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A study looking at a simpler cure for hepatitis C.
This study is looking at whether having fewer blood tests than usual during hepatitis C treatment provides the same excellent results.
This study is for adults age 18+ who have never before received treatment for hepatitis C.
The study lasts for 72 weeks (about a year and a half).
The hepatitis C drugs (sofosbuvir/velpatasvir) will be provided at no cost to study participants.
Contact us to see if you are eligible!
Rebecca Fry, FNP
Valery Hughes, FNP
Participant Information Sheet
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”
Short Title: Monitoring SOF/VEL in Treatment Naïve, Chronic HCV Participants
Brief Description: Scientists are looking at ways to simplify Hepatitis C (HCV) treatment. This study will include people who are infected with HCV without decompensated cirrhosis, 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 have the same efficacy as current standard monitoring tests (according to recent data and current practices for standard HCV monitoring). Participants will receive the fixed-dose combination 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.
• Agree to use contraception/birth control methods.
• Be 18 years old or older.
• Be willing to sign the consent after discussion 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 hepatic and renal function.
• Telephone calls or text messaging for some study time points.
• Adherence monitoring.
Duration of Study: 72 weeks. 12 weeks on study drug, followed by follow-up visits at weeks 24, 48 and 72.
For more information contact: Uptown: Rebecca MSN, FNP at (212) 746-4177 or Chelsea: Valery Hughes, FNP-BC, MS at (212) 746-7204