Full Title: “A Single-arm Study to Evaluate the Feasibility and Efficacy of a Minimal Monitoring Strategy to Deliver Pan-genotypic Ribavirin-free HCV Therapy to Chronically Infected HCV Treatment Naïve Populations Globally: The MINMON Study”
Scientists are looking at ways to simplify Hepatitis C (HCV) treatment. This study will include people who are infected with HCV without decompensated cirrhosis (a condition where the liver is damaged and does not work well), regardless of HIV-1 co-infection (both with or without HIV infection will be accepted; either on ART [experienced] or not having started treatment [naïve]); and never have used treatment for Hepatitis C.
Purpose of this Study: This study is trying to find out if minimal or less tests during treatment for Hepatitis C can be done safely compared to the current standard monitoring tests (according to recent data and current practices for standard HCV monitoring). Participants will receive the fixed-dose combination (single tablet) of Sofosbuvir/Velpatasvir (SOF/VEL) for 12 weeks.
Requirements to Enter Study (things that must be true for you):
- Not having been previously treated for Hepatitis C infection with any medications.
- Be willing to take drugs to treat HCV right away.
- Have certain tests done that will be explained to you by the study coordinator
- Agree to use contraception/birth control methods.
- Be 18 years old or older.
- Be willing to sign the consent after talking with the research staff.
Exclusion Criteria (things that cannot be true about you):
- Positive for the presence of Hepatitis B Virus.
- Breastfeeding or pregnancy.
- Known allergy/sensitivity or any hypersensitivity to components of study drug(s).
- Active drug or alcohol use or dependence and other conditions that would interfere with adherence to study.
- Acute or serious illness requiring systemic treatment and/or hospitalization within 35 days prior to study entry.
- Any history of other hepatic illnesses other than HCV.
Talk to your study staff for a complete list of inclusion/exclusion criteria.
- Fixed-dose combination of SOF/VEL single-tablet regimen for 12 weeks.
- Blood tests at clinic visits to check mainly liver and kidney function.
- Telephone calls or text messaging for some study time points.
- Adherence monitoring.
Duration of Study: 72 weeks. 12 weeks on study treatment, followed by follow-up visits at weeks 24, 48 and 72.