Real-world experience with ombitasvir/paritaprevir boosted with ritonavir and possibly combined with dasabuvir and ribavirin in HCV infection

Abstract

Ombitasvir/paritaprevir boosted with ritonavir and possibly combined with dasabuvir and ribavirin (OBV/PTV/r ± DSV ± RBV) is a new direct-acting antiviral (DAA) regimen which has improved efficacy of chronic hepatitis C virus (HCV) treatment significantly. OBV/PTV/r ± DSV ± RBV in clinical trials demonstrated sustained viral response (SVR) rates close to 100%. In this article we collected currently available data of 5726 patients for evaluation of OBV/PTV/r ± DSV ± RBV efficacy and safety in real-world experience. The sustained viral response rate in this large population was 97%, and it was exactly the same even in patients with liver cirrhotics. According to this meta-analysis, less than 3% of patients discontinued treatment due to adverse events.

Sustained virological response to ombitasvir/paritaprevir/ritonavir and dasabuvir treatment for hepatitis C: Real‐world data from a large healthcare provider

“…Cirrhotic patients in our study population had very high rates of SVR‐12, similar rate to noncirrhotic patients, which supports currently available real‐world data . As shown previously, SVR‐12 can be attained in GT1b patients with compensated cirrhosis and early HCC that has been eradicated .…”

“…These results are consistent with the SVR rates found in the clinical trials, as well as recently published real‐world data. A meta‐analysis of 5726 patients treated in several countries reported an SVR‐12 rate of 97%, and early evidence of OPrD ± RBV use in Poland indicated a rate of 207/209 (99.0%), ranging from 96.4% to 100.0% across subgroups . In line with these findings, results from an early US Veterans Affairs study indicate SVR rates of 98.0% (248/253) and 95.5% (705/738) with 12 weeks of OPrD without or with RBV, respectively …”

“…In the present analyses, 1% of patients had a record of on‐treatment decompensation and nonetheless achieved SVR‐12. Early real‐world data suggest that 2%‐5.4% of patients experience a serious adverse event, while less than 3% discontinue due to an adverse event . Future studies can utilize MHS’ comprehensive databases to investigate adverse events and assess broader outcomes such as healthcare resource utilization.…”

“…There is a need to gather real‐world evidence on adherence and effectiveness with OPrD ± RBV in order to identify drivers of effectiveness among patients with different fibrosis stages, comorbidities and access to healthcare services. To date, early real‐world data from several countries indicate SVR‐12 rates above 95%, including for cirrhotic patients …”

Prevalence of HCV genotypes in Poland – the EpiTer study

“…Moreover, the safety profile in the majority of patient populations is excellent, and the treatment duration usually does not exceed 12 weeks [3–5]. The new Polish reimbursement policy for HCV treatment, which is based on clinical practice guidelines of the Polish HCV Expert Group, provides an opportunity for successful reduction of HCV prevalence [6].…”