Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living 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.

  •   Table of Contents

Download Guidelines

Considerations for Antiretroviral Use in Special Patient Populations

Acute and Recent (Early) HIV Infection

Last Updated: October 25, 2018; Last Reviewed: October 25, 2018

Panel's Recommendations for Acute and Recent (Earlya) HIV Infection
Panel's Recommendations
  • Antiretroviral therapy (ART) is recommended for all individuals with HIV-1 infection (AI), including those with earlya HIV-1 infection.
  • Once initiated, the goal of ART is to suppress plasma HIV-1 RNA to undetectable levels (AIII). Testing for plasma HIV-1 RNA levels, CD4 T lymphocyte cell counts, and toxicity monitoring should be performed as recommended for patients with chronic HIV-1 infection (AII).
  • Genotypic drug resistance testing should be performed before initiation of ART to guide the selection of the regimen (AII).
  • ART can be initiated before drug resistance test results are available. Either boosted darunavir (DRV) or dolutegravir (DTG) with emtricitabine (FTC) plus either tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) are recommended regimens in this setting (AIII). The rationales and precautions for these regimens are discussed below.
  • A DRV-based regimen is a good option for people with early HIV-1 infection, because resistance to pharmacokinetically enhanced protease inhibitors (PIs) emerges slowly and clinically significant transmitted resistance to PIs is uncommon.
  • A DTG-based regimen is also a reasonable option; however, data regarding transmission of integrase strand transfer inhibitor (INSTI)-resistant HIV and the efficacy of DTG regimens in early HIV infection are more limited (AIII).
  • Preliminary data from Botswana suggested that infants born to women who were receiving dolutegravir (DTG) at the time of conception have an increased risk of neural tube defects. Until more information are available, DTG should not be prescribed for individuals:
    • Who are pregnant and within 12 weeks post-conception;
    • Who are of childbearing potential, who are sexually active, and who are not using effective contraception; or
    • Who are contemplating pregnancy.
  • When results of drug resistance testing are available, the treatment regimen can be modified if warranted (AII). In patients without transmitted drug-resistant virus, therapy should be initiated with one of the combination regimens that is recommended for patients with chronic HIV-1 infection (see What to Start) (AIII).
  • Patients starting ART should be willing and able to commit to life-long treatment and should understand the importance of adherence (AIII). Patients may choose to postpone ART, and providers, on a case-by-case basis, may recommend that patients defer therapy because of clinical or psychosocial factors.
Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = Data from randomized controlled trials; II = Data from well-designed nonrandomized trials or observational cohort studies with long-term clinical outcomes; III = Expert opinion

a Early infection represents either acute or recent infection.

Table 12. Identifying, Diagnosing, and Treating Acute and Recent HIV-1 Infection
Suspicion of Acute HIV-1 Infection:
  • Health care providers should consider the possibility of acute HIV-1 infection in individuals with signs, symptoms, or the laboratory findings described below and recent (within 2 to 6 weeks) high risk of exposure to HIV-1.a
    • Signs, symptoms, or laboratory findings of acute HIV-1 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-1 infection or a person at risk of HIV-1 infection, sharing of injection drug use paraphernalia, or any exposure in which an individual’s mucous membranes or breaks in the skin come in contact with bodily fluid that potentially carries HIV-1.
  • Differential Diagnosis: The differential diagnosis of HIV-1 infection may include but is not limited to viral illnesses such as EBV and non-EBV (e.g., cytomegalovirus) infectious mononucleosis syndromes, influenza, viral hepatitis, streptococcal infection, or syphilis.
Evaluation/Diagnosis of Acute HIV-1 Infection:
  • Acute HIV-1 infection is defined as detectable HIV-1 RNA or p24 antigen (the antigen used in currently available HIV Ag/Ab combination assays) in the setting of a negative or indeterminate HIV-1 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-1 antibody test result in a person with a reactive Ag/Ab test result or in whom acute HIV-1 infection is suspected requires plasma HIV-1 RNA testing to diagnose acute HIV-1 infection.
  • A positive result on a quantitative or qualitative plasma HIV-1 RNA test in the setting of a negative or indeterminate antibody test result indicates that acute HIV-1 infection is highly likely. In this case, the diagnosis of HIV-1 infection should be later confirmed by subsequent documentation of HIV-1 antibody seroconversion.
Antiretroviral Therapy After Diagnosis of Early HIV-1 Infection:
  • ART is recommended for all individuals with HIV-1 (AI) and should be offered to all patients with early HIV-1 infection.
  • A pregnancy test should be performed for all individuals who receive a diagnosis of early HIV infection and who are of childbearing potential (AIII).
  • Pregnant patients with early HIV-1 infection should begin ART as soon as possible for their own health and to prevent perinatal transmission of HIV-1 (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 prior to availability of resistance test results. If resistance is subsequently identified, treatment should be modified appropriately.
  • If no resistance data are available, then a pharmacologically boosted PI-based regimen is recommended, because resistance to PIs emerges slowly and clinically significant transmitted resistance to PIs is uncommon. Boosted DRV (DRV/r or DRV/c) plus FTC and either TDF or TAF is a recommended regimen in this setting (AIII). For similar reasons, DTG plus FTC and either TDF or TAF are reasonable options, although the data regarding transmission of INSTI-resistant HIV and the efficacy of this regimen in early HIV infection are limited (AIII).
  • Preliminary data from Botswana suggested that infants born to women who were receiving DTG at the time of conception have an increased risk of neural tube defects. Until more information is available, DTG should not be prescribed for individuals:
    • Who are pregnant and within 12 weeks post-conception (AII);
    • Who are of childbearing potential, who are sexually active, and who are not using effective contraception (AII); or
    • Who are contemplating pregnancy (AII).
  • In patients without transmitted drug-resistant virus, ART should be initiated with one of the combination regimens recommended for patients with chronic HIV-1 infection (see What to Start) (AIII).
  • Once initiated, the goal of ART should be sustained plasma virologic suppression, and ART should be continued indefinitely (AIII).
In some settings, behaviors that increase the risk of HIV-1 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-1 infection.

Key to Acronyms: Ag/Ab = antigen/antibody; ART = antiretroviral therapy; DRV = darunavir; DRV/c = darunavir/cobicistat; DRV/r = darunavir/ritonavir; DTG = dolutegravir; EBV = Epstein-Barr virus; FTC = emtricitabine; INSTI = integrase strand transfer inhibitor; PI = protease inhibitor; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate

Download Guidelines