Safety findings from the ongoing RUBY-1 study evaluating ombitasvir / paritaprevir / ritonavir in combination with dasabuvir (3D) in chronic hepatitis C virus (HCV) genotype 1 (GT1) patients with severe renal impairment or end-stage renal disease

April 25, 2015, Vienna, Austria: Preliminary data from an ongoing study revealed today 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. About The International Liver Congress™ This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Specialists share research studies and findings, and discuss the hottest topics related to liver disease. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. 2015 is a very special year for EASL and the hepatology community as they will celebrate the 50th annual meeting. The International Liver Congress™ takes place from April 22-26, 2015, Vienna, Austria. About EASL (www.easl.eu) Since EASL’s foundation in 1966, this not-for-profit organisation has grown to over 4,000 members from more than 100 countries around the world. EASL is the leading liver association in Europe, it attracts the foremost hepatology experts and has an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy. Contact For more information, please contact the ILC Press Office at: • ilc.press@easloffice.eu or • +44 (0)20 3580 5444 Late Breakers: Hall D Presentation time: 18:00-18:15 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

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