doiSerbia

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

Simonović-Babić Jasmina (University of Belgrade, Faculty of Medicine, Belgrade, Serbia + Clinical Centre of Serbia, Clinic for Infectious and Tropical Diseases, Belgrade, Serbia)
Bojović Ksenija (University of Belgrade, Faculty of Medicine, Belgrade, Serbia + Clinical Centre of Serbia, Clinic for Infectious and Tropical Diseases, Belgrade, Serbia)
Fabri Milotka (University of Novi Sad, Faculty of Medicine, Novi Sad, Serbia + Clinical Centre of Vojvodina, Clinic for Infectious Diseases, Novi Sad, Serbia)
Cvejić Tatjana (Clinical Centre of Serbia, Clinic for Gastroenterology, Belgrade, Serbia)
Svorcan Petar (Clinical Hospital Centre “Zvezdara”, Department of Hepatology and Gastroenterology, Belgrade, Serbia)
Nožić Darko (Military Medical Academy, Clinic for Infectious Diseases, Belgrade, Serbia + University of Defence, Faculty of Medicine, Belgrade, Serbia)
Jovanović Maja (University of Niš, Faculty of Medicine, Niš, Serbia + Clinical Centre of Niš, Clinic for Infectious Diseases, Niš, Serbia)
Škrbić Ranko (University of Banja Luka, Faculty of Medicine, Department of Pharmacology, Toxicology and Clinical Pharmacology, Banja Luka, Republic of Srpska, Bosnia and Herzegovina)
Stojiljković Miloš P. (University of Banja Luka, Faculty of Medicine, Department of Pharmacology, Toxicology and Clinical Pharmacology, Banja Luka, Republic of Srpska, Bosnia and Herzegovina)
Mijailović Željko (Clinical Hospital Centre “Zvezdara”, Department of Hepatology and Gastroenterology, Belgrade, Serbia + Clinical Centre of Kragujevac, Clinic for Infectious Diseases, Kragujevac, Serbia)

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 1. 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.

Keywords: antiviral agents, drug therapy, combination, hepatitis c, chronic, ritonavir, sulfonamides