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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014