Real-world effectiveness of 8-week treatment with ledipasvir/sofosbuvir in chronic hepatitis C

Peter Buggisch, Johannes Vermehren, Stefan Mauss, Rainer Günther, Eckart Schott, Anita Pathil, Klaus Boeker, Tim Zimmermann, Gerlinde Teuber, Heike-Pfeiffer Vornkahl, Karl-Georg Simon, Claus Niederau, Heiner Wedemeyer, Stefan Zeuzem

Ledipasvir/Sofosbuvir (LDV/SOF) for 8 to 24 weeks is approved for the treatment of chronic hepatitis C virus infection (HCV). In the ION-3 study 8 weeks of LDV/SOF was non-inferior to 12 weeks in previously untreated genotype 1 (GT1) patients without cirrhosis. According to the summary of product characteristics (SmPC), 8 weeks treatment may be considered in naïve non-cirrhotic GT1-patients. However, there are only limited data on the effectiveness of 8 week regimen of LDV/SOF under real-world conditions available. Aim of the present study was to characterise patients receiving 8 weeks LDV/SOF compared with 12 weeks treatment duration and to describe outcome of therapy in routine clinical practice. The German Hepatitis C-Registry is a large national real-world cohort that analyses effectiveness and safety of antiviral therapies in chronic HCV. This data set is based on 2,404 patients. Overall, 84.6% (2,034/2,404) of the Intention-to-Treat (ITT) population and 98.2% (2,029/2,066) of the Per Protocol (PP) population achieved SVR12. In the 8 week group, 85.1% (824/968) of ITT and 98.3% (821/835) of PP patients achieved SVR12, while in the 12 week group, 85.5% (1210/1415) of ITT, and 98.1% (1,208/1,231) of PP patients achieved SVR12. When treated according to the SmPC, 98.7% (739/749) of the patients achieved SVR12 (PP). Relapse was observed in 9.5% (2/21) of cirrhotic patients treated for 8 weeks (PP). Under real world conditions a high proportion of eligible patients received 8 week LDV/SOF treatment. Relapse occurred in particular in patients who did not meet the selection criteria according to the SmPC. In a large real-world cohort of patients mainly treated by physicians in private practice in Germany, shorter HCV treatment (8 week) resulted in equivalent cure rates to 12 weeks treatment in genotype 1 HCV-infected patients. Thus, shorter treatment can be recommended in these patients which would substantially reduce costs of therapy.