Merck announces positive Elbasvir/Grazoprevir trial results
pharmafile | October 9, 2015 | News story | Research and Development |
Merck has announced the publication of results from C-SURFER, the first Phase III clinical trial to investigate an all-oral, ribavirin-free chronic hepatitis C virus (HCV) treatment regimen in treatment-naive 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 III clinical trial evaluating the investigational, once-daily treatment regimen of elbasvir (50mg) and grazoprevir (100mg) in patients with advanced CKD were published online in the The Lancet Medical Journal.
Chronic HCV infection is both a cause and complication of the treatment of CKD. In patients with CKD, chronic HCV infection is associated with an increased risk of accelerated loss of remaining kidney function, kidney transplant failure and death. Furthermore, patients with chronic HCV infection and advanced CKD represent an unmet need due to a lack of demonstrated HCV treatment options for this group.
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).
These high rates were achieved regardless of patient characteristics in this study, including African-American patients, patients receiving hemodialysis and patients with the IL28B non-CC genotype, says Merck.
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 included headache, nausea and fatigue, yet rates in the active treatment group were comparable to those in the group that received placebo for the first 12 weeks.
Dr Howard Monsour Jr, chief of hepatology, Houston Methodist Hospital, says: “People with advanced chronic kidney disease represent an important segment of the chronic hepatitis C patient population. The publication of this study details the evidence supporting a potential future treatment option for these patients who are currently underserved.”
Joel Levy
