Torriani Francesca J, Rodriguez-Torres Maribel, Rockstroh Jürgen K, Lissen Eduardo, Gonzalez-García Juan, Lazzarin Adriano, Carosi Giampiero, Sasadeusz Joseph, Katlama Christine, Montaner Julio, Sette Hoel, Passe Sharon, De Pamphilis Jean, Duff Frank, Schrenk Uschi Marion, Dieterich Douglas T
Department of Medicine, Division of Infectious Diseases, University of California, San Diego, AntiViral Research Center, CA 92103, USA.
N Engl J Med. 2004 Jul 29;351(5):438-50. doi: 10.1056/NEJMoa040842.
Hepatitis C virus (HCV) infection is highly prevalent and is associated with substantial morbidity and mortality among persons infected with the human immunodeficiency virus (HIV). We compared the efficacy and safety of pegylated interferon alfa-2a (peginterferon alfa-2a) plus either ribavirin or placebo with those of interferon alfa-2a plus ribavirin for the treatment of chronic HCV infection in patients who were also infected with HIV.
A total of 868 persons who were infected with both HIV and HCV and who had not previously been treated with interferon or ribavirin were randomly assigned to receive one of three regimens: peginterferon alfa-2a (180 microg per week) plus ribavirin (800 mg per day), peginterferon alfa-2a plus placebo, or interferon alfa-2a (3 million IU three times a week) plus ribavirin. Patients were treated for 48 weeks and followed for an additional 24 weeks. The primary end point was a sustained virologic response (defined as a serum HCV RNA level below 50 IU per milliliter at the end of follow-up, at week 72).
The overall rate of sustained virologic response was significantly higher among the recipients of peginterferon alfa-2a plus ribavirin than among those assigned to interferon alfa-2a plus ribavirin (40 percent vs. 12 percent, P<0.001), or peginterferon alfa-2a plus placebo (40 percent vs. 20 percent, P<0.001). Among patients infected with HCV genotype 1, the rates of sustained virologic response were 29 percent with peginterferon alfa-2a plus ribavirin, 14 percent with peginterferon alfa-2a plus placebo, and 7 percent with interferon alfa-2a plus ribavirin. The corresponding rates among patients infected with HCV genotype 2 or 3 were 62 percent, 36 percent, and 20 percent. Neutropenia and thrombocytopenia were more common among patients treated with regimens that contained peginterferon alfa-2a, and anemia was more common among patients treated with regimens containing ribavirin.
Among patients infected with both HIV and HCV, the combination of peginterferon alfa-2a plus ribavirin was significantly more effective than either interferon alfa-2a plus ribavirin or peginterferon alfa-2a monotherapy.
丙型肝炎病毒（HCV）感染非常普遍，并且在感染人类免疫缺陷病毒（HIV）的人群中会导致相当高的发病率和死亡率。我们比较了聚乙二醇化干扰素α-2a（派罗欣）联合利巴韦林或安慰剂与干扰素α-2a联合利巴韦林治疗同时感染HIV和HCV的慢性HCV感染患者的疗效和安全性。
总共868例同时感染HIV和HCV且既往未接受过干扰素或利巴韦林治疗的患者被随机分配接受三种治疗方案之一：聚乙二醇化干扰素α-2a（每周180微克）联合利巴韦林（每日800毫克）、聚乙二醇化干扰素α-2a联合安慰剂或干扰素α-2a（每周三次，每次300万国际单位）联合利巴韦林。患者接受48周治疗，并额外随访24周。主要终点是持续病毒学应答（定义为随访结束时，即第72周时血清HCV RNA水平低于每毫升50国际单位）。
聚乙二醇化干扰素α-2a联合利巴韦林治疗组的持续病毒学应答总体率显著高于干扰素α-2a联合利巴韦林治疗组（40%对12%，P<0.001），也高于聚乙二醇化干扰素α-2a联合安慰剂治疗组（40%对20%，P<0.001）。在感染HCV 1型的患者中，聚乙二醇化干扰素α-2a联合利巴韦林治疗组的持续病毒学应答率为29%，聚乙二醇化干扰素α-2a联合安慰剂治疗组为14%，干扰素α-2a联合利巴韦林治疗组为7%。在感染HCV 2型或3型的患者中，相应的持续病毒学应答率分别为62%、36%和20%。中性粒细胞减少和血小板减少在接受含聚乙二醇化干扰素α-2a治疗方案的患者中更常见，贫血在接受含利巴韦林治疗方案的患者中更常见。
在同时感染HIV和HCV的患者中，聚乙二醇化干扰素α-2a联合利巴韦林的疗效显著优于干扰素α-2a联合利巴韦林或聚乙二醇化干扰素α-2a单药治疗。
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