Abstract
Background and aims. For the 8-week OPrD regimen, real world data are insufficient. This study aims to compare the efficacy of the two types of regimens (12-week versus 8-week) in a real world cohort of patients with genotype 1b. Material and methods. We analysed a multicentric retrospective cohort enrolling 1436 patients who started HCV therapy in 2018-2019. Liver fibrosis was staged in all subjects by Fibromax. Efficacy was assessed by the percentage of patients achieving SVR 12 weeks post-treatment (SVR12). Results. Out of the 1436 analysed patients, 112 received 8 weeks therapy and 1324 received 12 weeks. In this cohort the proportion of male patients was 25.2%, the median age 61 years, 28.2% were interferon pre-treated, and the rate of co-morbidities was 47%. 42% of the subjects had F2 fibrosis, 29% F1 fibrosis, 16% F3 and 12% F4. The SVR rate was comparable in both groups of patients (97% in those treated with OPrD 12 weeks vs 96.4% in those that received OPrD 8 weeks) (by intention-to-treat). In the 12 weeks arm, the drop-out rate was 0.8% and the rate of severe adverse events was 1%, while in the arm of 8 weeks therapy there were no severe adverse events reported and no drop-out (p = 0.25). The only predictive factor for non-response in both treatment arms was the male sex. Conclusions. OPrD 8 weeks proved to be highly efficient in our patients with a 96.4% SVR. No serious adverse events and no drop out were reported.
Highlights
Hepatitis C virus (HCV) infection is a major global health concern
One of the regimens approved by the Food and Drug Administration (FDA) in 2014 for patients with genotype 1 chronic HCV infection is Ombitasvir/Paritaprevir/ritonavir + Dasabuvir (OPrD)
The proportion of male patients was 25.2%, the median age was 61 years. 28.2% of patients were interferon pre-treated, and the rate of co-morbidities was 47%. 1.6% were co-infected with hepatitis B virus and 0.3% had a history of previously treated hepatocellular carcinoma
Summary
The estimated prevalence of virus C chronic infection In Romania, according to data published in 2010 was approximately 4% [2], but it is decreasing due to direct antiviral therapy received by approximately 35,000 patients with more than 96% achieving SVR [3,4,5,6]. One of the regimens approved by the Food and Drug Administration (FDA) in 2014 for patients with genotype 1 chronic HCV infection is Ombitasvir/Paritaprevir/ritonavir + Dasabuvir (OPrD). It contains 3 direct-acting HCV antiviral agents: Ombitasvir (NS5A inhibitor), Paritaprevir (NS3/NS4A protease inhibitors), and Dasabuvir (NS5B non-nucleoside polymerase inhibitor) and a CYP3A inhibitor, Ritonavir, which is not active on HCV, it acts as a pharmacokinetic enhancer, increasing plasma drug concentrations of Paritaprevir and drug exposure [15,16]. No serious adverse events and no drop out were reported
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