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RETROSPECTIVE COMPARISON OF STANDARD VERSUS PEGYLATED (PEG) INTERFERON (IFN) ALPHA-2B IN CHINESE PATIENTS WITH CHRONIC HEPATITIS B (CHB)
SK Fung, G Wong, FS Wong
Department of Medicine, University of Toronto, Toronto, ON
Background and Aims: Standard and PEG IFN are effective treatments for CHB. However, these different formulations of IFN have not been compared directly in phase 3 studies. The aim of this study was to retrospectively compare the efficacy of standard versus PEG IFN alpha-2b in patients with CHB.
Patients and METHODS: Consecutive consenting adult CHB patients attending the Toronto General Hospital Liver Clinic were treated with PEG IFN 80 ug s/c once weekly for 16-24 weeks (03/04-02/07) [group A] or standard IFN 10 MU s/c 3 times weekly for 16-24 weeks (02/97-01/07) [group B] and followed for >12 months after treatment. At baseline, liver enzymes, CBC, PT/INR, HBV serology, HBV DNA and genotype, abdominal ultrasound and liver biopsy were performed. Bloodwork was performed every month during treatment and every 3-6 months thereafter. Sustained response [HBeAg seroconversion, where appropriate; ALT normalization and suppression of HBV DNA <20,000 IU/ml 6-12 months after stopping therapy] was compared between the groups. Multivariate analysis was used to identify predictors of response.
RESULTS: 71 Chinese patients (47% M: 53% F, mean age 33 ± 8 years) were included. Pretreatment ALT was 130 ± 93 U/L, HBV DNA 7.9 ± 1.5 log10 IU/ml, and 59(83%) patients were HBeAg+ve. All patients were infected with HBV genotype B or C. 34(48%) patients comprised group A, and 37(52%) group B. Among HBeAg+ve patients, HBeAg seroconversion, ALT normalization and viral suppression occurred in 42% vs. 47% (p=0.43), 60% vs. 56% (p=0.79) and 40% vs. 41% (p=0.93) for patients in groups A vs. B, respectively. Predictors of sustained response included inflammation on biopsy and genotype B infection. Adverse event rates were similar between the groups.
CONCLUSIONS: Standard or PEG IFN alpha-2b given for a short duration (16-24 weeks) appears to achieve similar rates of sustained response in Chinese patients with CHB (approximately 40%). Patients with active inflammation on biopsy and genotype B are more likely to respond to IFN. Prospective randomized trials are necessary to confirm our findings.