Real-World Issues in HIV Prevention & Treatment

This activity is jointly provided by Global Education Group and Integritas Communications.

This activity is supported by an educational grant from Gilead Sciences, Inc. A satellite symposium held in conjunction with APhA2018.

In collaboration with The American Academy of HIV Medicine (AAHIVM).

MEDICAL COMMUNICATIONS INQUIRIES info@integritasgrp.com integritasgrp.com

JENNIFER COCOHOBA, PharmD, BCPS, AAHIVP

FACULTY

FACULTY

Professor of Clinical Pharmacy University of California, San Francisco School of Pharmacy Pharmacist, UCSF Women’s HIV Program San Francisco, California

Dr. Jennifer Cocohoba is Professor of Clinical Pharmacy at the University of California, San Francisco (UCSF) School of Pharmacy. Her academic responsibilities include educating health professional students on HIV pharmacotherapy, on monitoring and improving adherence, and on communications skills. A Board-Certified Pharmacotherapy Specialist and American Academy of HIV Medicine–credentialed pharmacist, she also serves as a faculty advisor and research mentor for the UCSF student-run free clinic, the Mabuhay Health Center.

Dr. Cocohoba is the clinical pharmacist for the UCSF Women’s HIV Program (WHP), a novel trauma-informed primary care HIV clinic, where she conducts medication therapy management and HIV regimen consultations, quality improvement initiatives, and research. Her research interests involve antiretroviral pharmacoepidemiology and national guideline concordance, chronic opioid use in persons living with HIV, sex-related HIV treatment disparities, and pharmacy-based interventions to improve medication adherence in underserved populations.

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DAN SCALES, PharmD FACULTY

Owner/Founder Scales’ Pharmacy Denver, Colorado

Dr. Dan Scales is the founder and operator of Scales’ Pharmacy in Denver, Colorado. After getting his doctor of pharmacy degree in 2007 from Butler University in Indianapolis, Indiana, he moved to Denver. There he managed community pharmacies for a major chain in environments that ranged from slow suburban neighborhoods to high traffic urban locations. In 2013, Dr. Scales ventured out with an elite, hand-selected team to open a practice focusing on HIV care and prevention, with an emphasis on innovative care delivery and community involvement.

Since the opening of Scales’ Pharmacy, Dr. Scales has been deeply involved with the State of Colorado’s strategy for care and prevention of HIV and sexually transmitted diseases as part of the Colorado AIDS Drug Assistance Program (ADAP) working group. He has also secured the State’s ADAP contract and helped create the pharmacy-based HIV testing programs being developed by the Centers for Disease Control and Prevention.

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ELYSE TUNG, PharmD, BCACP FACULTY

Clinical Assistant Professor University of Washington School of Pharmacy Director of Clinical Services Kelley-Ross Pharmacy—The Polyclinic Seattle, Washington

Dr. Elyse Tung is the Director of Clinical Services at Kelley-Ross Pharmacy in Seattle, Washington. Since 2009, she has worked on establishing innovative pharmacy practices including the first PrEP clinic managed by a pharmacist in a community pharmacy setting in 2015. Her previous experience also includes establishing a pharmacist-managed anemia clinic, travel clinic, and a transitionsof-care clinic in a senior care center. In 2014 she received the Washington State Pharmacy Association Innovative Pharmacy Practice Award.

Dr. Tung is also a Clinical Assistant Professor at the University of Washington School of Pharmacy. Prior to accepting this position, she completed her pharmacy practice residency at Swedish Medical Center in Seattle, and worked at Overlake Senior Care Center in Bellevue, Washington.

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TARGET AUDIENCE

The educational design of this activity addresses the needs of clinical pharmacists and other pharmacy staff involved in the care of patients with, or at risk of, human immunodeficiency virus (HIV) infection.

PREAMBLE

EDUCATIONAL OBJECTIVES

Upon completion of this activity, participants will be better able to: • Describe current HIV epidemiologic trends that inform universal HIV screening, identification of at-risk individuals, HIV prevention strategies, and HIV-care engagement strategies • Apply CDC guidelines for identification of individuals at risk for HIV acquisition and determination of preexposure prophylaxis (PrEP) eligibility • Demonstrate appropriate antiretroviral therapy (ART)–regimen selection at various stages of HIV treatment, including treatment initiation, treatment failure or viral resistance, and regimen simplification for long-term viral suppression • Provide patient education and support for optimized PrEP/ART effectiveness and safety

STATEMENT OF NEED/PROGRAM OVERVIEW

HIV incidence in the United States has recently declined, while advances in antiretroviral therapy (ART) have improved the longevity and quality of life of many people living with HIV.1,2 Nevertheless, opportunities to expand the capacity for HIV prevention and management abound. The Centers for Disease Control and Prevention (CDC) has issued updated guidance on HIV preexposure prophylaxis (PrEP) for certain high-risk cohorts.3-5 Additionally, evidence-based guidelines related to HIV testing and the comprehensive care of HIV-infected patients are updated frequently.6 Given the increasingly busy environments of most health care settings, it is not surprising that providers are challenged to stay abreast of the latest best-practice recommendations. Moreover, the resulting gaps in HIV care are often exacerbated by limitations in access to health care. Accessibility and fundamental skill sets make pharmacists well-positioned to improve comprehensive and collaborative efforts for HIV prevention and management.7 In this Evidence-Based Best Practices program, expert faculty will discuss the potential roles of pharmacists in testing for HIV infection, identifying patients who are eligible for PrEP, and selecting ART regimens for individuals living with HIV. The overall goal is to improve the ability of practicing pharmacists to engage in multidisciplinary and longitudinal HIV prevention and treatment strategies.

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REFERENCES

1. CDC Fact Sheet. HIV Incidence: Estimated Annual Infections in the U.S., 2008-2014. Overall and by Transmission Route. https://www.cdc.gov/nchhstp/newsroom/docs/factsheets/hiv-incidence-fact-sheet_508. pdf. Accessed January 26, 2018.

2. CDC. Understanding the HIV Care Continuum. 2017. https://www.cdc.gov/hiv/pdf/library/factsheets/cdc-hivcare-continuum.pdf. Accessed January 26, 2018.

3. CDC. USPHS Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2014. https://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf. Accessed January 26, 2017.

4. Grant RM, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.

N Engl J Med. 2010;363(27):2587-2599.

5. Baeten J, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399-410.

PREAMBLE

6. US Department of Health and Human Services (DHHS). Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescentarv/0. Updated 2018.

7. Schafer JJ, et al. ASHP guidelines on pharmacist involvement in HIV care. Am J Health Syst Pharm.

2016;73(7):468-494.

PROGRAM AGENDA 6:00 pm–6:30 pm

Registration and Dinner

6:30 pm–6:35 pm

Welcome and Preactivity Assessment Dan Scales, PharmD

6:35 pm–6:45 pm

The Critical Need for Pharmacy-Based Services Across the HIV Care Continuum Dan Scales, PharmD

6:45 pm–7:15 pm

Pharmacy-Based Primary HIV Prevention Elyse Tung, PharmD, BCACP

7:15 pm–7:45 pm

P harmacists’ Roles in Evolving HIV-Care Models: Consultation, Care, and Monitoring Jennifer Cocohoba, PharmD, BCPS, AAHIVP

7:45 pm–8:00 pm

Postactivity Assessment and Expert Q&A Session Dan Scales, PharmD

PHARMACIST ACCREDITATION STATEMENT

Global Education Group is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

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CREDIT DESIGNATION

Global Education Group designates this continuing education activity for 1.5 contact hours (0.15 CEUs) of the Accreditation Council for Pharmacy Education.

(Universal Activity Number – 0530-9999-17-442-L01-P) This is a knowledge-based activity.

PREAMBLE

For information about the accreditation of this program, please contact Global at 303-395-1782 or cme@globaleducationgroup.com.

INSTRUCTIONS TO RECEIVE CREDIT

In order to receive credit for this activity, submit a completed activity evaluation form at the conclusion of the program. We will upload your credit to the NABP CPE Monitor Service within 3 weeks. Please check your profile around April 7, 2018. If you do not see your credit at that time, please contact cme@globaleducationgroup. com prior to May 10, 2018.

FEE INFORMATION

There is no fee for this educational activity.

DISCLOSURE OF CONFLICTS OF INTEREST

Global Education Group (Global) requires instructors, planners, managers, and other individuals and their spouses/life partners who are in a position to control the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted by Global for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations.

The faculty reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this CME activity: Jennifer Cocohoba, PharmD, BCPS, AAHIVP Has nothing to disclose Dan Scales, PharmD

Has nothing to disclose

Elyse Tung, PharmD, BCACP Honoraria and Speakers Bureau: Gilead Sciences, Inc.

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The planners and managers reported the following financial relationships or relationships to products or devices they or their spouses/life partners have with commercial interests related to the content of this CME activity: Lindsay Borvansky

Nothing to disclose

Andrea Funk

Nothing to disclose

Ashley Marostica, RN, MSN

Nothing to disclose

Jim Kappler, PhD

Nothing to disclose

Jeanette Ruby, MD

Nothing to disclose

PREAMBLE

DISCLOSURE OF UNLABELED USE

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the US Food and Drug Administration. Global Education Group (Global) and Integritas Communications do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of any organization associated with this activity. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

DISCLAIMER

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed in this activity should not be used by clinicians without evaluation of patient conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

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CLINICAL PRACTICE GUIDELINES

»»ASHP Guidelines on Pharmacist Involvement in HIV Care.

Schafer JJ, et al. Am J Health Syst Pharm. 2016;73(7):468-494. https://www.researchgate.net/publication/299358491_ASHP_Guidelines_on_ Pharmacist_Involvement_in_HIV_Care

»»Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents.

US Department of Health and Human Services, 2017. https://aidsinfo.nih.gov/contentfiles/lvguidelines/adult_oi.pdf

»»Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living With HIV.

US Department of Health and Human Services, 2017. https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-treatment-guidelines/0/

»»Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. Centers for Disease Control and Prevention, 2014. https://stacks.cdc.gov/view/cdc/23447

»»Screening Guidelines for Non–AIDS-defining Cancers in HIV-Infected Individuals.

Mani D, Aboulafia DM. Curr Opin Oncol. 2013;25(5):518-525. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4581521/pdf/nihms-699505.pdf

»»STD and HIV Screening Recommendations.

RESOURCE CENTER

Centers for Disease Control and Prevention, 2017. https://www.cdc.gov/std/prevention/screeningreccs.htm

»»Updated PrEP Clinical Practice Guideline and PrEP Clinical Providers’ Supplement—2017.

Centers for Disease Control and Prevention, 2017. https://www.cdc.gov/hiv/pdf/guidelines/PrEPGL2017_CommentNotice.pdf

»»US Public Health Service: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2014. A Clinical Practice Guideline.

Centers for Disease Control and Prevention, 2014. https://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf

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CLINICAL RESOURCES

»»American Academy of HIV Medicine | Supporting the HIV Care Provider and the Profession. https://aahivm.org/

»»Brief Sexual History Tool.

Centers for Disease Control and Prevention. https://www.cdc.gov/actagainstaids/pdf/campaigns/hssc/hssc_sexualhistorytool_v4.pdf

»»Database of Antiretroviral Drug Interactions.

HIV Insite. University of California, San Francisco. http://arv.ucsf.edu/insite?page=ar-00-02

»»HIV Drug Interactions.

University of Liverpool (Web site), 2017. http://www.hiv-druginteractions.org/checker

»»HIV in the United States by Geography.

Centers for Disease Control and Prevention, 2017. https://www.cdc.gov/hiv/statistics/overview/geographicdistribution.html

»»PrEP Kit.

AIDS United, 2015. https://www.aidsunited.org/data/files/Site_18/PrEP_Kit_Dec15_final.pdf

»»Provider Information Sheet: PrEP During Conception, Pregnancy, and Breastfeeding.

Centers for Disease Control and Prevention. https://www.cdc.gov/hiv/pdf/prep_gl_clinician_factsheet_pregnancy_english.pdf

RESOURCE CENTER

»»State HIV Laws.

Centers for Disease Control and Prevention, 2017. https://www.cdc.gov/hiv/policies/law/states/

»»Taking a Sexual History.

NYC Health, 2015. https://www1.nyc.gov/assets/doh/downloads/pdf/csi/csi-prep-pep-sex-history.pdf

»»Transgender Health Learning Center.

University of California, San Francisco, 2018. http://transhealth.ucsf.edu/trans?page=lib-00-00 47

PATIENT RESOURCES

»»HIV Risk Reduction Estimator.

Centers for Disease Control and Prevention, 2017. https://wwwn.cdc.gov/hivrisk/

»»Centers for Disease Control and Prevention (CDC): HIV Basics.

The CDC is a division within the US Department of Health and Human Services (DHHS), the principal agency for protecting the health of all Americans. This comprehensive site provides extensive links to topics across the HIV-care continuum, including preexposure prophylaxis (PrEP). https://www.cdc.gov/hiv/basics/index.html

»»Positively Aware.

Positively Aware, created by TPAN (Test Positive Aware Network), is a source of HIV-treatment news for consumers, as well as an educational tool for HIV caregivers. The site features PrEP resources, including videos for men who have sex with men and transgender people. https://www.positivelyaware.com/

»»PrEP for U.S. Women: A Collection of Resources.

HIVE provides preconception and prenatal care and resources for women and couples affected by HIV. https://www.hiveonline.org/prep4women/

SMARTPHONE APPS (FREE)

»»Mango Health — Medicine Manager, Pill Reminder

RESOURCE CENTER

iPhone https://itunes.apple.com/us/app/mango-health-medication-manager/ id560657279?mt=8 Android https://play.google.com/store/apps/details?id=com.mangohealth.mango&hl=en

»»Medisafe — Medicine Manager, Pill Reminder iPhone https://itunes.apple.com/il/app/id573916946?mt=8

Android https://play.google.com/store/apps/details?id=com.medisafe.android.client

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SUGGESTED READING »»Removing the stigma of HIV.

American Pharmacists Association, 2017. https://www.pharmacist.com/article/removing-stigma-hiv

»»Antiretroviral prophylaxis for HIV prevention in heterosexual men and women.

Baeten JM, et al. N Engl J Med. 2012;367(5):399-410. http://www.nejm.org/doi/full/10.1056/NEJMoa1108524#t=article

»»Evaluating the impact of a pharmacist-led antiretroviral stewardship program on reducing drug interactions in HIV-infected patients.

Billedo JAS, et al. J Int Assoc Provid AIDS Care. 2016;15(1):84-88. http://journals.sagepub.com/doi/pdf/10.1177/2325957415600700

»»Benefit of continuous/immediate ART on disease risk: SMART & START combined analysis.

Borges AH, et al. 24th Conference on Retroviruses and Opportunistic Infections; February 13−16, 2017; Seattle, WA. Abstract 474. http://www.croiconference.org/sites/default/files/posters-2017/474_Borges.pdf

»»Pharmacists as providers of HIV pre-exposure prophylaxis.

Bruno C, Saberi P. Int J Clin Pharm. 2012;34(6):803-806. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3501608/pdf/nihms415425.pdf

»»Frequency of HIV testing and time from infection to diagnosis improve.

Centers for Disease Control and Prevention, 2017. https://www.cdc.gov/media/releases/2017/p1128-frequency-hiv-testing.html Centers for Disease Control and Prevention, 2012. https://www.cdc.gov/nchhstp/newsroom/2012/nhtdpressrelease2012.html

»»Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, doubleblind, placebo-controlled phase 3 trial.

Choopanya K, et al. Lancet. 2013;381(9883):2083-2090. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)61127-7/abstract

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RESOURCE CENTER

»»Innovative CDC effort expands HIV testing into pharmacies.

»»Pharmacist-provided rapid HIV testing in two community pharmacies.

Darin KM, et al. J Am Pharm Assoc (2003). 2015;55(1):81-88. http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.670.7159&rep=rep1&type=pdf

»»Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.

Grant RM, et al. N Engl J Med. 2010;363(27):2587-2599. http://www.nejm.org/doi/full/10.1056/NEJMoa1011205#t=article

»»90-90-90: An ambitious treatment target to help end the AIDS epidemic.

Joint United Nations Programme on HIV/AIDS (UNAIDS), 2014. http://www.unaids.org/sites/default/files/media_asset/90-90-90_en.pdf

»»Assessment of the benefits of and barriers to HIV pharmacist credentialing.

McLaughlin M, et al. J Am Pharm Assoc (2003). 2018 [In press]. http://www.japha.org/article/S1544-3191(17)31033-6/pdf

»»Initiation of antiretroviral therapy in early asymptomatic HIV infection.

RESOURCE CENTER

The INSIGHT START Study Group. N Engl J Med. 2015;373(9):795-807. http://www.nejm.org/doi/pdf/10.1056/NEJMoa1506816

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RECOMMENDED AND ALTERNATIVE HIV ANTIRETROVIRAL THERAPY (ART) REGIMENS FOR TREATMENT-NAIVE PATIENTS Recommended Initial ART Regimens for Most People With HIV

Recommended regimens have demonstrated durable virologic efficacy, favorable tolerability and toxicity profiles, and high ease of use.

INSTI + 2 NRTIs • DTG/ABC/3TCa (evidence rating: AI)—if HLA-B*5701–negative • DTG + tenofovirb/FTCa (AI for both TAF/FTC and TDF/FTC) • EVG/c/tenofovirb/FTC (AI for both TAF/FTC and TDF/FTC) • RALc + tenofovirb/FTCa (AI for TDF/FTC; AII for TAF/FTC) Boosted PI + 2 NRTIs In general, boosted DRV is preferred over boosted ATV • (DRV/c or DRV/r) + tenofovirb/FTCa (AI for DRV/r; AII for DRV/c) • (ATV/c or ATV/r) + tenofovirb/FTCa (BI) • (DRV/c or DRV/r) + ABC/3TCa—if HLA-B*5701–negative (BII) • (ATV/c or ATV/r) + ABC/3TCa—if HLA-B*5701–negative and HIV RNA <100,000 copies/mL (CI for ATV/r and CIII for ATV/c) NNRTI + 2 NRTIs • EFV + tenofovirb/FTCa (BI for EFV/TDF/FTC and BII for EFV + TAF/FTC) • RPV/tenofovirb/FTCa (BI)—if HIV RNA <100,000 copies/mL and CD4 >200 cells/µL INSTI + 2 NRTIs • RALc + ABC/3TCa (CII)—if HLA-B*5701–negative and HIV RNA <100,000 copies/mL Regimens to Consider When ABC, TAF, and TDF Cannot Be Usedd • DRV/r + RAL (BID) (CI)—if HIV RNA <100,000 copies/mL and CD4 >200 cells/µL • LPV/r + 3TCa (BID)e (CI) 3TC may be substituted for FTC, or vice versa, if a non–fixed-dose NRTI combination is desired.bTAF and TDF are two forms of tenofovir approved by the FDA. TAF has fewer bone and kidney toxicities than TDF, while TDF is associated with lower lipid levels. Safety, cost, and access are among the factors to consider when choosing between these drugs.cRAL can be given as 400 mg BID or 1200 mg (two 600mg tablets) once daily.dSeveral other NRTI-limiting treatment strategies are under investigation. eLPV/r plus 3TC is the only boosted PI plus 3TC regimen with published 48-week data in a randomized controlled trial in ART-naive patients. Limitations of LPV/r plus 3TC include twice-daily dosing, high pill burden, and greater rates of gastrointestinal side effects than other PIs. /, Indicates that components are available as coformulations; 3TC, lamivudine; ABC, abacavir; ART, antiretroviral therapy; ATV, atazanavir; ATV/c, atazanavir/cobicistat; ATV/r, atazanavir/ritonavir; BID, twice daily; CD4, CD4 T lymphocyte; DRV, darunavir; DRV/c, darunavir/cobicistat; DRV/r, darunavir/ritonavir; DTG, dolutegravir; EFV, efavirenz; EVG, elvitegravir; EVG/c, elvitegravir/cobicistat; FDA, Food and Drug Administration; FTC, emtricitabine; HLA, human leukocyte antigen; INSTI, integrase strand transfer inhibitor; LPV/r, lopinavir/ritonavir; NNRTI, non-nucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; RAL, raltegravir; RPV, rilpivirine; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.

US Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living With HIV. 2017. Updated October 17, 2017. www.aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/11/what-to-start.

Accessed February 8, 2018. a

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Recommended Initial ART Regimens in Certain Clinical Situations

2016 IAS–USA PANEL RECOMMENDATIONS: ANTIRETROVIRAL THERAPY (ART) REGIMENS FOR THE TREATMENT OF HIV INFECTION IN ADULTS Recommended initial ART regimens (listed in alphabetic order

by InSTI component) • Dolutegravir/abacavir/lamivudine (evidence rating AIa) • Dolutegravir plus TAF/emtricitabine (AIa)b • Elvitegravir/cobicistat/TAF/emtricitabine (AIa)b • Raltegravir plus TAF/emtricitabine (AIII)

——HLA-B*5701 testing should be performed prior to abacavir use (AIa); those who test positive should not be given abacavir (AIa) ——TDF/FTC is not recommended for individuals with or at risk of kidney or bone disease (osteopenia or osteoporosis; BIII)

Recommended initial ART regimens for individuals in whom an InSTI is not an option (listed in alphabetic order by non-InSTI component)

RESOURCE CENTER

• Darunavir (boosted) plus TAF (or TDF)/emtricitabine or abacavir/lamivudine (AIa)b • Efavirenz/TDF/emtricitabine (AIa) • Rilpivirine/TAF (or TDF)/emtricitabine (AIa)b

——Initial 2-drug regimens are recommended only in rare situations in which a patient cannot take abacavir, TAF, or TDF (BIa) ——HIV-infected pregnant women should initiate ART for their own health and to reduce the likelihood of HIV transmission to their infants (AIa)c ——For HIV-infected patients with hepatitis B virus coinfection, initiate ART that contains TDF or TAF (AIa), lamivudine or emtricitabine, and a third component (AIa) —— Entecavir may be used to treat hepatitis B virus infection (AIII). If HIV RNA is not suppressed, entecavir should be avoided because it can select for drug-resistant HIV (AIII) ——HIV-infected patients with hepatitis C virus coinfection should initiate ART with drugs that do not have significant drug interactions with hepatitis C virus therapies (AIIa) ——TDF is not recommended for patients with osteopenia or osteoporosis (BIII) ——Monitoring for development of kidney disease with estimated glomerular filtration rate, urinalysis, and testing for glycosuria and albuminuria or proteinuria is recommended when ART is initiated or changed and every 6 months (along with HIV RNA) once HIV RNA is stable (BIII) ——TDF should be avoided or dose adjusted in patients with a creatinine clearance rate below 60 mL/min (AIa) ——TAF is not recommended in patients with a creatinine clearance rate below 30 mL/min (AIa) ——TDF or TAF should be discontinued if a patient’s renal function worsens, particularly if there is evidence of proximal tubular dysfunction (AIIa) ——HIV-infected patients with end-stage renal disease should be evaluated for kidney transplantation with expectation of high rates of patient and graft survival (AIIa)

/, Indicates that components are available as coformulations; ART, antiretroviral therapy; HCV, hepatitis C virus; InSTI, integrase strand transfer; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.

Günthard HF, et al. JAMA. 2016;316(2):191-210.

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MONITORING FOR ART-RELATED ADVERSE EFFECTS Drug Class

Adverse Effects

Lab Monitoring

Integrase inhibitors

• Insomnia/dizziness • GI effects • Creatinine elevation • Psychiatric symptoms

• Serum creatinine

Protease inhibitors

• GI symptoms • Hyperlipidemia • Insulin resistance • Fat accumulation

• AST, ALT, ALP • Lipid panel • Fasting glucose and/ or HbA1c

Nucleoside reverse transcriptase inhibitors

• Renal insufficiency • Lactic acidosis • Hepatic steatosis • Lipoatrophy • Bone abnormalities (TDF) • Hyperlipidemia (TAF)

• Serum creatinine, Ca, Mg, Ph • Urinalysis (tenofovir) • HBsAg

Non-nucleoside reverse transcriptase inhibitors

• CNS (efavirenz) • Psychiatric/insomnia/ depression (efavirenz/ rilpivirine) • Hepatotoxicity

• AST, ALT, ALP, ECG (rilpivirine)

CCR5 inhibitors

• Orthostatic hypotension • Hepatotoxicity • Myositis

• AST, ALT, ALP, CK, blood pressure

ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; Ca, calcium; CCR5, C-C chemokine receptor type 5; CK, creatine kinase; CNS, central nervous system; ECG, electrocardiogram; GI, gastrointestinal; HbA1c, glycated hemoglobin; HBsAg, hepatitis B surface antigen; Mg, magnesium; Ph, phosphorus; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.

US Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. 2017. www.aidsinfo.nih.gov/contentfiles/lvguidelines/adultandadolescentgl.pdf. Accessed February 8, 2018.

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RESOURCE CENTER

Fusion inhibitors • Injection-site reactions

NOTES

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PREAMBLE

FACULTY

Please visit the CLINICAL RESOURCE CENTER for additional information and resources

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