Study Helps Hepatitis C Patients, Shows Path for Accelerating Research and Potential for Drug Approvals
In a new kind of real-world study, a “pragmatic” clinical trial, UF researchers found that hepatitis C patients who previously did not respond to oral drug therapy were cured by a recently approved drug regimen.
The study, published in the journal Gastroenterology’s December issue (available online) showed that the fixed-dose combination of glecaprevir/pibrentasvir, marketed as Mavyret™ by the manufacturer, AbbVie, cured hepatitis C in patients who previously did not respond to sofosbuvir plus an NS5A inhibitor. Glecaprevir/pibrentasvir can be used to treat all six common types of hepatitis C in patients without or with mild liver cirrhosis. Both drugs are direct-acting antivirals, a new type of drug that cures hepatitis C in nearly 95% of patients.
“This collaborative research effort has opened up new treatment options for hepatitis C patients who have failed prior therapy,” said study author David R. Nelson, M.D., senior vice president for health affairs at UF and president of UF Health. “Beyond the benefit for these patients, the study provides a model that others can follow in creating a real-world cohort, which may help future drug approvals, and inform on real-world safety and efficacy of approved drugs.”