Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults

Publication Date: December 1, 2022
Last Updated: December 2, 2022

Key Recommendations for When to Start Antiretroviral Therapy (ART)

  • Initiation of ART is recommended as soon as possible after diagnosis, ideally within 7 days, including on the same day as diagnosis or at the first clinic visit if the patient is ready and there is no suspicion for a concurrent opportunistic infection (evidence rating: AIII)
  • Structural barriers that could delay receipt of ART (including same-day), and impede care engagement, continuous ART access, and ART adherence should be identified and addressed using evidence-informed strategies (evidence rating: AIIa)
  • Initiation of ART at the time of diagnosis of acute HIV infection is recommended (evidence rating: AIIa)
  • Initiation of ART is recommended within 2 weeks of initiation of treatment for most opportunistic infections
    • For persons with active tuberculosis without evidence of tuberculous meningitis, ART should be initiated within 2 weeks after initiation of tuberculosis treatment, especially for those with CD4 cell count less than 50/μL (evidence rating: AIa)
    • For those with tuberculous meningitis, high-dose steroids should be initiated along with tuberculosis treatment and ART should be initiated within 2 weeks after starting tuberculosis treatment and steroids (evidence rating: BIa)
    • For individuals with cryptococcal meningitis with access to close monitoring and supportive care for adverse events, ART should be initiated 2 to 4 weeks after starting antifungal therapy (evidence rating: BIIb); ART-naive individuals who have asymptomatic cryptococcal antigenemia and a negative lumbar puncture result with no evidence of cryptococcal meningitis should start ART immediately (evidence rating: BIII)
    • Initiation of ART is recommended immediately in the setting of a new diagnosis of cancer with attention to drug-drug interactions (evidence rating: BIIa)

Recommended Initial Antiretroviral Therapy (ART) Regimens

Recommended for Most People With HIV
  • The following are recommended (in alphabetical order) for most people with HIV:
    • BIC/TAF/FTC (evidence rating: AIa)
    • Dolutegravir plus TXF/XTC (evidence rating: AIa)
    • DTG/3TC (only if HIV RNA <500 000 copies/mL and HBV coinfection not present). This regimen should not be used for rapid initiation when genotype, HIV RNA, and HBV serology results are not yet available (evidence rating: AIa)
  • Persons who acquired HIV while receiving preexposure prophylaxis with tenofovir alafenamide or tenofovir disoproxil fumarate with emtricitabine should have a blood sample for genotyping drawn prior to initiating therapy and a 3-drug regimen, preferably dolutegravir or bictegravir plus TXF/XTC, should be initiated if ART is to be started before genotype results are available (evidence rating: AIII)
  • Persons who acquired HIV after exposure to cabotegravir for preexposure prophylaxis should have a blood sample for InSTI genotyping drawn prior to beginning therapy with an InSTI-based regimen (evidence rating: AIII)
    • If therapy is desired before genotype results are available or if InSTI-resistance is present, a boosted PI regimen containing darunavir and TXF/XTC should be used (evidence rating: AIII)

Recommended During Pregnancy
  • TAF/XTC plus dolutegravir (evidence rating: AIa), withTDF/XTC plus dolutegravir a suitable alternative if tenofovir alafenamide is not available (evidence rating: AIa)
  • The following drugs may be used if dolutegravir is not an option:
    • Raltegravir (400 mg twice daily) (evidence rating: AIIa)
    • Atazanavir plus ritonavir (evidence rating: BIIa)
    • Darunavir plus ritonavir (evidence rating: BIIa)
    • Rilpivirine (evidence rating: BIIa)

Not Recommended to Initiate During Pregnancy Because of Inadequate Data to Support Use (Evidence Rating: AIII for All)
  • Bictegravir
  • Doravirine
  • Cabotegravir
  • DTG/3TC
  • If patient is already taking, and stable while taking, bictegravir- or doravirine-containing regimens or the 2-drug regimens DTG/3TC or DTG/RPV and wishes to continue, counsel patient about uncertainties regarding safety during pregnancy and monitor HIV RNA more frequently

Should Not Be Used During Pregnancy Because of Inadequate Drug Levels
  • Cobicistat-containing regimens (evidence rating: AIIb)

Recommended During Tuberculosis Treatment (in Alphabetical Order by Anchor Drug)
  • TXF/XTC is recommended with 1 of the followinga:
    • Dolutegravir (50 mg twice daily) (evidence rating: BIa)
    • Efavirenz (600 mg) (evidence rating: AIa)
    • Raltegravir (800 mg twice daily) (evidence rating: BIa)
  • A ritonavir-boosted PI regimen with TXF/XTC may be used only if it is not possible to use any of the above regimens. In that case, rifabutin (150 mg) should be substituted for rifampin (evidence rating: BIII)
  • Bictegravir, darunavir boosted with ritonavir or cobicistat, doravirine, EVG/COBI, long-acting cabotegravir plus rilpivirine, etravirine, and rilpivirine are not recommended with rifampin because of drug-drug interactions (evidence rating: AIIa)
  • DTG/3TC is not recommended with rifampin because of drug-drug interactions and inadequate data (evidence rating: BIII)
a There is a pharmacokinetic interaction between rifampin and tenofovir alafenamide; clinical data with coadministration are limited.

Weight Gain and Metabolic Complications While Receiving Antiretroviral Therapy (ART)

  • Documentation of weight and BMI at baseline and every 6 months is recommended for people with HIV initiating or switching regimens to identify those with excessive weight gain (evidence rating: AIIa)
  • Counseling regarding possibility of weight gain and potential cardiometabolic complications is recommended for people with HIV initiating or switching ART (evidence rating: AIII)
  • Yearly diabetes screening and assessment of cardiovascular risk score of patients receiving InSTI-based ART is recommended (evidence rating: BIII)
  • Lifestyle changes (exercise and diet) are recommended to support people with HIV who gain greater than 5% body weight (evidence rating: AIII)

Recommendations for Older People With HIV

  • Screening for HIV is recommended in older individuals to prevent late diagnosis with advanced disease (evidence rating: AIIa)
  • Initiation of ART is recommended as soon as possible after diagnosis, either the same day of diagnosis, first clinic visit, or within 7 days. Assessment of comorbidities, kidney function, and medications will influence the choice of ART (evidence rating: AIa)
  • Assessment of polypharmacy and simplification of complex regimens, both ART and comorbidity treatments, is recommended to improve adherence, prevent adverse drug-drug interactions, reduce falls risk, and reduce costs (evidence rating: AIIb)
  • Screening for comorbidities, impaired cognitive and function, poor mobility, frailty, and falls risk is recommended for older people with HIV, using validated tools. The frequency of assessment is determined by the baseline assessment (evidence rating: BIII)1
  • Consideration of integrated care models and Antiretroviral Stewardship models is recommended to improve outcomes and quality of life for people aging with HIV (evidence rating: BIII)

Recommendations for Persons at Risk for and With HIV Who Use Substances and Who Have Substance Use Disorders

  • Provide screening and treatment for substance use disorders to all persons at risk for and living with HIV (evidence rating: AIa)
  • Substance use treatment should be integrated into HIV prevention and treatment services (evidence rating: AIa)
  • Persons with substance use disorders and HIV infection or risk for HIV should receive integrated addiction treatment with:
    • Pharmacotherapy for opioid and alcohol use disorders (evidence rating: AIa)
    • Contingency management for stimulant use disorders (evidence rating: AIII)
  • Persons with opioid use and alcohol use disorders should be offered timely initiation of medications for substance use disorder regardless of HIV and HCV treatment plans (evidence rating: AIa)
  • Peer/patient support staff, telehealth, extended hours, mobile clinics, and walk-in clinic options should be available to persons with substance use disorders who are receiving HIV treatment or prevention (evidence rating: AIIb)
  • Peer/patient support staff, mobile health units, and pharmacy delivery services should be available to persons with substance use disorders who are receiving HIV treatment or prevention (evidence rating: AIIb)

Recommendations for COVID-19 and People With HIV

  • Primary COVID-19 vaccination and vaccine boosting is recommended for all people with HIV (evidence rating: AIa). For those who have untreated HIV infection or a CD4 cell count less than 200/μL, the primary vaccination series should include at least 3 vaccine doses, and vaccine booster doses are recommended regardless of age (evidence rating: AIIa)
  • If circulating SARS-CoV-2 variants anticipated to be susceptible, preexposure prophylaxis for susceptible subvariants with tixagevimab (300 mg) plus cilgavimab (300 mg) to prevent COVID-19 is recommended for adults and adolescents (aged ≥12 years and weighing ≥40 kg) with HIV who have untreated HIV infection or a CD4 cell count less than 200/μL or those not able to be fully vaccinated owing to a history of severe adverse reactions to a COVID-19 vaccine or its components (evidence rating: BIII)
  • Postexposure prophylaxis is not recommended for people with HIV (evidence rating: AIII). Currently available monoclonal antibody agents have not been shown to be sufficiently effective against the predominant circulating Omicron variants and subvariants
  • People with HIV who develop COVID-19 should be treated according to current guidelines for management of COVID-19, regardless of CD4 cell count or viral suppression (evidence rating: AIa)
  • People with HIV with CD4 cell counts less than 200/μL or without viral suppression who develop mild-moderate COVID-19 infection should be treated with ritonavir-boosted nirmatrelvir (evidence rating: AIIa). With the exception of maraviroc, ART can be co-administered with ritonavir-boosted nirmatrelvir without dose adjustment (except as needed for estimated glomerular filtration rate <60 mL/min), but people with HIV should be monitored closely for adverse effects while receiving this treatment. Drug-drug interactions may still limit the use of this treatment if medications used for underlying comorbidities or opportunistic infections are contraindicated with ritonavir-boosted nirmatrelvir
  • People with HIV who recover from severe COVID-19 should be monitored for postacute sequelae of SARS-CoV-2 (long COVID) and HIV treatment should be optimized to the extent possible to further reduce inflammatory responses to COVID-19 and HIV (evidence rating: AIII)

Recommendation Grading


  • 3TC: Lamivudine
  • ART: Antiretroviral Therapy
  • BIC: Bictegravir
  • BMI: Body Mass Index
  • COBI: Cobicistat
  • DTG: Dolutegravir
  • EVG: Elvitegravir
  • FTC: Emtricitabine
  • HBV: Hepatitis B Virus
  • HCV: Hepatitis C Virus
  • InSTI: Integrase Strand Transfer Inhibitor
  • PI: Protease Inhibitor
  • RPV: Rilpivirine
  • TAF: Tenofovir Alafenamide
  • TDF: Tenofovir Disoproxil Fumarate
  • TXF: Tenofovir Alafenamide Or Tenofovir Disoproxil Fumarate
  • XTC: Emtricitabine Or Lamivudine




Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults

Authoring Organization

Publication Month/Year

December 1, 2022

Last Updated Month/Year

August 16, 2023

Document Type


Country of Publication


Document Objectives

Based on a critical evaluation of new data, to provide clinicians with recommendations on use of antiretroviral drugs for the treatment and prevention of HIV, laboratory monitoring, care of people aging with HIV, substance use disorder and HIV, and new challenges in people with HIV, including COVID-19 and monkeypox virus infection.

Inclusion Criteria

Male, Female, Adult, Older adult

Health Care Settings

Ambulatory, Outpatient

Intended Users

Nurse, nurse practitioner, physician, physician assistant


Assessment and screening, Treatment, Management, Prevention

Diseases/Conditions (MeSH)

D006678 - HIV, D019380 - Anti-HIV Agents


prevention, human immunodeficiency virus (HIV), antiretroviral therapy (ART), HIV infections, HIV/AIDS, HIV, HIV-1, Antiretroviral Agents, pre-exposure prophylaxis, PrEP

Source Citation

Gandhi RT, Bedimo R, Hoy JF, et al. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2022 Recommendations of the International Antiviral Society–USA Panel. JAMA. Published online December 01, 2022. doi:10.1001/jama.2022.22246


Number of Source Documents
Literature Search Start Date
January 1, 2020
Literature Search End Date
October 1, 2022