Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Considerations for Antiretroviral Use in Special Patient Populations

Acute and Recent (Early) HIV Infection

Last Updated: December 18, 2019; Last Reviewed: December 18, 2019

Key Considerations and Recommendations for Acute and Recent (Early) HIV Infection
Key Considerations and Recommendations
  • Antiretroviral therapy (ART) is recommended for all individuals with HIV, including those with earlya HIV infection (AI). ART should be initiated as soon as possible after HIV diagnosis (AII).
  • The goal of ART is to suppress plasma HIV RNA to undetectable levels (AI) and to prevent transmission of HIV (AI). Testing for plasma HIV RNA levels, CD4 T lymphocyte cell counts, and toxicity monitoring should be performed as recommended for persons with chronic HIV infection (AII).
  • A sample for genotypic testing should be sent before initiation of ART (AIII). ART can be initiated before drug resistance testing and HLA B*5701 test results are available. In this setting, one of the following ART regimens is recommended (AIII):
    • Bictegravir (BIC)/tenofovir alafenamide (TAF)/emtricitabine (FTC)
    • Dolutegravir (DTG) with (TAF or tenofovir disoproxil fumarate [TDF])b plus (FTC or lamivudine [3TC])
    • Boosted darunavir (DRV) with (TAF or TDF)b plus (FTC or 3TC)
  • Pregnancy testing should be performed in individuals of childbearing potential before initiation of ART (AIII).
  • Data from an observational study in Botswana suggest there may be an increased risk of neural tube defects in infants born to individuals who were receiving DTG at the time of conception. Before initiating an integrase strand transfer inhibitor-based regimen in a person of childbearing potential, clinicians should review Table 6b for information to consider when choosing an ART regimen.
  • As there are no safety data for BIC use around the time of conception, an approach similar to that outlined for DTG should be considered for BIC-containing ART (AIII).
  • When the results of drug resistance and HLA-B*5701 testing are available, the treatment regimen can be modified if needed (AII).
  • Providers should inform individuals starting ART of the importance of adherence to achieve and maintain viral suppression (AIII).
Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = Data from randomized controlled trials; II = Data from well-designed non-randomized trials or observational cohort studies with long-term clinical outcomes; III = Expert opinion

a Early infection represents either acute or recent infection.
TAF and TDF are two forms of tenofovir that are approved in the United States. TAF has fewer bone and kidney toxicities than TDF, while TDF is associated with lower lipid levels. Safety, cost, and accessibility are among the factors to consider when choosing between these drugs.

Table 12. Identifying, Diagnosing, and Treating Acute and Recent HIV Infection
Suspicion of Acute HIV Infection:
  • Health care providers should consider the possibility of acute HIV infection in individuals with the signs, symptoms, or laboratory findings described below, and recent (within 2 to 6 weeks) high risk of exposure to HIV.a
    • Signs, symptoms, or laboratory findings of acute HIV infection may include but are not limited to one or more of the following: fever, lymphadenopathy, skin rash, myalgia, arthralgia, headache, diarrhea, oral ulcers, leucopenia, thrombocytopenia, and transaminase elevation.
    • High-risk exposures include sexual contact with a person who has HIV or a person at risk of HIV infection; sharing needles and syringes to inject drugs, as well as equipment used to prepare drugs for injection; or any exposure in which an individual’s mucous membranes or any breaks in the skin come in contact with bodily fluid that potentially carries HIV.
Differential Diagnosis:
  • The differential diagnosis of acute HIV infection may include but is not limited to viral illnesses such as EBV and non-EBV (e.g., CMV) infectious mononucleosis syndromes, influenza, viral hepatitis, streptococcal infection, or syphilis. Diagnosis of any STI should prompt HIV testing and consideration of acute or early HIV infection.
Testing to Diagnose/Confirm Acute HIV Infection:
  • Acute HIV infection is defined as detectable HIV RNA or p24 antigen (the specific antigen used in currently available HIV-1/2 Ag/Ab combination assays) in the setting of a negative or indeterminate HIV antibody test result.
  • A reactive HIV antibody test result or Ag/Ab combination test result must be followed by supplemental confirmatory testing.
  • A negative or indeterminate HIV antibody test result in a person with a reactive Ag/Ab test result or in whom acute HIV infection is suspected requires plasma HIV RNA testing to diagnose acute HIV infection.
  • A positive result on a quantitative or qualitative plasma HIV RNA test in the setting of a negative or indeterminate antibody test result indicates that acute HIV infection is highly likely. In this case, the diagnosis of HIV infection should be later confirmed by subsequent documentation of HIV antibody seroconversion.
ART After Diagnosis of Early HIV Infection:
  • ART is recommended for all individuals with HIV, including those with earlya HIV infection (AI). ART should be initiated as soon as possible after HIV diagnosis (AII).
  • Once initiated, the goals of ART are to achieve sustained plasma virologic suppression and to prevent HIV transmission (AII).
  • All individuals of childbearing potential who receive a diagnosis of early HIV infection should have a pregnancy test (AIII).
  • Pregnant individuals with early HIV infection should begin ART as soon as possible for their own health and to prevent perinatal transmission of HIV (AI).
  • A blood sample for genotypic drug resistance testing should be obtained before initiation of ART to guide the selection of the regimen (AII), but ART should be initiated as soon as possible, often before resistance test results are available. If resistance is subsequently identified, treatment should be modified as needed.
  • ART can be initiated before the results of drug resistance testing are known. In this setting, one of the following ART regimens is recommended (AIII):
    • DTG with (TAF or TDF)b plus (FTC or 3TC)
    • BIC/TAF/FTC
    • Boosted DRV with (TAF or TDF)b plus (FTC or 3TC)
  • Pregnancy testing should be performed in individuals of childbearing potential before initiation of ART (AIII).
  • Preliminary data from Botswana suggested that there is an increased risk of NTDs (0.9%) in infants born to women who were receiving DTG at the time of conception.45 Follow-up data, however, showed that the prevalence of NTDs in association with DTG exposure at conception is lower (0.3%), but still slightly higher than with non-DTG containing ARV regimens (0.1%).46,47 Before initiating an INSTI-based regimen in a person of childbearing potential, clinicians should review Table 6b for information to consider when choosing an ART regimen.
In some settings, behaviors that increase the risk of HIV infection may not be recognized or perceived as risky by the health care provider or the patient, or both. Thus, even in the absence of reported high-risk behaviors, symptoms and signs consistent with acute retroviral syndrome should motivate practitioners to consider a diagnosis of acute HIV infection.
TAF and TDF are two forms of TFV that are approved in the United States. TAF has fewer bone and kidney toxicities than TDF, while TDF is associated with lower lipid levels. Safety, cost, and accessibility are among the factors to consider when choosing between these drugs.


Key: 3TC = lamivudine; Ag/Ab = antigen/antibody; ART = antiretroviral therapy; ARV = antiretroviral; BIC = bictegravir; CMV = cytomegalovirus; DRV = darunavir; DTG = dolutegravir; EBV = Epstein-Barr virus; FTC = emtricitabine; INSTI = integrase strand transfer inhibitor; NTD = neural tube defect; STI = sexually transmitted infection; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; TFV = tenofovir

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