer/\DTP World Health Organization Dr. Madeline S. Salva
General Approaches to Management
Foreword from the WHO Health Organization “Post-Exposure Management for HIV, Hepatitis B and C in Healthcare Settings” National Center for Disease Prevention and Control – Department of Health and World Health Organization The HIV pandemic remains to threaten public health. According to UN, there were 33.2 million all over the world who were living with HIV in 2007. Although HIV prevalence in the country remains at low level (0.0168% in the general population in 2007), the potential to epidemic explosion remains a threat. This is due to the continuing exposure of our most-at-risk population (MARP) to unsafe behaviours like unprotected sex, very low condom use, and sharing injecting equipments among drug users. Apart from HIV, Hepatitis B and C infections affect many Filipinos today. Experts have noticed the high prevalence (16%) of chronic hepatitis. In 2006, the US Centres for Disease Prevention and Control classified. Philippines as highly endemic (>8% prevalence for Hepatitis B. Hepatitis C, on the other hand, is common among injecting drugs users. Multi-sectoral focused intervention efforts are being implemented in the country to control HIV and AIDS, including Sexually Transmitted Infections (STI). The Department of Health continues to provide leadership in STI prevention, treatment, care and support through its National Objectives for Health and the Philippine National AIDS Council’s 4th AIDS Medium Term Plan (AMTP IV). One of its most important functions is to ensure the safety of health care workers from the risks associated with the day-to-day exercise of providing quality health services. This guideline for Post-Exposure Management for HIV, Hepatitis B and C in Healthcare Settings aims to protect health care workers from the three dreaded viral infections. This guideline was developed by the National Center for Disease Prevention and Control (NCDPC) through
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Post Exposure Management (PEM) for HIV, Hepatitis B & C in Healthcare Settings
its National AIDS and STI Prevention and Control Program (NASPCP), with technical assistance of the World Health Organizations and Health Action Information Network (HAIN). Through this guideline, we expect that health care workers would be more confident and better able to provide care to People Living with HIV.
Francisco T. Duque III, MD, MSc Secretary of Health
General Approaches to Management
Message from the WHO Health Organization I would like to congratulate the Department of Health, National AIDS STI Prevention and Control Programme, the HIV AIDS Core Team Leaders of the different treatment hubs, partners from Civil Society Organizations, and clinicians from different field of specialties for putting their efforts together in the development of “Post-Exposure Management (PEM) for HIV, Hepatitis B and C in Healthcare Settings�. We are glad that this material was developed through a consultative process that involved programme planners, implementers, service providers and programme beneficiaries. Philippines is not spared by HIV. Local facts are sending very clear messages. Reports from the National HIV and AIDS Registry of the Department of Health-National Epidemiology Center showed increasing number of new HIV reported cases. In 2000, an average of one new HIV positive case was reported every three days. In 2007, there was one new case per day. In 2009, there were two new cases reported per day. Although sexual intercourse was still the most common mode of transmission, accounting for 90%, we need to make sure that we cover all modes of transmission to prevent entry of HIV. We need to put in place programmes that will benefit not only the most-at-risk populations, but people who are working in settings that provide treatment, care and support services as well. Prevention of HIV transmission in the healthcare setting is also a must. This manual was locally adapted based on the internationally set standards of preventing HIV transmission following accidental exposure to HIV infected objects, equipment, and specimens. Its current coverage expanded to set standards also on how to manage exposure to Hepatitis B and C. The manual was designed to serve as a quick and easy reference for our service providers on how to handle healthcare workers who had accidental exposure to HIV, Hepatitis B and C-infected instruments/ objects/specimens, while performing their duties. It will be constantly reviewed and updated to ensure compliance with the provisions of optimal treatment and care for intended beneficiaries.
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Post Exposure Management (PEM) for HIV, Hepatitis B & C in Healthcare Settings
We urge immediate dissemination, orientation and utilization of this manual. So that our healthcare professionals working to provide treatment, care and support in a clinical setting can also be protected and guided accordingly. Everyone should be engaged in our prevention efforts to halt the spread of HIV. We need to speed up our responses. The HIV clock is ticking. The time to protect yourself and others from STI, including HIV is NOW!
Dr. Soe Nyunt-U WHO Representative
Acknowledgements This document is a joint publication of the Philippine Department of Health thru its National AIDS and STI Prevention and Control Program (NASPCP) and World Health Organization (WHO) – Philippine Country Office. Dr. Jose Gerard Belimac, of the National Center for Disease Prevention and Control leads the Technical Working Group (TWG) of this interim guide. The following persons are acknowledged for their comments and contributions during the entire process of guideline development: Dr. Jaime Lagahid, Dr. Mario Baquilod, Dr. Honorata Catibog, Ms. Prescila Cuevas, Dr. Ethel Dano, Mr. Joel Atienza, Dr. Rosario Jessica Abrenica, Dr. Dorothy Mae Adamag, Mr. Garre Garcia, Dr. Jimmy Mendigo, Dr. Sebar Sala, Dr. Rossana Ditangco, Dr. Emerose Moreno, Dr. Nerisa Sescon, Dr. Charisa Tabora, Dr. Elizabeth Telan, Dr. Madeline Salva, Dr. Joyce Ducusin, Ms. Noemi Leis, Emilyne De Vera, Ma. Rosario Mayor
YOLANDA E. OLIVEROS, MD, MHSA
Director IV National Center for Disease Prevention and Control
Glossary / Acronyms 4th AIDS Medium Term Plan 2005-2010 blueprint for action in accelerating the country’s response to HIV and AIDS from 2005 to 2010. AIDS Acquired Immune Deficiency Syndrome; a disease of the human immune system characterized cytologically by a reduction in the numbers of CD4-bearing helper T cells to 20 percent or less of normal thereby rendering the subject highly vulnerable to life-threatening conditions (as Pneumocystis carinii pneumonia) and to some that become life threatening (as Kaposi’s sarcoma). This is caused by infection with HIV ARV Anti-retrovirals; medications used in the treatment of infections caused by retroviruses HCP Health Care Personnel; refers to workers in a health-care setting who are more prone to being infected with blood-borne diseases through occupational exposure Healthcare Setting refers to hospitals, clinics, and laboratories Hepatitis B double-stranded DNA virus (species Hepatitis B virus of the family Hepadnaviridae) that sometimes causes fatal hepatitis. The virus tends to persist in the serum and is transmitted especially by contact with infected blood (as by transfusion or by sharing contaminated needles in illicit intravenous drug use) or by contact with other infected bodily fluids (as semen) Hepatitis C single-stranded RNA virus of the family Flaviviridae (species Hepatitis C virus of the genus Hepacivirus) that tends to persist in the blood serum and is usually transmitted by infected blood (as by injection of an illicit drug, blood transfusion, or exposure to blood or blood products) and that accounts for most cases of non-A, non-B hepatitis PEM (Post – Exposure Management) a medical management after occupational exposure to blood and other potentially infectious bodily fluids/ tissues with risks of transmission of Hepatitis B/C and/or HIV. It includes Post Exposure Prophylaxis (PEP) for HIV and Hepatitis B. PEP (Post Exposure Prophylaxis) a medical intervention given to prevent the transmission of blood-borne pathogens following a potential exposure. PEP kit Starter pack for the initial provision of PEP for HIV. It contains the initial dose of necessary ARV, general information on PEP guidelines, patient’s consent form, and pregnancy test kit (optional). Standard precautions procedures that must be observed to prevent the transmission of infections from patients to health care personnel
Table of Contents
Introduction
1
Overview
3
General Approaches to Management
4
Treatment Protocols
6
Appendices
15
Directories
22
References
26
Introduction
Introduction The Philippines’ HIV situation has been described as low level epidemic, but recent data are showing rapid increase in the number of HIV reported cases. Other contributing factors for an epidemic explosion remain documented. In particular, the prevalence of sexually transmitted infections (STI) is a cause for concern due to its co-morbidity with HIV. The 2003 National Demographic Health Survey showed that among men age 15 – 49 who sought advice or treatment for STI, 60% were found to have STI and/or symptoms of STI. Meanwhile, experts have already raised the alarm for Hepatitis B. It is reported that 16% of the population has chronic Hepatitis B. Seventy percent of liver cancer is due to the virus. (Bravo,L. 3rd Hepatitis B Summit 2007)1 The risk of transmission of blood-borne diseases is significantly greater for workers in healthcare settings. For Hepatitis B infection, the risk of transmission is ten times greater for healthcare personnel than the general population. 2 For Hepatitis C, the US Centers for Disease Control and Prevention said that two in 100 healthcare personnel who have been exposed to HCV-contaminated blood either through needle or sharps injuries will develop an infection. For HIV, the 4th AIDS Medium Term Plan (AMTP4) acknowledges that the country has limited preventive interventions. To address this concern, one of the operational strategies adopted calls for the scaling up of “STI/HIV/AIDS prevention, information, and service delivery in the workplace.” To fill the gap in the provision of treatment for healthcare personnels who may have been exposed to blood-borne diseases, as well as in response to the operational strategy of the AMTP4, this manual is developed by the Department of Health (DOH) and the Health Action Information Network (HAIN) with assistance from the World Health Organization (WHO). The National Center for Disease Prevention and Control (NCDPC) of the Department of Health, together with HAIN and WHO, convened a
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Post Exposure Management (PEM) for HIV, Hepatitis B & C in Healthcare Settings
group of experts to deliberate on the development of PEP guidelines. The preparatory meetings resulted in a number of important recommendations eventually adopted and incorporated in this guideline: • Inclusion of Hepatitis B PEP and the clinical management of Hepatitis C. These two diseases share the same modes of transmission as HIV. This guideline will only cover occupational exposure of healthcare personnels in the healthcare setting.
Overview Definition and importance of PEP Post-exposure prophylaxis (PEP) is a series of immediate counseling, testing, and treatment to reduce the possibility of an infection for healthcare personnel who may have been exposed to blood-borne pathogens in the course of their works or activities.
Benefits of PEP If administered properly and immediately, PEP can reduce the risk of HIV infection by as much as 79%3 and Hepatitis B infection by 75%4. For Hepatitis C, however, PEP is largely ineffective. Instead, a post exposure management guideline will help in early detection of infection.
Risks involved in the provision of PEP A. HIV The potency of the anti-retroviral drugs to be used often leads to side effects ranging from nausea and headache to potentially fatal conditions. Non-completion of treatment or missing a dose may also lead to resistance.
Overview
With anti-retroviral drugs and a series of testing, the cost of PEP can run to approximately Php12,000.00. Given these issues, there is a need for healthcare personnels to seriously assess all factors before commencing PEP treatment.
B. Hepatitis B Hepatitis B vaccination, the premier component of Hepatitis B PEP, is relatively safe to administer. It also provides protection for up to 15 years. Typical side effects include pain in the injection site, fever, and temporary hair loss. The US Vaccine Adverse Event Reporting System recorded a low rate of anaphylaxis (1 in 600,000).
C. Hepatitis C There is no vaccine against Hepatitis C. For healthcare personnels confirmed to be infected with Hepatitis C and given interferon, they may experience flu-like symptoms. Other side effects of interferon include tiredness, hair loss, low blood count, moodiness, and depression. In severe cases, a patient may develop thyroid disease, severe depression, seizures, acute heart or kidney failure. Reminder: Strict adherence to standard precautions remains to be the best way to prevent occupational exposure to blood-borne infections.
D. Structures, policies, and supplies 1. All hospitals shall include Hepatitis B and C into the existing HIV awareness campaign conducted by the HIV and AIDS Core Team (HACT) and/or the Infection Control Committee. 2. All healthcare personnels (new entrants) employed in the clinical and ancillary departments shall be required to undergo mandatory Hepatitis B vaccination. 3. All healthcare personnels currently employed in the clinical and ancillary departments shall be given free Hepatitis B vaccination by the hospital.
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4. All cases of accidental exposure should be reported to the Infection Control Committe (ICC). It will assess and institute the decision whether to commence PEP or not. In case a hospital has a separate HIV and AIDS Core Team (HACT), it will assume responsibility for providing HIV PEP and further counseling. 5. A referral network should be developed. See attached flowchart, page 28. 6. All DOH treatment hubs should have PEP kits for HIV. Non DOH treatment hubs including private hospitals can access the PEP for HIV upon coordination with the HACT. 7. Hospitals and other health care facilities will shoulder the cost of treatment provided that the exposure occurred in the workplace and despite the healthcare provider’s strict compliance with standard precautions, and upon the joint recommendation of the ICC and HACT.
General Approaches to Management 1. Covered Health Care Personnel • Those with direct contact with patients (increased risk of sharps injuries or mucosal splash) • Those with direct contact/handling of sharps and/or bodily fluid-stained materials For direct skin exposure, consider the use of PEP especially if the healthcare provider has dermatitis, abrasion, or open wound.
2. Initial treatment / first aid • Allow wound or pricks to bleed briefly then wash it with soap and water. Antiseptic wash should only be used if there is no available clean water. • For mucosal splash, wash the exposed body part with large amount of water to flush out the fluid. • Immediately report the incident to the ICC, preferably within six hours after the exposure.
General Approaches to Management
3. Identification of exposure and assessment of risk • Characterize the exposure to blood and other potentially infectious body fluids • Identify if exposure is percutaneous, mucosal or direct skin exposure through an abraded or open wound
4. Evaluation of the source 1. Determine or evaluate source of exposure by medical history, risk behavior, & testing for Hepatitis B/C, HIV 2. If source is known infected with HIV and Hepatitis B, commence PEP immediately. For Hepatitis C commence PEM (Post Exposure Management). 3. If the status of the source is unknown, follow the treatment protocol for unknown sources/status. 4. Obtain the consent of the source to have his/her blood tested by offering counseling and treatment. 5. If the exposure is through sharps injury, it is not advisable to have the needle/device tested. Base the decision on the severity of the injury and if there is a presence of blood in the needle/device. Reminder: Confidentiality must be maintained at all times. Medical records of the source person may only be obtained through his or her physician. Counseling must precede all testing and/or treatments. Post test counseling must also be done regardless of the result.
5. Evaluation of exposed HCP • Evaluate and test exposed individual for Hepatitis B/ C & HIV • If the test is positive or if there is any clinical symptom of HIV infection at the preliminary visit, PEP should not be proposed and the patient should be referred to the nearest treatment hub.
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Post Exposure Management (PEM) for HIV, Hepatitis B & C in Healthcare Settings
Treatment Protocols 1. General guidelines • An exposed HCP must be evaluated as soon as possible, preferably during the first hours after the exposure (see HIV Algorithm). After counseling and obtaining informed consent, PEP should be initiated as soon as possible preferably within the 1st hours after exposure especially if the source is known to have HIV, PEP should not be offered beyond 72 hours after exposure. If the status of the source is unknown and there is a probable risk, start with a two-drug regimen. This may be either discontinued or modified if additional information becomes available. • Treatment is administered for four weeks. It is important to emphasize the need to complete the treatment. • All DOH treatment hubs should have at least two (2) PEP kits, while other hospitals, clinics, and laboratories should have at least one (1) kit containing the following: - Medication for the first three days, consisting of AZT and 3TC. Basic regimen may initially be given and expanded regimen may be given after further evaluation. Expanded regiment (AZT, 3TC and boosted protease inhibitors, eg lopinavir plus ritonavir) is considered if the source person is HIV infected and known to have a history of antiretroviral therapy (ART) resistance. - Pregnancy test kit (opt.) - Guidelines for both patient and doctor - Patient’s consent form for both testing and medication • If the exposed HCP refuses baseline testing and PEP, have him/her sign a waiver. • Consult the HACT chair of the nearest DOH – designated Treatment Hub if:
Treatment Protocols
- PEP initiation is delayed for more than 72 hours - HIV status of source is unknown - Exposed person is pregnant or breastfeeding - Source is known to have resistant HIV strain - There is a toxicity issue in drug selection 2. Pre-test counseling
• Discuss HIV antibody testing with the patient, including window period. • Counseling must be done in private, unless the HCP requests to have a companion. • The attending physician/counselor conducting the pretest counseling should also assess the mental and emotional status of the HCP and how he/she is going to cope with the possibility of a positive test. • Obtain the HCP’s written informed consent for baseline testing. • Extensive counseling and assistance must be provided to lessen the exposed person’s anxiety. • Exposed person should be advised on taking appropriate measures to prevent the possibility of transmission to other persons. • Strict confidentiality must be maintained at all times.
3. Testing (baseline and follow-up) • Baseline testing for HIV serology must be conducted to assess infection status at the time of exposure. Repeat testing at three months and six months. • Perform the following basic tests: FBS, CBC, BUN, Creatinine, ALT, ALS, and Urinalysis • Repeat basic tests two weeks after the commencement of PEP. If toxicity becomes evident, modify the treatment. • Watch out for: - hyperglycemia if regimen includes Protease Inhibitor - hemolytic anemia, crystalluria, hematuria if regimen includes Indinavir
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4. Post Test Counseling • All HCPs who underwent baseline testing must be given a post test counseling regardless of the result. • If the test is positive, provide the HCP with an initial emotional support. Make the necessary arrangement to refer the HCP to appropriate organizations or institutions providing counseling and support when needed. • Before commencing PEP treatment, all issues regarding PEP must be explained to the exposed person (risks involved, follow-up testing, and window period)
5. Drug selection • The decision to use a two- or three-drug combination should be based on the magnitude of risk, medical history, and other circumstances that may be affected by taking the prescribed medicines. (e.g., person is pregnant or breastfeeding). Whenever possible, expert advice must be sought when deciding on which medicines to be given. • The following medicines should not be prescribed to pregnant women: efavirenz, didanosine and stavudine combination, and Indinavir due to possible adverse effects on both the woman and the child. • Other drugs that are not recommended: abacavir, delavirdine, zalcitabine, and nevirapine. • Adverse reactions to drugs are the common reasons for discontinuing the treatment. Drugs without any contraindications may be prescribed to minimize the side effects. • Refer to page 20 for a listing of ARVs, its recommended dosages, advantages, and disadvantages.
6. Follow-up • Exposed person should be encouraged to report any acute illnesses during the follow-up period.
Treatment Protocols
A. HIV Step 1: Evaluation of Exposure & Risk Assessment* Type of Exposure Percutaneous Exposure Mucocutaneous Exposure
Table 1. Type of Exposure
More severe
Less Severe
Large bore hollow needle (<18 gauge), deep injury, or visible blood on needle/ device
Solid needle or s u p e r f i c i a l i n j u r y, no visible blood on needle/ device
Major splash
Few drops
Table 2. Risk Assessment High Risk Moderate Risk
Procedure
Materials
Low Risk
Probability of contact with blood and other body fluids, large volume mucosal splash, uncontrolled bleeding
Probability of contact with blood, mucosal splash unlikely
Low risk of contact with blood, mucosal splash unlikely
Blood or bloody body fluids
Cerebro-spinal fluid; pleural, pericardial, peritoneal, amniotic and vaginal or seminal fluids,
Urine, stool, nasal secretions, sputum, tears, vomitus (if not bloody)
Note: Tables 1 and 2 were adapted from Guidelines on Hospital-based Care for Patients with HIV/AIDS & Safe Practices and Procedures published by the Department of Health and the Philippine National AIDS Council and the February 2006 edition of â&#x20AC;&#x153;A pocket guide to adult HIV/AIDS treatment,â&#x20AC;? published by the US Health Resources and Services Administration)
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Post Exposure Management (PEM) for HIV, Hepatitis B & C in Healthcare Settings
HIV Algorithm EXPOSURE Is source material blood, bloody fluid, other potentially infectious material or an instrument contaminated with one of these substances?
YES
NO
NO PEP needed
What type of exposure?
Mucous membrane or skin integrity compromised (eg. Dermatitis, open wound)
Volume
Small e.g. few drops, short duration
Large e.g. several drops, major blood splash &/ longer duration (several minutes or more
Percutaneous exposure
Severity
Less Severe e.g. solid needle, scratch
Intact skin only
More Severe e.g. large-bore hollow needle, deep puncture, visible blood, needle used in blood vessel of source
Treatment Protocols
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Step 2: Determine the HIV Status of Source STATUS OF SOURCE Determined after proper counseling & testing
HIV POSITIVE
Low Titer Exposure Asymptomatic & high CD4 count, low VL (<1500 copies per ml)
For Percutaneous exposure and large volume mucosal exposure: START PEP For small volume mucosal exposure: PEP not recommended but may be given on request. Continue with Hepatitis B and C screening
High Titer Exposure advanced AIDS, primary HIV, high viral load or low CD4 count
For any Mucosal and Percutaneous exposure: START PEP Continue with Hepatitis B and C screening
HIV UNKNOWN
For percutaneous and large volume mucosal exposure: PEP not warranted, generally. Consider PEP if high risk factors present (eg. Setting in which exposure to HIVinfected person is likely) For small volume mucocutaneous exposure: NO PEP needed, Continue with Hepatitis B and C screening
HIV NEGATIVE
NO PEP needed. Continue with Hepatitis B and C screening
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Post Exposure Management (PEM) for HIV, Hepatitis B & C in Healthcare Settings
B. HEPATITIS B 1. General guideline • HCP should be given standard vaccination before employment. • Check for antibody titer against HBsAg one to two months after the completion of the three-dose vaccination. • Determine if source of exposure is positive for Hepatitis B. • If possible, determine anti-HBs titer of completely vaccinated HCP.
2. Post – Exposure Management (including PEP) for Hepatitis B Treatment Vaccination/Ab Response of workers Source is HBsAg Source is HBsAg Positive Negative
Source unknown or not available for testing
Unvaccinated
HBIG (0.06mL/ kg IM) x 1 + Vaccinate vaccine (0.5mL)
Vaccinate
Vaccinated – responder (Adequate anti- HBs > 10mIU/ mL
NO PEP
NO PEP
NO PEP
Vaccinated – nonresponder
HBIG (0.06mL/ kg IM) x 1 and revaccinated or HBIG (0.06mL/ kg IM) x 2 (at time of exposure and one month after exposure
NO PEP
If known high risk treat as HBsAg positive
Source: US Public Health Service Guidelines for the Management of Occupa.tional Exposures to HIV, Hepatitis B, and Hepatitis C. September 30, 2005
Treatment Protocols
•
Source is known to be positive: - If HCP has no prior Hepatitis B vaccination or did not respond to a previous complete Hepatitis B vaccination series, provide the HCP with both HBIG and hepatitis vaccine, preferably within 24 hours after the exposure. Administer HBIG and vaccine in separate injection sites. The vaccine series should be completed. - If HCP is known non-responder after a 2nd vaccine series, give 2 doses HBIG 1 month apart. - If HCP is yet to complete the vaccination series at the time of exposure, complete the series and give the appropriate dose of HBIG - If HCP responded favorably (developed anti-HBs titers >10mIU/mL) to a previous vaccination series, no additional vaccine dose is needed. - If HCP completed a previous vaccination series but did not undergo a post-vaccination testing, give a single vaccine booster dose. Test for anti-HBs titers after one month.
• Status of source is unknown - If HCP has no prior vaccination, commence the first dose of the vaccination within 24 hours of the exposure. Consider HBIG if source is high risk. - If HCP is not yet completely vaccinated, complete the vaccine series. The vaccine series should be completed. Test for anti-HBs titers after one month. - If HCP has completed the series, no further treatment is required. • Source is known to be negative: - If HCP is unvaccinated, initiate vaccine series - If HCP is yet to complete the vaccination series at the time of exposure, complete the series. - If HCP completed a previous vaccination, no treatment is needed. • If HCP is known to be positive, refer to a specialist for a close follow-up.
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Post Exposure Management (PEM) for HIV, Hepatitis B & C in Healthcare Settings
3. Recommended vaccination dosage and schedule Vaccine Type*
Preparation*
Dosage
Hepatits B Vaccine (recombinant DNA)
10mcg/0.5mL monodose vial (IM) (pediatric)
3 doses at 0,1,6 months
20mcg/mL monodose vial (IM) (adult) (For more than 10 years old)
3 doses at 0,1,6 months
*Source: PNDF Vol.1, 7th Ed. 2008
C . HEPATITIS C Post Exposure Management 1. Testing • If possible, conduct a baseline testing for anti-HCV of the source person. • Baseline and follow-up testing for exposed HCP should include the following: - Baseline testing for anti-HCV and ALT activity - Follow up testing for anti-HCV and ALT activity at four to six months - For a quicker diagnosis, conduct an HCV RNA test at four to six weeks. - If the anti-HCV test yields a positive result, check for ALT (alanine aminotransferase) level. A high ALT level indicates liver inflammation. 2. Treatment • An HCP who tested positive and who has a high level of ALT should be referred to a specialist. • Pegylated interferon and ribavirin has a response rate of 40% to 80%. Interferon monotherapy may be substituted for ribavirin if there is a contraindication.
Treatment Protocols
Appendices A. Consent to Medical Treatment Form I, _____________________________________, acknowledge that I have received education and counseling on PEP for HIV, Hepatitis B and C. I also acknowledge that Dr._______________________________________ has explained the potential benefits, the limitations, the possible side effects, and the contraindications of the medicines that are being offered to me. I further acknowledge that Dr. _________________________ has explained to me the modalities of the treatments.
Having understood all of the above, I agree to take the baseline HIV and Hepatitis B testing and the so-called post exposure prophylaxis.
__________________________ Signature of Patient
________________________
Place, date and time
__________________________
________________________
Witness (signature and name)
Place, date, and time
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Post Exposure Management (PEM) for HIV, Hepatitis B & C in Healthcare Settings
B. Waiver Form
I, _____________________________________, acknowledge that I have received and education and counseling on PEP for HIV, Hepatitis B and C. I also acknowledge that Dr.______________________________________ has explained the potential benefits, the limitations, the possible side effects, and the contraindications of the medicines that are being offered to me. I further acknowledge that Dr. _________________________ has explained to me the modalities of the treatments. Having understood all of the above, I refuse to take the so-called post exposure prophylaxis. I understand that my refusal absolves the (Name of hospital, clinic, or laboratory) _________________________ ______________________________ from any liabilities that might arise later on.
__________________________ Signature of Patient
________________________
__________________________ Signature of Patient
__________________________ Witness (signature and name)
Place, date and time
________________________
Place, date and time
________________________ Place, date, and time
Appendices
B. Basic and expanded HIV PEP regimen ARV Regimen
Dosing
Advantages
Disadvantages
BASIC REGIMEN I. Preferred Basic Regimen* ZDV: 300 mg twice daily, with food; total: 600 mg ZDV: 300 mg tablet daily Zidovudine (ZDV; AZT) + lamivudine (3TC)
3TC: 150 mg tablet 3TC: 300 mg once daily or Fixed Drug 150 mg twice Combination (FDC) daily tablet, 300 mg ZDV + 150 mg 3TC FDC: one tablet twice daily
ZDV associated with decreased risk for HIV transmission
Side effects (especially nausea and fatigue) common and might result in low adherence
•ZDV used more often than other drugs for PEP for health-care personnel (HCP)
•Source-patient virus resistance to this regimen possible
•Serious toxicity rare when used for PEP
•Potential for delayed toxicity (oncogenic/ teratogenic) unknown
•Side effects predictable and manageable with antimotility and anti emetic agents •Can be used by pregnant HCP II. Alternative Basic Regimens Tenofovir DF (TDF) TDF: 300 mg + lamivudine (3TC) once daily TDF: 300 mg tablet 3TC: 300 mg once daily or 3TC: see above 150 mg twice daily
3TC: see above
TDF
•TDF
Same class warnings as nucleoside reverse transcriptase inhibitors (NRTIs)
Convenient dosing (single pill once daily) Resistance profile activity against certain thymidine analogue mutations Well tolerated
Drug interactions Increased TDF concentrations among persons taking atazanavir and lopinavir/ ritonavir; need to monitor patients for TDF-associated toxicities Preferred dosage of atazanavir if used with TDF: 300 mg + ritonavir 100 mg once daily + TDF 300 mg once daily
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Post Exposure Management (PEM) for HIV, Hepatitis B & C in Healthcare Settings
Lamivudine 3TC: 300 mg (3TC) + stavudine once daily or (d4T) 150 mg twice daily 3TC: see above d4T: 30 mg PO d4T: 30 mg tablet every 12 hours irrespective of FDC: 3TC 150 body weight mg + d4T 30 mg tablets FDC: 1 tablet PO every 12 hours
3TC: see above d4T:
Possibility that source-patient virus is resistant to this regimen Potential for delayed toxicity (oncogenic/teratogenic) unknown
EXPANDED REGIMEN I. Preferred Expanded Regimen* Basic regimen plus: Lopinavir/ ritonavir (LPV/ RTV)
LPV/RTV: 2 tablets PO every 12 hours
Potent HIV protease inhibitor Generally welltolerated
Lopinavir 200 mg / ritonavir 50 mg tablets
Potential for serious or lifethreatening drug interactions Might accelerate clearance of certain drugs, including oral contraceptives(requiring alternative or additional contraceptive measures for women taking these drugs) Can cause severe hyperlipidemia, especially hypertriglyceridemia GI (e.g., diarrhea) events common
II. Alternative Expanded Regimens Basic regimen plus: Saquinavir (SQV) + ritonavir (RTV) SQV: 200 mg capsule RTV: 100 mg capsule
SQV 1,000 mg (five capsules) + RTV 100 mg, twice daily
Generally welltolerated, although GI events common
Potential for serious or lifethreatening drug interactions â&#x20AC;˘Substantial pill burden
Appendices
Basic regimen plus: Indinavir (IDV) + ritonavir (RTV)
IDV 800 mg + RTV 100 mg twice daily without regard to food
Potent HIV inhibitor
Potential for serious or lifethreatening drug interactions Serious toxicity (e.g., nephrolithiasis) possible; consumption of 8 glasses of fluid/day required Hyperbilirubinemia common; must avoid this drug during late pregnancy
IDV: 400 mg capsule
Requires acid for absorption and cannot be taken simultaneously with ddl, chewable/dispersible buffered tablet formulation (doses must be separated by > 1 hour)
RTV: 100 mg capsule Basic regimen plus: Nelfinavir (NFV) NFV: 250 or 625 mg tablet
NFV: 1,250 mg (2 x 625 mg or 5 x 250 mg tablets), twice daily with a meal
Generally welltolerated
Diarrhea or other GI events common Potential for serious and/or lifethreatening drug interactions
Basic regimen plus: Efavirenz (EFV) EFV: 50, 100, 200 capsules â&#x20AC;˘EFV: 600 mg tablet
EFV: 600 mg daily, at bedtime
Does not require phosphorylation before activation and might be active earlier than other antiretroviral agents (a theoretic advantage of no demonstrated clinical benefit) Once daily dosing
Drug associated with rash (early onset) that can be severe and might rarely progress to Stevens-Johnson syndrome â&#x20AC;˘Differentiating between early drug-associated rash and acute seroconversion can be difficult and cause xtraordinary concern for the exposed person Central nervous system side effects (e.g., dizziness, somnolence, insomnia, or abnormal dreaming) common; severe psychiatric symptoms possible (dosing before bedtime might minimize these side effects) Teratogen; should not be used during pregnancy Potential for serious or life-threatening drug interactions
*Source: WHO/ILO Guidelines on PEP for HIV Prevention 2007 ANTIRETROVIRAL AGENTS GENERALLY NOT RECOMMENDED FOR USE AS PEP
1. Nevirapine (NVP)
2. Zalcitabine (ddC)
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Post Exposure Management (PEM) for HIV, Hepatitis B & C in Healthcare Settings
C. Flow of Network Referral Accidental Occupational Exposure
Is the hospital capable of instituting PEP?
YES
Follow steps as stated in the treatment algorithm
NO
Collect appropriate samples from source Refer exposed HCP with source sample to the Regional Hospital or treatment hub nearest to the health care facilities Perform screening process on the referred HCP and source sample Follow-up exposed HCP for assessment of response to PEP. (For Hepatitis B where vaccines are available, the Regional Hospital shall determine the level of response and institute follow-up procedures and refer accordingly if procedures are not available.
Appendices
D. General Algorithm FOR HCP Exposure to potentially infectious material
Follow first aid procedures
Report incident to HACT and/ or ICC. Include the following details: - employee identification - date, time and place of exposure - details of exposure including amount and type of fluid or material and severity of exposure - circumstances surrounding the exposure FOR HACT/ ICC Refer to PEP algorithms for HIV, Hepatitis B and Hepatitis C
E. Indicators for Evaluating the Post – Exposure Management (PEM) for HIV, Hepatitis B and Hepatitis C (to be collated by CMPS from HACT and ICC annually) 1. Numbers of HCP (Health Care Personnel) who seek evaluation for PEM 2. Numbers of HCP qualified for PEP for HIV and Hepatitis B 3. Number of HCP prescribed PEP for HIV and Hepatitis B 4. Number of HCP completed the PEP for HIV and Hepatitis B
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Post Exposure Management (PEM) for HIV, Hepatitis B & C in Healthcare Settings
Directories LIST of TREATMENT HUBS
Contact Details
Point Person
Quiricada St., Sta. Cruz, Manila Department of Health Compound, FILINVEST Corporate City, Alabang, Muntinlupa City
(02) 7438301 local 6000
HACT Leader
(02) 8072628 local 208; 5668807
HACT Leader
Philippine General Hospital (PGH)
Taft Ave., Manila
(02) 5673394
HACT Leader
Ilocos Training and Regional Medical Center (ITRMC)
San Fernando City, La Union
(072) 2421143 local 122
HACT Leader
Baguio General Hospital and Medical Center (BGHMC)
BGHMC Compound, Baguio City
(074) 4422012; 4423165
HACT Leader
Bicol Regional Training and Teaching Hospital (BRTTH)
Legaspi City, Bicol
(052) 4830015
HACT Leader
Cagayan Valley Medical Center
Tuguegarao City, Cagayan Valley
Jose B. Lingad Memorial Medical Center
San Fernando City, Pampanga
Treatment Hub
Address
LUZON San Lazaro Hospital (SLH) Research Institute for Tropical Medicine (RITM)
VISAYAS
(078) 8467240; 8443789 (045) 9613921; 961 - 3380
HACT Leader HACT Leader
Vicente Sotto Sr. Memorial Medical Center (VSSMMC)
B. Rodriguez St., Cebu City
(032) 2537564
HACT Leader
Western Visayas Medical Center (WVMC)
Mandurriao, Iloilo City
(033) 3212841 to 50
HACT Leader
Directories
Corazon Locsin Montelibano Memorial Regional Hospital (CLMMRH)
Lacson St., Bacolod City
(034) 4351591 local 226; 4332697
HACT Leader
Davao Medical Center
J.P. Laurel Ave., Davao City
(082) 2244915 / 2221347
HACT Leader
Zamboanga City Medical Center
Dr. Evangelista St., Sta. Catalina, Zamboanga City
(062) 9910573
HACT Leader
MINDANAO
LIST OF DOH REGIONAL HOSPITALS (As of FEBRUARY 27, 2008)
CHD FOR ILOCOS
ILOCOS TRAINING AND REGIONAL MEDICAL CENTER San Fernando, La Union
Dr. FRANCISCO A. VALDEZ Chief of Hospital III
BAGUIO GENERAL HOSPITAL AND MEDICAL CENTER BGHMC Cmpd., Baguio City
Dr. MANUEL V. FACTORA Medical Center Chief I
CHD FOR CORDILLERA
CHD FOR CAGAYAN VALLEY VETERANS REGIONAL HOSPITAL Bayombong, Nueva Vizcaya
Dr. CIRILO GALINDEZ Chief of Hospital III
(072) 700-1766; 7003719 (075) 242-1143
(074) 442-3165; 4424080; 523-6077 (075) 523-4103 (F) (078) 321-3561 to 64; 321-3560 (F) 805-3560 (F)
CHD FOR CENTRAL LUZON JOSE B. LINGAD MEMORIAL REGIONAL HOSPITAL San Fernando, Pampanga
Dr. VENANCIO BANZON Chief of Hospital III
(045) 961-3921; 9613380
CHD FOR SOUTHERN TAGALOG (CALABARZON-A) BATANGAS REGIONAL HOSPITAL Batangas City
Dr. RENATO DIMAYUGA Chief of Hospital III
(043) 723-0165; 7230517
CHD FOR SOUTHERN TAGALOG (MIMAROPA-B) OSPITAL NG PALAWAN Puerto Princesa City
Dr. GLORIFINO JUAN Medical Center Chief I
(048) 434-6864 (TF); 433-2721; 433-2981; 433-2982; 434-6199
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Post Exposure Management (PEM) for HIV, Hepatitis B & C in Healthcare Settings
CHD FOR BICOL
BICOL REGIONAL TRAINING AND TEACHING HOSPITAL Legaspi City CORAZON LOCSIN MONTELIBANO MEMORIAL REGIONAL HOSPITAL Bacolod City
Dr. ROGELIO RIVERA Chief of Hospital III
CHD FOR WESTERN VISAYAS Dr. EPIFANIA SIMBUL OIC Chief of Hospital III
(052) 483-0017; 4830886 (TL); 483-0015 (034) 433-2697; 4351591
CHD FOR CENTRAL VISAYAS
VICENTE SOTTO MEMORIAL MEDICAL CENTER Cebu City
Dr. GERARDO AQUINO Chief of Hospital III
(032) 253-9882 to 91; 253-2592
CHD FOR EASTERN VISAYAS EASTERN VISAYAS REGIONAL MEDICAL CENTER Tacloban City
Dr. ALBERTO DE LEON Chief of Hospital III
(053) 321-3129; 3218724; 321-3363
CHD FOR WESTERN MINDANAO ZAMBOANGA CITY MEDICAL CENTER Zamboanga City
Dr. ROMEO A. ONG Chief of Hospital III
(062) 991-2934; 9910537; 992-2832;9930565; 993-2555
CHD FOR NORTHERN MINDANAO
HILARION A. RAMIRO SR. REGIONAL AND TEACHING HOSPITAL Ozamis City
Dr. JESUS MARTIN SANCIANGCO Chief of Hospital II
088 521-0022
CHD FOR SOUTHERN MINDANAO DAVAO REGIONAL HOSPITAL Tagum, Davao del Norte
Dr. ROMULO BUSUEGO Chief of Hospital III
(084) 217-3347; 2182823; 400-3050
CHD FOR CENTRAL MINDANAO COTABATO REGIONAL MEDICAL CENTER Sinsuat Ave., Cotabato City
CARAGA REGIONAL HOSPITAL - Surigao City
Dr. HELEN P. YAMBAO Chief of Hospital III
CHD FOR CARAGA Dr. PONCIANO S. LIMCANGCO-Chief of Hospital III
(064) 421-2194; 4212340; 421-2373 (064) 421-2192 (F) mc12@mozcom.com
(086) 231-7090; 826-3157; 826-2459
Directories
References: 4th AIDS Medium Term Plan 2005 – 2010. Published by the Philippine National AIDS Council, with assistance from UNAIDS. 4th AIDS Medium Term Plan 2005 – 2010 and Operation Plan 2007 – 2008. Published by the Philippine National AIDS Council, with assistance from UNAIDS. A pocket guide to adult HIV/AIDS treatment February 2006 edition. Available online: http://www.hrsa.gov/tools/HIVpocketguide/PktGPEP.html Date accessed: July 14, 2007 Clinical Management of HIV Infection in the Philippines. Published by the Philippine National AIDS Council. Frequently Asked Questions About Hepatitis C. Available online: http:// www.cdc.gov/ncidod/diseases/hepatitis/c/faq.htm Date accessed: September 8, 2007 Guidelines on hospital-based care for patients with HIV/AIDS & safe practices and procedures. Prepared by the Department of Health through the Philippine National AIDS Council. Panlilio A., Cardo, D., Grohskopf L. Heneine W., and Ross C.S. Updated US Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Post Exposure Prophylaxis. MMWR September 30, 2005. Available online: http://www.cdc.gov/mmwr/ preview/mmwrhtml/r5409a1.htm Date accessed: July 11, 2007 Puro V., De Carli G., Cicalini S., Soldani F., Balslev U., Begovac J., and al. European recommendations for the management of healthcare workers occupationally exposed to hepatitis B virus and hepatitis C virus. Euro Surveill 2005;10(10):260-4. Available online: http://www.eurosurveillance. org/em/v10n10/1010-226.asp Date accessed: August 16, 2007 Standards in Infection Control for Healthcare Facilities. Published by the Department of Health, 2005. Sexually Transmitted Diseases Treatment Guidelines 2006. Available online: http://www.cdc.gov/std/treatment/2006/hepatitis-b.htm#hepb7 Date accessed: Aug 22, 2007 Treatment after exposure to HIV. Available online: http://www.aids.org/Factsheets/156-Treatment-After-Exposure-to-HIV-PEP. html Date accessed: June 26, 2007
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Post Exposure Management (PEM) for HIV, Hepatitis B & C in Healthcare Settings
Updated US Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Post Exposure Prophylaxis. MMWR June 29, 2001. Available online: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5011a1.htm Date accessed: July 11, 2007 Online reference tools http://www.nlm.nih.gov/medlineplus/mplusdictionary.html www.aidsinfo.nih.gov Philippine National Drug Formulary (PNDF). Essentail Drugs List Vol.1 7th Ed. 2008 Joint WHO/ILO guidelines on Post â&#x20AC;&#x201C; Exposure Prophylaxis to Prevent HIV Infection. 2007 The Sanford Guide to Antimicrobial Therapy 2008.
TECHNICAL WORKING GROUP Dr. Mario S. Baquilod Medical Officer VII Infectious Disease Office, NCPDC - DOH Dr. Jose Gerard Belimac Program Manager National AIDS/STI Prevention and Control Program (NASPCP)
Dr. Jimmy Mynardo Mendigo Medical Specialist II Ilocos Training & Regional Medical Center Dr. Emerose F. Moreno Medical Specialist II CHD - IVB - DOH Mimaropa
Dr. Sebar S. Sala Mr. Joel D. Atienza Medical Officer Supervising Health Program Officer Zamboanga City Medical Center NASPCP Dr. Nerissa Isabel Sescon Dr. Rosario Jessica T. Abrenica Medical Specialist Medical Specialist III Remedios AIDS Foundation, Inc. San Lazaro Hospital Head, HIV/AIDS Pavilion Dr. Charissa Fay Corazon B. Tabora Medical Specialist III Dr. Dorothy D. May Agdamag Research Institute for Tropical Medicine Program Manager Tropical Disease Foundation Dr. Elizabeth Freda Telan Medical Specialist I Mr. Garre R. Garcia STD/AIDS Cooperative Central Laboratory Vice-President (SACCL)/ San Lazaro Hospital National Reference Pinoy Plus Association Laboratory