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Paritaprevir/ritonavir, ombitasvir plus dasabuvir for East Asian non‐cirrhotic hepatitis C virus genotype 1b patients receiving hemodialysis
Author(s) -
Liu ChenHua,
Shih YuLueng,
Yang ShengShun,
Lin ChihLin,
Fang YuJen,
Cheng PinNan,
Chen ChiYi,
Peng ChengYuan,
Hsieh TsaiYuan,
Chiu YenCheng,
Su TungHung,
Liu ChunJen,
Yang HungChih,
Chen PeiJer,
Chen DingShinn,
Kao JiaHorng
Publication year - 2019
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/jgh.14672
Subject(s) - medicine , ombitasvir , paritaprevir , dasabuvir , ritonavir , gastroenterology , hemodialysis , adverse effect , hepatitis c , hepatitis c virus , discontinuation , ribavirin , surgery , viral load , immunology , virus , antiretroviral therapy
Background and Aim Data regarding the efficacy and safety of paritaprevir/ritonavir, ombitasvir plus dasabuvir (PrOD) for East Asian non‐cirrhotic hepatitis C virus genotype 1b (HCV GT1b) patients receiving hemodialysis were limited. Methods Forty‐six HCV GT1b non‐cirrhotic patients receiving hemodialysis who received PrOD for 12 weeks were prospectively enrolled in seven academic centers in Taiwan. The primary efficacy endpoint was sustained virologic response 12 weeks off‐therapy (SVR 12 ). Patients' baseline characteristics, early virokinetics, and HCV resistance‐associated substitutions (RASs) potentially related to SVR 12 were analyzed. The safety profiles were also assessed. Results The SVR 12 rate was 100% (46 of 46 patients). Patients' baseline characteristics, on‐treatment viral decline, and baseline HCV resistance‐associated substitutions did not affect SVR 12 . All patients tolerated treatment well. One patient with folliculitis temporarily discontinued treatment, and another two patients had serious adverse events (SAEs), which were considered not related to PrOD treatment. The common adverse events were pruritus (19.6%), fatigue (15.2%), and upper respiratory tract infection (6.5%). Twelve (19.6%) and one (2.2%) patients had hemoglobin levels < 10 and 8.5 g/dL, respectively, which were related to renal impairment. Five (10.9%) patients had on‐treatment total bilirubin level of 1.5–3.0 mg/dL, but none developed hepatic decompensation. The bilirubin levels peaked at week 1 of treatment and then declined with continuous treatment. Conclusion Treatment with PrOD for 12 weeks is efficacious and well‐tolerated for East Asian non‐cirrhotic HCV GT1b patients receiving hemodialysis.