Gilead Announces Phase 2 Data for Investigational All-Oral Regimen of Sofosbuvir Plus GS-5816 for the Treatment of Chronic Hepatitis C
All three studies evaluated SOF 400 mg plus GS-5816 25 or 100 mg, with and without ribavirin (RBV), for eight or 12 weeks. Rates of sustained virologic response (SVR12) ranged from 88 percent to 100 percent among those receiving SOF plus GS-5816 100 mg for 12 weeks – the regimen selected for Phase 3 studies. Patients who achieve SVR12 are considered cured of HCV infection.
“There continues to be a need for simple, interferon- and ribavirin-free
treatment regimens that are effective for all hepatitis C patients,
regardless of genotype,” said
The first study, GS-US-342-0109 (Oral #197), evaluated 12 weeks of SOF plus GS-5816 with and without RBV in treatment-experienced genotype 1 and 3 patients with and without cirrhosis. The genotype 1 patients had all failed a prior treatment course that included a protease inhibitor. The number and proportion of patients achieving SVR12 are summarized in the table below.
SVR12 Rates Among Treatment-Experienced Patients in Study GS-US-342-0109
|SOF+GS-5816 100 mg||100% (n=20/20)||100% (n=7/7)||100% (n=27/27)||88% (n=23/26)|
|SOF+GS-5816 100 mg +RBV||100% (n=18/18)||90% (n=9/10)||100% (n=26/26)||
The second study, ELECTRON 2 (Oral #79), evaluated the same combination of SOF plus GS-5816, with and without RBV, for eight weeks in non-cirrhotic, treatment-naïve genotype 3 patients. Patients receiving SOF with GS-5816 100 mg achieved SVR12 rates of 100 percent (n=26/26) with RBV and 96 percent (n=26/27) without RBV.
The third study, GS-US-342-0102, evaluated SOF plus GS-5816, with and
without RBV, among non-cirrhotic treatment-naïve patients. The results
of Part A of the study evaluating 12 weeks of therapy were presented at
the 49th Annual Meeting of the
The results of Part B, presented at the Liver Meeting this week (Oral #80), evaluated eight weeks of SOF plus GS-5816, with and without RBV, in patients with genotype 1 or 2 HCV infection. Among genotype 1 patients receiving SOF plus GS-5816 100 mg, SVR12 rates were 81 percent (n=25/31) and 90 percent (n=26/29), with and without RBV, respectively. Genotype 2 patients achieved SVR12 rates of 88 percent (n=23/26) with RBV and 88 percent (n=23/26) without RBV.
SOF plus GS-5816 was well tolerated in over 800 patients with HCV infection evaluated in these three studies. There was a low incidence of serious adverse effects and few discontinuations due to adverse events. The most frequently reported adverse events (>10%) were fatigue, headache, nausea and insomnia. The most frequently observed hematologic abnormality was hemoglobin decrease in the RBV-containing treatment groups.
GS-5816 is an investigational product and its safety and efficacy have not been established.
Additional information about these studies can be found at www.clinicaltrials.gov.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the
possibility of unfavorable longer-term results from these studies and
other ongoing and subsequent clinical trials involving sofosbuvir plus
GS-5816, alone or in combination with other products, for the treatment
of HCV. In addition, Gilead may make a strategic decision to discontinue
development of GS-5816 if, for example, Gilead believes
commercialization will be difficult relative to other opportunities in
its pipeline. These risks, uncertainties and other factors could cause
actual results to differ materially from those referred to in the
forward-looking statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in
detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended
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