Myers Robert P, Benhamou Yves, Bochet Marie, Thibault Vincent, Mehri Delphine, Poynard Thierry
Service d'Hépato-Gastroentérologie, Groupe Hospitalier Pitié-Salpêtrière, Paris, France.
AIDS. 2004 Jan 2;18(1):75-9. doi: 10.1097/00002030-200401020-00009.
Pegylated interferon alpha (PEG-IFN-alpha) and ribavirin is the most effective available treatment for chronic hepatitis C virus (HCV) infection. Its role in HIV/HCV-co-infected patients who have failed IFN-based therapy is unclear.
The aim of this study was to determine the safety and efficacy of this therapy in HIV/HCV-co-infected non-responders and relapsers.
An open-label cohort study of 32 non-responders and relapsers to IFN (with or without ribavirin). Patients were treated for 48 weeks with PEG-IFN-alpha 2b and ribavirin.
A sustained virological response (SVR) defined as a negative HCV-RNA level 24 weeks after the end of treatment.
The mean age of the patients was 40 years; 78% were men, 67% had genotype 1, and 36% had bridging fibrosis or cirrhosis. The majority had a CD4 cell count greater than 200 cells/microl (97%) and an undetectable HIV-RNA level (81%). Fifteen patients (47%) withdrew because of adverse events, predominantly neuropsychiatric. In an intention-to-treat analysis, a SVR was observed in five patients (16%); 9% with genotype 1 versus 29% with genotype 3 and 33% with genotype 4 (P = NS). Additional, but statistically non-significant, univariate predictors of response were lower serum HCV-RNA (P = 0.07) and higher alanine aminotransferase levels (P = 0.055) at baseline. No patient with bridging fibrosis or cirrhosis responded. Treatment had a minimal impact on HIV parameters.
PEG-IFN-alpha 2b and ribavirin is a potentially useful therapy in HIV/HCV-co-infected patients who have failed standard IFN-based regimens. Strategies to improve adherence are vital so as to maximize long-term response rates.
聚乙二醇化干扰素α（PEG-IFN-α）联合利巴韦林是目前治疗慢性丙型肝炎病毒（HCV）感染最有效的方法。其在基于干扰素治疗失败的HIV/HCV合并感染患者中的作用尚不清楚。
本研究旨在确定该疗法在HIV/HCV合并感染的无反应者和复发者中的安全性和有效性。
一项针对32例对干扰素（联合或不联合利巴韦林）无反应者和复发者的开放标签队列研究。患者接受聚乙二醇化干扰素α 2b联合利巴韦林治疗48周。
持续病毒学应答（SVR），定义为治疗结束后24周HCV-RNA水平为阴性。
患者的平均年龄为40岁；78%为男性，67%为基因1型，36%有桥接纤维化或肝硬化。大多数患者CD4细胞计数大于200个/微升（97%）且HIV-RNA水平检测不到（81%）。15例患者（47%）因不良事件退出，主要是神经精神方面的不良事件。在意向性分析中，5例患者（16%）出现SVR；基因1型患者为9%，基因3型患者为29%，基因4型患者为33%（P=无显著性差异）。其他但在统计学上无显著意义的反应单变量预测因素为基线时较低的血清HCV-RNA（P=0.07）和较高的丙氨酸转氨酶水平（P=0.055）。有桥接纤维化或肝硬化的患者均无反应。治疗对HIV参数影响极小。
聚乙二醇化干扰素α 2b联合利巴韦林对基于标准干扰素方案治疗失败的HIV/HCV合并感染患者可能是一种有用的疗法。提高依从性的策略至关重要，以便使长期反应率最大化。
