Open Access Research article

Safety and efficacy of protease inhibitor based combination therapy in a single-center “real-life” cohort of 110 patients with chronic hepatitis C genotype 1 infection

Malte H Wehmeyer1, Friederike Eißing1, Sabine Jordan1, Claudia Röder1, Annette Hennigs1, Olaf Degen2, Anja Hüfner2, Sandra Hertling2, Stefan Schmiedel1, Martina Sterneck1, Jan van Lunzen2, Ansgar W Lohse1, Julian Schulze zur Wiesch1* and Stefan Lüth1

Author Affiliations

1 I. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf, Martinistr. 52, Hamburg 20246, Germany

2 Ambulanzzentrum des UKE, Fachbereich Infektiologie, Hamburg Germany

For all author emails, please log on.

BMC Gastroenterology 2014, 14:87  doi:10.1186/1471-230X-14-87

Published: 5 May 2014

Abstract

Background

The combination of boceprevir or telaprevir with peginterferon-alfa and ribavirin for the treatment of patients infected with HCV genotype 1 has led to significantly increased rates of sustained virological response (SVR) in phase III trials. There is only limited data regarding the safety and efficacy in a “real-life” cohort.

Methods

We analyzed a cohort of 110 unselected HCV patients who started triple therapy from September 2011 to February 2013 by chart review with focus on the individual course of treatment, complications and outcome. We excluded 8 patients from analysis because of HIV-coinfection (N = 6) or status post liver transplant (N = 2). Importantly, 41 patients displayed F3 or F4 fibrosis, 10 patients had a history of treatment with protease/polymerase inhibitors and 15 patients were prior partial- or null-responder.

Results

SVR12 was achieved in 62 of the 102 patients (60.8%). A high rate of serious adverse events (N = 30) was observed in 22 patients including 2 fatalities in cirrhotic diabetes patients. Age >50 years, liver cirrhosis, bilirubin >1.1 mg/dl (P < 0.01, each), platelets <100,000/μl (P = 0.01), ASAT >100 U/l (P = 0.03) and albumin ≤35 g/l (P = 0.04) at baseline were associated with occurence of a SAE.

Conclusions

The frequency of SVR in a “real-life” treatment setting is slightly lower as compared to the results of the phase III trials for telaprevir or boceprevir. Importantly, we observed a high frequency of SAE in triple therapy, especially in patients with liver cirrhosis.

Keywords:
Boceprevir; Serious adverse events; SAE; Side effects; Sustained virological response; SVR; Telaprevir