For treatment-naïve and virologically suppressed adults with HIV-1. See Full Indication.

DHHS RECOMMENDATION

DHHS RECOMMENDATION

DHHS Regimen

The DHHS Panel now
recommends DTG/3TC (AI)*

Rating for Recommendations=Strong (A)

Rating of Evidence=Data from randomized controlled trials (I)

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As an Initial Regimen for Most People With HIV-1, Except for Individuals:

  • With HBV co-infection
  • Who will start ART before results of HIV genotypic resistance testing for RT or HBV testing are available
  • With HIV RNA >500,000 copies/mL

For Virologically Suppressed Adults With HIV-1:

  • Without HBV co-infection
  • For individuals with no evidence of resistance to DTG or 3TC

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, observational cohort studies with long-term clinical outcomes, relative bioavailability/bioequivalence studies, or regimen comparisons from randomized switch studies; III=expert opinion.

The DHHS Guidelines also recommend the following initial regimens for most people with HIV-1 with an AI rating: BIC/FTC/TAF, DTG/ABC/3TC only if HLA-B*5701-negative, and DTG + (FTC or 3TC) + (TAF or TDF).

Based on data from the TANGO trial, in which the participants had no history of virologic failure or evidence of resistance to DTG or 3TC and did not have HBV co-infection.

 

3TC=lamivudine; ABC=abacavir;  ART=antiretroviral therapy; BIC=bictegravir; DHHS=Department of Health and Human Services; DTG=dolutegravir; FTC=emtricitabine; HBV=hepatitis B virus; RT=reverse transcriptase; TAF=tenofovir alafenamide; TDF=tenofovir disoproxil fumarate.

Reference:

1. DHHS Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. US Department of Health and Human Services. Updated June 3, 2021. Accessed October 5, 2021. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/AdultandAdolescentGL.pdf

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