This post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Copegus® tablets (ribavirin, COPE) will evaluate the safety and efficacy of SOF administered in combination with ribavirin under real world use in Japan. Among adult patients with chronic genotype 2 hepatitis C virus (HCV) infection and treated with SOF+ribavirin in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.
Study Type
OBSERVATIONAL
Enrollment
552
SOF 400 mg tablets administered orally once daily
COPE tablets administered orally in a divided daily weight-based dose according to the package insert for the approved Copegus® labeling in Japan (\< 60 kg = 600 mg , \> 60 kg to ≤ 80 kg = 800 mg, and \> 80 kg = 1000 mg)
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Amagasaki-shi, Japan
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Asahi-shi, Japan
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Asahikawa-shi, Japan
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Beppu-shi, Japan
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Chichibu-shi, Japan
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Fujioka-shi, Japan
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Fukui-shi, Japan
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Hamamatsu, Japan
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Iizuka-shi, Japan
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Inzai-shi, Japan
...and 35 more locations
Incidence of adverse drug reaction (ADR) under real world settings
Time frame: Up to 16 weeks
Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24)
SVR12 and SVR24 are defined as HCV RNA \< the lower limit of quantification (LLOQ) 12 and 24 weeks following the last dose of study drug, respectively.
Time frame: Posttreatment Weeks 12 and 24
Proportion of participants with HCV NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks
Time frame: Approximately 12 weeks after treatment completion or discontinuation
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