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Clinical Trial
. 2014 Jul;63(7):1150-8.
doi: 10.1136/gutjnl-2013-305667. Epub 2013 Nov 7.

Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C

M Colombo  1 , I Fernández  2 , D Abdurakhmanov  3 , P A Ferreira  4 , S I Strasser  5 , P Urbanek  6 , C Moreno  7 , A Streinu-Cercel  8 , A Verheyen  9 , W Iraqi  10 , R DeMasi  11 , A Hill  12 , J M Läuffer  13 , I Lonjon-Domanec  10 , H Wedemeyer  14
Affiliations
Free PMC article
Clinical Trial

Safety and on-treatment efficacy of telaprevir: the early access programme for patients with advanced hepatitis C

M Colombo et al. Gut. 2014 Jul.
Free PMC article

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 1-4 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.

Keywords: ANEMIA; HEPATITIS C; INTERFERON.

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Figures

Figure 1
Figure 1
Outcome of treatment at weeks 4 and 12, by prior treatment. Shown are the week 4 and 12 outcomes of treatment by subgroup: treatment naive (n=321), prior treatment relapsers (n=531), previous partial responders (n=436) and previous null (n=203). Data for patients who had previously experienced viral breakthrough (n=49) and whose prior response to treatment was unspecified (n=47) have not been represented.
Figure 2
Figure 2
Incidence and prevalence of any grade telaprevir (TVR)-related anaemia (A) and rash (B). Shown are the incidence and prevalence rates of the Intent to Treat population by month from start of TVR treatment.
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References

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