Chronic Hepatitis C virus infection MedDRA version: 19.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 19.0 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: sofosbuvir/velpatasvir
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sofosbuvir
CAS Number: 1190307-88-0
Other descriptive name: SOFOSBUVIR
Concentration unit: mg milligra
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 age = 18 years 3. Chronic HCV infection (= 6 months) as documented by prior medical history or liver biopsy 4. Genotype 3 HCV at screening as determined by the central laboratory. Any non-definitive HCV genotype results will exclude the subject from participation. 5. HCV RNA =104 IU/mL at Screening 6. Confirmation of cirrhosis by any of the methods (such as liver biopsy, Fibroscan results etc). 7. Subjects must have a determination of treatment experience 8. If treatment experienced, the subject’s medical records must include details of prior treatment regimen(s). 9. A negative serum pregnancy test is required for subjects (unless permanently sterile or greater than two years post-menopausal). 10. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception. 11. Lactating females must agree to discontinue nursing before the first dose of study drug is administered. 12. Subject must be able to comply with the dosing instructions for study drug administration and be able to complete the study schedule of assessments. Subjects with HIV coinfection may be eligible, provided they satisfy these additional inclusion criteria: 13. Completed at least 3 months of any prior HIV ARV therapy and maintained HIV RNA 100 cells/mm3 prior to Screening. Subjects with an isolated or unconfirmed HIV RNA >50 copies/mL (or >LLOQ if the local laboratory assay’s LLOQ is 50= copies/mL) are not excluded 14. No history of HIV-associated opportunistic infections within 6 months of Screening. 15. On a stable, protocol-approved, ARV regimen for = 8 weeks prior to Screening and is expected to continue the current ARV regimen through the end of study. 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 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Current or prior history of any of the following: a. Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically-significant illness (other than HCV/HIV) are also excluded. b. Gastrointestinal disorder or postoperative condition that could interfere with the absorption of the study drug. c. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy. d. Solid organ or bone marrow transplantation. e. Significant pulmonary disease, significant cardiac disease, or porphyria. f. Clinically significant hemoglobinopathy (e.g., sickle cell disease, thalassemia). g. Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years. Subjects with psychiatric illness (without the prior mentioned conditions) that is well-controlled on a stable treatment regimen for at least 12 months prior to enrollment or has not required medication in the last 12 months may be included. h. Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible. i. Active, serious infection (other than HIV or HCV) requiring parental antibiotics, antivirals or antifungals within 30 days prior to baseline. 2. Child-Pugh-Turcotte (CPT) Score >7 at Screening 3. Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis 4. Screening ECG with clinically significant abnormalities 5. Subjects with laboratory parameters at screening as outlined in the protocol ?? 6. Prior exposure to VEL or any HCV NS5A inhibitor. 7. Pregnant or nursing female or male with pregnant female partner. 8. Females who may wish to become pregnant and/or plan to undergo egg harvesting during the course of the study and up to 6 months of the last dose of study drug 9. Chronic liver disease of a non-HCV etiolog (e.g., hemochromatosis, Wilson’s disease, alfa-1 antitrypsin deficiency, cholangitis). 10. Active infection with hepatitis B virus (HBV). 11. Infection with HIV 2 12. Clinically-relevant alcohol or drug abuse within 12 months of screening, as determined by the investigator. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the investigator. 13. Use of any prohibited concomitant medications as described in Section 5.5 14. Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day). 15. Known hypersensitivity to VEL, SOF (and metabolites), or RBV. 16. The presence of contraindications to RBV. 17. Participation in a clinical study with an investigational drug or biologic within 3 months prior to Baseline/Day 1. 18. Treatment for HCV infection with experimental or approved regimens within 3 months of Baseline/Day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of study treatment with Sofosbuvir(SOF)/Velpatasvir(VEL, GS-5816) FDC and SOF/VEL FDC and Ribavirin (RBV) for 12 weeks as measured by the proportion of subjects with sustained virologic response 12 weeks after cessation of treatment regimen (SVR12) ? To evaluate the safety and tolerability of each treatment regimen;Secondary Objective: To determine the proportion of subjects who attain SVR at 4 weeks after cessation of each treatment regimen (SVR4) To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of each treatment regimen To evaluate the emergence of viral resistance to SOF and VEL during treatment and after cessation of treatment;Primary end point(s): The primary efficacy endpoint is SVR12 (HCV RNA < LLOQ 12 weeks after cessation of study treatment regimen) in the Full Analysis Set (FAS). The primary safety endpoint is any AE that led to permanent discontinuation of study drug.;Timepoint(s) of evaluation of this end point: 12 weeks after treatment end | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints include the proportion of subjects who attain sustained virologic response at 4 weeks after cessation of the study treatment regimen (SVR4); the proportion of subjects who have HCV RNA < LLOQ by visit while on study treatment; absolute and change from baseline/Day 1 in HCV RNA through Week 12; and the proportion of subjects with virologic failure.;Timepoint(s) of evaluation of this end point: 4 and 12 weeks after treatment end | — |
Countries
Spain
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed