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Phase 3 Study of Sofosbuvir and Ribavirin (FISSION)

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ClinicalTrials.gov Identifier: NCT01497366
Recruitment Status : Completed
First Posted : December 22, 2011
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 527 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients With Chronic Genotype 2 or 3 HCV Infection
Study Start Date : December 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sofosbuvir+RBV
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
 Drug: Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
Other Names:
  • Sovaldi™
  • GS-7977
  • PSI-7977

Drug: RBV

Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose

  • Dose of sofosbuvir+RBV group based on baseline weight: < 75kg = 1000 mg and ≥ 75 kg = 1200 mg
  • Dose of PEG+RBV group: 800 mg
Active Comparator: PEG+RBV
Participants were randomized to receive PEG+RBV for 24 weeks.
 Drug: PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
Other Name: Pegasys®

Drug: RBV

Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose

  • Dose of sofosbuvir+RBV group based on baseline weight: < 75kg = 1000 mg and ≥ 75 kg = 1200 mg
  • Dose of PEG+RBV group: 800 mg


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) [ Time Frame: Post-treatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation.


Secondary Outcome Measures :
  1. Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities [ Time Frame: Up to 24 weeks plus 30 days following the last dose of study drug ]
  2. Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24) [ Time Frame: Post-treatment Week 24 ]
    SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation.

  3. Percentage of Participants With HCV RNA < LLOQ on Treatment [ Time Frame: Up to 12 Weeks ]
  4. Change From Baseline in HCV RNA [ Time Frame: Baseline to Week 12 ]
  5. Percentage of Participants With Virologic Failure During Treatment [ Time Frame: Baseline up to Week 24 ]

    Virologic failure was defined as either

    • Viral breakthrough: HCV RNA ≥ 25 IU/mL after having previously had HCV RNA < 25 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement
    • Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement
    • Non-response: HCV RNA persistently ≥ 25 IU/ml while on treatment (through Week 12)

  6. Percentage of Participants With Viral Relapse Following Treatment [ Time Frame: Up to Post-treatment Week 24 ]
    Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved < LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement.


Eligibility Criteria
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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:

  • Chronic Genotype 2 or 3 HCV-infection
  • Naive to all HCV antiviral treatment(s)

Exclusion Criteria:

  • Positive test at Screening for HBsAg, anti-hepatitis B core immunoglobulin M antibody (anti-HBc IgM Ab), or anti-HIV Ab
  • History of any other clinically significant chronic liver disease
  • A history consistent with decompensated liver disease
  • History or current evidence of psychiatric illness, immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, seizure disorder or anticonvulsant use, poorly controlled diabetes, cancer, or a history of malignancy, that makes the subject unsuitable for the study.
  • Participation in a clinical study within 3 months prior to first dose
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): NCT01497366


Locations
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Sponsors and Collaborators
Gilead Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01497366    
Other Study ID Numbers: P7977-1231
First Posted: December 22, 2011    Key Record Dates
Results First Posted: April 2, 2014
Last Update Posted: April 2, 2014
Last Verified: March 2014
Keywords provided by Gilead Sciences:
HCV genotype 2 (GT-2)
HCV genotype 3 (GT-3)
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
 Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents