Browsing by Author "Mijailović, Željko (6506982098)"

Introduction The triple therapy which consists of one of the protease inhibitor plus pegylated interferon and ribavirin (P/R) is the standard of care for the treatment of chronic hepatitis C virus (HCV) genotype 1(G1) infection both in treatment-naive and experienced patients. Objective The aim of this study was to analyze the efficacy and tolerability of this regime in hospital practice in Serbia. Methods From July 2012 to October 2012, 20 previously treated patients with advanced fibrosis and HCV G1 infection were included in the triple antiviral regimen in six referral centers in Serbia. All patients were treated with response guide therapy (RGT) regime according to the boceprevir treatment protocol. During the 4-week lead-in period all patients received peginterferon plus ribavirin. After the lead-in period boceprevir was added in the dosage of 800 mg three times a day orally. The subsequent treatment varied according to virologic response and fibrosis. During the therapy HCV RNA level was measured at week 4, 8, 12, 24 of the treatment for the assessment of virologic response profile. All patients who completed therapy were assessed at the end of the treatment and at the end of an additional 24-week treatment-free period for a sustained virologic response (SVR). Results The total of 20 patients with advanced fibrosis was treated. Among patients with an undetectable HCV RNA level at week 8 the rate of SVR was 100%. No patient with decrease in the HCV RNA level <1 log 10 IU/ml at treatment week 4 achieved SVR. The overall rate of SVR was 55%. The safety profile of the treatment regimen was good. Anemia was reported in 25% of patients. There was no life-threatening treatment adverse event. Conclusion Boceprevir in combination with P/R achieved fairly good SVR rates in patients that were "most difficult to treat" who failed on dual therapy and was effective among patients with cirrhosis. © 2015 Serbia Medical Society. All rightsreserved.

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. © 2019, Inst. Sci. inf., Univ. Defence in Belgrade. All rights reserved.