PrOD ± ribavirin highly effective in HCV patients with advanced hepatic fibrosis, compensated cirrhosis
Use of paritaprevir/ritonavir, ombitasvir, and dasabuvir (PrOD) with or without ribavirin is very effective in the treatment of chronic hepatitis C with advanced hepatic fibrosis or compensated cirrhosis, according to a recent study, adding that Child-Pugh A6 must be an exclusion criterion for first-line treatment in these patients.
Of the 898 patients, 887 (98.8 percent) achieved sustained virologic response 12 weeks off therapy (SVR12) based on the per-protocol analysis (patients receiving ≥1 dose of any study medication and hepatitis C virus (HCV) RNA data available at post-treatment week 12). The only significant factor of poor SVR12 was Child-Pugh A6 (odds ratio [OR], 0.168; 95 percent CI, 0.043–0.659; p=0.011).
Fifty-four (5.7 percent) patients discontinued treatment due to hepatic decompensation (n=18; 1.9 percent) and other adverse reactions. In multivariate analyses, old age (OR, 1.062; 1.008–1.119; p=0.024) and Child-Pugh A6 (OR, 4.957; 1.691–14.528; p=0.004) significantly correlated with hepatic decompensation.
The authors enrolled 941 patients treated in four hospitals (the Keelung, the Linkuo, the Chiayi and the Kaohsiung Chang Gung Memorial Hospital) through a nationwide government-funded programme in Taiwan. Patients with HCV and advanced hepatic fibrosis or compensated cirrhosis received 12 weeks of PrOD for HCV-1b and 12 or 24 weeks of PrOD plus ribavirin therapy for HCV-1a without or with cirrhosis.
Ultrasonography, fibrosis index based on 4 factors (FIB-4) test, or transient elastography/acoustic radiation force impulse (ARFI) was used to confirm the advanced hepatic fibrosis or compensated cirrhosis in patients. Safety and efficacy of PrOD were evaluated.