Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: SOF/VEL
Intervention description: 400/100 mg FDC tablet(s) administered orally once daily
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks
      in adults with chronic hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV RNA detected at screening

          -  Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy

          -  Classification as treatment naïve or treatment experienced. Approximately 20% may be
             treatment-experienced.

          -  Cirrhosis determination (approximately 20% may have cirrhosis)

          -  Females of childbearing potential must have a negative urine pregnancy test at
             Screening and on Day 1 prior to enrollment.

          -  Male individuals and female individuals of childbearing potential who engage in
             heterosexual intercourse must agree to use protocol specified method(s) of
             contraception as described in the study protocol

          -  Lactating females must agree to discontinue nursing before the study drug is
             administered

          -  Adults must be able to comply with the dosing instructions for study drug
             administration and able to complete the study schedule of assessments

        Key Exclusion Criteria:

          -  Current or prior history of any of the following:

               -  Clinically-significant illness (other than HCV) or any other major medical
                  disorder that may interfere with individual's treatment, assessment or compliance
                  with the protocol

               -  Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal
                  hemorrhage)

               -  Liver transplantation

               -  Hepatocellular carcinoma (HCC) (as determined by appropriate imaging at screening
                  for those with cirrhosis) or current malignancy for which the patient is
                  receiving treatment or which may interfere with individual's treatment,
                  assessment or compliance with the protocol.

          -  Screening laboratory parameters outside of defined threshold

          -  Prior exposure to HCV NS5A inhibitor

          -  Pregnant or nursing female

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

          -  Use of any prohibited concomitant medications as described in study protocol

          -  Known hypersensitivity to VEL, SOF, or formulation excipients

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.