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Data on the use of antiretroviral drugs, including new drugs and formulations, for the treatment and prevention of HIV infection continue to guide optimal practices.
To evaluate new data and incorporate them into current recommendations for initiating HIV therapy, monitoring individuals starting on therapy, changing regimens, preventing HIV infection for those at risk, and special considerations for older people with HIV.
New evidence was collected since the previous International Antiviral (formerly AIDS) Society–USA recommendations in 2018, including data published or presented at peer-reviewed scientific conferences through August 22, 2020. A volunteer panel of 15 experts in HIV research and patient care considered these data and updated previous recommendations.
From 5316 citations about antiretroviral drugs identified, 549 were included to form the evidence basis for these recommendations. Antiretroviral therapy is recommended as soon as possible for all individuals with HIV who have detectable viremia. Most patients can start with a 3-drug regimen or now a 2-drug regimen, which includes an integrase strand transfer inhibitor. Effective options are available for patients who may be pregnant, those who have specific clinical conditions, such as kidney, liver, or cardiovascular disease, those who have opportunistic diseases, or those who have health care access issues. Recommended for the first time, a long-acting antiretroviral regimen injected once every 4 weeks for treatment or every 8 weeks pending approval by regulatory bodies and availability. For individuals at risk for HIV, preexposure prophylaxis with an oral regimen is recommended or, pending approval by regulatory bodies and availability, with a long-acting injection given every 8 weeks. Monitoring before and during therapy for effectiveness and safety is recommended. Switching therapy for virological failure is relatively rare at this time, and the recommendations for switching therapies for convenience and for other reasons are included. With the survival benefits provided by therapy, recommendations are made for older individuals with HIV. The current coronavirus disease 2019 pandemic poses particular challenges for HIV research, care, and efforts to end the HIV epidemic.
Conclusion and Relevance
Advances in HIV prevention and management with antiretroviral drugs continue to improve clinical care and outcomes among individuals at risk for and with HIV.
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Corresponding Author: Michael S. Saag, MD, School of Medicine, University of Alabama at Birmingham, 845 19th St S, BBRB 256, Birmingham, AL 35294 (email@example.com).
Accepted for Publication: September 2, 2020.
Published Online: October 14, 2020. doi:10.1001/jama.2020.17025
Author Contributions: Dr Saag had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Saag, Gandhi, Hoy, Landovitz, Thompson, Sax, Smith, Benson, del Rio, Eron, Fätkenheuer, Günthard, Jacobsen, Volberding.
Acquisition, analysis, or interpretation of data: Saag, Hoy, Landovitz, Thompson, Sax, Smith, Benson, Buchbinder, del Rio, Fätkenheuer, Günthard, Molina, Volberding.
Drafting of the manuscript: Saag, Gandhi, Hoy, Landovitz, Thompson, Sax, Smith, Benson, del Rio, Fätkenheuer, Jacobsen, Volberding.
Critical revision of the manuscript for important intellectual content: Saag, Hoy, Landovitz, Thompson, Sax, Smith, Benson, Buchbinder, Eron, Fätkenheuer, Günthard, Molina.
Statistical analysis: Fätkenheuer.
Obtained funding: Jacobsen.
Administrative, technical, or material support: Saag, Sax, Smith, Fätkenheuer, Jacobsen, Volberding.
Supervision: Saag, Landovitz, Smith, Benson, Fätkenheuer, Molina, Jacobsen.
Conflict of Interest Disclosures: Drs Saag reported receiving grants paid to his institution from Gilead Sciences and ViiV Healthcare. Dr Gandhi reported serving on advisory boards and receiving personal fees from Gilead, Merck, and Theratechnologies. Dr Hoy reported receiving personal fees paid to her institution from Gilead Sciences, ViiV Healthcare, and Merck, Sharp & Dohme Australia. Dr Landovitz reported reported serving on advisory boards and receiving personal fees and travel reimbursement from Gilead Sciences and Merck; and receiving personal fees and travel reimbursement from Roche. Dr Thompson reported receiving research support paid to the AIDS Research Consortium of Atlanta for the conduct of clinical trials from Bristol-Myers Squibb, Cepheid Inc, Cytodyn Inc, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme, Frontier Biotechnology, and ViiV Healthcare. Dr Sax reported serving on advisory boards and receiving grants and personal fees from Gilead and ViiV; and serving on advisory boards and receiving personal fees from Janssen and Merck. Dr Smith reported receiving grants from the National Institutes of Health; and serving as a consultant and receiving personal fees from Arena Pharma, Bayer, and AIDS Healthcare Foundation; and serving on advisory boards and receiving personal fees from FluxErgy. Dr Benson reported receiving grants paid to her institution from the National Institutes of Health and Gilead; and receiving personal fees from ViiV Healthcare, GlaxoSmithKline, IDSA, and IAS-USA. Dr Buchbinder reported receiving nonfinancial support (study drug) from Gilead Sciences. Dr del Rio reported receiving grants from the National Institutes of Health. Dr Eron reported receiving grants and personal fees from ViiV Healthcare, Gilead Sciences, and Janssen; and receiving personal fees from Merck. Dr Fätkenheuer reported receiving grants and personal fees from Janssen Cilag; receiving grants and travel reimbursement from Gilead; serving on advisory boards and receiving grants from Merck Sharp & Dohme; and serving on advisory boards and receiving personal fees from ViiV Healthcare. Dr Günthard reported receiving grants from the Swiss National Science Foundation, the Swiss HIV Cohort Study, the National Institutes of Health, Gilead Sciences, the Yvonne Jacob Foundation; and serving as a consultant and receiving personal fees from Merck, Gilead Sciences, and ViiV Healthcare. Dr Molina reported serving on advisory boards and receiving personal fees from Gilead, Merck, and ViiV Healthcare. Dr Volberding reported receiving personal fees from Merck and Gilead. No other disclosures were reported.
Funding/Support: The work is sponsored and funded by the International Antiviral Society–USA (IAS-USA). IAS-USA is a mission-based, nonmembership, 501(c)(3) not-for-profit organization. No private sector or government funding was used to support the effort. Panel members are not compensated for participation in the effort.
Role of the Funder/Sponsor: The IAS-USA determined the need to update recommendations, selected the panel members, and provided administrative support and oversight. The panel designs and conducts the work; collects, manages, analyzes, and interprets the data; and prepares, reviews, and approves the manuscript.
Additional Contributions: We thank Michelle Valderama, BS (production and web manager from the IAS-USA), for assistance in managing the manuscript versions, and Kimberly R. Powell, MIS (systematic review methodologist from Emory University), for conducting the PubMed and EMBASE literature searches. Neither received additional compensation beyond their normal salaries. We dedicate this article to the memory of Timothy Ray Brown.
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