Reichard O, Norkrans G, Frydén A, Braconier J H, Sönnerborg A, Weiland O
Department of Infectious Diseases, Huddinge University Hospital, Stockholm, Sweden.
Lancet. 1998 Jan 10;351(9096):83-7. doi: 10.1016/s0140-6736(97)06088-1.
Pilot studies suggested that more patients with chronic hepatitis C virus (HCV) infection had a sustained virological response when treated with the combination of interferon alpha-2b and ribavirin than with interferon alpha-2b alone. We investigated the biochemical and virological responses and safety of treatment with interferon alpha-2b and ribavirin compared with interferon alpha-2b alone.
In this double-blind trial 100 patients were randomly assigned to treatment with interferon alpha-2b (3 MU three times a week) in combination with ribavirin (1000 or 1200 mg per day) or placebo for 24 weeks and then followed up for a further 24 weeks. A further follow-up was done 1 year after active treatment stopped. The primary endpoint was the sustained virological response, defined as no detectable HCV RNA by PCR at both week 24 and week 48. Retrospectively, the baseline HCV-RNA load was analysed as a predictor of a sustained virological response. Data were analysed by intention to treat.
18 (36%) of the 50 patients in the interferon alpha-2b and ribavirin group had a sustained virological response compared with nine (18%) of the 50 patients in the interferon alpha-2b and placebo group (p = 0.047). At the 1 year follow-up the proportion of patients with a virological response was greater in the interferon alpha-2b and ribavirin group than the interferon alpha-2b and placebo group (42 vs 20%, p = 0.03), respectively. More patients with baseline HCV-RNA concentrations greater than 3 x 10(6) genome equivalents (Eq) per mL had a sustained response with interferon alpha-2b and ribavirin than with interferon alpha-2b and placebo (12/29 vs 1/26, p = 0.009), whereas the sustained response did not differ between the two treatment groups for HCV-RNA amounts less than 3 x 10(6) Eq per mL (6/21 vs 8/24, p = 0.67), respectively.
More patients with chronic hepatitis C have a sustained virological response with interferon alpha-2b and ribavirin than with only interferon alpha-2b treatment. We suggest that patients with high HCV-RNA loads should be treated with interferon alpha-2b and ribavirin.
初步研究表明，与单独使用α-2b干扰素治疗相比，慢性丙型肝炎病毒（HCV）感染患者联合使用α-2b干扰素和利巴韦林治疗时，获得持续病毒学应答的患者更多。我们比较了α-2b干扰素联合利巴韦林与单独使用α-2b干扰素治疗的生化和病毒学应答及安全性。
在这项双盲试验中，100例患者被随机分配接受α-2b干扰素（3 MU，每周3次）联合利巴韦林（每天1000或1200 mg）或安慰剂治疗24周，随后再随访24周。在停止积极治疗1年后进行进一步随访。主要终点为持续病毒学应答，定义为在第24周和第48周通过PCR均检测不到HCV RNA。回顾性分析基线HCV-RNA载量作为持续病毒学应答的预测指标。数据按意向性分析。
α-2b干扰素联合利巴韦林组50例患者中有18例（36%）获得持续病毒学应答，而α-2b干扰素联合安慰剂组50例患者中有9例（18%）获得持续病毒学应答（p = 0.047）。在1年随访时，α-2b干扰素联合利巴韦林组病毒学应答患者的比例高于α-2b干扰素联合安慰剂组（分别为42%和20%，p = 0.03）。基线HCV-RNA浓度大于每毫升3×10(6)基因组当量（Eq）的患者中，α-2b干扰素联合利巴韦林治疗获得持续应答的患者多于α-2b干扰素联合安慰剂治疗的患者（12/29比1/26，p = 0.009），而对于HCV-RNA量小于每毫升3×10(6) Eq的患者，两组的持续应答无差异（分别为6/21和8/24，p = 0.67）。
与仅用α-2b干扰素治疗相比，更多慢性丙型肝炎患者联合使用α-2b干扰素和利巴韦林时获得持续病毒学应答。我们建议HCV-RNA载量高的患者应采用α-2b干扰素和利巴韦林治疗。
