BACKGROUND:In chronic hepatitis C virus-infected patients cirrhosis is associated with less effective INF-based treatment and higher risk of complications. New IFN-free direct-acting antiviral therapies have greatly improved sustained virologic response (SVR) rates in patients with cirrhosis, nonetheless the rates are still lower than in patients without cirrhosis.

OBJECTIVES: To assess the real world effectiveness of treatment with OBV/PTV/r ± DSV in patients with HCV infection and compensated cirrhosis participating in Polish public drug program.

METHODS: Registry that included patients with cirrhosis treated with OBV/PTV/r ± DSV, who entered the drug program from Oct 1 2015 to Jan 31 2016 in seven non-randomly selected hospitals (N=265). Data on genotype, comorbidities, past treatment, end of treatment response, SVR24 and reason for early treatment cessation (including AE) was collected retrospectively.

RESULTS: From 265 patients with cirrhosis receiving treatment (ITT population) 263 completed treatment (2 fatalities) and 256 had SVR24 assessed (4 lost to follow up and 3 fatalities) (PP population). Analysed group comprised 50% male, 54% treatment-experienced, prevailing comorbidities were hypertension (38%) and diabetes (16%). 250 patients achieved SVR24 – 94% in ITT population, 98% in PP population. Results are consistent with the efficacy in noncirrhotic patients from the same registry; from 238 patients with liver fibrosis stages F1-F3 (ITT) SVR24 was assessed in 225 patients (PP) and 222 achieved SVR24 (93% in ITT population, 99% in PP population).

CONCLUSIONS: Real world data from Poland regarding OBV/PTV/r ± DSV therapy of HCV infected patients with cirrhosis confirms the high effectiveness of this regimen. Presented results are further reinforced by RWE study performed by Flisiak et al. (2017), where 90 patients with cirrhosis reached SVR24 (72% in ITT and 99% in PP population). The results indicate the effectiveness of Polish drug program.