Results of Phase III trial of MK 5172 + MK 8742 (grazoprevir + elbasvir) in hepatitis C plus CKD published in The Lancet- Merck

Merck announced the publication of results from C-SURFER, the first Phase III clinical trial to investigate MK 5172 + MK 8742 (grazoprevir + elbasvir), 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 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 medical journal The Lancet.

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 black patients, patients receiving haemodialysis and patients with the IL28B non-CC genotype. Among those receiving elbasvir plus grazoprevir in the primary analysis population, 99% (115/116) achieved SVR12, with one relapse 12 weeks after the end of treatment. In a secondary analysis, 94% (115/122) achieved SVR12. Adverse events included headache, nausea and fatigue.

See: "Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4–5 chronic kidney disease (the C-SURFER study): a combination phase 3 study," David Roth et al. The Lancet, Published Online: 05 October 2015, DOI: http://dx.doi.org/10.1016/S0140-6736(15)00349-9