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

Multicenter Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir Fix Dose combination_The HepNet Acute HCV-V Study

This is a single arm multicenter pilot study to evaluate the efficacy and safety of treatment with sofosbuvir (SOF)/velpatasvir (VEL) fix dose combination (FDC) in patients with acute hepatitis C virus (HCV) infection.

Study Overview

• Status: Completed
• Conditions: Hepatitis C; Acute Hepatitis C
• Intervention / Treatment: Drug: Sofosbuvir and Velpatasvir

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10349
    • Zentrum für Infektiologie Prenzlauer Berg
  • Berlin, Germany, 13353
    • Charité Campus Virchow-Klinikum, Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
  • Berlin-Friedrichshain, Germany, 10243
    • Allgemeinmedizinische und internistische Praxis
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I
  • Essen, Germany, 45122
    • Universitätsklinikum Essen, Klinik für Gastroenterologie und Hepatologie
  • Frankfurt, Germany, 60590
    • Klinikum der J.W. Goethe-Universität Frankfurt
  • Hamburg, Germany, 20146
    • Infektionsmedizinisches Centrum Hamburg (ICH) Study Center
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf, I. Medizinische Klinik und Poliklinik
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover, Innere Medizin, Klinik für Gastroenterologie, Hepatologie und Endokrinologie
  • Köln, Germany, 50674
    • Praxis Hohenstaufenring
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig, Klinik und Poliklinik für Gastroenterologie
  • München, Germany, 81675
    • Klinikum rechts der Isar der TU-München, II Medizinische Klinik und Poliklinik
  • Stuttgart, Germany, 70197
    • Gemeinschaftspraxis - Infectomed
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg, Medizinische Klinik II, Schwerpunkt Infektiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Willing and able to provide written informed consent
2. Male or female, age > 18 years
3. HCV RNA > 10^3 IU/mL at screening

4. Confirmation of acute HCV infection documented by either:

   1. Documented seroconversion to HCV antibody (anti-HCV) positivity within the 4 months preceding screening
   2. Documented conversion to HCV RNA positivity within the 4 months preceding screening
   3. 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
5. Body mass index (BMI) ≥18 kg/m2

6. Subjects must have the following laboratory parameters at screening:

   1. INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
   2. HbA1c ≤ 10%
   3. Creatinine clearance (CLcr) ≥ 30 mL/min, as calculated by the Cockcroft-Gault equation (using actual body weight)

7. 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
8. 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:

1. Subject has been treated with any investigational drug or device within 42 days of the Screening visit
2. Co-Infection with HIV
3. 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.
4. Solid organ transplantation
5. Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug (for example, gastric bypass or severe ulcerative colitis).
6. Clinical signs of hepatic decompensation (i.e., clinical ascites, encephalopathy or variceal hemorrhage).
7. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
8. 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.
9. Significant drug allergy (such as anaphylaxis or hepatotoxicity).
10. Pregnant or nursing female
11. 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.
12. 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)
13. 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;
14. Known hypersensitivity to SOF/VEL or formulation excipients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sofosbuvir and Velpatasvir; SOF/VEL FDC film-coated tablet, oral, SOF 400 mg/VEL 100 mg daily, 8 weeks	Drug: Sofosbuvir and Velpatasvir; All subjects will receive one film-coated tablet of sofosbuvir/velpatasvir (400/100 mg) orally once daily for 8 weeks.; Other Names: Epclusa 400 mg/100 mg film-coated tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with sustained virological response (undetectable HCV RNA) 12 weeks after discontinuation of therapy	Measured by the portion of subjects with sustained virological response (undetectable HCV RNA)	12 weeks after discontinuation of therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean HCV RNA viral load at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after stop of therapy	Measured by mean HCV RNA viral load	at baseline, after 2 weeks, 4 weeks and 8 weeks of therapy, and 12 weeks after stop of therapy
Proportion of subjects who reached ALT normalization (ALT < ULN) after 8 weeks of therapy and 12 weeks after discontinuation of therapy	Measured by the proportion of subjects who reached ALT normalization (ALT < ULN)	after 8 weeks of therapy, and 12 weeks after discontinuation of therapy
Assessment of frequency and severity of adverse events (AEs)	Collection of all AEs	through study completion, an average of 20 weeks

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Collaborators: Gilead Sciences; HepNet Study House, German Liverfoundation; German Center for Infection Research
• Investigators: Principal Investigator: Markus Cornberg, Prof. Dr., Hannover Medical School, Clinic for Gastroenterology, Hepatology, and Endocrinology

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2019
• Primary Completion (Actual): June 8, 2021
• Study Completion (Actual): June 8, 2021

Study Registration Dates

• First Submitted: January 24, 2019
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 28, 2019

Study Record Updates

• Last Update Posted (Actual): July 6, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Acute hepatitis C virus (HCV) infection
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Anti-Infective Agents; Antiviral Agents; Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
• Other Study ID Numbers: HepNet-aHCV-V; 2018-003474-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No