Brief Report: Efficacy and Safety of Switching to a Single-Tablet Regimen of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1/Hepatitis B-Coinfected Adults

J Acquir Immune Defic Syndr. 2016 Nov 1;73(3):294-298. doi: 10.1097/QAI.0000000000001069.

Abstract

Coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF) has high efficacy and improved renal and bone safety in multiple phase 3 trials; TAF single agent is being studied in 2 phase 3 trials in patients with chronic hepatitis B. We report the results of an open-label, noncomparative switch study evaluating the efficacy and safety of E/C/F/TAF in HIV/hepatitis B virus (HBV)-coinfected adults. At 48 weeks, 91.7% of the 72 participants maintained or achieved virologic suppression (HIV-1 RNA <50 copies/mL; HBV DNA <29 IU/mL). Seroconversion occurred in 2.9% of hepatitis B surface antigen-positive participants and in 3.3% of HBV e antigen-positive participants; 40% of those with abnormal alanine aminotransferase normalized. E/C/F/TAF was associated with improved renal function and reduced bone turnover. These data support the use of E/C/F/TAF in treating HIV/HBV coinfection.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study

MeSH terms

  • Adenine / administration & dosage
  • Adenine / adverse effects
  • Adenine / analogs & derivatives
  • Alanine
  • Anti-HIV Agents / administration & dosage*
  • Anti-HIV Agents / adverse effects*
  • Anti-HIV Agents / therapeutic use
  • Cobicistat / administration & dosage
  • Cobicistat / adverse effects
  • Coinfection
  • Drug Combinations*
  • Drug Substitution
  • Emtricitabine / administration & dosage
  • Emtricitabine / adverse effects
  • Female
  • HIV Infections / complications*
  • HIV Infections / drug therapy*
  • HIV Infections / immunology
  • Hepatitis B / complications*
  • Hepatitis B / drug therapy*
  • Hepatitis B / immunology
  • Humans
  • Male
  • Middle Aged
  • Quinolones / administration & dosage
  • Quinolones / adverse effects
  • Tenofovir / analogs & derivatives
  • Treatment Outcome

Substances

  • Anti-HIV Agents
  • Drug Combinations
  • Quinolones
  • elvitegravir
  • Tenofovir
  • tenofovir alafenamide
  • Emtricitabine
  • Adenine
  • Cobicistat
  • Alanine