Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
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| ClinicalTrials.gov Identifier: NCT01682720 |
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Recruitment Status :
Completed
First Posted : September 11, 2012
Results First Posted : October 9, 2014
Last Update Posted : October 9, 2014
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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Brief Summary:
This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis C | Drug: SOF Drug: RBV Drug: Placebo to match SOF Drug: Placebo to match RBV | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 421 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977+Ribavirin for 12 Weeks in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection. |
| Study Start Date : | September 2012 |
| Actual Primary Completion Date : | October 2013 |
| Actual Study Completion Date : | January 2014 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Sofosbuvir
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo 12 Weeks (GT2/3)
Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
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Drug: Placebo to match SOF
Placebo to match SOF administered orally once daily Drug: Placebo to match RBV Placebo to match RBV administered orally in a divided daily dose |
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Experimental: SOF 12 Weeks (GT2/3)
Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
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Drug: SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Other Names:
Drug: RBV Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
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Experimental: SOF 24 Weeks (GT3)
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
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Drug: SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Other Names:
Drug: RBV Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
Primary Outcome Measures :
- Percentage of Participants With Sustained Virologic Response 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) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
- Adverse Events Leading to Permanent Discontinuation of Study Drug(s) [ Time Frame: Up to 24 weeks ]The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.
Secondary Outcome Measures :
- 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 SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
- Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse [ Time Frame: Up to Posttreatment Week 24 ]
Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.
Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.
Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age > 18 with chronic genotype 2 or 3 HCV infection
- HCV RNA > 10,000 IU/mL at screening
- Subjects must be treatment naive or treatment experienced
- Presence or absence of cirrhosis; a liver biopsy may be required
- Healthy according to medical history and physical examination with the exception of HCV diagnosis
- Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
Exclusion Criteria:
- Prior use of any other inhibitor of the HCV NS5B Polymerase
- History of any other clinically significant chronic liver disease
- Evidence of or history of decompensated liver disease
- HIV or chronic hepatitis B virus (HBV) infection
- Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- Chronic use of immunosuppressive agents or immunomodulatory agents
- History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study or not be in the best interest of the subject in the opinion of the investigator
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): NCT01682720
Locations
Show 77 study locations
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Rob Hyland, DPhil | Gilead Sciences Study Director |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01682720 |
| Other Study ID Numbers: |
GS-US-334-0133 2012-001942-16 ( EudraCT Number ) |
| First Posted: | September 11, 2012 Key Record Dates |
| Results First Posted: | October 9, 2014 |
| Last Update Posted: | October 9, 2014 |
| Last Verified: | October 2014 |
Keywords provided by Gilead Sciences:
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HCV Genotype 2 Genotype 3 |
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 |