Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC) - NCT01514890

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• 作者：Christophe H¨¦zode ; H¨¦l¨¨ne Fontaine ; C¨¦line Dorival ; Dominique Larrey ; Fabien Zoulim ; Val¨¦rie Canva ; Victor de Ledinghen ; Thierry Poynard ; Didier Samuel ; Marc Bourli¨¨re ; Jean-Pierre Zarski ; Jean-Jacques Raabe ; Laurent Alric ; Patrick Marcellin ; Ghassan Riachi ; Pierre-Henri Bernard ; V¨¦ronique Loustaud-Ratti ; Sophie M¨¦tivier ; Albert Tran ; Lawrence Serfaty ; et al.
• 关键词：Chronic hepatitis C ; Cirrhosis ; Treatment ; Boceprevir ; Telaprevir ; Safety
• 刊名：Journal of Hepatology
• 出版年：2013
• 出版时间：September, 2013
• 年：2013
• 卷：59
• 期：3
• 页码：434-441
• 全文大小：763 K

文摘

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Background & Aims

In phase III trials, the safety profile of triple therapy (pegylated interferon/ribavirin with boceprevir or telaprevir) seems to be similar in HCV treatment-experienced cirrhotic and non-cirrhotic patients, but few cirrhotics were included. We report the week 16 safety and efficacy analysis in a cohort of compensated cirrhotics treated in the French Early Access Programme.

Methods

674 genotype 1 patients, prospectively included, received 48 weeks of triple therapy. The analysis is restricted to 497 patients reaching week 16.

Results

A high incidence of serious adverse events (40.0 % ), and of death and severe complications (severe infection or hepatic decompensation) (6.4 % ), and a difficult management of anaemia (erythropoietin and transfusion use in 50.7 % and 12.1 % ) were observed. Independent predictors of anaemia <8 g/dl or blood transfusion were: female gender (OR 2.19, 95 % CI 1.11-4.33, p = 0.024), no lead-in phase (OR 2.25, 95 % CI 1.15-4.39, p = 0.018), age ?65 years (OR 3.04, 95 % CI 1.54-6.02, p = 0.0014), haemoglobin level (?12 g/dl for females, ?13 g/dl for males) (OR 5.30, 95 % CI 2.49-11.5, p = 0.0001). Death or severe complications were related to platelets count ?100,000/mm³ (OR 3.11, 95 % CI 1.30-7.41, p = 0.0105) and albumin <35 g/dl (OR 6.33, 95 % CI 2.66-15.07, p = 0.0001), with a risk of 44.1 % in patients with both. However, the on-treatment virological response was high.

Conclusions

The safety profile was poor and patients with platelet count ?100,000/mm³ and serum albumin <35 g/L should not be treated with the triple therapy.