SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection
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| ClinicalTrials.gov Identifier: NCT01962441 |
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Recruitment Status :
Completed
First Posted : October 14, 2013
Results First Posted : February 5, 2016
Last Update Posted : June 20, 2017
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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Brief Summary:
This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis C | Drug: SOF Drug: RBV Drug: Peg-IFN | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 601 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3B Randomized, Open-Label, Multi-Center Trial Assessing Sofosbuvir + Ribavirin for 16 or 24 Weeks and Sofosbuvir + Pegylated Interferon + Ribavirin for 12 Weeks in Subjects With Genotype 2 or 3 Chronic HCV Infection. |
| Actual Study Start Date : | September 24, 2013 |
| Actual Primary Completion Date : | January 7, 2015 |
| Actual Study Completion Date : | July 7, 2016 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Sofosbuvir
| Arm | Intervention/treatment |
|---|---|
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Experimental: SOF+RBV 16 weeks
SOF+RBV for 16 weeks
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Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: RBV 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+RBV 24 weeks
SOF+RBV for 24 weeks
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Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: RBV 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+RBV+Peg-IFN 12 weeks
SOF+RBV+Peg-IFN for 12 weeks
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Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: RBV 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) Drug: Peg-IFN 180 µg administered via subcutaneous injection once weekly |
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Experimental: Retreatment Substudy
Participants from the SOF+RBV arms (16 weeks or 24 weeks) who experienced virologic failure on treatment, or during the posttreatment period at or before Posttreatment Week 24 may be eligible to enroll into the Retreatment Substudy to receive SOF+RBV+Peg-IFN for 12 weeks.
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Drug: SOF
400 mg tablet administered orally once daily
Other Names:
Drug: RBV 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) Drug: Peg-IFN 180 µg administered via subcutaneous injection once weekly |
Primary Outcome Measures :
- Percentage of Participants With Sustained Virologic Response (SVR) 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, 15 IU/mL) at 12 weeks after stopping study treatment.
- Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 24 weeks ]
Secondary Outcome Measures :
- Percentage of Participants With SVR 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 after stopping study treatment, respectively.
- Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24 [ Time Frame: Weeks 1, 2, 4, 8, 12, 16, 20, and 24 ]
- HCV RNA at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]
- Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 [ Time Frame: Baseline; Weeks 1, 2, 4, 8, and 12 ]
- Percentage of Participants Experiencing On-Treatment Virologic Failure [ Time Frame: Up to 24 weeks ]
On-treatment virologic failure was defined as:
- Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
- Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
- Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
- Percentage of Participants Experiencing Viral Relapse [ Time Frame: Up to Posttreatment Week 24 ]Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.
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
Key Inclusion Criteria:
- Male or female, age greater than or equal to 18 years.
- Confirmed chronic HCV infection.
- Subjects will have cirrhosis status assessment; liver biopsy may be required.
- Genotype 2 subjects must have cirrhosis of the liver to be eligible.
- Treatment-naive or prior treatment failure to ≥12 weeks of an interferon- based regimen that was not discontinued prematurely due to an adverse event
- Infection with HCV genotype 2 or 3 as determined at Screening
- Body mass index (BMI) greater than or equal to 18 kg/m^2
- Screening laboratory values within predefined thresholds.
- Liver imaging (e.g., ultrasound) within 6 months of Baseline/Day 1 is required in cirrhotic patients to exclude hepatocellular carcinoma (HCC). In the event of intrahepatic lesions, triple phase CT scan or MRI should be performed to exclude HCC.
- Subject must be of generally good health as determined by the Investigator.
Key Exclusion Criteria:
- Prior use of any other inhibitor of the HCV nonstructural protein (NS)5B polymerase
- Pregnant or nursing female or male with pregnant female partner
- History of any other clinically significant chronic liver disease.
- HIV or chronic hepatitis B virus (HBV) infection.
- Malignancy with the exception of certain resolved skin cancers.
- Chronic use of systemically administered immunosuppressive agents.
- Clinically-relevant drug or alcohol abuse.
- History of solid organ transplantation.
- 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.
- Known hypersensitivity to interferon, RBV, the study investigational medicinal product, the metabolites, or formulation excipients.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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): NCT01962441
Locations
Show 78 study locations
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Gilead Study Director | Gilead Sciences |
Publications of Results:
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01962441 |
| Other Study ID Numbers: |
GS-US-334-0153 2013-002641-11 ( EudraCT Number ) |
| First Posted: | October 14, 2013 Key Record Dates |
| Results First Posted: | February 5, 2016 |
| Last Update Posted: | June 20, 2017 |
| Last Verified: | May 2017 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Gilead Sciences:
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7977 GS-7977 PSI-7977 |
Sofosbuvir (SOF) Pegylated Interferon (Peg-IFN) Ribavirin (RBV) |
Additional relevant MeSH terms:
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Sofosbuvir Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Flaviviridae Infections RNA Virus Infections Antiviral Agents Anti-Infective Agents |