Boceprevir early-access for advanced-fibrosis/cirrhosis in Asia-Pacific hepatitis C virus genotype 1 non-responders/relapsers.

AIM: To examined the efficacy and safety of treatment with boceprevir, PEGylated-interferon and ribavirin (PR) in hepatitis C virus genotype 1 (HCVGT1) PR treatment-failures in Asia. METHODS: The Boceprevir Named-Patient Program provided boceprevir to HCVGT1 PR treatment-failures. Participating physicians were invited to contribute data from their patients: baseline characteristics, on-treatment responses, sustained virological response at week 12 (SVR12), and safety were collected and analysed. Multivariate analysis was performed to determine predictors of response. RESULTS: 150 patients were enrolled from Australia, Malaysia, Singapore and Thailand (Asians = 86, Caucasians = 63). Overall SVR12 was 61% (Asians = 59.3%, Caucasians = 63.5%). SVR12 was higher in relapsers (78%) compared with non-responders (34%). On-treatment responses predicted SVR, with undetectable HCVRNA at week 4, 8 and 12 leading to SVR12s of 100%, 87%, and 82% respectively, and detectable HCVRNA at week 4, 8 and 12, leading to SVR12s 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 in the same manner with regards to on-treatment responses. Those with the IL28B CC genotype (80%) had higher SVRs than those with the CT/TT (56%) genotype (P = 0.010). Multivariate analysis showed that TW8 and TW12 responses 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. CONCLUSION: Boceprevir can be used successfully in PR treatment failures with a SVR12 > 80% if they have good on-treatment responses; however, discontinuations occurred in 30% because of virological failure or adverse events.

Randomized double blind placebo-controlled trial of a Chinese herbal therapy (CH100) in chronic hepatitis C.

BACKGROUND AND AIM: Hepatitis C virus (HCV) is a common infection with serious health consequences. Alternative therapies are often used for hepatitis C. The aim of the present study was to examine CH100, a Chinese herbal remedy, for efficacy in therapy of chronic HCV. METHODS: A randomized double blind placebo-controlled study in a tertiary outpatient clinic of CH100 over 24 weeks with 24 weeks follow-up in patients with chronic HCV infection. Alanine aminotransferase (ALT), HCV-RNA, quality of life (by SF-36) and side-effects were examined regularly. Ninety-seven patients were enrolled of which 91 were suitable for analysis. RESULTS: No significant differences were observed between patients receiving CH100 (n = 61) or placebo (n = 30) at baseline or during follow-up in either ALT or viral titer. However, patients receiving CH100 had a fall in mean ALT over time (P = 0.05 at week 4, P = 0.26 at week 12, and P = 0.04 at week 24), with reversion to baseline during post-treatment follow up. No significant side-effects were observed although mild complaints were common. Quality of life scores improved in both groups with time, and bodily pain significantly improved in CH100 recipients. CONCLUSION: CH100 appears to be no better than placebo in the treatment of patients with chronic HCV infection.