Clinical Data
The published efficacy results from the randomized, double-blind, placebo-controlled C-EDGE CO-STAR trial showed 92 percent (184/201) of patients receiving ZEPATIER for 12 weeks in the study’s immediate treatment group achieved SVR12, with comparable rates across GT1a (94%, 144/154), GT1b (93%, 28/30) and GT4 (92%, 11/12) patients; in the limited number of GT6 patients, SVR12 was 20 percent (1/5). These results classify patients who cleared their baseline infection but subsequently acquired a new infection as treatment failures; previously presented results from this trial considered these patients as treatment successes, according to the study protocol. A supportive analysis showed that the vast majority of patients were adherent to therapy, despite ongoing use of drugs of potential abuse (e.g., cocaine, heroin, amphetamines) by the majority of patients throughout the trial. The rates of adverse events were generally comparable between active treatment and placebo groups, with the most common adverse events (greater than 10%) in both groups including fatigue (16%, 20%), headache (12%, 13%) and nausea (11%, 9%), respectively. Secondary efficacy endpoint (SVR24) and reinfection analyses were presented at The International Liver Congress™ in April 2016.