GS-5885: Interim Phase II data

Interim data from the open-label, U.S. Phase II Study 120 trial in 141 treatment-naïve patients with chronic HCV genotype 1 infection showed that 74 patients receiving an all-oral regimen of high-dose GS-5885, tegobuvir, GS-9451 and ribavirin achieved HCV RNA levels <25 IU/mL at week 2. In 27 evaluable patients who stopped treatment at week 12, 96% achieved an SVR 4 weeks after the end of treatment. Viral breakthrough occurred in 8 of 55 patients with HCV genotype 1a infection. The most common adverse events were headache, fatigue, diarrhea, nausea and rash.

Patients received twice-daily 30 mg tegobuvir, once-daily 200 mg GS-9451 and ribavirin in combination with once-daily 30 or 90 mg GS-5885 for 12 or 24 weeks. Patients who did not achieve HCV RNA levels <25 IU/mL at week 2 were switched to peginterferon alfa-2a-containing rescue therapy. Patients in the high-dose GS-5885 arm who achieved HCV RNA levels <25 IU/mL at week 2 and remained undetectable at week 12 were re-randomized to stop therapy or continue treatment for an additional 12 weeks. Based on the results, Gilead said it has selected the 90 mg dose of GS-5885 for further clinical development. Data for the low-dose GS-5885 arm were not disclosed. Data were presented at the European Association for the Study of the Liver meeting in Barcelona. ...