Study GS-US-216-0114: ATV + ritonavir + FTC/TDF QD vs ATV + cobicistat + FTC/TDF

Gallant JE. J Infect Dis. 2013 Jul;208(1):32-9; J Acquir Immune Defic Syndr . 2015 Jul 1; 69 (3): 338-40

Type of ARV Trial
Head-to-head comparative trials for first line ART since 2006
» RTV vs Cobi
» ATV/r + FTC/TDF vs ATV/c + FTC/TDF


  • COBI was non inferior to RTV in combination with ATV plus FTC/TDF up to week 144
    • Both regimens achieved high rates of virologic success
  • Safety and tolerability profiles of the 2 regimens were comparable
  • Once-daily COBI is a safe and effective pharmaco -enhancer of the protease inhibitor ATV
  • Renal safety was comparable between treatment arms
    • Discontinuation due to renal events was 2.9% in the COBI group and 3.2% in the RTV group at W144
    • Proximal renal tubulopathy occurred in 7 vs 7 patients (2.0%)
    • A small, but significantly higher with COBI, increase in creatinine was seen in both groups, as early as week 2, with peak at week 8, and stabilization through 144 weeks


* Randomisation was stratified by HIV RNA (≤ or > 100,000 c/mL) at screening

Objective :

  • Non inferiority of COBI compared with RTV at W48: % HIV RNA < 50 c/mL by intention to treat, snapshot analysis (lower limit for the 95% CI for the difference = -12%, 95% power)

Baseline characteristics and patient disposition

Response to treatment at week 48

Viral suppression was high in both treatment arms, for various subgroups, including patients with HIV RNA > 100,000 c/mL at baseline

Mean CD4/mm3 increase at W48 :
+ 213 COBI vs + 219 RTV

Response to treatment at week 144 (ITT, snapshot)

Criteria for resistance testing :

Confirmed HIV-1 RNA load rebound of ≥ 400 c/mL or not obtaining HIV RNA < 400 c/mL by or after week 8

Resistance data up to week 144

Adverse events occurring in > 10% of patients in either group (W48)

Laboratory abnormalities at W48

Adverse events leading to discontinuation of study drug

Proximal renal tubulopathy

  • 7 in each group
  • In 5 of the 7 patients in the COBI group and 6 of the 7 patients in the RTV group, PRT occurred after week 48

Serum Creatinine and eGFR

Median change in fasting lipids at week 144 (mg/dL)

  • No difference in TC:HDL ratio changes between arms (-0.3 vs -0.2)