Premium
Telaprevir‐based triple therapy for chronic hepatitis C patients with advanced fibrosis: a prospective clinical study
Author(s) -
Ogawa E.,
Furusyo N.,
Nakamuta M.,
Kajiwara E.,
Nomura H.,
Dohmen K.,
Takahashi K.,
Satoh T.,
Azuma K.,
Kawano A.,
Tanabe Y.,
Kotoh K.,
Shimoda S.,
Hayashi J.
Publication year - 2013
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.12494
Subject(s) - medicine , telaprevir , ribavirin , itpa , gastroenterology , pegylated interferon , cirrhosis , adverse effect , discontinuation , combination therapy , hepatitis c , hepatitis c virus , immunology , virus
Summary Background Antiviral treatment is recommended for chronic hepatitis C patients with advanced fibrosis to reduce and prevent cirrhosis‐related complications. Aim To evaluate the efficacy and safety of telaprevir ( TVR )‐based triple therapy for patients with advanced fibrosis in a clinical practice setting. Methods This prospective, multicentre study consisted of 102 patients with advanced fibrosis ( METAVIR score F3‐4) who were infected with HCV genotype 1b. All received 12 weeks of TVR in combination with 24 weeks of pegylated interferon ( PEG ‐ IFN ) α2b and ribavirin ( RBV ). Results The sustained virological response ( SVR ) rate was 69.6% (71 of 102). Notably, for treatment‐naïve and prior relapse patients the SVR rate was over 80%. Previous treatment response, interleukin 28B polymorphism (rs8099917) and rapid virological response (undetectable HCV RNA at week 4) were independently associated with SVR . To achieve SVR , an adequate dosage of PEG ‐ IFN α2b (≥1.2 μg/kg/week) and RBV (≥7.5 mg/kg/day) is preferable; however, the mean weight‐adjusted TVR dosage had little impact on treatment outcome. Although severe blood cytopaenia and a dermatological disorder were frequently found, the rate of discontinuation due to adverse effects was 12.7%. The inosine triphosphatase CC allele (rs1127354) was independently associated with the development of severe anaemia, and lower serum albumin level (<35 g/L) was associated with the occurrence of infection. Conclusions The great gain in the SVR rate by telaprevir‐based triple therapy offsets the problems with adverse effects; thus, it should be considered as a potent treatment protocol for patients with advanced fibrosis, especially for those with treatment‐naïve and prior relapse.