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Completed

NCT Number: NCT01497366

Phase 3 Study of Sofosbuvir and Ribavirin

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Canberra Hospital, Garran, Australian Capital Territory, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sofosbuvir

Drug

Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily

Other names: Sovaldi™, GS-7977, PSI-7977

PEG

Drug

Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

Other names: Pegasys®

RBV

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Acronym: FISSION

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 22, 2011
Registry last updated
Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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