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J Gastroenterol Hepatol. 2019 Apr 1. doi: 10.1111/jgh.14672. [Epub ahead of print]

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

Liu CH1,2,3, Shih YL4, Yang SS5,6,7, Lin CL8, Fang YJ3, Cheng PN9, Chen CY10, Peng CY11, Hsieh TY4, Chiu YC9, Su TH1,2, Liu CJ1,2, Yang HC12, Chen PJ1,2,13, Chen DS1,2,14, Kao JH1,2,13.

Author information

1
Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
2
Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan.
3
Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Douliou, Taiwan.
4
Division of Gastroenterology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.
5
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Taichung Veterans General Hospital, Taichung, Taiwan.
6
School of Medicine, Chung Shan Medical University, Taichung, Taiwan.
7
Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.
8
Department of Gastroenterology, Taipei City Hospital, Renai Branch, Taipei, Taiwan.
9
Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan.
10
Department of Internal Medicine, Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi, Taiwan.
11
Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
12
Department of Microbiology, National Taiwan University College of Medicine, Taipei, Taiwan.
13
Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.
14
Genomics Research Center, Academia Sinica, Taipei, Taiwan.

Abstract

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 (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 resistance-associated substitutions did not affect SVR12 . 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.

KEYWORDS:

dasabuvir; direct-acting antiviral agent; hemodialysis; hepatitis C virus; ombitasvir; paritaprevir; ritonavir

PMID:
30931537
DOI:
10.1111/jgh.14672

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