Daily versus thrice-weekly interferon alfa-2b plus ribavirin for the treatment of chronic hepatitis C in HIV-infected persons: a multicenter randomized controlled trial.
Daily versus thrice-weekly interferon alfa-2b plus ribavirin for the treatment of chronic hepatitis C in HIV-infected persons: a multicenter randomized controlled trial.
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每日与每周三次干扰素 α-2b 加利巴韦林治疗 HIV 感染者慢性丙型肝炎的比较：一项多中心随机对照试验。
DOI：
10.1097/00126334-200404150-00004
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发表时间：
2004
期刊：
影响因子：
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通讯作者：
HepatitisResourceNetworkClinicalTrialsGroup
中科院分区：
文献类型：
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作者：
Sulkowski,MarkS;Felizarta,Franco;Smith,Cheryl;Slim,Jidah;Berggren,Ruth;Goodman,Russell;Ball,Lisa;Khalili,Mandana;Dieterich,DouglasT;HepatitisResourceNetworkClinicalTrialsGroup
在艾滋病毒感染者中，慢性丙型肝炎病毒（HCV）感染导致大量发病率和死亡率。然而，很少有研究评估干扰素α（IFN）和利巴韦林（RBV）治疗合并感染的人的安全性和有效性。因此，进行了一项随机、对照、开放标签、多中心试验，以确定IFN α-2b每日3 mIU + RBV 800 mg/d与IFN α-2b每周3次（TIW）+RBV 800 mg/d相比，在HCV初治、HIV感染、代偿性肝病和HIV疾病稳定的受试者中的安全性、耐受性和疗效。主要终点是持续病毒学应答（SVR），定义为停止HCV治疗后24周检测不到HCV RNA水平。在进入研究时，两组受试者在年龄、性别、HCV基因型和HIV疾病状态方面相似。在180例随机化受试者中，162例接受了至少1剂研究药物，构成了改良的意向治疗人群。治疗12周后，122例（75%）患者进行了血清HCV RNA水平评估;在这些受试者中，分别有33例（42%）和13例（16%）接受每日和TIW IFN治疗的受试者观察到早期病毒学应答（检测不到HCV RNA或较基线下降> 2 log 10）（P< 0.001）。在每日和TIW IFN的受试者中分别观察到15例（19.0%）和7例（8.4%）SVR（P= 0.05）。两组的不良事件相似。然而，虽然未观察到死亡或机会性感染，但近30%的受试者因不良事件停止治疗，7例受试者发生严重不良事件。总之，SVR实现了19%的HIV/HCV合并感染的受试者接受每日IFN加RBV治疗，但治疗的有效性大大降低了相对较高的治疗相关的毒性。
Among HIV-infected persons, chronic hepatitis C virus (HCV) infection causes substantial morbidity and mortality. However, few studies have evaluated the safety and efficacy of interferon alfa (IFN) and ribavirin (RBV) therapy in co-infected persons. Accordingly, a randomized, controlled, open-label, multicenter trial was conducted to establish the safety, tolerability, and efficacy of IFN alfa-2b 3 mIU daily plus RBV 800 mg/d compared with IFN alfa-2b 3 mIU thrice weekly (TIW) plus RBV 800 mg/d in HCV treatment–naive, HIV-infected subjects with compensated liver disease and stable HIV disease. The primary endpoint was sustained virologic response (SVR), defined as an undetectable HCV RNA level 24 weeks after discontinuation of HCV therapy. At study entry, subjects in both groups were similar with respect to age, gender, HCV genotype, and HIV disease status. Of 180 randomized subjects, 162 received at least 1 dose of study medication, constituting the modified intention-to-treat population. After 12 weeks of therapy, 122 (75%) had serum HCV RNA levels assessed; of these subjects, early virologic response (undetectable HCV RNA or> 2 log10 decrease from baseline) was observed in 33 (42%) and 13 (16%) of subjects taking daily and TIW IFN, respectively (P< 0.001). SVR was observed in 15 (19.0%) and 7 (8.4%) of subjects taking daily and TIW IFN, respectively (P= 0.05). Adverse events were similar in both groups. However, while no deaths or opportunistic infections were observed, nearly 30% of subjects stopped treatment due to adverse events and 7 subjects experienced a serious adverse event. In conclusion, SVR was achieved in 19% of HIV/HCV coinfected subjects treated with daily IFN plus RBV, but the effectiveness of therapy was substantially diminished by relatively high rates of treatment-related toxicity.