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

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.