Evolving Models of HIV Care

In collaboration with:

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

This activity is supported by an independent educational grant from Gilead Sciences, Inc.

MEDICAL COMMUNICATIONS INQUIRIES info@integritasgrp.com integritasgrp.com

Jonathan A. Colasanti, MD, MSPH

FACULTY

FACULTY

Cochair Assistant Professor of Medicine, Infectious Diseases Emory University School of Medicine Assistant Professor of Medicine, Global Health Rollins School of Public Health at Emory University Associate Medical Director of the Infectious Diseases Program Grady Health System Atlanta, Georgia

Jason Halperin, MD, MPH Cochair Assistant Professor of Medicine Tulane University School of Medicine Physician, CrescentCare New Orleans, Louisiana

Paul E. Sax, MD

Faculty Advisor Professor of Medicine Harvard Medical School Clinical Director, Division of Infectious Diseases and HIV Program Brigham and Women’s Hospital Boston, Massachusetts

3

FACULTY

FACULTY

Richard A. Elion, MD

Associate Clinical Professor of Internal Medicine George Washington University Medical Director, Center for Athletic Performance Enhancement (CAPE) Washington, District of Columbia

Joseph J. Eron Jr., MD

Professor of Medicine Chief, Division of Infectious Diseases University of North Carolina at Chapel Hill Chapel Hill, North Carolina

Serena P. Koenig, MD, MPH

Assistant Professor of Medicine, Harvard Medical School Associate Physician, Division of Global Health Equity and Division of Infectious Diseases Brigham and Women’s Hospital Boston, Massachusetts

Mary W. Montgomery, MD

Instructor, Harvard Medical School Associate Physician, Infectious Diseases Division Brigham and Women’s Hospital Boston, Massachusetts

Allan E. Rodriguez, MD

Professor of Clinical Medicine University of Miami Miller School of Medicine Miami, Florida

Sarah Rowan, MD

Assistant Professor of Medicine Division of Infectious Diseases and General Internal Medicine University of Colorado Denver Associate Director of HIV and Viral Hepatitis Prevention Denver Public Health Denver, Colorado

4

TARGET AUDIENCE

FACULTY

This activity is intended for infectious diseases and human immunodeficiency virus (HIV)– specialist physicians and other clinicians and stakeholders involved in the care of patients with HIV infection.

STATEMENT OF NEED/PROGRAM OVERVIEW

Best-practice recommendations for treatment of patients infected with human immunodeficiency virus (HIV) are continually evolving and now include strategies related to early initiation of antiretroviral therapy (ART) in patients with newly diagnosed HIV.1 Rapid, same-day ART initiation protocols offer a promising option for improving linkage to HIV care, decreasing time to viral suppression, and improving long-term viral suppression.2 Shorter time to viral suppression is associated with improved short-term and long-term outcomes for people living with HIV, and benefits the community by decreasing the period in which individuals have transmittable virus.3 Implementation of same-day ART requires a sustained emphasis on the importance of viral suppression for HIV prevention, as well as technical and logistical assistance for its implementation.4 Further, rapid-ART protocols and services must be accompanied by innovative strategies to promote retention in care, especially within vulnerable populations.5 Geared to the needs of HIV-specialist clinicians, this HIV Experts and Evidence™ live meeting series will present recent data related to rapid ART initiation, solutions to logistical and clinical barriers that can impede access to sameday ART regimens, and real-world approaches to enhanced retention in care.

REFERENCES

1. U.S. Department of Health and Human Services. Guidelines for Use of Antiretroviral Agents in HIV-1−Infected Adults and Adolescents Living with HIV. Last reviewed and updated October 25, 2018. https://aidsinfo.nih.gov/ guidelines/html/1/adult-and-adolescent-arv/0. Accessed February 11, 2019.

2. Pilcher CD, et al. The effect of same-day observed initiation of antiretroviral therapy on HIV viral load and treatment outcomes in a US public health setting. J Acquir Immune Defic Syndr. 2017;74(1):44-51.

3. The INSIGHT START Study Group. Initiation of antiretroviral therapy in early asymptomatic HIV infection. N Engl J Med. 2015;373(9):795-807.

4. Colasanti J, et al. Implementation of a rapid entry program decreases time to viral suppression among vulnerable persons living with HIV in the southern United States. Open Forum Infect Dis. 2018;5(6):ofy104.

5. Coffey S, et al. RAPID ART: High virologic suppression rates with immediate ART initiation in a vulnerable urban clinic population AIDS . 2018 [Epub ahead of print].

5

PROGRAM AGENDA

• Getting to Zero: Ending the HIV Epidemic • Early, Sustained Viral Suppression—A Key Disease-Management and Prevention Strategy • Rapid Antiretroviral Therapy (ART) Initiation: Operationalizing Early Viral Suppression • Addressing Barriers to Rapid Start

PREAMBLE

• Manage This Patient: An Interactive Case-Based Activity • Concluding Comments: Looking Forward—Will You Have a Rapid ART Initiation Protocol in Place in 1 Year?

EDUCATIONAL OBJECTIVES

After completing this activity, the participant should be better able to:

• Reduce time from HIV diagnosis to viral suppression to improve patient outcomes and prevent HIV transmission • Select appropriate regimens for rapid ART initiation based on current guidelines and patient characteristics • Implement strategies designed to decrease barriers to the provision of rapid ART to patients with newly diagnosed HIV infection

PHYSICIAN ACCREDITATION STATEMENT

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Global Education Group (Global) and Integritas Communications. Global is accredited by the ACCME to provide continuing medical education for physicians.

PHYSICIAN CREDIT DESIGNATION

Global Education Group designates each activity in this live series for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

6

NURSING CONTINUING EDUCATION

Global Education Group is accredited with distinction as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

This educational activity for 1.5 contact hours is provided by Global Education Group. Nurses should claim only the credit commensurate with the extent of their participation in the activity.

PHARMACIST ACCREDITATION STATEMENT

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

PREAMBLE

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 - 0530-9999-19-053-L02-P) This is a knowledge-based activity.

GLOBAL CONTACT INFORMATION

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

INSTRUCTIONS TO RECEIVE CREDIT

To receive credit for this activity, submit a completed activity posttest and evaluation form at the conclusion of the program. You will be emailed a certificate within 3 weeks. If you do not receive your credit at that time, please contact cme@globaleducationgroup.com. For ACPE learners, please check the CPE monitor for your CE credit within 60 days of the activity.

FEE INFORMATION AND REFUND/CANCELLATION POLICY 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.

7

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: Jonathan A. Colasanti, MD, MSPH

Nothing to disclose

PREAMBLE

Richard A. Elion, MD Grant/Research Support: Gilead Sciences, Inc; Honoraria: Gilead Sciences, Inc., ViiV Healthcare; Speakers Bureau: Gilead Sciences, Inc. Joseph J. Eron, Jr, MD Consultant/Independent Contractor: Gilead Sciences, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., ViiV Healthcare; Grant/Research Support: The University of North Carolina receives research funding for clinical trials on which Dr. Eron is funded as an investigator from Gilead Sciences, Inc., Janssen Pharmaceuticals, Inc., and ViiV Healthcare Jason Halperin, MD, MPH

Nothing to disclose

Serena P. Koenig, MD, MPH

Nothing to disclose

Mary W. Montgomery, MD

Nothing to disclose

Allan E. Rodriguez, MD

Nothing to disclose

Sarah Rowan, MD

Grant/Research Support: Gilead Sciences, Inc.

Paul E. Sax, MD Consultant/Independent Contractor: AbbVie Inc., Bristol-Myers Squibb, Gilead Sciences, Inc., GlaxoSmithKline/ViiV Healthcare, Janssen Pharmaceuticals, Inc., Merck & Co., Inc.; Grant/ Research Support: Bristol-Myers Squibb, Gilead Sciences, Inc., GlaxoSmithKline/ViiV Healthcare, Merck & Co., Inc. 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: Ashley Marostica, RN, MSN

Nothing to disclose

Lindsay Borvansky

Nothing to disclose

Andrea Funk

Nothing to disclose

Liddy Knight

Nothing to disclose

Ashley Cann

Nothing to disclose

Jeanette Ruby, MD

Nothing to disclose

Jim Kappler, PhD

Nothing to disclose

8

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 do not recommend the use of any agent outside of the labeled indications.

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.

9

PREAMBLE

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.

SLIDES

10

SLIDES

11

SLIDES

12

SLIDES

13

SLIDES

14

SLIDES

15

SLIDES

16

SLIDES

17

SLIDES

18

SLIDES

19

SLIDES

20

SLIDES

21

SLIDES

22

SLIDES

23

SLIDES

24

SLIDES

25

SLIDES

26

SLIDES

27

SLIDES

28

SLIDES

29

SLIDES

30

SLIDES

31

SLIDES

32

SLIDES

33

SLIDES

34

SLIDES

35

CLINICAL PRACTICE GUIDELINES »»Guidelines for Managing Advanced HIV Disease and Rapid Initiation of Antiretroviral Therapy.

World Health Organization, 2017. http://apps.who.int/iris/bitstream/handle/10665/255884/9789241550062-eng. pdf;jsessionid=0A6E5E725ED06FB8819CD33465F107D0?sequence=1

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

US Department of Health and Human Services, 2017 (last updated March 2019). https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/0

»»HIV Testing Guidelines.

Centers for Disease Control and Prevention (CDC), 2018. https://www.cdc.gov/hiv/guidelines/testing.html

CLINICAL RESOURCES »»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

»»AIDSVu.

RESOURCE CENTER

Emory University Rollins School of Public Health, Gilead Sciences, Inc., and the Center for AIDS Research at Emory University (CFAF), 2018. http://map.aidsvu.org/map

»»AtlasPlus Presentation Slides: HIV Diagnoses by County, 2014.

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC. https://www.cdc.gov/nchhstp/atlas/slides/images/New-diseases-slide-17.jpg.

»»Database of Antiretroviral Drug Interactions.

HIV InSite. University of California, San Francisco, 2018. http://hivinsite.ucsf.edu/interactions

»»Harm Reduction Coalition. http://harmreduction.org/

36

»»HEP Drug Interactions.

University of Liverpool, last reviewed March 2019. https://www.hep-druginteractions.org/

»»Status of State Medicaid Expansion Decisions: Interactive Map.

Kaiser Family Foundation, 2019. https://www.kff.org/medicaid/issue-brief/status-of-state-medicaid-expansion-decisionsinteractive-map/.

PATIENT RESOURCES »»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 PrEP. https://www.cdc.gov/hiv/basics/index.html

»»Project Inform

Project Inform provides up-to-date information to help people living with HIV and HCV make the best choices regarding their treatment and care.

Hepatitis C and HIV Coinfection Booklets https://www.projectinform.org/coinfection/ Sex-C: Sex and Hepatitis C Prevention Tips for Gay Men https://www.projectinform.org/sex-c/ Sexual Transmission of Hepatitis C: A Guide for HIV-Positive Gay Men https://www.projectinform.org/pdf/hcvtoolkit_patient_transmission.pdf 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 MSM and transgender people. https://www.positivelyaware.com/

37

RESOURCE CENTER

»»Positively Aware

SMARTPHONE PILL-REMINDER APPS (FREE) »»Mango Health — Medicine Manager, Pill Reminder

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

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

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

SUGGESTED READING »»Effects of a multicomponent intervention to streamline initiation of antiretroviral therapy in Africa: a stepped-wedge cluster-randomised trial.

Amanyire G, et al. Lancet HIV. 2016;3(11):e539-e548. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5408866/pdf/nihms814293.pdf

»»RAPID ART: high virologic suppression rates with immediate ART initiation in a vulnerable urban clinic population.

RESOURCE CENTER

Coffey S, et al. AIDS. 2018. [Epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/30585846

»»Antiretroviral therapy for the prevention of HIV-1 transmission.

Cohen MS, et al. N Engl J Med. 2016;375(9):830-839. https://www.nejm.org/doi/pdf/10.1056/NEJMoa1600693

»»Prevention of HIV-1 infection with early antiretroviral therapy.

Cohen MS, et al. N Engl J Med. 2011;365(6):493-505. https://www.nejm.org/doi/pdf/10.1056/NEJMoa1105243

38

»»A rapid entry program in the South: improving access to care and time to viral suppression.

Colasanti J, et al. 25th Conference on Retroviruses and Opportunistic Infections (CROI) 2018; March 4−7, 2018; Boston, MA. Poster 1109. http://www.croiconference.org/sites/default/files/posters-2018/1430_Colasanti_1109.pdf

»»Continuous retention and viral suppression provide further insights into the HIV care continuum compared to the cross-sectional HIV care cascade.

Colasanti J, et al. Clin Infect Dis. 2016;62(5):648-654. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4741359/pdf/civ941.pdf

»»HIV viral load and transmissibility of HIV infection: undetectable equals untransmittable.

Eisinger RW, et al. JAMA. 2019;321(5):451-452. https://jamanetwork.com/journals/jama/fullarticle/2720997

»»Linkage and antiretroviral therapy within 72 hours at a federally qualified health center in New Orleans.

Halperin J, et al. AIDS Patient Care STDS. 2018;32(2):39-41. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5808385/pdf/apc.2017.0309.pdf

»»Rapid HIV care cuts time to viral suppression in half.

Schoen J, Gallagher G. Healio Infect Dis News. 2018. https://www.healio.com/infectious-disease/hiv-aids/news/online/%7B335314a8-2d5940ce-85f1-b7ccd7ea9930%7D/rapid-hiv-care-cuts-time-to-viral-suppression-in-half INSIGHT START Study Group. N Engl J Med. 2015;373(9):795-807. https://www.nejm.org/doi/pdf/10.1056/NEJMoa1506816

»»Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: a randomized unblinded trial.

Koenig SP, et al. PLoS Med. 2017;14(7):e1002357. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5526526/pdf/pmed.1002357.pdf

39

RESOURCE CENTER

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

»»Effect of offering same-day ART vs usual health facility referral during home-based HIV testing on linkage to care and viral suppression among adults with HIV in Lesotho: the CASCADE randomized clinical trial.

Labhardt ND, et al. JAMA. 2018;319(11):1103-1112. https://jamanetwork.com/journals/jama/article-abstract/2674479?redirect=true

»»Association of implementation of a universal testing and treatment intervention with HIV diagnosis, receipt of antiretroviral therapy, and viral suppression in East Africa.

Petersen M, et al. JAMA. 2017;317(21):2196-2206. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5734234/?report=printable

»»The effect of same-day observed initiation of antiretroviral therapy on HIV viral load and treatment outcomes in a U.S. public health setting.

Pilcher CD, et al. J Acquir Immune Defic Syndr. 2017;74(1):44-51. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5140684/pdf/nihms800557.pdf

»»Initiating antiretroviral therapy for HIV at a patient’s first clinic visit: the RapIT randomized controlled trial.

Rosen S, et al. PLoS Med. 2016;13(5):e1002015. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4862681/pdf/pmed.1002015.pdf

»»Trends in the San Francisco human immunodeficiency virus epidemic in the “Getting to Zero” era.

Scheer S, et al. Clin Infect Dis. 2018;66(7):1027-1034. https://academic.oup.com/cid/article/66/7/1027/4584392

»»A trial of early antiretrovirals and isoniazid preventive therapy in Africa.

TEMPRANO ANRS 12136 Study Group. N Engl J Med. 2015;373(9):808-822. https://www.nejm.org/doi/pdf/10.1056/NEJMoa1507198

»»Pooled week 48 efficacy and baseline resistance: B/F/TAF in treatment-naïve patients.

White K, et al. CROI 2018. March 4−7, 2018; Boston, MA. Abstract 532. http://www.croiconference.org/sites/default/files/posters-2018/1430_White_532.pdf

40

NOTES

41

NOTES

42

Please visit the CLINICAL RESOURCE CENTER for additional information and resources

ExchangeCME.com/HIVART19

Š 2019 Global Education Group and Integritas Communications. All rights reserved.

No part of this syllabus may be used or reproduced in any manner whatsoever without written permission except in the case of brief quotations embedded in articles or reviews.