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Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection

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ClinicalTrials.gov Identifier: NCT01910636
Recruitment Status : Completed
First Posted : July 29, 2013
Results First Posted : March 24, 2015
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Sofosbuvir Drug: RBV Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 2 HCV Infection
Study Start Date : February 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : June 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Sofosbuvir+RBV 12 weeks
Participants will receive sofosbuvir+RBV for 12 weeks.
 Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®

Drug: RBV
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing according to the approved Copegus labeling in Japan (< 60 kg = 600 mg , > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
Other Name: Copegus®


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

  2. Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) [ Time Frame: Up to 12 weeks ]
    The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.


Secondary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]
    SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

  2. Percentage of Participants Experiencing Viral Breakthrough [ Time Frame: Up to 12 weeks ]
    Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values.

  3. Percentage of Participants Experiencing Viral Relapse [ Time Frame: Up to Posttreatment Week 24 ]
    Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic genotype 2 HCV-infection
  • Male or female, age ≥ 20 years
  • Body weight ≥ 40 kg
  • HCV RNA ≥ 10,000 IU/mL at screening

Exclusion Criteria:

  • Current or prior history of clinically significant illness other than HCV
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of a non-HCV etiology
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01910636


Locations
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Japan
Akita, Japan
Chiba, Japan
Chiyoda-ku, Japan
Gifu, Japan
Ichikawa, Japan
Itabashi-ku, Japan
Izunokuni, Japan
Kita-Ku, Japan
Kurashiki, Japan
Kurume, Japan
Matsumoto, Japan
Musashino, Japan
Nishinomiya, Japan
Ogaki, Japan
Omura, Japan
Sapporo, Japan
Shinjuku-ku, Japan
Suita, Japan
Yamagata, Japan
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Steven Knox Gilead Sciences
More Information
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01910636    
Other Study ID Numbers: GS-US-334-0118
First Posted: July 29, 2013    Key Record Dates
Results First Posted: March 24, 2015
Last Update Posted: March 24, 2015
Last Verified: March 2015
Keywords provided by Gilead Sciences:
HCV genotype 2 (GT-2)
Additional relevant MeSH terms:
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Hepatitis C
Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
 Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents