Hepatitis C Virus Infection MedDRA version: 14.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Sofosbuvir
Product Code: GS-7977
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sofosbuvir
CAS Number: 1190307-88-0
Other descriptive name: GS-7977
Concentration unit: mg m
Sponsors
Gilead Sciences Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Willing and able to provide written informed consent 2) Male or female, aged 18 years or older 3) Chronic HCV infection 4) Willing to undergo liver biopsy, if required 5) Genotype 2 subjects must have cirrhosis of the liver to be eligible 6) Treatment-naïve or prior treatment failure to =12 weeks of an interferon-based regimen that was not discontinued prematurely due to an adverse event 7) Infection with HCV genotype 2 or 3 10) A negative serum pregnancy test is required for female subjects (unless surgically sterile or greater than two years post-menopausal). Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception. Lactating females must agree to discontinue nursing before the IMP is administered. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 540 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1) Prior exposure to an direct-acting antiviral targeting the HCV NS5B polymerase 2) Pregnant or nursing female or male with pregnant female partner 3) Chronic liver disease of a non-HCV etiology 4) Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) 5) Significant psychiatric conditions 6) Autoimmune disease 7) Severe chronic pulmonary obstructive disease 8) History of significant cardiac disease including prior myocardial infarction or arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this study are: - To determine the efficacy of sofosbuvir (SOF)+ Ribavirin (RBV) for 16 or 24 weeks as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of treatment (SVR12) - To determine the efficacy of SOF+RBV+pegylated interferon alfa 2a (PEG) for 12 weeks as measured by the proportion of subjects with SVR12 - To evaluate the safety and tolerability of all 3 treatment arms as assessed by review of the accumulated safety data;Secondary Objective: The secondary objectives of this study are: - To determine the proportion of subjects who attain SVR at 4 and 24 weeks after discontinuation of treatment (SVR4 and SVR24) - To evaluate the kinetics of circulating HCV RNA during and after treatment discontinuation - To evaluate the emergence of viral resistance to SOF during and after treatment discontinuation;Primary end point(s): The primary efficacy endpoint is SVR12 (HCV RNA <LLOQ 12 weeks after discontinuation of therapy). The primary safety endpoint is any AE leading to permanent discontinuation of study drug(s).;Timepoint(s) of evaluation of this end point: 12 Weeks after last dose of study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints include the proportion of subjects with HCV RNA < LLOQ at each on-treatment visit and 4 and 24 weeks after discontinuation of active therapy (SVR4 and SVR24); HCV RNA (log10 IU/mL) and change from baseline in HCV RNA (log10 IU/mL); viral breakthrough; and relapse.;Timepoint(s) of evaluation of this end point: During treatment and 4 and 24 weeks after last dose of study drug | — |
Countries
Australia, Canada, New Zealand, United Kingdom, United States
Contacts
Public ContactMedical Monitor
Gilead Sciences Inc.
Outcome results
None listed