The online version of this article (doi:10.1186/1471-230X-14-87) contains supplementary material, which is available to authorized users.
Julian Schulze zur Wiesch and Stefan Lüth contributed equally to this work.
Malte H. Wehmeyer has served as a speaker for BMS. Sabine Jordan, Olaf Degen, Martina Sterneck, Jan van Lunzen, Ansgar W. Lohse, Julian Schulze zur Wiesch and Stefan Lüth have served as speakers for Roche, Janssen-Cilag and MSD. Annette Hennigs has served as a speaker for Janssen-Cilag. Friederike Eißing, Claudia Röder, Anja Hüfner, Sandra Hertling and Stefan Schmiedel declare no conflict of interest.
MHW drafted the originial manuscript, contributed to study design, performed the statistical analysis, interpreted the results and collected the data; FE performed additional statistical analysis and collected the data. SJ, AHe, OD, AHü, SH, SS and MS collected the data; CR contributed to the study design; JvL contributed to study design and data collection; AWL critically revised the manuscript; JSzW and SL contributed to study design, collected data and critically revised the manuscript. All authors read and approved the final manuscript.
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.
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.
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.
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.
Additional file 1: Virological and adverse events definitions, grading of laboratory events and further information on the DAA experienced patients.(DOC 22 KB)
Additional file 2: Course of therapy in DAA-experienced patients, as well as in patients with special comorbidities.(PDF 249 KB)
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- 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 Wehmeyer
Jan van Lunzen
Ansgar W Lohse
Julian Schulze zur Wiesch
- BioMed Central
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