Preliminary data from an ongoing study revealed at The International Liver Congress™ 2015 suggest that a combination of three direct-acting antivirals (DAAs) is well tolerated in patients with severe renal impairment or end-stage renal disease when used either with or without ribavirin. In addition, the combination led to rapid hepatitis C viral load suppression with no virological failures seen in the preliminary data from the ongoing open-label study.
In the study, treatment naïve non-cirrhotic adults with chronic HCV GT1 infection and chronic kidney disease (CKD) classified as stage 4 or stage 5, received 12 weeks of treatment with ombitasvir / paritaprevir / ritonavir and dasabuvir (3D) either with or without ribavirin. There was a 24-week post-treatment follow-up period. As of February 18 2015, 17 of a planned 20 patients in Cohort 1 had received treatment and six had completed treatment. The combination has been well tolerated to date, with no treatment-related serious adverse events, one hemoglobin decline to <8 g/dL, and no premature discontinuations of DAAs.
Limited data are available on the safety for treating hepatitis C infection (HCV) in patients with severe renal impairment or end-stage renal disease and many of these patients currently go untreated and are vulnerable to disease progression.
Presenter: Paul Pockros (United States)
Abstract LO1: Safety of ombitasvir/paritaprevir/ritonavir plus dasabuvir for treating HCV GT1 infection in patients with severe renal impairment or end-stage renal disease: the RUBY-I study.