Paritaprevir/ritonavir, ombitasvir plus dasabuvir for East-Asian non-cirrhotic hepatitis C virus genotype 1b patients receiving hemodialysis

Chen-Hua Liu, Yu-Lueng Shih, Sheng-Shun Yang, Chih-Lin Lin, Yu-Jen Fang, Pin-Nan Cheng, Chi-Yi Chen, Cheng-Yuan Peng, Tsai-Yuan Hsieh, Yen-Cheng Chiu, Tung-Hung Su, Chun-Jen Liu, Hung-Chih Yang, Pei-Jer Chen, Ding-Shinn Chen, Jia-Horng Kao
Journal of Gastroenterology and Hepatology 2019 April 1

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 7 academic centers in Taiwan. The primary efficacy endpoint was sustained virologic response 12 weeks off-therapy (SVR12 ). Patients' baseline characteristics, early virokinetics and HCV resistance-associated substitutions (RASs) potentially related to SVR12 were analyzed. The safety profiles were also assessed.

RESULTS: The SVR12 rate was 100% (46 of 46 patients). Patients' baseline characteristics, on-treatment viral decline, and baseline HCV RASs did not affect SVR12 . All patients tolerated treatment well. One patient with folliculitis temporarily discontinued treatment, and another two patients had SAEs, which were considered not related to PrOD treatment. The common AEs 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 g/dL 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.

CONCLUSIONS: Treatment with PrOD for 12 weeks is efficacious and well-tolerated for East-Asian non-cirrhotic HCV GT1b patients receiving hemodialysis.

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