Use-Results Surveillance Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection

A Prospective Observational Post-Marketing Study of Sovaldi® Plus Rebetol® in Japanese Patients With Chronic Genotype 2 Hepatitis C Virus Infection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02562742

Enrollment

554

Registered

2015-09-29

Start date

2015-11-12

Completion date

2017-06-12

Last updated

2017-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Hepatitis C virus, observational, post-marketing, sofosbuvir, Infection

Brief summary

This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Rebetol® capsules (ribavirin, REB) 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.

Interventions

DRUGSOF

SOF 400 mg tablets administered orally once daily

DRUGREB

REB capsules administered orally in a divided daily weight-based dose according to the package insert for the approved Rebetol® labeling in Japan (\< 60 kg = 600 mg , \> 60 kg to ≤ 80 kg = 800 mg, and \> 80 kg = 1000 mg)

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis * Patients who are prescribed SOF+REB Key

Exclusion criteria

* None Note: Other protocol defined Inclusion/

Design outcomes

Primary

Measure	Time frame
Incidence of adverse drug reaction (ADR) under real world settings	Up to 16 weeks

Secondary

Measure	Time frame	Description
Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24)	Posttreatment Weeks 12 and 24	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.
Proportion of participants with HCV NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks	Approximately 12 weeks after treatment completion or discontinuation	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026