Archive for July 17, 2016

Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2016 Recommendations of the International Antiviral Society–USA Panel

JAMA July 12, 2016 V.316 N.2 P.191-210

Special Communication

Huldrych F. Günthard, MD; Michael S. Saag, MD; Constance A. Benson, MD; Carlos del Rio, MD; Joseph J. Eron, MD; Joel E. Gallant, MD, MPH; Jennifer F. Hoy, MBBS, FRACP; Michael J. Mugavero, MD, MHSc; Paul E. Sax, MD; Melanie A. Thompson, MD; Rajesh T. Gandhi, MD; Raphael J. Landovitz, MD; Davey M. Smith, MD; Donna M. Jacobsen, BS; Paul A. Volberding, MD

1University Hospital Zurich and Institute of Medical Virology, University of Zurich, Zurich, Switzerland

2University of Alabama at Birmingham, Birmingham

3University of California San Diego School of Medicine, San Diego

4Emory University Rollins School of Public Health and School of Medicine, Atlanta, Georgia

5University of North Carolina at Chapel Hill School of Medicine, Chapel Hill

6Southwest CARE Center, Santa Fe, New Mexico

7Alfred Hospital and Monash University, Melbourne, Australia

8Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

9AIDS Research Consortium of Atlanta, Atlanta, Georgia

10Massachusetts General Hospital and Harvard Medical School, Boston

11University of California Los Angeles

12University of California San Diego, La Jolla

13International Antiviral Society–USA, San Francisco, California

14University of California San Francisco


New data and therapeutic options warrant updated recommendations for the use of antiretroviral drugs (ARVs) to treat or to prevent HIV infection in adults.


To provide updated recommendations for the use of antiretroviral therapy in adults (aged ≥18 years) with established HIV infection, including when to start treatment, initial regimens, and changing regimens, along with recommendations for using ARVs for preventing HIV among those at risk, including preexposure and postexposure prophylaxis.


Review  A panel of experts in HIV research and patient care convened by the International Antiviral Society–USA reviewed data published in peer-reviewed journals, presented by regulatory agencies, or presented as conference abstracts at peer-reviewed scientific conferences since the 2014 report, for new data or evidence that would change previous recommendations or their ratings. Comprehensive literature searches were conducted in the PubMed and EMBASE databases through April 2016. Recommendations were by consensus, and each recommendation was rated by strength and quality of the evidence.


Newer data support the widely accepted recommendation that antiretroviral therapy should be started in all individuals with HIV infection with detectable viremia regardless of CD4 cell count. Recommended optimal initial regimens for most patients are 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (InSTI). Other effective regimens include nonnucleoside reverse transcriptase inhibitors or boosted protease inhibitors with 2 NRTIs. Recommendations for special populations and in the settings of opportunistic infections and concomitant conditions are provided. Reasons for switching therapy include convenience, tolerability, simplification, anticipation of potential new drug interactions, pregnancy or plans for pregnancy, elimination of food restrictions, virologic failure, or drug toxicities. Laboratory assessments are recommended before treatment, and monitoring during treatment is recommended to assess response, adverse effects, and adherence. Approaches are recommended to improve linkage to and retention in care are provided. Daily tenofovir disoproxil fumarate/emtricitabine is recommended for use as preexposure prophylaxis to prevent HIV infection in persons at high risk. When indicated, postexposure prophylaxis should be started as soon as possible after exposure.

Conclusions and Relevance 

Antiretroviral agents remain the cornerstone of HIV treatment and prevention. All HIV-infected individuals with detectable plasma virus should receive treatment with recommended initial regimens consisting of an InSTI plus 2 NRTIs. Preexposure prophylaxis should be considered as part of an HIV prevention strategy for at-risk individuals. When used effectively, currently available ARVs can sustain HIV suppression and can prevent new HIV infection. With these treatment regimens, survival rates among HIV-infected adults who are retained in care can approach those of uninfected adults.


July 17, 2016 at 4:30 pm

Sexual Activity Without Condoms and Risk of HIV Transmission in Serodifferent Couples When the HIV-Positive Partner Is Using Suppressive Antiretroviral Therapy

JAMA July 12, 2016 V.316 N.2 P.171-181

Alison J. Rodger, MD; Valentina Cambiano, PhD; Tina Bruun, RN; Pietro Vernazza, MD; Simon Collins; Jan van Lunzen, PhD; Giulio Maria Corbelli; Vicente Estrada, MD; Anna Maria Geretti, MD; Apostolos Beloukas, PhD; David Asboe, FRCP; Pompeyo Viciana, MD; Félix Gutiérrez, MD; Bonaventura Clotet, PhD; Christian Pradier, MD; Jan Gerstoft, MD; Rainer Weber, MD; Katarina Westling, MD; Gilles Wandeler, MD; Jan M. Prins, PhD; Armin Rieger, MD; Marcel Stoeckle, MD; Tim Kümmerle, PhD; Teresa Bini, MD; Adriana Ammassari, MD; Richard Gilson, MD; Ivanka Krznaric, PhD; Matti Ristola, PhD; Robert Zangerle, MD; Pia Handberg, RN; Antonio Antela, PhD; Sris Allan, FRCP; Andrew N. Phillips, PhD; Jens Lundgren, MD; for the PARTNER Study Group

1Research Department of Infection and Population Health, University College London, London, United Kingdom

2Department of Infectious Diseases/CHIP, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark

3Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital, St Gallen, Switzerland

4HIV i-Base, London, United Kingdom

5University Medical Center Hamburg-Eppendorf, Hamburg-Eppendorf, Germany

6European AIDS Treatment Group, Bruxelles, Belgium

7Hospital Clinico San Carlos and Universidad Complutense, Madrid, Spain

8Institute of Infection and Global Health, University of Liverpool, Liverpool, United Kingdom

9Chelsea and Westminster NHS Foundation Trust, London, United Kingdom

10Hospital Virgen del Rocío, Sevilla, Spain

11Hospital General de Elche & Universidad Miguel Hernández, Alicante, Spain

12IrsiCaixa Foundation, UAB, UVIC-UCC, Hospital Universitari “Germans Trias i Pujol,” Badalona, Catalonia, Spain

13Department of Public Health, Nice University Hospital and EA 6312, University Nice Sophia-Antipolis, France

14Rigshospitalet, Copenhagen, Denmark

15Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland

16Unit of Infectious Diseases and Dermatology, Department of Medicine, Karolinska Institutet, and Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden

17Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland

18Academic Medical Center, Amsterdam, the Netherlands

19Medical University of Vienna, Vienna, Austria

20Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland

21Department of Internal Medicine 1, University Hospital of Cologne, Cologne, Germany

22Ospedal San Paolo, Milan, Italy

23Ospedale L. Spallanzani, Roma, Italy

24Praxis Driesener Straße, Berlin, Germany

25Helsinki University Central Hospital, Helsinki, Finland

26Medical University Innsbruck, Innsbruck, Austria

27Hvidovre Universitets Hospital, Hvidovre, Denamrk

28Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain

29Coventry and Warwickshire Hospital, Coventry, United Kingdom


A key factor in assessing the effectiveness and cost-effectiveness of antiretroviral therapy (ART) as a prevention strategy is the absolute risk of HIV transmission through condomless sex with suppressed HIV-1 RNA viral load for both anal and vaginal sex.


To evaluate the rate of within-couple HIV transmission (heterosexual and men who have sex with men [MSM]) during periods of sex without condoms and when the HIV-positive partner had HIV-1 RNA load less than 200 copies/mL.

Design, Setting, and Participants 

The prospective, observational PARTNER (Partners of People on ART—A New Evaluation of the Risks) study was conducted at 75 clinical sites in 14 European countries and enrolled 1166 HIV serodifferent couples (HIV-positive partner taking suppressive ART) who reported condomless sex (September 2010 to May 2014). Eligibility criteria for inclusion of couple-years of follow-up were condomless sex and HIV-1 RNA load less than 200 copies/mL. Anonymized phylogenetic analysis compared couples’ HIV-1 polymerase and envelope sequences if an HIV-negative partner became infected to determine phylogenetically linked transmissions.


Condomless sexual activity with an HIV-positive partner taking virally suppressive ART.

Main Outcomes and Measures 

Risk of within-couple HIV transmission to the HIV-negative partner


Among 1166 enrolled couples, 888 (mean age, 42 years [IQR, 35-48]; 548 heterosexual [61.7%] and 340 MSM [38.3%]) provided 1238 eligible couple-years of follow-up (median follow-up, 1.3 years [IQR, 0.8-2.0]). At baseline, couples reported condomless sex for a median of 2 years (IQR, 0.5-6.3). Condomless sex with other partners was reported by 108 HIV-negative MSM (33%) and 21 heterosexuals (4%). During follow-up, couples reported condomless sex a median of 37 times per year (IQR, 15-71), with MSM couples reporting approximately 22 000 condomless sex acts and heterosexuals approximately 36 000. Although 11 HIV-negative partners became HIV-positive (10 MSM; 1 heterosexual; 8 reported condomless sex with other partners), no phylogenetically linked transmissions occurred over eligible couple-years of follow-up, giving a rate of within-couple HIV transmission of zero, with an upper 95% confidence limit of 0.30/100 couple-years of follow-up. The upper 95% confidence limit for condomless anal sex was 0.71 per 100 couple-years of follow-up.

Conclusions and Relevance 

Among serodifferent heterosexual and MSM couples in which the HIV-positive partner was using suppressive ART and who reported condomless sex, during median follow-up of 1.3 years per couple, there were no documented cases of within-couple HIV transmission (upper 95% confidence limit, 0.30/100 couple-years of follow-up). Additional longer-term follow-up is necessary to provide more precise estimates of risk.


July 17, 2016 at 4:28 pm

Visions for an AIDS-Free Generation: Red Ribbons of Hope

JAMA July 12, 2016 V.316 N.2 P.154-155


Preeti N. Malani, MD, MSJ

1Division of Infectious Diseases, Department of Internal Medicine, University of Michigan Health System, Ann Arbor, Michigan

2Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan

3Associate Editor, JAMA

July 12, 2016, Vol 316, No. 2 >

When the initial cases of AIDS were reported in 1981, the human immunodeficiency virus (HIV) was yet to be identified, scientists did not understand how HIV was transmitted and prevented, and effective treatment would not become available for many years.

Today, the antiretroviral armamentarium is large and increasing. Preferred regimens are well tolerated, effective, and convenient; there are no lingering questions about whether early antiretroviral therapy (ART) improves outcomes.1

However, the promise of ART is not reaching everyone. Globally, more than 37 million people are living with HIV, 20 million of whom are not receiving ART.2 Even in well-resourced health systems, linkage to care, retention in care, and adherence to medications remain major barriers to viral suppression and ultimately barriers to prevention….


July 17, 2016 at 4:27 pm

Antiretrovirals for HIV Treatment and Prevention: The Challenges of Success

JAMA July 12, 2016 V.316 N.2 P.151-153


Kenneth H. Mayer, MD; Douglas S. Krakower, MD

1The Fenway Institute, Fenway Health, Boston, Massachusetts

2Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts

3Department of Medicine, Harvard Medical School, Boston, Massachusetts

After the first case reports of AIDS were described in 1981, it soon became clear that the epidemic constituted a public health emergency. Although the first antiretrovirals were evaluated in clinical trials in the 1980s, it was not until the mid-1990s that the clinical efficacy of combination antiretroviral chemotherapy was demonstrated to prevent immunocompromise and to restore health to people living with AIDS. When the International Antiviral Society–USA (IAS-USA) published its first antiretroviral guidelines in JAMA in conjunction with the International AIDS Conference in Vancouver in 1996,1 it represented the beginning of a new era, suggesting that the pandemic might be controlled by treatment. In the current issue of JAMA, the IAS-USA presents its most recent set of guidelines,2 reflecting substantial changes over the past 20 years in the development of more potent combinations of drugs with fewer adverse effects, the advent of coformulated medications, and the evidence that antiretroviral agents have a vital role in HIV prevention…..


July 17, 2016 at 4:25 pm

Condomless Sex With Virologically Suppressed HIV-Infected Individuals: How Safe Is It?

JAMA July 12, 2016 V.316 N.2 P.149-151


Eric S. Daar, MD; Katya Corado, MD

Los Angeles Biomedical Research Institute, Division of HIV Medicine, Harbor-UCLA Medical Center, Torrance, California

The use of antiretroviral therapy (ART) across the globe has had a profound influence on the natural history of HIV infection. Although the pandemic continues to spread, one of the greatest advances in prevention since the use of ART in pregnancy to avoid vertical transmission was the recognition that the same treatment prevents horizontal transmission. Many cohorts have suggested this benefit,1,2 findings that in part led to the Swiss Commission statement in 2008 that HIV-infected individuals who have had suppressed plasma HIV RNA load for longer than 6 months and who do not have sexually transmitted infections (STIs) were not sexually infectious.3 Although the statement was controversial at the time, the cohort data were compelling, and there have been very few case reports of an HIV transmission event from a virologically suppressed person and no events identified in a systemic review of patients with suppressed plasma HIV RNA load in cohort studies and randomized controlled trials…


July 17, 2016 at 4:24 pm

Marking Time in the Global HIV/AIDS Pandemic

JAMA July 12, 2016 V.316 N.2 P.145-146


Gerald Friedland, MD

AIDS Program, Section of Infectious Diseases, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut

In June 1981, the US Centers for Disease Control and Prevention published the first case reports of the yet to be named global pandemic of HIV/AIDS. Unknown at the time of the first few reported cases, HIV had already spread widely in populations of men who had sex with men, people who injected drugs and their heterosexual partners in the United States and Europe, and in large populations of men, women, and children in Africa. Since that date of first recognition, the magnitude and consequences of the US and global HIV pandemic have been carefully documented.

The International AIDS Conference (first held in 1985, and since 1988, organized by the International AIDS Society [IAS]) has come to serve as a timepiece, marking advances and setbacks, and major turning points in the pandemic. The first decades of the pandemic were associated with increasing morbidity and mortality as HIV/AIDS became one of the leading causes of death among young men and women worldwide. Over time, the biology and routes of HIV transmission were identified and increasingly understood. Subsequently, the development of antiretroviral therapy (ART) halted the progression of disease and restored health for those who could access this lifesaving treatment….


July 17, 2016 at 4:23 pm

An HIV Vaccine: Mapping Uncharted Territory

JAMA July 12, 2016 V.316 N.2 P.143-144


Anthony S. Fauci, MD

National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland

Scaling up access to antiretroviral therapy and proven approaches to HIV prevention potentially could control the HIV/AIDS pandemic and reduce it to a low level of endemicity. However, a safe and effective HIV vaccine would help reach this goal more quickly and in a more sustained way.

The scientific quest for an HIV vaccine spans nearly 3 decades and has taken multiple pathways, including attempts to induce antibody responses, T-cell responses, or combinations of both. These efforts have included human efficacy trials of monomeric HIV envelope glycoproteins, vectors containing inserts of HIV genes expressing envelope and other viral proteins, and prime-boost regimens that combine both approaches…


July 17, 2016 at 4:22 pm


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