HIV Infection and AIDS Guidelines

Updated: Jan 13, 2023
  • Author: Shelley A Gilroy, MD, FACP, FIDSA; Chief Editor: Michael Stuart Bronze, MD  more...
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CDC Guidelines on HIV Screening in Men Who Have Sex with Men

The following are guidelines on HIV screening among men who have sex with men (MSM) [160] :

  • The CDC concludes that the evidence, programmatic experience, and expert opinions are insufficient to warrant changing the recommendation of annual screening for men who have sex with men (MSM) to more frequent screening (every 3 or 6 months).
  • Providers in clinical settings should offer HIV screening at least annually to all sexually active MSM.
  • Clinicians can also consider the potential benefits of more frequent HIV screening (eg, every 3 or 6 months) for some asymptomatic sexually active MSM based on their individual risk factors, local HIV epidemiology, and local policies.
  • Among MSM who are prescribed preexposure prophylaxis, HIV testing every 3 months and immediate testing whenever signs and symptoms of acute HIV infection are reported is indicated.
  • MSM who experience a specific high-risk sexual exposure or have symptoms of recent HIV infection should seek immediate HIV testing, and clinicians should be alert for the symptoms of acute HIV infection and provide appropriate diagnostic testing.
  • Tenofovir alafenamide (TAF)/emtricitabine (FTC) is now included as an alternative for pre-exposure prophylaxis (PrEP) in men who have sex with men (MSM).

European AIDS Clinical Society Guidelines

The European AIDS Clinical Society (EACS) has issued updated guidelines on the management of HIV infection. In this latest version of the guidelines (version 10), a new drug-drug interaction panel has been introduced. The guidelines have six main sections, including a general overview table of all major issues in patients living with HIV infection; recommendations on antiretroviral treatment (ART); drug-drug interactions; and diagnosis, monitoring, and treatment of comorbidities, coinfections, and opportunistic diseases. [161]

Antiretroviral therapy

A new recommendation in the updated guideline favors an unboosted integrase strand transfer inhibitor (INSTI) with high genetic barrier (bictegravir [BIC] or dolutegravir [DTG]) as a third agent for therapy initiation in treatment-naïve individuals with HIV infection.

Two nucleos(t)ide reverse transcriptase inhibitors (NRTIs) plus doravirine (DOR) has been included among the recommended regimens.

Tenofovir disoproxil fumarate (TDF)/lamivudine (3TC) has been added as a backbone, when indicated.

DTG plus 3TC dual therapy has been upgraded as a recommended regimen.

High-genetic-barrier INSTI or protease inhibitors pharmacologically boosted with cobicistat or ritonavir (PI/b) are recommended as initial therapy for primary HIV infection if resistance testing is unavailable.

Ritonavir- or cobicistat-boosted darunavir (DRV/b) plus rilpivirine (RPV) has been included as a dual-therapy option.

Monotherapy with PI/b is not recommended.

Initiation of ART in patients with tuberculosis (TB) and HIV coinfection who have a CD4 cell count of more than 50/µL may be deferred up to 8 weeks after TB treatment has been started.

Tenofovir alafenamide (TAF)/emtricitabine (FTC), raltegravir (RAL) once daily, and bictegravir (BIC) have been added as potential drugs for postexposure prophylaxis (PEP).

TAF/FTC is now included as an alternative for pre-exposure prophylaxis (PrEP) in men who have sex with men (MSM) and transgender women.


Screening for kidney disease should incorporate albumin/creatinine ratio for glomerular disease and protein/creatinine ratio for screening for and diagnosing antiretroviral-related tubulopathy.

Lipid targets have been updated in terms of the threshold for ART modification, from 20% 10-year risk for cardiovascular disease (CVD) to 10% 10-year risk for CVD.

Medical management of hypertension has been updated to include amended drug-sequencing suggestions and recommended drugs.

The workup of liver disease among individuals with HIV infection should now include a fourth step to include risk stratification based on risk prediction tools and transient elastography and an updated algorithm for surveillance of varices.


Department of Health and Human Services

The US Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents has published guidelines to help providers integrate treatment as prevention (TasP) into their clinical practice. The Panel emphasizes the importance of screening and early diagnosis of HIV. In order for persons with HIV to benefit from early diagnosis, the Panel recommends that ART be started immediately or as soon as possible after diagnosis to increase the uptake of ART, decrease the time required to achieve linkage to care and virologic suppression for individual patients, reduce the risk of HIV transmission, and improve the rate of virologic suppression among persons with HIV. [162]

The guidelines recommend the following:

  • An initial antiretroviral (ARV) regimen for a treatment-naive patient generally consists of two nucleoside reverse transcriptase inhibitors (NRTIs) administered in combination with a third active ARV drug from one of three drug classes: an integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI), or a protease inhibitor (PI) with a pharmacokinetic (PK) enhancer (also known as a booster; the two drugs used for this purpose are cobicistat and ritonavir).
  • Data also support the use of the two-drug regimen, dolutegravir plus lamivudine, for initial treatment.
  • Before initiating antiretroviral therapy (ART) in a person of childbearing potential, clinicians should discuss the person’s intentions regarding pregnancy and a pregnancy test should be performed (AIII). Clinicians should refer to the Perinatal Guidelines for recommendations on initial ARV regimen for an ART-naive person around the time of conception and during pregnancy.

The Panel on Antiretroviral Guidelines for Adults and Adolescents (the Panel) classifies the following regimens as Recommended Initial Regimens for Most People with HIV (in alphabetical order):

For those with HIV who have no prior use of long-acting cabotegravir (CAB-LA) as pre-exposure prophylaxis (PrEP), the following regimens are recommended: 

  • Bictegravir/tenofovir alafenamide/emtricitabine (AI) (There are insufficient data to recommend Bictegravir during pregnancy.)
  • Dolutegravir/abacavir/lamivudine—only for individuals who are HLA-B*5701 negative and without chronic hepatitis B virus (HBV) coinfection (AI)
  • Dolutegravir plus (emtricitabine or lamivudine) plus (tenofovir alafenamide [TAF] or tenofovir disoproxil fumarate [TDF]) (AI)
  • Dolutegravir/lamivudine (AI)—except for individuals with HIV RNA >500,000 copies/mL, HBV coinfection, or when ART is to be started before the results of HIV genotypic resistance testing for reverse transcriptase or HBV testing are available.

For those with HIV and prior use of CAB-LA as PrEP, INSTI genotypic resistance testing should be done before beginning ART. If treatment is begun before receiving results of genotypic testing, the following regimen is recommended:

  • Boosted darunavir plus (TAF or TDF) plus (FTC or 3TC)—pending the results of the genotype test (AIII). 

DHHS guidelines further recommend the following:

  • To address individual patient characteristics and needs, the Panel also provides a list of Recommended Initial Regimens in Certain Clinical Situations (see Table 6 below). 
  • Given the many excellent options for initial therapy, selection of a regimen for a particular patient should be guided by such factors as virologic efficacy, toxicity, pill burden, dosing frequency, drug-drug interaction potential, resistance test results, comorbid conditions, access, and cost. Table 7 provides guidance on choosing an ARV regimen based on selected clinical case scenarios. Table 9 highlights the advantages and disadvantages of different components in a regimen.
  • Patients without prior ART who wish to begin long-acting intramuscular cabotegravir (CAB) and rilpivirine (RPV) should first achieve viral suppression on another regimen before shifting to oral, and then injectable, CAB and RPV (see Optimizing Antiretroviral Therapy in the Setting of Virologic Suppression).