Study shows Merck Zepatier resulted in high sustained virologic response rates
Merck has announced the presentation of findings from a retrospective database analysis of patients with chronic hepatitis C virus genotype 1 or 4 infection who have chronic kidney disease and were treated with Zepatier - elbasvir and grazoprevir - in the U.S. Department of Veterans Affairs healthcare system. Among patients who completed therapy, the analysis showed 95.6% of patients with severe CKD and 97.1% of patients with moderate CKD achieved sustained virologic response, defined as HCV RNA below the limit of quantification at least 10-12 weeks after the end of treatment. For patients with missing HCV RNA data after at least 10-12 weeks after treatment completion, analyses were conducted on a post-hoc basis using the last HCV RNA data available after week 4 after therapy completion. The response rates in the real-world setting of the VA further supplement findings from controlled clinical studies of Zepatier. In the U.S., Zepatier is indicated for the treatment of chronic HCV GT1 or GT4 infection in adults. Zepatier is indicated for use with ribavirin in certain patient populations. The U.S. Prescribing Information for Zepatier includes a Boxed Warning about the risk of hepatitis B virus reactivation in patients co-infected with HCV and HBV. In controlled clinical studies of Zepatier, SVR was the primary endpoint defined as HCV RNA less than lower limit of quantification at 12 weeks after the cessation of treatment. The retrospective observational analysis included 5,845 patients with chronic HCV infection who received Zepatier between February 1 and December 31, 2016. Patients were identified from the VA Corporate Data Warehouse, a national repository of VA electronic medical records.