Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon (POSITRON)
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| ClinicalTrials.gov Identifier: NCT01542788 |
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Recruitment Status :
Completed
First Posted : March 2, 2012
Results First Posted : February 17, 2014
Last Update Posted : May 19, 2014
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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Brief Summary:
This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Hepatitis C | Drug: SOF Drug: RBV Drug: Placebo to match SOF Drug: Placebo to match RBV | Phase 3 |
Participants who were randomized to the placebo arm and completed all scheduled study procedures were eligible to receive active SOF+RBV in open-label Study GS-US-334-0109.
Participants who do not achieve sustained virologic response (SVR) were eligible for enrollment in the Sequence Registry Study GS-US-248-0123. The purpose of the Sequence Registry Study is to monitor the persistence of resistant mutations for up to 3 years.
Participants who achieved SVR were eligible for enrollment in the SVR Registry Study GS-US-248-0122. The purpose of the SVR Registry Study is to evaluate durability of SVR for up to 3 years after treatment.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 278 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| 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 Subjects With Chronic Genotype 2 or 3 HCV Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon |
| Study Start Date : | March 2012 |
| Actual Primary Completion Date : | November 2012 |
| Actual Study Completion Date : | February 2013 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Sofosbuvir
| Arm | Intervention/treatment |
|---|---|
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Experimental: SOF+RBV
Participants were randomized to receive SOF+RBV for 12 weeks.
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Drug: SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
Other Names:
Drug: RBV Ribavirin (RBV) was administered as a tablet orally according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg). |
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Placebo Comparator: Placebo
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks.
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Drug: Placebo to match SOF
Placebo to match SOF was administered orally once daily. Drug: Placebo to match RBV Placebo to match RBV was administered orally twice daily. |
Primary Outcome Measures :
- Percentage of Participants Achieving SVR12 [ Time Frame: Post-treatment Week 12 ]SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy
- Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug [ Time Frame: Baseline to Week 12 ]The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment.
Secondary Outcome Measures :
- Percentage of Participants Achieving SVR4 [ Time Frame: Post-treatment Week 4 ]SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy
- Percentage of Participants Achieving SVR24 [ Time Frame: Post-treatment Week 24 ]SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy
- Percentage of Participants Experiencing Viral Breakthrough [ Time Frame: Baseline to Week 12 ]Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values
- Percentage of Participants Experiencing Viral Relapse [ Time Frame: End of treatment to post-treatment Week 24 ]Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
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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:
- Infection with HCV genotype 2 or 3
- Cirrhosis determination
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Subject meets one of the following classifications:
- IFN unwilling
- IFN ineligible
- IFN intolerant
- Screening laboratory values within defined thresholds
- Subject has not been treated with any investigational drug or device within 30 days of the Screening visit
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria:
- Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
- Pregnant or nursing female or male with pregnant female partner
- Current or prior history of clinical hepatic decompensation
- History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
- Excessive alcohol ingestion or significant drug abuse
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): NCT01542788
Locations
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Sponsors and Collaborators
Gilead Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01542788 |
| Other Study ID Numbers: |
GS-US-334-0107 |
| First Posted: | March 2, 2012 Key Record Dates |
| Results First Posted: | February 17, 2014 |
| Last Update Posted: | May 19, 2014 |
| Last Verified: | May 2014 |
Keywords provided by Gilead Sciences:
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HCV genotype 2 (GT-2) HCV genotype 3 (GT-3) HCV Sustained Virologic Response Direct Acting Antiviral |
Combination Therapy Interferon intolerant Interferon ineligible GS-7977 Ribavirin |
Additional relevant MeSH terms:
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Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Hepatitis, Chronic Sofosbuvir Antiviral Agents Anti-Infective Agents |