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Multicenter Study
. 2019 May 8;9(1):7086.
doi: 10.1038/s41598-019-43554-3.

Real-world safety and efficacy of paritaprevir/ritonavir/ombitasvir plus dasabuvir ± ribavirin in patients with hepatitis C virus genotype 1 and advanced hepatic fibrosis or compensated cirrhosis: a multicenter pooled analysis

Chun-Hsien Chen  1 , Chien-Hung Chen  2 , Chih-Lang Lin  3 , Chun-Yen Lin  4 , Tsung-Hui Hu  2 , Shui-Yi Tung  1 , Sen-Yung Hsieh  4 , Sheng-Nan Lu  1   2 , Rong-Nan Chien  4 , Chao-Hung Hung  5   6 , I-Shyan Sheen  4
Affiliations
Multicenter Study

Real-world safety and efficacy of paritaprevir/ritonavir/ombitasvir plus dasabuvir ± ribavirin in patients with hepatitis C virus genotype 1 and advanced hepatic fibrosis or compensated cirrhosis: a multicenter pooled analysis

Chun-Hsien Chen et al. Sci Rep. .

Abstract

Paritaprevir/ritonavir, ombitasvir, and dasabuvir (PrOD) with or without ribavirin shows favorable results in hepatitis C virus genotype 1 (HCV-1) patients in terms of safety and efficacy, but real-world data remain limited for those with advanced hepatic fibrosis (fibrosis 3, F3) or compensated cirrhosis (F4). A total of 941 patients treated in four hospitals (the Keelung, the Linkuo, the Chiayi and the Kaohsiung Chang Gung Memorial Hospital) through a nationwide government-funded program in Taiwan were enrolled. Patients with HCV and advanced hepatic fibrosis or compensated cirrhosis received 12 weeks of PrOD in HCV-1b and 12 or 24 weeks of PrOD plus ribavirin therapy in HCV-1a without or with cirrhosis. Advanced hepatic fibrosis or compensated cirrhosis was confirmed by either ultrasonography, fibrosis index based on 4 factors (FIB-4) test, or transient elastography/acoustic radiation force impulse (ARFI). The safety and efficacy (sustained virologic response 12 weeks off therapy, SVR12) were evaluated. An SVR12 was achieved in 887 of 898 (98.8%) patients based on the per-protocol analysis (subjects receiving ≥1 dose of any study medication and HCV RNA data available at post-treatment week 12). Child-Pugh A6 (odds ratio: 0.168; 95% confidence interval (CI): 0.043-0.659, p = 0.011) was the only significant factor of poor SVR12. Fifty-four (5.7%) patients were withdrawn early from the treatment because of hepatic decompensation (n = 18, 1.9%) and other adverse reactions. Multivariate analyses identified old age (odds ratio: 1.062; 95% CI: 1.008-1.119, p = 0.024) and Child-Pugh A6 (odds ratio: 4.957; 95% CI: 1.691-14.528, p = 0.004) were significantly associated with hepatic decompensation. In conclusion, this large real-world cohort proved PrOD with or without ribavirin to be highly effective in chronic hepatitis C patients with advanced hepatic fibrosis or compensated cirrhosis. However, Child-Pugh A6 should be an exclusion criterion for first-line treatment in these patients.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
On-treatment virological response during PrOD-based therapies. PrOD: HCV-1b with and without cirrhosis; PrOD + RBV/12w: HCV-1a without cirrhosis; PrOD + RBV/24w: HCV-1a with cirrhosis.
Figure 2
Figure 2
Overall SVR12 rate. PrOD: HCV-1b with and without cirrhosis; PrOD + RBV/12w: HCV-1a without cirrhosis; PrOD + RBV/24w: HCV-1a with cirrhosis.
Figure 3
Figure 3
Patients co-infected with HBV and HCV received PrOD-based therapies.
See this image and copyright information in PMC

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