doiSerbia

Boceprevir in genotype 1 chronic hepatitis C: First experiences in Serbia

Simonović-Babić Jasmina (School of Medicine, Belgrade + Clinical Center of Serbia, Clinic of Infectious and Tropical Diseases, Belgrade)
Bojović Ksenija (School of Medicine, Belgrade + Clinical Center of Serbia, Clinic of Infectious and Tropical Diseases, Belgrade)
Fabri Milotka (Faculty of Medicine, Novi Sad + Clinic of Infectious Diseases, Novi Sad)
Kostić Velimir (Faculty of Medicine, Niš + Clinic of Infectious Diseases, Niš)
Jovanović Maja (Faculty of Medicine, Niš + Clinic of Infectious Diseases, Niš)
Mijailović Željko (Faculty of Medical Sciences, Kragujevac + Clinic of Infectious Diseases, Kragujevac)
Svorcan Petar (School of Medicine, Belgrade + Zvezdara Clinical Hospital Center, Department of Gastroenterology and Hepatology, Belgrade)
Janković Goran (School of Medicine, Belgrade + Clinical Center of Serbia, Clinic of Gastroenterohepatology, Belgrade)

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-naпve 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.

Keywords: chronic hepatitis C, protease inhibitor, boceprevir