Final results of Boceprevir early access for advanced fibrosis/cirrhosis in Asia-Pacific HCV genotype 1 non-responders/relapser patients (Beacon Study).

Wattana Sukeepaisarnjaroen, Tri Pham, Tawesak Tanwandee, Saroja Nazareth, Sam Galhenage, Lindsay Mollison, Leanne Totten, Alan Wigg, Rosalie Altus, Anton Colman, Brenda Morales, Susan Mason, Tracey Jones, Nadine Leembruggen, Vince Fragomelli, Cheryl Sendall, Richard Guan, Dede Sutedja, Soek Tan, Yock DanYin-Mei Lee, Widjaja Luman, Eng Teo, Yin Than, Teerha Piratvisuth, Seng Lim

Research output: Contribution to journalMeeting Abstractpeer-review

Abstract

Background and aims: There is a paucity of information on pegylated-interferon and ribavirin (PR) HCV genotype 1 (HCVGT1) treatment-failures in Asia, hence we evaluated such patients in a boceprevir named-patient program (BNPP). Methods: The BNPP provided boceprevir to HCVGT1 PR treatment-failures. Asia-Pacific BNPP physicians were invited to participate by collating data from their patients: baseline characteristics, on-treatment responses, sustained virological response at week 12 (SVR12), and safety was collected and analysed. Multivariate analysis was performed to determine predictors of response. Results: A total of 150 patients were enrolled from Australia, Malaysia, Singapore and Thailand (Asians=87, Caucasians=63). Baseline features were mean age 52, 76% males, 53% relapsers, 46% cirrhotics, and IL28B non-CC 51%. Overall SVR12 was 61% (Asians=59.3%, Caucasians=63.5%). SVR12 was higher in relapsers (78%) compared to non-responders (34%). On-treatment responses predict SVR, with undetectable HCVRNA at week 4, 8, 12 leading to SVR12 of 100%, 87%, and 82% respectively, and detectable HCVRNA at week 4, 8, 12, leading to SVR12 of 58%, 22% and 6% respectively. Asian patients were similar to Caucasian patients with regards to on-treatment responses. Patients with cirrhosis (n=69), also behaved the same manner with regards to on-treatment responses. Those with IL28B CC (80%) had higher SVR than those with CT/TT(56%) genotypes (p=0.010). Multivariate analysis showed TW8 and TW12 response were independent predictors of SVR. Serious adverse events occurred in 18.6%: sepsis(2%), decompensation(2.7%) and blood transfusion(14%). Discontinuations occurred in 30.7% with 18.6% fulfilling stopping rules. Conclusions: Boceprevir in PR treatment failures achieves 61% SVR12, but those with good on-treatment responses had SVR12 >80%. SAEs and AEs were not as high as CUPIC study, and discontinuations occurred in 30%. There is still a role for boceprevir in good responders while pending the arrival of the next generation anti-virals.
Original languageEnglish
Article number1023
Pages (from-to)698A
Number of pages1
JournalHepatology
Volume60
Issue number4 (Suppl)
DOIs
Publication statusPublished - Oct 2014
Externally publishedYes
EventThe 65th Annual Meeting of the American Association for the Study of Liver Diseases: The Liver Meeting 2014 -
Duration: 7 Nov 2014 → …

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