Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection
Status:
Completed
Trial end date:
2017-05-09
Target enrollment:
Participant gender:
Summary
Early identification of acute HCV infection is essential to prevent chronic infections and
the long-term liver disease complications that may occur. Early identification and treatment
of HCV during the acute phase can result in significantly higher response rates with shorter
durations of therapy.
Pegylated-interferon alfa (PEG-IFN) was the typical treatment for HCV infection. Participants
subcutaneously inject PEG-IFN where the average duration of treatment was approximately 20
weeks. With the advancement of direct-acting antivirals (DAAs), it was possible to see if a
new DAA might be non-inferior compared to (PEG-IFN).
The study was designed to see if a fixed-dose combination tablet can replace the old HCV
treatments by being more effective, safer and better tolerated in HIV-infected participants
with new HCV infection. The study was a Phase I, open-label, two cohort clinical trial, in
which 44 acutely HCV-infected HIV-1 positive participants were enrolled. Participants in each
cohort were evaluated in two steps: on treatment (Step 1) and follow-up after discontinuing
study treatment (Step 2). The cohorts were enrolled sequentially. Participants in Cohort 1
were enrolled and administered oral Sofosbuvir (SOF) in combination with weight-based
ribavirin (RBV). Participants in Cohort 2 were enrolled and administered an oral fixed dose
combination of Ledipasvir/Sofosbuvir (LDV/SOF).
Phase:
Phase 1
Details
Lead Sponsor:
AIDS Clinical Trials Group
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Treatments:
Interferons Ledipasvir Ledipasvir, sofosbuvir drug combination Ribavirin Sofosbuvir