Health Condition 1: null- Chronic hepatitis C virus (HCV) infection
Conditions
Interventions
Intervention1: Sofosbuvir tablets: 1. Genotype 1, treatment-naïve, receiving 16 weeks of SOF + RBV
30 subjects will be enrolled in the study and receive oral dose of sofosbuvir 400 mg
Sponsors
Gilead Sciences Inc
Klinera Corporation India
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria Subjects must meet all of the following inclusion criteria to be eligible for participation in this study 1 Willing and able to provide written informed consent 2 Male or female age greater than or is equal to 18 years 3 HCV RNA greater than or is equal to 10raise to 4 IU per mL at screening 4 Confirmed chronic HCV infection as documented by either a a positive anti HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline per Day 1 visit or b a liver biopsy prior to the Baseline per Day 1 visit with evidence of chronic HCV infection 5 HCV genotype 1 or 3 at screening as determined by the Central Laboratory Any non definitive results will exclude the subject from study participation 6 Documented HCV treatment naive defined as no prior exposure to any IFN RBV or other approved or experimental direct acting antiviral targeting HCV 7 Approximately 30 percent of subjects may have compensated cirrhosis at screening a Cirrhosis is defined as any one of the following Liver biopsy showing cirrhosis eg Metavir score is equal to 4 or Ishak score greater than or is equal to 5 Fibroscan showing cirrhosis or results greater than 12.5 kPa FibroTest score of greater than 0.75 AND an AST platelet ratio index APRI of greater than 2 performed during Screening b Absence of cirrhosis is defined as any one of the following Liver biopsy within 2 years of Screening showing absence of cirrhosis Fibroscan with a result of less than or is equal to 12.5 kPa within 6 months of Baseline per Day1 FibroTest score of less than or is equal to 0.48 AND APRI of less than or is equal to 1 performed during Screening In the absence of a definitive diagnosis of the presence or absence of cirrhosis by the above criteria a liver biopsy is required Liver biopsy results supersede the results obtained by Fibroscan or FibroTest 8 For subjects with cirrhosis Results from liver imaging done within 6 months of Baselin per Day 1that exclude hepatocellular carcinoma HCC 9 Body mass index BMI greater than or is equal to 18 kg per m2 10 Screening ECG without clinically significant abnormalities 11 Subjects must have the following laboratory parameters at screening a ALT less than or is equal to 10 of the upper limit of normal ULN b AST less than or is equal to 10 of ULN c Hemoglobin greater than or is equal to 12 g per dL for male greater than or is equal to 11 g per dL for female subjects d Platelets greater than or is equal to 50000 cells per mm3 e INR less than or is equal to 1.5 of ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR f Albumin greater than or is equal to 3 g per dL g Direct bilirubin less than or is equal to 1.5 of ULN h HbA1c less than or is equal to 10 percent i Creatinine clearance greater than or is equal to 60 mL per min as calculated by the Cockcroft Gault equation 12 A female subject is eligible to enter the study if it is confirmed that she is a Not pregnant or nursing b Of non-childbearing potential ie women who have had a hysterectomy both ovaries removed or medically documented ovarian failure, or are postmenopausal wome
Exclusion criteria
Exclusion criteria: Exclusion Criteria Subjects who meet any of the following exclusion criteria are not to be enrolled in this study. 1. Pregnant or nursing female or male with pregnant female partner 2. Chronic liver disease of a non HCV etiology (eg, hemochromatosis, Wilsonâ??s disease, alpha 1 antitrypsin deficiency, cholangitis) 3. Infection with hepatitis B virus HBV or human immunodeficiency virus HIV 4. Contraindication to RBV therapy, eg. history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia. 5. History of malignancy diagnosed or treated within 5 years recent localized treatment of squamous or non invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening; subjects under evaluation for malignancy are not eligible. 6. Chronic use of systemically administered immunosuppressive agents eg, prednisone equivalent 10 mg per day 7. Clinically relevant drug or alcohol abuse within 12 months of screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription should be approved by the investigator. 8. Excessive alcohol ingestion, defined as 3 glasses per day 1 glass is equivalent to 284 mL beer, 125 mL wine, or 25 mL distilled spirits for females and 4 glasses per day for males. 9. History of solid organ transplantation 10. Current or prior history of clinical hepatic decompensation eg, ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome and hepatopulmonary syndrome 11. History of clinically significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol 12. History of a gastrointestinal disorder or post operative condition that could interfere with the absorption of the study drug 13. History of significant pulmonary disease, significant cardiac disease or porphyria 14. History of difficulty with blood collection and or poor venous access for the purposes of phlebotomy 15. Use of any prohibited concomitant medications as described in Section 5.6 16. Known hypersensitivity to RBV, the study investigational medicinal product, the metabolites, or formulation excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ To determine the antiviral efficacy of SOF plus RBV in treatment naive subjects with chronic genotype 1 HCV infection and in treatment naive subjects with chronic genotype 3 HCV infection, as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR12) â?¢ To assess the safety and tolerability of SOF plus RBV in treatment naive subjects with chronic genotype 1 or 3 HCV infection as measured by review of the accumulated safety data Timepoint: 16 and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To determine the proportion of subjects who attain sustained virologic response(SVR) at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24) â?¢ To evaluate the kinetics of circulating HCV RNA during treatment and after treatment discontinuation â?¢ To evaluate the emergence of viral resistance to sofosbuvir during treatment and after treatment discontinuationTimepoint: 16 and 24 weeks | — |
Countries
India
Contacts
Public ContactPravin Moily
Klinera Corporation India
Outcome results
None listed