Boceprevir for chronic HCV genotype 1 infection in treatmentexperienced patients with severe fibrosis or cirrhosis: The Greek real-life experience

Spilios Manolakopoulos; Hariklia Kranidioti; John Goulis; John Vlachogiannakos; John Elefsiniotis; Elias A. Kouroumalis; John Koskinas; George Kontos; Eftychia Evangelidou; Polyxeni Doumba; Emmanouel Sinakos; Irini Vafiadou; Mairi Koulentaki; George Papatheodoridis; Evangelos Akriviadis

Authors Spilios Manolakopoulos, Hariklia Kranidioti, John Goulis, John Vlachogiannakos, John Elefsiniotis, Elias A. Kouroumalis, John Koskinas, George Kontos, Eftychia Evangelidou, Polyxeni Doumba, Emmanouel Sinakos, Irini Vafiadou, Mairi Koulentaki, George Papatheodoridis, Evangelos Akriviadis.

Abstract

Background The aim of our study was to evaluate the safety and efficacy of triple therapy using boceprevir (BOC) with pegylated interferon (pIFN)/ribavirin (RBV) in chronic hepatitis C (CHC) genotype 1 (G1) treatment-experienced patients with advanced fibrosis or compensated cirrhosis.

Methods We report the Greek experience on the first CHC patients who received BOC-based regimen. From September 2011 to June 2012, 26 treatment-experienced CHC patients and G1 with bridging fibrosis or compensated cirrhosis received 48 weeks of BOC+pIFN+RBV antiviral therapy. Data on complete blood counts and HCV RNA levels were obtained prior to therapy, at treatment weeks 4, 8, 12, 24, 36, 48 and 24 weeks aft er the end of treatment.

Results A full set analysis was performed in 25 of 26 patients. Nine patients (36%) achieved sustained viral response (SVR). Ten patients (40%) stopped the therapy because of futility rules and 3 (12%) due to adverse events. Four patients (16%) developed a virological breakthrough (3 of those presented futility rules as well) and 2 (8%) relapse. All patients who achieved SVR had G 1b, 6 (67%) were non-cirrhotic and 5 (55%) had >1 log decline in baseline HCV RNA levels at week 4 of the treatment. There were no deaths, while two patients were hospitalized due to side effects.

Conclusion The triple therapy with BOC+pIFN+RBV in this cohort of real-lifeÂ treatmentexperienced CHC G1 patients and advanced liver disease was safe offering cure in the majority of those who could tolerate and complete treatment under a close monitoring.

Keywords Protease inhibitors, boceprevir, HCV G1 infection

Ann Gastroenterol 2015; 28 (4): 481-486