@article {Colombo1150, author = {M Colombo and I Fern{\'a}ndez and D Abdurakhmanov and P A Ferreira and S I Strasser and P Urbanek and C Moreno and A Streinu-Cercel and A Verheyen and W Iraqi and R DeMasi and A Hill and J M L{\"a}uffer and I Lonjon-Domanec and H Wedemeyer}, title = {Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C}, volume = {63}, number = {7}, pages = {1150--1158}, year = {2014}, doi = {10.1136/gutjnl-2013-305667}, publisher = {BMJ Publishing Group}, abstract = {Background and aim Severe adverse events (AEs) compromise the outcome of direct antiviral agent-based treatment in patients with advanced liver fibrosis due to HCV infection. HEP3002 is an ongoing multinational programme to evaluate safety and efficacy of telaprevir (TVR) plus pegylated-interferon-α (PEG-IFNα) and ribavirin (RBV) in patients with advanced liver fibrosis caused by HCV genotype 1 (HCV-1). Methods 1782 patients with HCV-1 and bridging fibrosis or compensated cirrhosis were prospectively recruited from 16 countries worldwide, and treated with 12 weeks of TVR plus PEG-IFN/RBV, followed by 12 or 36 weeks of PEG-IFN and RBV (PR) alone dependent on virological response to treatment and previous response type. Results 1587 patients completed 12 weeks of triple therapy and 4 weeks of PR tail (53\% cirrhosis, 22\% HCV-1a). By week 12, HCV RNA was undetectable in 85\% of naives, 88\% of relapsers, 80\% of partial responders and 72\% of null responders. Overall, 931 patients (59\%) developed grade 1{\textendash}4 anaemia (grade 3/4 in 31\%), 630 (40\%) dose reduced RBV, 332 (21\%) received erythropoietin and 157 (10\%) were transfused. Age and female gender were the strongest predictors of anaemia. 64 patients (4\%) developed a grade 3/4 rash. Discontinuation of TVR due to AEs was necessary in 193 patients (12\%). Seven patients died (0.4\%, six had cirrhosis). Conclusions In compensated patients with advanced fibrosis due to HCV-1, triple therapy with TVR led to satisfactory rates of safety, tolerability and on-treatment virological response with adequate managements of AEs.}, issn = {0017-5749}, URL = {https://gut.bmj.com/content/63/7/1150}, eprint = {https://gut.bmj.com/content/63/7/1150.full.pdf}, journal = {Gut} }