Nasti G, Di Gennaro G, Tavio M, Cadorin L, Tedeschi R M, Talamini R, Carbone A, Tirelli U
Division of Oncological Medicine A, National Cancer Institute, Aviano, Pordenone, Italy.
AIDS. 2001 Sep 28;15(14):1783-7. doi: 10.1097/00002030-200109280-00006.
The role combination therapy with interferon alfa-2b and tribavirin (US: ribavirin) plays in producing sustained virological responses in patients with HIV and chronic hepatitis C (HCV) infection is still unknown.
To determine the feasibility and sustained response of interferon alfa-2b and tribavirin combination therapy.
Phase II study.
Seventeen patients were enrolled at the National Cancer Institute, Aviano, Italy and received combination therapy with interferon alfa-2b 3 MIU subcutaneously three times a week plus tribavirin 1000-1200 mg/day for 24 weeks. Antiretroviral therapy was concomitantly given in all but one patient.
At the end of treatment, five (31%) patients achieved clearance of HCV RNA and 11 (69%) showed normalized liver function enzyme levels. In three patients, serum HCV RNA concentration was still undetectable 24 weeks after treatment, with an overall sustained virological response rate of 19% The serum liver enzymes were still normal in 10 patients 24 weeks after treatment, the overall sustained biochemical response rate being 62% All patients with HCV RNA clearance at the end of treatment and 24 weeks after treatment had a concomitant biochemical response. Overall the combination treatment was well tolerated.
Our data confirm that the combination of interferon alfa-2b and tribavirin is well tolerated and feasible in patients with HIV-HCV co-infection and it can be associated safely with highly active antiretroviral therapy. The sustained response achieved with the drug combination does not seem to be any better than that achieved with 12 months of monotherapy with interferon alfa-2b.
干扰素α-2b与三氮唑核苷(美国:利巴韦林)联合治疗在人类免疫缺陷病毒(HIV)和慢性丙型肝炎(HCV)感染患者中产生持续病毒学应答的作用仍不清楚。
确定干扰素α-2b与三氮唑核苷联合治疗的可行性和持续应答情况。
II期研究。
17例患者入选意大利阿维亚诺国家癌症研究所,接受干扰素α-2b 3百万国际单位皮下注射,每周3次,加三氮唑核苷1000 - 1200毫克/天,共治疗24周。除1例患者外,所有患者均同时接受抗逆转录病毒治疗。
治疗结束时,5例(31%)患者实现HCV RNA清除,11例(69%)患者肝功能酶水平恢复正常。3例患者治疗后24周血清HCV RNA浓度仍不可检测,总体持续病毒学应答率为19%。治疗后24周10例患者血清肝酶仍正常,总体持续生化应答率为62%。治疗结束时及治疗后24周所有实现HCV RNA清除的患者均伴有生化应答。总体而言,联合治疗耐受性良好。
我们的数据证实,干扰素α-2b与三氮唑核苷联合治疗在HIV - HCV合并感染患者中耐受性良好且可行,并且可以安全地与高效抗逆转录病毒治疗联合使用。该药物联合治疗所取得的持续应答似乎并不比干扰素α-2b单药治疗12个月所取得的效果更好。