Real-life data on the efficacy and safety of ombitasvir/paritaprevir//ritonavir + dasabuvir + ribavirin in the patients with genotype 1 chronic hepatitis c virus infection in serbia

Abstract

© 2019, Inst. Sci. inf., Univ. Defence in Belgrade. All rights reserved. Background/Aim. The era of direct-acting antiviral (DAA) regimen in the treatment of chronic hepatitis C virus (HCV) started in 2011. The aim of this study was to assess the antiviral efficacy and safety of DAA regimen, ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) + dasabuvir (DSV) + ribavirin (RBV), in patients with chronic HCV infection, genotype Methods. The real-life data were collected. The study was multicentric and included seven infectious diseases and hepatology departments in Serbia. A total of 21 patients were enrolled in the OBV/PTV/r + DSV + RBV early access program, 20 of which were previously treated with pegylated interferon + RBV, while 1 was treatment-naive. All patients received the adequate doses of these antiviral drugs. RBV was not given to the patients with HCV genotype 1b infection according to the therapeutic protocol. For the majority of patient, the treatment duration lasted for 12 weeks. For the patients with liver cirrhosis, who were infected with HCV genotype 1a, the duration of treatment was 24 weeks. Viremia was assessed at four points in time: At baseline, 4 weeks after the treatment beginning (rapid viral response, RVR), 12 or 24 weeks after the treatment beginning (end of treatment response – ETR) and 12 weeks after the end of treatment (sustained viral response – SVR). SVR, as a confirmation of the absence of HCV was considered as endpoint of successful treatment. Results. Complete RVR, ETR and SVR were achieved in 64.71%, 85.71% and 95.24% of the patients, respectively. Only 3 patients had mild adverse effects which did not required dose reduction. Conclusion. The treatment of the patients with a chronic HCV infection with OBV/PTV/r + DSV + RBV resulted in excellent antiviral activity and tolerability. Apstrakt Uvod/Cilj. Era direktno delujućeg antivirusnog (DAA) režima lečenja bolesnika sa hroničnom hepatitis C virusnom (HCV) infekcijom započela je 2011. godine. Cilj rada bio je ispitivanje efikasnosti i bezbednosti DAA režima ombitasvir (OBV)/paritaprevir (PTV)/ritonavir (r) + dasabuvir (DSV) + ribavirin (RBV), kod bolesnika sa genotip 1 HCV infekci jom u Srbiji. Metode. U multicentričnu studiju je bilo uključeno sedam centara u Srbiji. Prikupljeni su podaci iz realnog života. U rani pristupni program OBV/PTV/r + DSV + RBV bio je uključen 21 bolesnik od kojih jedan nije prethodno lečen, dok je ostalih 20 prethodno lečeno pegilovanim interferonom i RBV. Svi bolesnici su dobijali odgovarajuće doze lekova. Bolesnici sa HCV genotipom 1b nisu dobijali RBV u skladu sa terapijskim protokolom. Za većinu bolesnika trajanje terapije je iznosilo 12 nedelja. Za četvoro bolesnika sa cirozom i HCV genotipom 1a trajanje terapije je iznosilo 24 nedelje. Viremija je određivana četiri puta: Pre početka terapije, 4 nedelje posle početka terapije (rapidni virusološko odgovor – RVR), 12 ili 24 nedelje nakon početka terapije (kraj terapije – ETR) i 12 nedelja nakon završetka terapije (stabilan virusološki odgovor – SVR). Postignut SVR kao potvrda odsustva virusne RNK u serumu, smatran je završnicom uspešnog lečenja. Rezultati. Kompletan RVR, ETR i SVR postignut je kod 64,71%, 85,71%, i 95,24% bolesnika sukcesivno. Samo 3 bolesnika imali su blage neželjene efekte koji nisu zahtevali korekciju doze lekova. Zaključak. Lečenje bolesnika sa hroničnom HCV infekcijom sa OBV/PTV/r + DSV + RBV pokazalo je odličnu antivirusnu aktivnost i podnošljivost.