Z Gastroenterol 2013; 51 - A26
DOI: 10.1055/s-0033-1347476

On-treatment and projected sustained viral responses with boceprevir-based triple therapy in previous treatment-failure HCV patients with advanced fibrosis or cirrhosis. Interim analysis of the Hungarian named patient program cohort

B Hunyady 1, M Abonyi 2, K Csefkó 3, A Haragh 1, G Horváth 4, V Jancsik 5, M Makara 6, E Makkai 7, Z Müller 8, Z Ozsvár 8, P Ribiczey 9, B Sipos 10, O Szabó 11, F Szalay 2, L Szentgyörgyi 12, E Újhelyi 13, M Varga 3 G Weisz 10, and the Hunagrian Boceprevir Named Patient Program
  • 1Department of Gastroenterology, Kaposi Mór Teaching Hospital, Kaposvár
  • 2First Department of Medicine, Semmelweis University, Budapest
  • 3Third Department of Medicine, Réthy Pál Hosital, Békéscsaba
  • 4Hepatology Center of Buda, Budapest
  • 5Outpatiant Clinic, Kenézy Hospital, Debrecen
  • 6Outpatient Clinic, Szent László Hospital, Budapest
  • 7Department of Infectology, Magyar Imre Hospital, Ajka
  • 8Department of Infectology, Szent György Hospital, Székesfehérvár
  • 9Department of Infectology, Zala Megyei Hospital, Zalaegerszeg
  • 10First Department of Medicine, Jósa András Teaching Hospital, Nyíregyháza
  • 11Third Department of Medicine, Szent László Hospital, Budapest
  • 12Infectology and Hepatology Outpatient Clinic, Szent Borbála Kórház, Tatabánya
  • 13Fifth Department of Medicine, Immunology Laboratory, Szent László Hospital, Budapest

Background and Aims: Efficacy and safety of boceprevir+peginterferon/ribavirin (B+PR) therapy in pervious treatment failure HCV genotype 1 pts with advanced liver fibrosis (F3) or cirrhosis (F4) have been analyzed, with special attention to previous null-responder cirrhotics.

Methods: Real life data of the Hungarian Boceprevir Named Patient Program have been retrospectively collected. Treatment: 4-weeks PR lead-in, followed by 44 weeks B+PR therapy according to label (no response guided therapy), with w12 (HCV RNA> 100 IU/mL) and w24 (HCV RNA> 15 IU/mL) futility rules. Intent to treat (ITT) w24 (N = 148), per protocol w48 (PP EoTR, N = 30) interim efficacy and safety results, and projections for ITT EoTR and sustained viral responses (SVR) are reported.

Results: Baseline characteristics: age: 29 – 71 (mean: 56.4) years; bodyweight: 52 – 107 (mean: 77.5)kg; male: 43%; cirrhotic: 48%; previous null-responder: 36%, partial responder: 38%, relapser: 26%; genotype G1a: 5%, G1b: 95%; high baseline viral load: 66%. Sixty pts stopped therapy by w24, 36 pts due to w12, 12 pts due to w24 futility rules, 12 pts due to adverse events (AE). IITT number and percent of pts with HCV RNA< 15 IU/mL at w24 amongst previous null-responders, partial responders, or relapsers: 27/53 (51%), 32/56 (57%), or 29/39 (74%), respectively (total: 88/148 [59%]). HCV RNA< 15 IU/mL at w24 was numerically (not statistically) lower in cirrhotics 39/72 (54%) versus non-cirrhotics 49/76 (64%). 14/27 (52%) previous null responder cirrhotics reached HCV RNA< 15 IU/mL by w24. Out of those pts eligible to continue therapy beyond w24, PP 34/37 (92%) have reached negative PCR by w48 (51 pending). Based on these PP EoTR result and a 14% relapse rate (by literature1), 53% ITT EoTR and 45% ITT SVR can be expected; 30% in previous null-responder cirrhotics. 12 pts developed resistance associated variants. No death has been reported so far. Fourteen pts (9%) experienced serious AE (10 cirrhotics, 5 non-cirrhotics). Reported rate of grade 3 – 4 anemia, thrombopenia, neutropenia or any other AE were 9%, 5%, 16%, or 17%, respectively.

Conclusions: Based on projections from our data, efficacy of B+PR therapy might exceed our expectations in previous null-responder cirrhotics. Final results to be presented.

1Bacon NEJM 2011;364:1207 – 17