Results from Merck’s Phase 3 Study of Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir in Patients with Advanced Chronic Kidney Disease Published in The Lancet

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The FINANCIAL — Merck, known as MSD outside the United States and Canada, on October 5 announced the publication of results from C-SURFER, the first Phase 31 clinical trial to investigate an all-oral, ribavirin-free chronic hepatitis C virus (HCV) treatment regimen in treatment-naïve and treatment-experienced patients with advanced chronic kidney disease (CKD) stages 4 or 5 and chronic HCV genotype 1 (GT1) infection.

Data from the Phase 3 clinical trial evaluating the investigational, once-daily treatment regimen of elbasvir (50mg)2 and grazoprevir (100mg)3 in patients with advanced CKD were published online in the medical journal The Lancet. Data from this study were initially presented at The International Liver CongressTM 2015 in April 2015; additional information about that presentation and the design of the study can be found on the Merck newsroom, according to Merck.

“People with advanced chronic kidney disease represent an important segment of the chronic hepatitis C patient population,” said Dr. Howard Monsour, Jr., chief of hepatology, Houston Methodist Hospital. “The publication of this study details the evidence supporting a potential future treatment option for these patients who are currently underserved.”

The peer-reviewed, published results show that 12 weeks of therapy with elbasvir plus grazoprevir in patients with chronic HCV GT1 infection and advanced CKD resulted in high rates of sustained virologic response 12 weeks after the completion of treatment (SVR12). High rates of SVR were achieved regardless of patient characteristics in this study, including African-American patients, patients receiving hemodialysis and patients with the IL28B non-CC genotype. Among those receiving elbasvir plus grazoprevir in the primary analysis population, 99 percent (115/116) achieved SVR12, with one relapse 12 weeks after the end of treatment. In a secondary analysis that included six additional patients excluded from the primary efficacy analysis for non-virologic reasons (study discontinuation unrelated to study drug, loss to follow-up, noncompliance, etc.), 94 percent (115/122) achieved SVR12. Adverse events reported at or above 10 percent frequency in the active and placebo treatment groups included headache, nausea and fatigue; rates in the active treatment group were comparable to those in the group that received placebo for the first 12 weeks.

 

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