Effectiveness and safety of a generic fixed-dose combination of nevirapine, stavudine, and lamivudine in HIV-1-infected adults in Cameroon:: open-label multicentre trial
Effectiveness and safety of a generic fixed-dose combination of nevirapine, stavudine, and lamivudine in HIV-1-infected adults in Cameroon:: open-label multicentre trial
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DOI：
10.1016/s0140-6736(04)16586-0
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发表时间：
2004-07-03
期刊：
影响因子：
168.9
通讯作者：
Delaporte, E
中科院分区：
文献类型：
--
作者：
Laurent, C;Kouanfack, C;Delaporte, E
背景非专利固定剂量组合已通过世卫组织的资格预审，可用于在资源有限的国家治疗艾滋病毒感染者。然而，尽管它们被广泛使用，但由于缺乏关于有效性、安全性和质量的临床数据，一些主要捐助机构尚未推荐它们。我们的目标是评估非洲最常见的处方治疗之一的这些问题，奈韦拉平、司他夫定和拉米夫定的通用固定剂量组合。方法在喀麦隆进行了一项为期24周的开放标签多中心试验，跟踪60名患者。所有患者每天两次接受一片固定剂量的联合药物治疗。在意向治疗分析中，主要的结果衡量指标是研究结束时病毒载量低于400拷贝/毫升的患者的比例。基线时发现，92%的患者(n=55)患有艾滋病；CD4细胞计数的中位数为118个细胞/毫升(IQR 78-167)，血浆HIV-1RNA的中位数为104 736拷贝/毫升(40 804-243 787)。无法检测到病毒载量的患者比例(
Background Generic fixed-dose combinations have been prequalified by WHO to treat HIV-infected patients in resource-limited countries. Despite their widespread use they are, however, not yet recommended by some of the major donor agencies owing to scarcity of clinical data on effectiveness, safety, and quality. We aimed to assess these issues for one of the most frequently prescribed treatments in Africa, a generic fixed-dose combination of nevirapine, stavudine, and lamivudine.Methods 60 patients were followed in an open-label, 24-week multicentre trial in Cameroon. All patients received one tablet of the fixed-dose combination drug twice daily. The primary outcome measure was the proportion of patients with viral load less than 400 copies per mL at the end of the study period, in an intention-to-treat analysis.Findings At baseline, 92% of patients (n=55) had AIDS; median CD4 count was 118 cells per muL (IQR 78-167) and median plasma HIV-1 RNA was 104 736 copies per mL (40 804-243 787). The proportion of patients with undetectable viral load (