Background: Paritaprevir/ritonavir, Ombitasvir, Dasabuvir (PrOD) regimen for treatment of HCV has been associated with hepatic decompensation (HD), especially in patients with pre-treatment cirrhosis, but large scale studies are not available to quantify the risk.
Methods: We analyzed HCV infected persons in the ERCHIVES database treated with a PrOD regimen for hepatic decompensation (HD), liver transplantation and death. Participants were followed up to 12 weeks post-treatment. We excluded those with HIV, HBsAg+ and pre-existing diagnosis of HD and hepatocellular carcinoma
Results: We identified 3,728 persons on PrOD, cirrhosis was present at baseline in 23%. There were 15 HD events, but no liver transplants or deaths in the study time frame. Incidence rate [95% CI] of HD/1,000 treatments initiated was 10.6[5.89,17.36]. Among those with baseline cirrhosis, the rate was 36.9[19.1,64.5], while among those without cirrhosis at baseline, the rate was 2.7[0.6,8.0]. Advanced fibrosis at baseline was associated with increased risk of HD (HR [95% CI] per 0.5 unit increase in FIB-4 score: 1.11[1.07,1.16]). In multivariable Cox regression analysis, advanced fibrosis was associated with an increased risk of HD (HR per 0.5 unit increase in FIB-4: 1.11[1.07,1.16]).
Conclusion: The overall incidence of HD in persons treated with PrOD regimen, while on treatment and up to 12 weeks after completion of treatment was low and predominantly observed in those with cirrhosis at baseline.
K. M. Marks, None
O. Shaikh, None
K. E. Sherman, None