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Completed

NCT Number: NCT01682720

Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.

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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

Medizinische Universitat Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 with chronic genotype 2 or 3 HCV infection
  • HCV RNA > 10,000 IU/mL at screening
  • Subjects must be treatment naive or treatment experienced
  • Presence or absence of cirrhosis; a liver biopsy may be required
  • Healthy according to medical history and physical examination with the exception of HCV diagnosis
  • Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication

Exclusion criteria

  • Prior use of any other inhibitor of the HCV NS5B Polymerase
  • History of any other clinically significant chronic liver disease
  • Evidence of or history of decompensated liver disease
  • HIV or chronic hepatitis B virus (HBV) infection
  • Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
  • Chronic use of immunosuppressive agents or immunomodulatory agents
  • History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study or not be in the best interest of the subject in the opinion of the investigator

Treatment and study plan

SOF

Drug

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

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

RBV

Drug

Ribavirin (RBV) 200 mg 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)

Placebo to match SOF

Drug

Placebo to match SOF administered orally once daily

Placebo to match RBV

Drug

Placebo to match RBV administered orally in a divided daily dose

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response 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, < 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.

  2. Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

    Time frame: Up to 24 weeks

    The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.

Secondary outcomes

  1. Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    Time frame: Posttreatment Weeks 4 and 24

    SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.

  2. Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse

    Time frame: Up to Posttreatment Week 24

    Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.

    Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.

    Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977+Ribavirin for 12 Weeks in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection.

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Sep 11, 2012
Registry last updated
Oct 9, 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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