February 19, 2013
Gilead’s Sofosbuvir for Hepatitis C Meets Primary Endpoint in Fourth Pivotal Phase 3 Study
-- Initial Regulatory Filings Planned for Q2 2013 --
“This study demonstrates that all-oral therapy with sofosbuvir provides
significant efficacy among difficult-to-treat hepatitis C patients who
could not be cured by prior regimens containing pegylated interferon and
now have limited treatment options,” said
In the FUSION study, HCV genotype 2 or 3 patients who failed prior interferon-based therapy were randomized (1:1) to receive either a 12-week (n=103) or 16-week (n=98) course of sofosbuvir 400 mg once daily plus RBV (1,000 or 1,200 mg/day). Sixty-three percent of patients were infected with genotype 3. In the 12-week arm, SVR12 rates were 86 percent among genotype 2 and 30 percent among genotype 3 patients. In the 16-week arm, SVR12 rates were 94 percent among genotype 2 and 62 percent among genotype 3 patients. Among the 34 percent of FUSION participants who had compensated cirrhosis at baseline, 31 percent achieved SVR12 in the 12-week arm, and 66 percent achieved SVR12 in the 16-week arm. All patients in the study became HCV negative on treatment, and relapse accounted for all virologic failures.
No patients discontinued sofosbuvir or RBV due to adverse events. The most common adverse events reported in ≥15 percent of patients in the study were fatigue, headache, insomnia and nausea.
Results from all four pivotal Phase 3 studies of sofosbuvir – FUSION, POSITRON, FISSION and NEUTRINO – will support the initial regulatory filing for sofosbuvir as part of all-oral therapy with RBV among genotype 2 and 3 treatment-naïve, treatment-experienced and interferon-intolerant HCV patients, and for sofosbuvir in combination with RBV and pegylated interferon among treatment-naïve patients with genotypes 1, 4, 5 and 6.
Full results from these studies will be presented at a future scientific conference. Additional information about these and other ongoing clinical studies of sofosbuvir can be found at www.clinicaltrials.gov. Sofosbuvir is an investigational product and its safety and efficacy have not yet been established.
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 that the proportion of patients who maintain a sustained
virologic response with longer follow up will not be as favorable as the
sustained virologic response rates reported in this press release, and
the possibility of unfavorable results from other clinical trials
involving sofosbuvir. As a result, sofosbuvir may never be successfully
commercialized. In addition, Gilead may make a strategic decision to
discontinue development of the compound if, for example, Gilead believes
commercialization will be difficult relative to other opportunities in
its pipeline. Further, Gilead may be unable to file for regulatory
approval of sofosbuvir in the currently anticipated timelines or at all.
If marketing approval is granted for this product, there may be
significant limitations on its use. 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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Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)