Resistance Analysis of Bictegravir-Emtricitabine-Tenofovir Alafenamide in HIV-1 Treatment-Naive Patients through 48 Weeks

Antimicrob Agents Chemother. 2019 Apr 25;63(5):e02533-18. doi: 10.1128/AAC.02533-18. Print 2019 May.

Abstract

In clinical studies GS-US-380-1489 (study 1489) and GS-US-380-1490 (study 1490), bictegravir-emtricitabine-tenofovir alafenamide (B-F-TAF), dolutegravir-abacavir-lamivudine (DTG-ABC-3TC), and dolutegravir plus emtricitabine-tenofovir alafenamide (DTG+F-TAF) treatment achieved high rates of virologic suppression in HIV-1 treatment-naive participants through week 48. Preexisting primary drug resistance was present at levels of 1.3% integrase strand transfer inhibitor resistance (INSTI-R), 2.7% nucleoside reverse transcriptase inhibitor resistance (NRTI-R), 14.1% nonnucleoside reverse transcriptase inhibitor resistance (NNRTI-R), and 3.5% protease inhibitor resistance (PI-R) in the 1,274 participants from these studies. These mutations did not affect treatment outcomes. Resistance analyses in 13 virologic failures found no emergent resistance to study drugs.

Keywords: bictegravir; clinical trial; resistance; treatment naive.

MeSH terms

  • Adenine / analogs & derivatives*
  • Adenine / therapeutic use
  • Anti-HIV Agents / therapeutic use*
  • Antiviral Agents / therapeutic use*
  • Dideoxynucleosides / therapeutic use
  • Drug Combinations
  • Drug Resistance, Viral
  • Emtricitabine / therapeutic use*
  • HIV Infections / drug therapy
  • HIV Infections / virology
  • HIV-1 / drug effects
  • HIV-1 / pathogenicity
  • Heterocyclic Compounds, 4 or More Rings / therapeutic use*
  • Humans
  • Lamivudine / therapeutic use
  • Reverse Transcriptase Inhibitors / therapeutic use
  • Tenofovir / therapeutic use

Substances

  • Anti-HIV Agents
  • Antiviral Agents
  • Dideoxynucleosides
  • Drug Combinations
  • Heterocyclic Compounds, 4 or More Rings
  • Reverse Transcriptase Inhibitors
  • abacavir, lamivudine drug combination
  • emtricitabine tenofovir alafenamide
  • Lamivudine
  • bictegravir
  • Tenofovir
  • tenofovir alafenamide
  • Emtricitabine
  • Adenine