Laurent Christian, Bourgeois Anke, Mpoudi-Ngolé Eitel, Ciaffi Laura, Kouanfack Charles, Mougnutou Rose, Nkoué Nathalie, Calmy Alexandra, Koulla-Shiro Sinata, Delaporte Eric
Institut de Recherche pour le Développement, UMR 145 (IRD/University of Montpellier 1), Montpellier, France.
AIDS Res Hum Retroviruses. 2008 Mar;24(3):393-9. doi: 10.1089/aid.2007.0219.
We compared the tolerability and effectiveness of two major first-line regimens used in resource-limited settings, namely zidovudine-lamivudine-nevirapine and stavudine-lamivudine-nevirapine. HIV-1-infected adults in Cameroon were enrolled in a prospective cohort study between 2001 and 2003. They were eligible if they had AIDS or a CD4 cell count below 350/mm(3), a Karnofsky score over 50%, and no contraindications to antiretroviral treatment. The patients were followed up to 2 years. Of 169 patients, 85 received zidovudine-lamivudine-nevirapine and 84 stavudine-lamivudine-nevirapine. The incidence rates of treatment changes, death, drug resistance, and severe adverse effects were, respectively, 12.0 [95% confidence interval (CI) 7.2-19.9] and 10.9 (CI 6.4-18.3) per 100 person-years; 5.7 (CI 2.8-11.4) and 7.6 (CI 4.2-13.7); 2.9 (CI 1.1-7.7) and 5.0 (CI 2.4-10.6); and 41.7 (CI 30.2-57.6) and 49.1 (CI 36.1-66.6). The Kaplan-Meier curves for the likelihood of remaining on the initial regimen (p = 0.8) and for survival (p = 0.5) did not differ significantly between the groups. In Cox multivariate analysis only a lower baseline CD4 cell count was associated with death (p < 0.001). The proportion of patients with undetectable viral load and the increase in the CD4 cell count were similar in the two groups. Anemia was rare (4% vs. 6%). Five cases of severe peripheral neuropathy and one case of lipodystrophy occurred. This study suggests that the zidovudine-lamivudine-nevirapine combination is a safe first-line treatment, even in settings with few laboratory resources. In view of stavudine toxicity, these results support recommendations calling for a gradual switch from stavudine- to zidovudine-based regimens.
我们比较了在资源有限环境中使用的两种主要一线治疗方案的耐受性和有效性，即齐多夫定-拉米夫定-奈韦拉平方案和司他夫定-拉米夫定-奈韦拉平方案。2001年至2003年期间，喀麦隆的HIV-1感染成人被纳入一项前瞻性队列研究。如果他们患有艾滋病或CD4细胞计数低于350/mm³、卡诺夫斯基评分超过50%且无抗逆转录病毒治疗的禁忌证，则符合入选条件。对患者进行了长达2年的随访。169名患者中，85人接受了齐多夫定-拉米夫定-奈韦拉平治疗，84人接受了司他夫定-拉米夫定-奈韦拉平治疗。治疗方案变更、死亡、耐药和严重不良反应的发生率分别为每100人年12.0[95%置信区间（CI）7.2 - 19.9]和10.9（CI 6.4 - 18.3）；5.7（CI 2.8 - 11.4）和7.6（CI 4.2 - 13.7）；2.9（CI 1.1 - 7.7）和5.0（CI 2.4 - 10.6）；以及41.7（CI 30.2 - 57.6）和49.1（CI 36.1 - 66.6）。两组在继续使用初始治疗方案的可能性（p = 0.8）和生存（p = 0.5）的Kaplan-Meier曲线方面无显著差异。在Cox多变量分析中，仅较低的基线CD4细胞计数与死亡相关（p < 0.001）。两组中病毒载量检测不到的患者比例以及CD4细胞计数的增加相似。贫血罕见（4%对6%）。发生了5例严重周围神经病变和1例脂肪代谢障碍。这项研究表明，即使在实验室资源有限的环境中，齐多夫定-拉米夫定-奈韦拉平联合用药也是一种安全的一线治疗方法。鉴于司他夫定的毒性，这些结果支持了呼吁逐步从基于司他夫定的方案转向基于齐多夫定的方案的建议。
