A Review of the Efficacy and Safety of Genvoya® (Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide) in the Management of HIV-1 Infection

J Pharm Pract. 2018 Apr;31(2):216-221. doi: 10.1177/0897190017710519. Epub 2017 May 30.

Abstract

Introduction: This review evaluates the efficacy and safety of Genvoya® (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide [EVG/c/TAF/FTC]), a single-tablet regimen used for the management of HIV-1 infection. Phase II and III randomized clinical trials evaluate the efficacy and safety of EVG/c/TAF/FTC and tenofovir disoproxil fumerate (TDF)-containing arms; renal impairment, bone mineral density, metabolic effects, and other adverse events are topics explored within this review.

Methods: A MEDLINE with full text and PubMed literature search was conducted for the past 5 years, up to April 2016.

Results: Virologic suppression was similar between the EVG/c/TAF/FTC and TDF-containing groups (<50 copies/mL) at week 48. The bone mineral density in the hip and spine showed a significant reduction in the TDF-containing groups. The glomerular filtration rate increased in patients in the EVG/c/TAF/FTC arm and there were significant differences in total proteinuria, albuminuria, and tubular proteinuria in patients switching to EVG/c/TAF/FTC. The most common adverse events were diarrhea, nausea, and headache.

Discussion: The coformulated Genvoya regimen is well tolerated and effective in treatment-naive and virologically suppressed patients. Data seem to suggest it may also be effective and safe in patients with mild to moderate renal impairment. The lower-dosed single-tablet regimen has significantly reduced bone and renal side effects.

Keywords: Genvoya; HIV-1; cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide; tenofovir disoproxil fumarate.

Publication types

  • Review

MeSH terms

  • Anti-HIV Agents / adverse effects
  • Anti-HIV Agents / pharmacology
  • Anti-HIV Agents / therapeutic use*
  • Clinical Trials, Phase III as Topic / methods
  • Cobicistat / adverse effects
  • Cobicistat / pharmacology
  • Cobicistat / therapeutic use*
  • Diarrhea / chemically induced
  • Disease Management*
  • Drug Combinations
  • Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
  • Emtricitabine / adverse effects
  • Emtricitabine / pharmacology
  • Emtricitabine / therapeutic use*
  • HIV Infections / diagnosis
  • HIV Infections / drug therapy*
  • HIV Infections / epidemiology
  • HIV-1 / drug effects*
  • Headache / chemically induced
  • Humans
  • Nausea / chemically induced
  • Quinolones / adverse effects
  • Quinolones / pharmacology
  • Quinolones / therapeutic use*
  • Randomized Controlled Trials as Topic / methods
  • Tenofovir / adverse effects
  • Tenofovir / analogs & derivatives*
  • Tenofovir / pharmacology
  • Tenofovir / therapeutic use
  • Treatment Outcome

Substances

  • Anti-HIV Agents
  • Drug Combinations
  • Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
  • Quinolones
  • Tenofovir
  • Emtricitabine
  • Cobicistat