Brief Report: Cobicistat Compared With Ritonavir as a Pharmacoenhancer for Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate: Week 144 Results

J Acquir Immune Defic Syndr. 2015 Jul 1;69(3):338-40. doi: 10.1097/QAI.0000000000000598.

Abstract

Background: Cobicistat (COBI) is a pharmacoenhancer with no antiretroviral activity.

Methods: International, randomized double-blind active-controlled trial to evaluate the efficacy and safety of COBI vs ritonavir (RTV) as a pharmacoenhancer of atazanavir in combination with emtricitabine/tenofovir disoproxil fumarate in HIV treatment-naive patients followed through week 144.

Results: At Week 144, virologic suppression was achieved in 72% (COBI) and 74% (RTV) of patients. Adverse events leading to study drug discontinuation occurred in 11% of patients in each group. Median changes in serum creatinine (mg/dL) were +0.13 (COBI) and +0.07 (RTV) and were unchanged from week 48.

Conclusions: Once-daily COBI is a safe and effective pharmacoenhancer of the protease inhibitor atazanavir.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenine / administration & dosage
  • Adenine / adverse effects
  • Adenine / analogs & derivatives
  • Adenine / therapeutic use
  • Adult
  • Anti-HIV Agents / administration & dosage
  • Anti-HIV Agents / therapeutic use*
  • Atazanavir Sulfate
  • Carbamates / administration & dosage*
  • Carbamates / adverse effects
  • Cobicistat
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives
  • Deoxycytidine / therapeutic use
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Synergism
  • Drug Therapy, Combination
  • Emtricitabine
  • Female
  • HIV Infections / drug therapy
  • HIV-1 / drug effects
  • Humans
  • Male
  • Oligopeptides / administration & dosage
  • Oligopeptides / adverse effects
  • Oligopeptides / therapeutic use
  • Organophosphonates / administration & dosage
  • Organophosphonates / adverse effects
  • Organophosphonates / therapeutic use
  • Pyridines / administration & dosage
  • Pyridines / adverse effects
  • Pyridines / therapeutic use
  • RNA, Viral / blood
  • Ritonavir / administration & dosage
  • Ritonavir / adverse effects
  • Ritonavir / therapeutic use
  • Tenofovir
  • Thiazoles / administration & dosage*
  • Thiazoles / adverse effects
  • Viral Load

Substances

  • Anti-HIV Agents
  • Carbamates
  • Oligopeptides
  • Organophosphonates
  • Pyridines
  • RNA, Viral
  • Thiazoles
  • Deoxycytidine
  • Atazanavir Sulfate
  • Tenofovir
  • Emtricitabine
  • Adenine
  • Cobicistat
  • Ritonavir