First-generation protease inhibitor-triple therapy: SVR 24, safety, and predictors of response in a large single center

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RESEARCH

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First-generation protease inhibitor-triple therapy: SVR 24, safety, and predictors of response in a large single center cohort Christoph R Werner1, Carolin Franz1, Daniel P Egetemeyr1, Robert Beck2, Nisar P Malek1, Ulrich M Lauer1 and Christoph P Berg1*

Abstract Background/Aims: Aim of this retrospective study was to analyze the efficacy, safety, and predictors of treatment success for first-generation-PI triple therapies, including either boceprevir or telaprevir, in a mono-centric “real-life” setting with respect to SVR 24. Patients: 131 patients (102 patients telaprevir, 29 patients boceprevir) were treated. Of these, 33/131 patients were treatment naïve, 72/131 patients had been pretreated with PEG-IFN/RBV (PR) (thereof: 36 with non-response, 30 with relapse, 6 unknown), and 26/131 patients previously had received non-pegylated interferon. 96/131 patients were infected with HCV genotype 1b. 41/131 patients had liver cirrhosis. Results: 95/131 (73%) patients achieved SVR 24. SVR rates for subgroups were: 26/33 (79%) for treatment naïve, 25/30 (83%) for PR-relapse, 20/36 (56%) for PR-non-response, 21/26 (81%) for non-PR pretreated patients, (26/41) 63% for patients with liver cirrhosis, 23/35 (66%) genotype 1a, 72/96 (75%) genotype 1b. Predictors of SVR 24 were eRVR and a negative viral load at PI-treatment week 4 (p < 0.0001), negative predictors were quantifiable HCV viral load at PI-treatment week 4 (p < 0.0001), baseline platelet count < 100/nl (p < 0.0001), and previous PR-non-response (p = 0.006). 33/131 (25%) patients discontinued treatment prematurely, of those 14/131 (11%) patients due to virological failure. Side effects were frequent (anemia 59/131 [45%], severe infections 6/131 [5%]). Conclusions: According to our SVR 24 results, efficacy of PI-based triple therapy in our “real-life” cohort is comparable to the large multi-centric clinical trials. Pronounced side effects are frequent during therapy and often need complex therapeutic interventions. Since new DAA are available, it is open to discussion, if first-generation PI-triple therapy is no longer indicated at all. Keywords: Telaprevir, Boceprevir, Hepatitis C, Sustained virological response, Liver cirrhosis, Side effects

Introduction The prevalence of hepatitis C virus (HCV) infection in western countries is in the range of 0.2-2%, while worldwide about 170 million people are threatened by the disease. In Europe and Northern America, HCV genotype 1 infections are most prevalent with figures of about 50% [1-3]. From the turn of the millennium until 2011 the standard of care for treatment of HCV consisted of pegylated interferon (PEG-IFN), and ribavirin (RBV), * Correspondence: [email protected] 1 Department of Gastroenterology, Hepatology, and Infectiology, University Hospital Tübingen, Tübingen, Germany Full list of author information is available at the end of the article

thus achieving sustained viral response (SVR) rates of about 50% for HCV genotype 1 patients [4-8]. Unfortunately, many HCV genotype