Introduction
Antiretroviral therapy (ART) for the treatment of HIV has improved steadily since the advent of potent combination therapy in 1996. Effective ART has significantly reduced HIV-associated morbidity and mortality and has transformed HIV into a chronic condition with life expectancy approaching that of people without HIV.1,2 Additionally, sustained viral suppression achieved through ART effectively prevents the risk of sexual HIV transmission.3-5
The U.S. Department of Health and Human Services (HHS) Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) is a working group of the Office of AIDS Research Advisory Council (OARAC). The Panel’s primary goal is to provide HIV care practitioners with evidence-based HIV treatment and management recommendations for adults and adolescents with HIV in the United States.
The Panel reviews new evidence and updates recommendations when needed and on an ongoing basis. These guidelines include recommendations on laboratory evaluations and monitoring, treatment goals, benefits of ART and considerations when initiating therapy, ART for the prevention of HIV transmission, choice of the initial ART regimen, management of nonadherence, virologic failure and drug resistance, optimizing antiretroviral (ARV) regimens, management of adverse effects and drug interactions, and special ART-related considerations in specific populations. As people with HIV are living longer, age‑related and chronic comorbidities have become increasingly important considerations. Accordingly, these guidelines also address comorbidity-related topics, such as cardiovascular and metabolic complications associated with HIV and ART.
The Panel works closely with the HHS Panel on Antiretroviral Therapy and Medical Management of Children Living With HIV to provide recommendations for adolescents at different stages of growth and development. Recommendations for ARV regimens in these guidelines are most appropriate for postpubertal adolescents (i.e., those with sexual maturity ratings [SMR] of 4 and 5). Clinicians should follow recommendations in the Pediatric Antiretroviral Guidelines when initiating ART in adolescents with an SMR of 3 or lower. For the most updated recommendations on ART use during pregnancy and postpartum, clinicians should refer to the Perinatal Guidelines.
For recommendations related to pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) for people who do not have HIV, clinicians should consult recommendations from the Centers for Disease Control and Prevention.6-9
These guidelines represent current knowledge on the use of ARV drugs. Because the science of HIV evolves rapidly, the availability of new ARVs and new clinical data may change therapeutic options and preferences. It should be noted that information included in these guidelines may not always be consistent with approved labeling for the specific drugs or indications, and the use of the terms “safe” and “effective” may not be synonymous with the U.S. Food and Drug Administration–defined legal standards for drug approval. The Panel frequently updates the guidelines (current and archived versions of the guidelines are available on the Clinicalinfo website). However, updates to the guidelines may not keep pace with the release of new data, and the guidelines cannot offer guidance on care for all clinical scenarios. Patient management decisions should be based on clinical judgement and attention to unique patient circumstances.
The Panel recognizes the importance of clinical research in generating evidence to address unanswered questions related to the optimal safety and efficacy of ART and HIV care. The Panel encourages both the development of protocols and patient participation in well-designed Institutional Review Board–approved clinical trials. To address these research needs, key unanswered questions are included at the end of updated chapters to guide future research priorities.
Guidelines Development Process
Topic | Comment |
|---|---|
| Goal of the guidelines | Provide guidance to HIV care practitioners on the optimal use of antiretroviral (ARV) agents for the treatment of HIV in adults and adolescents in the United States. |
| Panel members | The U.S. Department of Health and Human Services (HHS) Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) is composed of approximately 50 voting members who have expertise in HIV care and research, and includes at least one representative from each of the following HHS agencies: Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), and National Institutes of Health (NIH). Approximately two-thirds of the Panel members are nongovernmental scientific members from academia or clinical practice, with expertise in such areas as HIV and antiretroviral therapy (ART) clinical care, research, virologic failure and drug resistance, adolescent medicine, HIV immunology, viral hepatitis, women’s health, biostatistics, and pharmacology. The Panel also includes four to five community members with knowledge of HIV treatment and care. The U.S. government representatives are appointed by their respective agencies. Nongovernmental members are selected after an open call for nominations. Each member serves on the Panel for a 4‑year term, with an option for reappointment for an additional term. Panel members lead or serve on up to four writing teams in drafting and revising the guidelines chapters. See the Panel Roster for a list of current Panel members. On occasion, the Panel invites outside consultants with expertise in specific topics (e.g., HIV-2, transplantation, pharmacology) to assist in writing the guidelines. |
| Financial disclosure | All members of the Panel submit a written financial disclosure annually, reporting any association with manufacturers of ARV drugs or diagnostics used to manage HIV infection. The latest version of the Financial Disclosure list is available on the Clinicalinfo website. |
| Users of the guidelines | HIV treatment providers, infectious disease specialists, other health care professionals, and trainees. |
| Developer | Panel on Antiretroviral Guidelines for Adults and Adolescents—a working group of the Office of AIDS Research Advisory Council (OARAC) |
| Funding source | Office of AIDS Research, NIH |
| Evidence collection | The recommendations in the guidelines are based on studies published in peer‑reviewed journals or data available in FDA drug labels. On some occasions, particularly when new information may affect patient safety, unpublished data presented at major conferences or prepared by the FDA and/or manufacturers as warnings to the public may be used as evidence to revise the guidelines. When sufficient data are not available to provide guidance, the Panel occasionally makes recommendations based on expert opinion. |
| Recommendation grading | As described in Table 2 below |
| Method of synthesizing data | Each section of the guidelines is assigned to a working group of Panel members with expertise in the section’s area of interest. The working groups synthesize available data and propose recommendations to the Panel. The Panel discusses all proposals during monthly teleconferences. To be included in the guidelines, a recommendation must be endorsed by a majority of voting members. Recommendations endorsed by the Panel are included in the guidelines. |
| Other guidelines | These guidelines focus on antiretroviral therapy (ART) for adults and adolescents with HIV. For a more detailed discussion on the use of ART in children and prepubertal adolescents (those with sexual maturity ratings of 1 to 3), clinicians should refer to the Pediatric Antiretroviral Guidelines. These guidelines also include a brief discussion on the management of women of childbearing potential and pregnant women. For more details on the use of ARV drugs during pregnancy, see the Perinatal Guidelines. |
| Update plan | The Panel meets monthly by teleconference to review data that may warrant modification of the guidelines. Updates may be prompted by new drug approvals (or new indications, dosing formulations, or frequency of dosing), new safety or efficacy data, or other information relating to ARV drugs that may have an impact on the clinical care of people with HIV. In the event of new data of clinical importance, the Panel may post an interim announcement with recommendations on the Clinicalinfo website until the guidelines can be updated with the appropriate changes. Updated guidelines are available on the Clinicalinfo website. |
| Public comments | A 2-week public comment period follows the release of the updated guidelines on the Clinicalinfo website. The Panel reviews comments to determine whether additional revisions to the guidelines are indicated. The public also may submit comments to the Panel at any time at [email protected]. |
Basis for Recommendations
Recommendations in these guidelines are based on scientific evidence and expert opinion. Each recommendation statement includes a letter (A, B, or C) that represents the strength of the recommendation and a Roman numeral (I, II, or III) that represents the quality of the evidence that supports the recommendation (see Table 2 below).
Strength of Recommendation | Quality of Evidence for Recommendation |
|---|---|
A: Strong recommendation for the statement B: Moderate recommendation for the statement C: Weak recommendation for the statement | I: One or more randomized trials with clinical outcomes and/or validated laboratory endpoints II: One or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes III: Expert opinion |
References
- Marcus JL, Leyden WA, Alexeeff SE, et al. Comparison of overall and comorbidity-free life expectancy between insured adults with and without HIV infection, 2000–2016. JAMA Netw Open. 2020;3(6):e207954. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32539152.
- Trickey A, Sabin CA, Burkholder G, et al. Life expectancy after 2015 of adults with HIV on long-term antiretroviral therapy in Europe and North America: a collaborative analysis of cohort studies. Lancet HIV. 2023;10(5):e295-e307. Available at: https://www.ncbi.nlm.nih.gov/pubmed/36958365.
- Cohen MS, Chen YQ, McCauley M, et al. Antiretroviral therapy for the prevention of HIV-1 transmission. N Engl J Med. 2016;375(9):830-9. Available at: https://pubmed.ncbi.nlm.nih.gov/27424812.
- Bavinton BR, Pinto AN, Phanuphak N, et al. Viral suppression and HIV transmission in serodiscordant male couples: an international, prospective, observational, cohort study. Lancet HIV. 2018;5(8):e438-e447. Available at: https://www.ncbi.nlm.nih.gov/pubmed/30025681.
- Rodger AJ, Cambiano V, Bruun T, et al. Risk of HIV transmission through condomless sex in serodifferent gay couples with the HIV-positive partner taking suppressive antiretroviral therapy (PARTNER): final results of a multicentre, prospective, observational study. Lancet. 2019;393(10189):2428-2438. Available at: https://www.ncbi.nlm.nih.gov/pubmed/31056293.
- Centers for Disease Control and Prevention. Clinical guidance for PrEP. 2025. Available at: https://www.cdc.gov/hivnexus/hcp/prep/index.html.
- Tanner MR, O’Shea JG, Byrd KM, et al. Antiretroviral postexposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV - CDC recommendations, United States, 2025. MMWR Recomm Rep. 2025;74(1):1-56. Available at: https://www.ncbi.nlm.nih.gov/pubmed/40331832.
- Kofman AD, Struble KA, Heneine W, et al. 2025 US Public Health Service guidelines for the management of occupational exposures to human immunodeficiency virus and recommendations for post-exposure prophylaxis in healthcare settings. Infect Control Hosp Epidemiol. 2025;46(9):863-873. Available at: https://www.ncbi.nlm.nih.gov/pubmed/41569270.
- Patel RR, Hoover KW, Lale A, Cabrales J, Byrd KM, Kourtis AP. Clinical recommendation for the use of injectable lenacapavir as HIV preexposure prophylaxis - United States, 2025. MMWR;74(35):541-549. 2025. Available at: https://www.cdc.gov/mmwr/volumes/74/wr/mm7435a1.htm.
Guidelines Development Process
| Topic | Comment |
|---|---|
| Goal of the guidelines | Provide guidance to HIV care practitioners on the optimal use of antiretroviral (ARV) agents for the treatment of HIV in adults and adolescents in the United States. |
| Panel members | The U.S. Department of Health and Human Services (HHS) Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) is composed of approximately 50 voting members who have expertise in HIV care and research, and includes at least one representative from each of the following HHS agencies: Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), and National Institutes of Health (NIH). Approximately two-thirds of the Panel members are nongovernmental scientific members from academia or clinical practice, with expertise in such areas as HIV and antiretroviral therapy (ART) clinical care, research, virologic failure and drug resistance, adolescent medicine, HIV immunology, viral hepatitis, women’s health, biostatistics, and pharmacology. The Panel also includes four to five community members with knowledge of HIV treatment and care. The U.S. government representatives are appointed by their respective agencies. Nongovernmental members are selected after an open call for nominations. Each member serves on the Panel for a 4‑year term, with an option for reappointment for an additional term. Panel members lead or serve on up to four writing teams in drafting and revising the guidelines chapters. See the Panel Roster for a list of current Panel members. On occasion, the Panel invites outside consultants with expertise in specific topics (e.g., HIV-2, transplantation, pharmacology) to assist in writing the guidelines. |
| Financial disclosure | All members of the Panel submit a written financial disclosure annually, reporting any association with manufacturers of ARV drugs or diagnostics used to manage HIV infection. The latest version of the Financial Disclosure list is available on the Clinicalinfo website. |
| Users of the guidelines | HIV treatment providers, infectious disease specialists, other health care professionals, and trainees. |
| Developer | Panel on Antiretroviral Guidelines for Adults and Adolescents—a working group of the Office of AIDS Research Advisory Council (OARAC) |
| Funding source | Office of AIDS Research, NIH |
| Evidence collection | The recommendations in the guidelines are based on studies published in peer‑reviewed journals or data available in FDA drug labels. On some occasions, particularly when new information may affect patient safety, unpublished data presented at major conferences or prepared by the FDA and/or manufacturers as warnings to the public may be used as evidence to revise the guidelines. When sufficient data are not available to provide guidance, the Panel occasionally makes recommendations based on expert opinion. |
| Recommendation grading | As described in Table 2 below |
| Method of synthesizing data | Each section of the guidelines is assigned to a working group of Panel members with expertise in the section’s area of interest. The working groups synthesize available data and propose recommendations to the Panel. The Panel discusses all proposals during monthly teleconferences. To be included in the guidelines, a recommendation must be endorsed by a majority of voting members. Recommendations endorsed by the Panel are included in the guidelines. |
| Other guidelines | These guidelines focus on antiretroviral therapy (ART) for adults and adolescents with HIV. For a more detailed discussion on the use of ART in children and prepubertal adolescents (those with sexual maturity ratings of 1 to 3), clinicians should refer to the Pediatric Antiretroviral Guidelines. These guidelines also include a brief discussion on the management of women of childbearing potential and pregnant women. For more details on the use of ARV drugs during pregnancy, see the Perinatal Guidelines. |
| Update plan | The Panel meets monthly by teleconference to review data that may warrant modification of the guidelines. Updates may be prompted by new drug approvals (or new indications, dosing formulations, or frequency of dosing), new safety or efficacy data, or other information relating to ARV drugs that may have an impact on the clinical care of people with HIV. In the event of new data of clinical importance, the Panel may post an interim announcement with recommendations on the Clinicalinfo website until the guidelines can be updated with the appropriate changes. Updated guidelines are available on the Clinicalinfo website. |
| Public comments | A 2-week public comment period follows the release of the updated guidelines on the Clinicalinfo website. The Panel reviews comments to determine whether additional revisions to the guidelines are indicated. The public also may submit comments to the Panel at any time at [email protected]. |
Basis for Recommendations
Recommendations in these guidelines are based on scientific evidence and expert opinion. Each recommendation statement includes a letter (A, B, or C) that represents the strength of the recommendation and a Roman numeral (I, II, or III) that represents the quality of the evidence that supports the recommendation (see Table 2 below).
Strength of Recommendation | Quality of Evidence for Recommendation |
|---|---|
A: Strong recommendation for the statement B: Moderate recommendation for the statement C: Weak recommendation for the statement | I: One or more randomized trials with clinical outcomes and/or validated laboratory endpoints II: One or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes III: Expert opinion |
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