Davis G L, Esteban-Mur R, Rustgi V, Hoefs J, Gordon S C, Trepo C, Shiffman M L, Zeuzem S, Craxi A, Ling M H, Albrecht J
University of Florida College of Medicine, Gainesville 32610-0214, USA.
N Engl J Med. 1998 Nov 19;339(21):1493-9. doi: 10.1056/NEJM199811193392102.
Interferon alfa is the only effective treatment for patients with chronic hepatitis C. Forty percent of patients have an initial response to this therapy, but most subsequently relapse. We compared the effect of interferon alone with that of interferon plus oral ribavirin for relapses of chronic hepatitis C.
We studied 345 patients with chronic hepatitis C who relapsed after interferon treatment. A total of 173 patients were randomly assigned to receive standard-dose recombinant interferon alfa-2b concurrently with ribavirin (1000 to 1200 mg orally per day, depending on body weight) for six months, and 172 patients were assigned to receive interferon and placebo.
At the completion of treatment, serum levels of hepatitis C virus (HCV) RNA were undetectable in 141 of the 173 patients who were treated with interferon and ribavirin and in 80 of the 172 patients who were treated with interferon alone (82 percent vs. 47 percent, P<0.001). Serum HCV RNA levels remained undetectable 24 weeks after the end of treatment in 84 patients (49 percent) in the combination-therapy group, but in only 8 patients (5 percent) in the interferon group (P<0.001). Sustained normalization of serum alanine aminotransferase concentrations and histologic improvement were highly correlated with virologic response. Base-line serum HCV RNA levels of 2 x 10(6) copies per milliliter or less were associated with higher rates of response in both treatment groups. Viral genotypes other than type 1 were associated with sustained responses only in the combination-therapy group. Combined therapy caused a predictable fall in hemoglobin concentrations but otherwise had a safety profile similar to that of interferon alone.
In patients with chronic hepatitis C who relapse after treatment with interferon, therapy with interferon and oral ribavirin results in higher rates of sustained virologic, biochemical, and histologic response than treatment with interferon alone.
干扰素α是慢性丙型肝炎患者唯一有效的治疗方法。40%的患者对该疗法有初始反应，但大多数随后复发。我们比较了单用干扰素与干扰素加口服利巴韦林治疗慢性丙型肝炎复发的效果。
我们研究了345例干扰素治疗后复发的慢性丙型肝炎患者。总共173例患者被随机分配接受标准剂量重组干扰素α-2b与利巴韦林同时治疗（根据体重每天口服1000至1200毫克），持续6个月，172例患者被分配接受干扰素和安慰剂治疗。
治疗结束时，173例接受干扰素和利巴韦林治疗的患者中有141例丙型肝炎病毒（HCV）RNA血清水平检测不到，172例单用干扰素治疗的患者中有80例检测不到（82%对47%，P<0.001）。联合治疗组84例患者（49%）在治疗结束后24周血清HCV RNA水平仍检测不到，而干扰素组仅8例患者（5%）检测不到（P<0.001）。血清丙氨酸转氨酶浓度持续正常化和组织学改善与病毒学反应高度相关。两个治疗组中，基线血清HCV RNA水平每毫升2×10⁶拷贝或更低与更高的反应率相关。1型以外的病毒基因型仅在联合治疗组与持续反应相关。联合治疗导致血红蛋白浓度可预测性下降，但在其他方面其安全性与单用干扰素相似。
在干扰素治疗后复发的慢性丙型肝炎患者中，干扰素和口服利巴韦林联合治疗比单用干扰素治疗导致更高的持续病毒学、生化和组织学反应率。
