Bonjoch Anna, Paredes Roger, Domingo Pere, Cervantes Manel, Pedrol Enric, Ribera Esteve, Force Lluís, Llibre Josep M, Vilaró Josep, Dalmau David, Cucurull Josep, Mascaró Jaume, Masabeu Angels, Pérez-Alvarez Núria, Puig Jordi, Cinquegrana Denise, Clotet Bonaventura
Lluita contra la SIDA Found, AIDS Care Unit, Universitat Autònoma de Barcelona, Hospital Germans Trias i Pujol, Badalona.
AIDS Res Hum Retroviruses. 2006 Apr;22(4):321-9. doi: 10.1089/aid.2006.22.321.
Using a multicenter, cross-sectional, observation study, the long-term safety, metabolic profile, and viral efficacy of nevirapine (NVP)-based approaches in HIV-1-infected patients treated for at least 2 years were assessed. For 4 months, all consecutive HIV-1-infected patients who had been receiving an NVP-containing regimen for at least 2 years were recruited. A total of 613 patients were included with a median follow-up period of 43 months (IQR: 31-51). At baseline, 24.5% (150 patients) were treatment naive, 41.5% (254 patients) switched for simplification purposes, and 34% (209 patients) were failing HAART. Increases by five times or more in AST/ALT values were observed in fewer than 2% of patients. Only 5.7% of all adverse events reported during the investigation were attributable to NVP. The percentage of patients with normal HDL cholesterol levels rose from 17.7% at baseline to 35.4% at the last visit. At the latest time point available for analysis, 76% of naive and 74% of those who had switched had HIV-1 RNA loads of <50 copies/ml, while 59% of salvage patients achieved this level of viral suppression. Factors associated with viral suppression at the latest visit were adequate adherence (OR: 2.58, 95% CI: 0.85-7.78, p < 0.001), first-line treatment (OR: 3.02, 95% CI: 1.52-6.00, p = 0.002), and baseline CD4 cells >400 cells/microl (OR: 2.34, 95% CI: 1.22-4.47, p = 0.010). Exposure to nevirapine for up to 4 years is safe. Liver toxicity is infrequent and generally mild. HDL cholesterol levels consistently increase over time and viral suppression is maintained.
采用多中心横断面观察性研究，评估了以奈韦拉平（NVP）为基础的治疗方案在接受至少2年治疗的HIV-1感染患者中的长期安全性、代谢情况和病毒学疗效。连续4个月招募了所有接受含NVP方案治疗至少2年的HIV-1感染患者。共纳入613例患者，中位随访期为43个月（四分位间距：31 - 51个月）。基线时，24.5%（150例患者）为初治患者，41.5%（254例患者）因简化治疗方案而换药，34%（209例患者）接受高效抗逆转录病毒治疗（HAART）失败。不到2%的患者AST/ALT值升高了5倍或更多。在调查期间报告的所有不良事件中，仅5.7%归因于NVP。高密度脂蛋白胆固醇（HDL）水平正常的患者比例从基线时的17.7%升至末次随访时的35.4%。在可用于分析的最新时间点，初治患者中有76%、换药患者中有74%的HIV-1 RNA载量<50拷贝/ml，而挽救治疗患者中有59%实现了这种病毒抑制水平。与末次随访时病毒抑制相关的因素包括依从性良好（比值比：2.58，95%置信区间：0.85 - 7.78，p<0.001）、一线治疗（比值比：3.02，95%置信区间：1.52 - 6.00，p = 0.002）以及基线CD4细胞>400个/微升（比值比：2.34，95%置信区间：1.22 - 4.47，p = 0.010）。长达4年的奈韦拉平暴露是安全的。肝毒性不常见且一般较轻。HDL胆固醇水平随时间持续升高，病毒抑制得以维持。
