Racial differences in responses to interferon‐β‐1a in chronic hepatitis C unresponsive to interferon‐α: a better response in Chinese patients

Abstract

Re-treatment with interferon-alpha alone for chronic hepatitis C nonresponders to interferon-alpha monotherapy is almost ineffective. This multicentre, randomized, parallel-group, dose-finding study evaluated the efficacy of interferon-beta-1a in the treatment of chronic hepatitis C patients unresponsive to interferon-alpha. A total of 267 patients were randomized to one of four groups: subcutaneous interferon-beta-1a 12 MIU (44 microg) or 24 MIU (88 microg) administered three times weekly or daily. Patients were treated for 48 weeks and then followed up for an additional 24 weeks. There was a trend towards a dose-response relationship regarding virological [loss of detectable serum hepatitis C virus (HCV) RNA] and biochemical response (normalization of serum alanine aminotransferase). Overall, 22 patients (8.3%) had a virological response at the end of treatment; nine patients (3.4%) had a sustained virological response (SVR). Strikingly, 21.7% (5/23) of Chinese patients achieved SVR. Univariate analysis revealed that race was the only variable related to SVR [odds ratio (OR) 16.6; 95% CI 4.1-67.3; P < 0.0001]. Multiple logistic regression analysis also confirmed that more Chinese patients achieved SVR than non-Chinese patients (OR 12.3; 95% CI 2.6-59.3; P = 0.0017). In addition, complete clearance of HCV-RNA occurred earlier in Chinese than in non-Chinese responders (median 2 vs 30 weeks; P = 0.020). Thirty-six patients were withdrawn from treatment because of adverse events. Most adverse events were mild or moderate in severity. In conclusion, interferon-beta-1a provided considerable clinical benefit in Chinese patients with chronic hepatitis C unresponsive to interferon-alpha. The evaluation of interferon-beta-1a in this setting is progressing.

Recombinant Interferon-Beta-1a Plus Ribavirin for the Treatment of Chronic HCV Infection: A Prospective, Randomized, Comparative Pilot Study

“…Such finding has also been observed in IFN-α therapy. 28 Recently, Chan et al 29 strongly supported the use of IFN-β-1a as an alternative to the IFN-α for Asian patients with chronic hepatitis C. The present study was more consistent with that from Cheng et al 21 since we would expect a much better response from the treatment-naïve population. The other interesting finding in our study was the trend toward a better response for IFN-β-1a therapy in the patients with higher baseline viral load.…”

“…Recently, two other studies using IFN-β-1a had been reported. Cheng et al 21 reported results of IFN-β-1a monotherapy in 270 patients who had HCV infection that was non-responsive to IFN-α therapy. Although the overall SVR was merely 3.4%, a sub-group analysis provided the interesting finding that Chinese population achieved a significantly higher SVR (21.7%) suggesting an ethnic factor at the work.…”

“…One possibility of the better response seen in our study could be the ethnic factor suggested by Cheng et al 21 According to their analysis, Caucasian population seemed to response poorly with IFN-β-1a therapy. Such finding has also been observed in IFN-α therapy.…”

“…20 Another recent report has highlighted its potential therapeutic properties in Chinese population. 21 However, all of these studies had been performed without a comparative IFN-α treatment arm. We had conducted a prospective, randomized, comparative pilot study with two arms consisting of IFN-β-1a plus ribavirin versus IFN-α plus ribavirin in Korean population to investigate the efficacy and safety of both combination therapies in the same clinical setting.…”

Natural interferon-beta treatment for patients with chronic hepatitis C in Japan

“…Recombinant human interferon-beta-1a and interferon-beta1b are produced in mammalian cells or Escherichia coli, respectively [57] . It was reported that recombinant human interferon-beta-1a with or without ribavirin has an excellent safety profile, and after 24-wk-treatment of recombinant human interferon-beta-1a with or without ribavirin, SVR was 21.6% and 27.4% in HCV genotype 1 and genotype 2 patients, respectively [57][58][59][60] . Peginterferonbeta-1a may be beneficial for patients infected with HCV [61,62] .…”