Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir

This is a single arm multicenter pilot study to evaluate the efficacy and safety of treatment with SOF/VEL FDC for 8 weeks in patients with acute HCV infection as measured by the proportion of subjects with sustained viral response (undetectable HCV RNA) 12 weeks after stop of therapy.

Inclusion criteria

• Willing and able to provide written informed consent
• Male or female, age > 18 years
• HCV RNA > 10^3 IU/mL at screening
• Confirmation of acute HCV infection documented by either:

• Documented seroconversion to HCV antibody (anti-HCV) positivity within the 4 months preceding screening
• Documented conversion to HCV RNA positivity within the 4 months preceding screening
• or known or suspected exposure to HCV within the 4 months preceding screening with 10 times elevated serum ALT level at screening or 4 month preceding screening without evidence of confounding liver disorders
• Body mass index (BMI) ≥18 kg/m2
• Subjects must have the following laboratory parameters at screening:

• INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
• HbA1c ≤ 10%
• Creatinine clearance (CLcr) ≥ 30 mL/min, as calculated by the Cockcroft-Gault equation (using actual body weight)
• A negative serum pregnancy test is required for female subjects (unless surgically sterile or women ≥ 54 years of age with cessation for 24 ≥ months of previously occurring menses). Complete abstinence from intercourse. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not permitted.

Or

Consistent and correct use of 1 of the following methods of birth control listed below, in addition to a male partner who correctly uses a condom, from the date of Screening until the end of follow up:

• intrauterine device (IUD) with a failure rate of < 1% per year
• female barrier method: cervical cap or diaphragm with spermicidal agent
• tubal sterilization
• vasectomy in male partner
• hormone-containing contraceptive:

• implants of levonorgestrel
• injectable progesterone
• oral contraceptives (either combined or progesterone only)
• contraceptive vaginal ring
• transdermal contraceptive patch
• Subject must be able to comply with the dosing instructions for study drug administration and be able to complete the study schedule of assessments

Exclusion criteria

• Subject has been treated with any investigational drug or device within 42 days of the Screening visit
• Co-Infection with HIV
• Clinically-significant illness (other than HCV) or any other major medical disorder that, in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol.
• Solid organ transplantation
• Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug (for example, gastric bypass or severe ulcerative colitis).
• Clinical signs of hepatic decompensation (i.e., clinical ascites, encephalopathy or variceal hemorrhage).
• Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
• Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 2 years. Subjects with psychiatric illness that is well-controlled on a stable treatment regimen for at least 12 months prior to screening or has not required medication in the last 12 months may be included.
• Significant drug allergy (such as anaphylaxis or hepatotoxicity).
• Pregnant or nursing female
• Clinically-relevant drug or alcohol abuse that significantly impairs patient compliance. Uncontrolled users of intravenous drugs will not be permitted to enroll in the study.
• Clinical relevant (not controlled) liver disease of a non-HCV etiology (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
• Use of any prohibited concomitant medications within 21 days before the Baseline/Day 1 visit. The use of amiodarone is prohibited from 60 days prior to Day 1 through the end of treatment;
• Known hypersensitivity to SOF/VEL or formulation excipients