Interferon α‐2b with and without ribavirin in the treatment of hepatitis B e antigen–positive chronic hepatitis B

Abstract

To study whether interferon (IFN) ␣ and ribavirin combination therapy has a beneficial effect for hepatitis B e antigen (HBeAg)-positive chronic hepatitis B, we enrolled 119 such patients in a randomized study. Fifty-nine patients received 5 million units of IFN-␣2b daily for 4 weeks followed by 5 million units three times a week for 28 weeks, plus 1,200 mg ribavirin daily. Sixty patients received the same dosage of IFN plus placebo. They were followed up for 24 weeks posttreatment, and 105 patients (88%) completed the entire course of 56 weeks. By intention-to-treat analysis, the rate of combined response (serum hepatitis B virus [HBV] DNA <2.5 pg/mL and HBeAg seroconversion) was 17% versus 25% between the IFN/ribavirin and IFN/placebo group, respectively, at the end of treatment (P ‫؍‬ .35) and 25% vs. 20% at the end of follow-up (P ‫؍‬ .32). Using quantitative real-time polymerase chain reaction assay, the log(10) reduction of serum HBV DNA was 1.05 ؎ 1.72 (mean ؎ SD) versus 1.29 ؎ 1.91 between the two groups at the end of treatment (P ‫؍‬ .49) and was 2.15 ؎ 2.15 versus 1.21 ؎ 2.48 at the end of follow-up (P ‫؍‬ .04). Prolonged observations in 83 patients suggested that the combined response was 29% (n ‫؍‬ 17) versus 20% (n ‫؍‬ 12) at 48 weeks after the end of treatment, respectively (P ‫؍‬ .17). The safety profile was similar, except that the IFN/ribavirin group had a higher risk of anemia (15% vs. 0%; P ‫؍‬ .002). In conclusion, for the treatment of HBeAg-positive chronic hepatitis B, adding ribavirin does not seem to increase the efficacy of IFN. (HEPATOLOGY 2006;43:742-749.)

Role of viral factors in the natural course and therapy of chronic hepatitis B

“…However, these studies, on the association of HBV genotype with response to standard interferon were limited by small sample sizes and retrospective study design. Our recent randomized study on 119 HBeAg-positive patients also showed that genotype B patients have a better sustained HBeAg seroconversion rate to 32 weeks of standard IFN-based therapy than genotype C patients (44% vs. 22%, P = 0.02) [109]. The relationship between viral genotype and response to pegylated interferon is similar to that observed with standard interferon.…”

Implications of Hepatitis B Virus Genomic Variations on Treatment Outcomes

“…In a subsequent large randomized trial, consistent findings were noted [18]. A total of 119 HBeAg-positive patients received 5 MU of IFN-2b daily for 4 weeks followed by 5 MU three times weekly for 28 weeks.…”

Antiviral treatment of chronic hepatitis B virus infections: the past, the present and the future

“…PEG-IFN -2b is effective against HBeAg-positive CHB, but combinations with lamivudine [94] or ribavirin [95] gave no additional benefit. In contrast, a recent combination treatment study in CHB patients by Wursthorn et al using PEG-IFN -2b and adefovir showed a strong reduction in HBV DNA, cccDNA and HBsAg levels [96].…”