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

DHHS RECOMMENDATION

DHHS RECOMMENDATION

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

Rating for Recommendations=Strong (A)

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

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

The DHHS Panel on Antiretroviral Guidelines has issued a recommendation for the administration of ART based on results of clinical studies and expert opinion. With the December 2019 update, the Panel has added DTG/3TC to the list of Recommended Initial Regimens for Most People With HIV in the "What to Start" section. For recommendations, see Table 6a: "Recommended Antiretroviral Regimens for Initial Therapy" on page G-4. The Panel has also updated their recommendation for Optimizing Antiretrovial Therapy in the Setting of Virologic Suppression in the "Management of the Treatment-Experienced Patient" section. For more information, see page I-25: Two-Drug Regimens.

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. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/AdultandAdolescentGL.pdf. Updated December 18, 2019. Accessed July 16, 2020.

DLLWCNT200029