Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir
Hepatitis C, Acute Hepatitis C
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Acute hepatitis C virus (HCV) infection
Eligibility Criteria
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
Sites / Locations
- Allgemeinmedizinische und internistische Praxis
- Zentrum für Infektiologie Prenzlauer Berg
- Charité Campus Virchow-Klinikum, Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
- Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I
- Universitätsklinikum Essen, Klinik für Gastroenterologie und Hepatologie
- Klinikum der J.W. Goethe-Universität Frankfurt
- Infektionsmedizinisches Centrum Hamburg (ICH) Study Center
- Universitätsklinikum Hamburg-Eppendorf, I. Medizinische Klinik und Poliklinik
- Medizinische Hochschule Hannover, Innere Medizin, Klinik für Gastroenterologie, Hepatologie und Endokrinologie
- Praxis Hohenstaufenring
- Universitätsklinikum Leipzig, Klinik und Poliklinik für Gastroenterologie
- Klinikum rechts der Isar der TU-München, II Medizinische Klinik und Poliklinik
- Gemeinschaftspraxis - Infectomed
- Universitätsklinikum Würzburg, Medizinische Klinik II, Schwerpunkt Infektiologie
Arms of the Study
Arm 1
Experimental
Sofosbuvir and Velpatasvir
SOF/VEL FDC film-coated tablet, oral, SOF 400 mg/VEL 100 mg daily, 8 weeks