HIV Experts & Evidence™: Evolving Models of HIV Care by Integritas Communications

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

ACTIVITY CO-CHAIRS FACULTY

Jonathan A. Colasanti, MD, MSPH

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 of the Grady Health System Atlanta, Georgia

Paul E. Sax, MD

Professor of Medicine Harvard Medical School Clinical Director, Division of Infectious Diseases and HIV Program Brigham and Womenâ&#x20AC;&#x2122;s Hospital Boston, Massachusetts

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 The University of North Carolina (UNC) School of Medicine Director, Clinical Core UNC Center for AIDS Research Adjunct Professor of Epidemiology, Gillings School of Global Public Health Vice Chief, Division of Infectious Diseases Vice Chair, AIDS Clinical Trials Group (ACTG) National Institutes of Health (NIH) HIV Research Network Chapel Hill, North Carolina

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

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 Womenâ&#x20AC;&#x2122;s Hospital Boston, Massachusetts

Vincent C. Marconi, MD

FACULTY

Professor of Medicine Division of Infectious Diseases, Department of Medicine Emory University School of Medicine Professor of Global Health Rollins School of Public Health at Emory University Director, HIV Research Program Atlanta VA Medical Center Atlanta, Georgia

Mary W. Montgomery, MD

Instructor, Harvard Medical School Associate Physician, Infectious Diseases Division Brigham and Womenâ&#x20AC;&#x2122;s Hospital Boston, Massachusetts

Allan E. Rodriguez, MD

Professor of Clinical Medicine Director of Behavioral/Social Science & Community Outreach Core Miami Center for AIDS Research Division of Infectious Diseases University of Miami Miller School of Medicine Miami, Florida

Sarah Rowan, MD

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

TARGET AUDIENCE

This activity is intended for infectious diseases clinicians and other HIV treaters, as well as primary care providers (PCPs) and other community stakeholders involved in the care of patients with HIV infection.

EDUCATIONAL OBJECTIVES

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

PREAMBLE

• Help patients achieve viral suppression quickly after HIV diagnosis to optimize long-term patient outcomes and reduce the risk of HIV transmission • Select appropriate regimens for same-day ART or expedited ART based on current efficacy and safety data • Implement strategies designed to overcome barriers to the provision of rapid ART to patients with newly diagnosed HIV infection

STATEMENT OF NEED/PROGRAM OVERVIEW

Best practice recommendations for treatment of patients infected with HIV are continually evolving and now include strategies related to early initiation of antiretroviral therapy (ART).1 The results of pivotal clinical trials have demonstrated not only the benefits of early and continuous ART for long-term health outcomes in people living with HIV,2,3 but also a profound decrease in HIV transmission.4 Same-day HIV diagnosis and treatment approaches have been developed to minimize the rate of attrition that occurs in the interval between diagnosis and initiation of ART, and to address the barriers that often lead to delayed treatment.5 Although the body of literature documenting the success and feasibility of same-day–start protocols is growing,6 most HIV-care clinicians are not fully aware of the benefits of these strategies, and even fewer provide patients with an opportunity to initiate rapid, same-day ART regimens. Geared to the needs of HIV-specialist clinicians, this HIV Experts and Evidence™ live meeting series will present updates to the national HIV elimination goals, review recent data related to rapid ART initiation, and offer solutions to logistical and clinical barriers that can impede patient access to appropriate same-day ART regimens for new HIV infections.

REFERENCE

1. The Office of National AIDS Policy. National HIV/AIDS strategy for the United States: updated to 2020. 2015. https:// obamawhitehouse.archives.gov/sites/default/files/docs/national_hiv_aids_strategy_update_2020.pdf. Accessed March 7, 2018. 2. The INSIGHT START Study Group. Initiation of antiretroviral therapy in early asymptomatic HIV infection. N Engl J Med. 2015;373(9):795-807. 3. The SMART Study Group. CD4+ count-guided interruption of antiretroviral treatment. N Engl J Med. 2006;355(22):2283-2296. 4. Cohen MS, et al. Antiretroviral therapy for the prevention of HIV-1 transmission. N Engl J Med. 2016;375(9):830-839. 5. Geng EH, Havlir DV. The science of rapid start—from the when to the how of antiretroviral initiation. PLoS Med. 2017;14(7):e1002358. 6. Pilcher CD, et al. The effect of same-day observed initiation of antiretroviral therapy on HIV viral load and treatment outcomes in a U.S. public health setting. J Acquir Immune Defic Syndr. 2017;74(1):44-51.

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.

Global Education Group designates this a Live series for a maximum of 1.0 AMA PRA Category 1 Creditâ&#x201E;˘. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nursing Continuing Education

Global Education Group is accredited with distinction as a provider of continuing nursing education by the American Nurses Credentialing Centerâ&#x20AC;&#x2122;s Commission on Accreditation. This educational activity for 1.0 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.

Credit Designation

Global Education Group designates this continuing education activity for 1.0 contact hour(s) (0.10 CEUs) of the Accreditation Council for Pharmacy Education. (Universal Activity Number - 0530-9999-18-170-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.

PREAMBLE

Physician Credit Designation

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.

FEE INFORMATION AND REFUND/CANCELLATION POLICY There is no fee for this educational activity.

PREAMBLE

DISCLOSURE OF CONFLICTS OF INTEREST

Global Education Group (Global) requires instructors, planners, managers and other individuals and their spouse/life partner 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: Jonathan A. Colasanti, MD, MSPH

Nothing to disclose

Paul E. Sax, MD Consultant/Independent Contractor: AbbVie, Bristol-Myers Squibb, Gilead Sciences, Inc., GlaxoSmith Kline/ViiV Healthcare, Merck, Janssen; Grant/Research Support: Bristol-Myers Squibb, Gilead Sciences, Inc., Glaxo-Smith Kline/ViiV Healthcare, Merck Richard A. Elion, MD Grant/Research Support: Gilead Sciences, Inc.; Honoraria: Gilead Sciences, Inc., ViiV Healthcare; Speakerâ&#x20AC;&#x2122;s Bureau: Gilead Sciences, Inc. Joseph J. Eron, Jr, MD Consultant/Independent Contractor: Gilead Sciences, Janssen, Merck, 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 â&#x20AC;&#x201C; from Gilead Sciences, Inc., Janssen and ViiV Healthcare Jason Halperin, MD, MPH

Nothing to disclose

Serena P. Koenig, MD, MPH

Nothing to disclose

Vincent C. Marconi, MD Grant/Research Support: Gilead Sciences, Inc., ViiV Healthcare Mary W. Montgomery, MD

Nothing to disclose

Allan E. Rodriguez, MD

Nothing to disclose

Sarah Rowan, MD

Grant/Research Support: Gilead Sciences, Inc.

Ashley Marostica, RN, MSN

Nothing to disclose

Lindsay Borvansky

Nothing to disclose

Andrea Funk

Nothing to disclose

Liddy Knight

Nothing to disclose

Jeanette Ruby, MD

Nothing to disclose

Jim Kappler, PhD

Nothing to disclose

PREAMBLE

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:

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 manufacturerâ&#x20AC;&#x2122;s product information, and comparison with recommendations of other authorities.

SLIDES

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 2018). https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/0

»»HIV Testing Guidelines.

Centers for Disease Control and Prevention, 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.

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

RESOURCE CENTER

»»Database of Antiretroviral Drug Interactions. HIV InSite. University of California, San Francisco, 2018. http://hivinsite.ucsf.edu/interactions

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

»»HEP Drug Interactions.

University of Liverpool, 2018. https://www.hep-druginteractions.org/

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

»»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

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

Colasanti J. 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.

RESOURCE CENTER

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

»»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, et al. Healio Infectious Disease 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

»»Initiation of antiretroviral therapy in early asymptomatic HIV infection. 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 S, et al. PLoS Med. 2017;14(7):e1002357. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5526526/pdf/pmed.1002357.pdf

»»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. Peterson 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

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

RESOURCE CENTER

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

»»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 treatmentnaïve patients. White KL, et al. 25th Conference on Retroviruses and Opportunistic Infections (CROI), 2018. March 4−7, 2018; Boston, MA Abstract 532. http://www.croiconference.org/sites/default/files/posters-2018/1430_White_532.pdf

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/

RESOURCE CENTER

Sexual Transmission of Hepatitis C: A Guide for HIV-Positive Gay Men https://www.projectinform.org/pdf/hcvtoolkit_patient_transmission.pdf

»»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 MSM and transgender people. https://www.positivelyaware.com/

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

RESOURCE CENTER

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

NOTES 38

Please visit the CLINICAL RESOURCE CENTER for additional information and resources

ExchangeCME.com/HIVARTResources18

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.