Phase 3 Study of Sofosbuvir and Ribavirin (FISSION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01497366
First received: December 19, 2011
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Hepatitis C
Drug: Sofosbuvir
Drug: PEG
Drug: RBV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) [ Time Frame: Post-treatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24) [ Time Frame: Post-treatment Week 24 ] [ Designated as safety issue: No ]
    SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation.

  • Percentage of Participants With HCV RNA < LLOQ on Treatment [ Time Frame: Up to 12 Weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in HCV RNA [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants With Virologic Failure During Treatment [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: Yes ]

    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)

  • Percentage of Participants With Viral Relapse Following Treatment [ Time Frame: Up to Post-treatment Week 24 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 527
Study Start Date: December 2011
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497366

  Show 97 Study Locations
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01497366     History of Changes
Other Study ID Numbers: P7977-1231
Study First Received: December 19, 2011
Results First Received: January 15, 2014
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HCV genotype 2 (GT-2)
HCV genotype 3 (GT-3)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014