Sofosbuvir/Velpatasvir for Hepatitis C
(MINMON-J Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the drug Sofosbuvir/Velpatasvir for treating Hepatitis C?
The drug Sofosbuvir/Velpatasvir has been shown to be effective in treating Hepatitis C, achieving high cure rates across all 6 genotypes of the virus. It is effective for patients with and without liver cirrhosis, and even for those who have failed previous treatments, with common side effects being mild, such as headache and fatigue.12345
Is Sofosbuvir/Velpatasvir safe for humans?
How is the drug Sofosbuvir/Velpatasvir unique for treating Hepatitis C?
Sofosbuvir/Velpatasvir is unique because it is a once-daily, single-tablet regimen that works for all major types of Hepatitis C, making it a versatile option for patients with different genotypes. It is effective even in patients with cirrhosis (liver scarring) or those who have HIV-1 co-infection, and it generally has low rates of side effects.127910
What is the purpose of this trial?
The goal of this clinical trial is to learn whether a low-barrier treatment program can help people with hepatitis C virus (HCV) who are in jail start and complete treatment more easily. This study focuses on adults at the Rhode Island Department of Corrections who have active HCV and are awaiting trial.The study asks:* Can a simplified, low-barrier HCV treatment program work in a jail setting?* Do participants finish treatment and get cured using this approach?All participants will receive a 12-week course of the HCV medication sofosbuvir/velpatasvir (Epclusa). If they are released before completing treatment, they will take the remaining doses with them. Community Health Workers (CHWs) will help support participants after release, including reminding them to take medications and helping them get follow-up lab work.Researchers will measure:* Whether participants are cured of HCV* Whether the treatment approach is easy to use (feasible), acceptable, and followed correctly (fidelity)* Whether the program could be used in other jails or expanded in the futureThis study may help bring HCV treatment to more people in jail, reduce community spread of the virus, and support national goals to eliminate HCV.
Eligibility Criteria
This trial is for adults with active hepatitis C virus (HCV) who are currently incarcerated at the Rhode Island Department of Corrections and awaiting trial. The study aims to see if a simplified treatment program can help them start and complete HCV treatment more easily.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 12-week course of sofosbuvir/velpatasvir (Epclusa) for HCV treatment
Follow-up
Participants are monitored for HCV cure and adherence post-treatment, including support from Community Health Workers
Long-term follow-up
Participants are assessed for maintenance of HCV cure and engagement in care 6 months post-treatment
Treatment Details
Interventions
- Sofosbuvir / Velpatasvir
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lifespan
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator