Closed to accrual
A5380: A Phase II Trial of Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection (PURGE-C)
This is a study to treat participants, with or without HIV, who are found to have been recently infected with the Hepatitis C virus (HCV). This known as acute HCV.
People who are recently infected with HCV are often considered to have acute HCV. People with acute HCV have a good chance of being cured of the infection when they are treated with a combination of two drugs within the first 6 months of being infected. This study is being done to see if a shorter course of treatment will be effective if started early in the infection (Step 1). In case of failure with this shorter course of treatment, a longer and different treatment for HCV will be offered (Step 2).
- Age ≥18 years of age
- With or without HIV. If living with HIV, on a stable treatment (antiretroviral regimen) or untreated due to lack of treatment per physician.
- HIV RNA <50 and CD4 >100 cells/ mm3 (CD4 cells are a kind of white blood cell that are a measure of the immune system)
- May not have Hepatitis B or prior Hepatitis C
- Recently infected with HCV
- Cannot be pregnant or breastfeeding
- Must be willing to use birth control to prevent pregnancy
- Must be willing to come to study visits
- Must be able to swallow pills
- May not have other known liver disease
Treatments Or Drugs Involved With Study
Glecaprevir/pibrentasvir (G/P) Fixed-dose Combination (FDC-single tablet) three pills by mouth once a day for 4 weeks (Step 1). If this medicine does not work for you after the 4 weeks or you become infected again while on study, you will be asked to take the G/P with or without Ribavirin for a longer time, 8-16 weeks longer.
Duration Of Study
Up to 28 weeks on Step 1 and up to an additional 40 weeks if on Step 2.