A Double-Blind Randomized Controlled Study to Evaluate the Efficacy of Low-Dose Oral Interferon-Alpha in Preventing Hepatitis C Relapse

作者：Lee Chuan Mo; Chen Chi Yi; Chien Rong Nan; Tseng Kuo Chih; Peng Cheng Yuan; Tung Shui Yi; Fang Yi Jen; Huang Yi Hsiang; Lu Sheng Nan; Hung Chao Hung; Tsai Tsung Jang; Fang Chien Chung; Hsu Chao Wei; Yeh Chau Ting^*

来源：Journal of Interferon and Cytokine Research, 2014, 34(3): 187-194.

DOI：10.1089/jir.2013.0074

Low-dose oral interferon could exert immune-modulating effects in human. We conducted a clinical trial to investigate the efficacy of oral interferon-alpha in preventing hepatitis C relapse. Totally 169 genotype 1b chronic hepatitis C patients having achieved end-of-therapy virological clearance were randomized to receive interferon-alpha lozenge 500 IU/day (n=59), 1,500 IU/day (n=53), or placebo (n=57) for 24 weeks. Overall, no significant differences were found for the relapse rates in the 3 groups (P%26gt;0.05). However, in patients with fibroindex 1.4-1.7, relapse occurred in 1/12 (8.3%) 500 IU-group patients versus 9/21 (42.9%) patients of the other groups (P=0.05). In 158 patients receiving at least 4 weeks of oral interferon, significantly higher platelet count was found at the end of trial in the 500 IU group (P=0.003). In thrombocytopenic patients, a significantly expedited recovery of platelet count was found in the 500 IU group (P=0.002). No drug-related severe adverse events were reported. In conclusion, at 500 IU/day, oral interferon exerted a borderline suppression effect of virological relapse in chronic hepatitis C patients with mild liver fibrosis. Additionally, it significantly expedited platelet count recovery after the end of peginterferon therapy.

• 出版日期2014-3-1
• 单位长春大学; 中国医科大学