Gilead Sciences GILD today announced topline results from the Phase 3
FUSION study evaluating 12- and 16-week courses of therapy with the once-daily
nucleotide sofosbuvir plus ribavirin (RBV) in treatment-experienced patients
with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who failed
prior treatment. The study met its primary efficacy endpoint of superiority
compared to a predefined historic control sustained virologic response (SVR)
rate of 25 percent. In FUSION, 50 percent of patients (n=50/100) in the
12-week arm and 73 percent of patients (n=69/95) in the 16-week arm achieved
SVR12 (p<0.001 for both arms).
“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 Norbert Bischofberger, PhD, Executive Vice
President of Research and Development and Chief Scientific Officer. “With
positive results from all four Phase 3 trials now in hand, Gilead is on track
to meet its goal of filing regulatory applications in the United States and
Europe in the second quarter.”
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.
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