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Effectiveness and safety of daclatasvir plus asunaprevir for patients with hepatitis C virus genotype 1b aged 75 years and over with or without cirrhosis
Author(s) -
Ogawa Eiichi,
Furusyo Norihiro,
Yamashita Naoki,
Kawano Akira,
Takahashi Kazuhiro,
Dohmen Kazufumi,
Nakamuta Makoto,
Satoh Takeaki,
Nomura Hideyuki,
Azuma Koichi,
Koyanagi Toshimasa,
Kotoh Kazuhiro,
Shimoda Shinji,
Kajiwara Eiji,
Hayashi Jun
Publication year - 2017
Publication title -
hepatology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.123
H-Index - 75
eISSN - 1872-034X
pISSN - 1386-6346
DOI - 10.1111/hepr.12738
Subject(s) - daclatasvir , medicine , simeprevir , gastroenterology , ns5a , adverse effect , cirrhosis , hepatitis c virus , sofosbuvir , hepatitis c , virology , hepacivirus , ribavirin , virus
Aim The aim of this study was to evaluate the efficacy and safety of 24‐week daclatasvir (NS5A inhibitor) plus asunaprevir (NS3/4 A protease inhibitor) treatment for elderly patients with hepatitis C virus (HCV) genotype 1b infection.Methods This prospective, multicenter study consisted of 321 Japanese HCV genotype 1b patients who were interferon‐ineligible/intolerant or non‐responders to interferon‐based regimens, including 103 (32.1%) aged ≥75 years and 127 (39.6%) with cirrhosis. Sustained virological response (SVR) at 24 weeks after the end of treatment and adverse effects were analyzed according to age. Results The overall SVR rate was 90.3%. In terms of by age, 94.5% (69/73), 88.3% (128/145), and 90.3% (93/103) of the patients aged <65, 65–74, and ≥75 years, respectively, achieved SVR. For the entire cohort, pre‐existent NS5A resistance‐associated variants and prior simeprevir failure were independently associated with treatment failure. According to the analysis of patients without these unfavorable pretreatment factors, 90.8% (89/98) aged ≥75 years achieved SVR, although this was significantly lower than for those aged <65 years (98.5%, 66/67) ( P < 0.05). The frequency of adverse effects was comparable for the <75 and ≥75 age groups, the most common being an elevated alanine aminotransferase level (>150 U/L, 8.7%), however, no decompensating events were seen.Conclusions Daclatasvir plus asunaprevir for HCV genotype 1b was well tolerated and effective for patients without pre‐existent NS5A resistance‐associated variants or simeprevir failure, irrespective of fibrosis status. However, it was less effective for very old patients aged ≥75 years compared to those aged <65.