Premium
Efficacy of ledipasvir/sofosbuvir with or without ribavirin for 12 weeks in genotype 1b HCV patients previously treated with a nonstructural protein 5A inhibitor‐containing regimen
Author(s) -
Ikeda Hiroki,
Watanabe Tsunamasa,
Shimizu Hirohito,
Hiraishi Tetsuya,
Kaneko Rena,
Baba Toshiyuki,
Takahashi Hideaki,
Matsunaga Kotaro,
Matsumoto Nobuyuki,
Yasuda Hiroshi,
Okuse Chiaki,
Iwabuchi Shogo,
Suzuki Michihiro,
Itoh Fumio
Publication year - 2018
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.13074
Subject(s) - daclatasvir , sofosbuvir , ns5a , ledipasvir , ribavirin , regimen , biology , virology , medicine , hepatitis c virus , virus , hepacivirus
Aim The therapeutic benefit of adding ribavirin (RBV) to 12 weeks of ledipasvir/sofosbuvir (LDV/SOF) for patients who experienced failure of a previous nonstructural protein (NS) 5A inhibitor‐containing regimen is unclear. Methods A total of 29 genotype 1b HCV patients who had failed prior daclatasvir (DCV) plus asunaprevir (ASV) treatment were retreated for 12 weeks of LDV/SOF, with or without RBV. Antiviral efficacy and predictive factors associating with a sustained virological response at 24 weeks (SVR24) were evaluated retrospectively. Results SVR24 was achieved in 67% (10/15) of patients who received LDV/SOF with, and 64% (9/14) without, RBV. The SVR24 rates were 80% in patients with, and 58% without, mild fibrosis (FIB‐4 < 3.25). The SVR24 rate was lower with unfavorable IL28B rs8099917 SNP genotypes; specifically, the TT, TG and GG had SVR24 rates of 78%, 50% and 40%. The SVR24 rate was lower with a poor response to prior DCV plus ASV, where relapse, viral breakthrough and no response had SVR24 rates 71%, 58% and 0%. The SVR24 rate was lower with the number of NS5A resistance‐associated substitutions (RAS), where 2, 3, 4 and 5 RAS had SVR24 rates of 78%, 67%, 50% and 0%. A patient with an NS5A‐P32 deletion, which shows resistance to next‐generation NS5A inhibitors, was retreated with LDV/SOF with RBV and achieved SVR24. Conclusions The addition of RBV to 12 weeks of LDV/SOF has little therapeutic benefit when retreating patients in whom a prior NS5A inhibitor‐containing regimen had failed.