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Elbasvir/grazoprevir demonstrates sustained virologic response in HCV
16 November 2015 • Author: Victoria White
Merck has announced the results from its Phase 3 C-EDGE CO-STAR clinical trial evaluating the efficacy and safety of the elbasvir/grazoprevir in patients with chronic hepatitis C virus (HCV) genotypes (GT) 1, 4 or 6 infection who inject drugs and are receiving opioid agonist therapy (OAT).
Elbasvir/grazoprevir is Merck’s investigational, once-daily, fixed-dose combination therapy containing elbasvir (HCV NS5A replication complex inhibitor) and grazoprevir (HCV NS3/4A protease inhibitor).
In the trial, 95% of patients treated with elbasvir/grazoprevir for 12 weeks in the pre-specified primary efficacy analysis population achieved sustained virologic response 12 weeks after the completion of treatment (SVR12). Adherence to treatment was high, with 97% of patients taking at least 95%of their study medication over the 12 weeks of therapy.
Patietns on opioid agonist therapy were able to achieve high virologic cure rates
“Injection drug use is a major factor fuelling the global hepatitis C crisis, yet people with chronic hepatitis C virus infection who inject drugs often remain overlooked and underserved,” said Dr Ronald Nahass, president, ID CARE, New Jersey. “Patients in this study with chronic hepatitis C virus infection on opioid agonist therapy, including many who continued to use drugs during the trial, were able to complete treatment with elbasvir/grazoprevir and achieve high virologic cure rates.”
“Limited research has been conducted in people with chronic hepatitis C virus infection undergoing treatment for injection drug use because of the perceived challenges and complexities involved in treating this population,” said Dr Eliav Barr, vice president, infectious diseases, Merck Research Laboratories. “This is one of the largest clinical trials to date evaluating an all-oral, once-daily, ribavirin-free investigational treatment regimen for patients with chronic hepatitis C virus infection on opioid agonist therapy and reflects Merck’s ongoing commitment to study the diverse real-world population of people living with this disease.”
Injection drug use is the most common risk factor for chronic HCV in the US, and rates of transmission and reinfection are higher among injection drug users than in other people with HCV.
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