A5360: Monitoring SOF-VEL in Treatment Naive, HCV Participants with Active Infection

A5360: A Single-arm Study to Evaluate the Feasibility and Efficacy of a Minimal Monitoring Strategy to Deliver Pan-genotypic Ribavirin-free HCV Therapy to HCV Infected Populations who are HCV Treatment Naïve with Evidence of Active HCV Infection: The MINMON Study

Study Description
Scientists are looking at ways to simplify hepatitis C treatment. This is an open-label study to assess the feasibility and efficacy of a minimal monitoring (MINMON) approach in active hepatitis C virus (HCV)-infected, treatment-naïve participants, with and without HIV co-infection. Study participants will receive the fixed-dose combination of sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks, with minimal monitoring and follow-up to week 72.

Why is this study being done?

  • To find out if minimal or fewer tests during treatment for hepatitis C have the same efficacy as current standard HCV monitoring.

Who can join?

  • Men and women 18 years of age and older
  • Have chronic hepatitis C infection and have not previously been treated for HCV 
  • With or without HIV co-infection; either on HIV treatment or have never started treatment
  • Not positive for hepatitis B virus
  • No history of liver illnesses other than HCV

What do I need to do in the study?

  • Participants will receive 12 weeks of SOF/VEL and will only be seen at follow-up clinic visits at weeks 24, 48, and 72. Blood tests will check mainly liver and kidney function. Telephone calls, emails, or text messaging will be used for monitoring adherence and any side effects between clinic visits.

What treatments or drugs are involved with this study?
The study treatment that will be provided throughout the study is a fixed-dose, single-tablet regimen of combination SOF/VEL.



Study Status: