Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate single tablet for HIV-1 infection treatment

Ann Pharmacother. 2012 Dec;46(12):1671-7. doi: 10.1345/aph.1R468. Epub 2012 Nov 7.

Abstract

Objective: To review the clinical trials, pharmacologic characteristics, safety, and efficacy of the elvitegravir/cobicistat/emtricitabine/tenofovir single tablet formulation (Stribild).

Data sources: Literature searches were performed in MEDLINE (1948-September 2012) and PubMed (1966-September 2012) using the search terms GS-9137, elvitegravir, GS 9350, cobicistat, quad pill, Stribild, and integrase inhibitors. Abstracts from HIV/AIDS conferences were reviewed.

Study selection and data extraction: Phase 3 studies evaluating the safety and efficacy of Stribild were preferentially evaluated, as well as relevant references from the published studies.

Data synthesis: Stribild contains complete antiretroviral therapy for HIV-1 infection in a single tablet. It is the first once-daily therapy option available with an integrase inhibitor and a novel pharmacokinetic boosting agent. Stribild has shown noninferiority in viral load suppression at 48 weeks when compared with dual nucleoside/nucleotide reverse transcriptase inhibitor and either a ritonavir-boosted protease inhibitor or nonnucleoside reverse transcriptase inhibitor regimen. Stribild was well tolerated, but some patients experienced increases in serum creatinine early in treatment that stabilized over time.

Conclusions: Stribild is the first single-tablet regimen for HIV-1 infection treatment containing an integrase inhibitor. It is expected to have a prominent place in the formularies of health plans providing care for individuals with HIV-1 infection.

Publication types

  • Comparative Study
  • Review

MeSH terms

  • Adenine / administration & dosage
  • Adenine / adverse effects
  • Adenine / analogs & derivatives*
  • Adenine / therapeutic use
  • Anti-HIV Agents / administration & dosage
  • Anti-HIV Agents / adverse effects
  • Anti-HIV Agents / therapeutic use*
  • Carbamates / administration & dosage
  • Carbamates / adverse effects
  • Carbamates / therapeutic use*
  • Clinical Trials, Phase III as Topic
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / therapeutic use*
  • Drug Combinations
  • Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
  • HIV Infections / drug therapy*
  • HIV Integrase Inhibitors / administration & dosage
  • HIV Integrase Inhibitors / adverse effects
  • HIV Integrase Inhibitors / therapeutic use
  • Humans
  • Organophosphonates / administration & dosage
  • Organophosphonates / adverse effects
  • Organophosphonates / therapeutic use*
  • Quinolones / administration & dosage
  • Quinolones / adverse effects
  • Quinolones / therapeutic use*
  • Tablets
  • Thiazoles / administration & dosage
  • Thiazoles / adverse effects
  • Thiazoles / therapeutic use*
  • Viral Load / drug effects

Substances

  • Anti-HIV Agents
  • Carbamates
  • Drug Combinations
  • Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
  • HIV Integrase Inhibitors
  • Organophosphonates
  • Quinolones
  • Tablets
  • Thiazoles
  • Deoxycytidine
  • Adenine