Research Department of Infection & Population Health, University College London Medical School, Royal Free Campus, London, UK.
HIV Med. 2011 May;12(5):259-68. doi: 10.1111/j.1468-1293.2010.00877.x. Epub 2010 Aug 31.
The durability of combination antiretroviral therapy (cART) regimens can be measured as time to discontinuation because of toxicity or treatment failure, development of clinical disease or serious long-term adverse events. The aim of this analysis was to compare the durability of nevirapine, efavirenz and lopinavir regimens based on these measures.
Patients starting a nevirapine, efavirenz or lopinavir-based cART regimen for the first time after 1 January 2000 were included in the analysis. Follow-up started ≥ 3 months after initiation of treatment if viral load was <500 HIV-1 RNA copies/mL. Durability was measured as discontinuation rate or development/worsening of clinical markers.
A total of 603 patients (21%) started nevirapine-based cART, 1465 (51%) efavirenz, and 818 (28%) lopinavir. After adjustment there was no significant difference in the risk of discontinuation for any reason between the groups on nevirapine and efavirenz (P=0.43) or lopinavir (P=0.13). Compared with the nevirapine group, those on efavirenz had a 48% (P=0.0002) and those on lopinavir a 63% (P<0.0001) lower risk of discontinuation because of treatment failure and a 31% (P=0.01) and 66% (P<.0001) higher risk, respectively, of discontinuation because of toxicities or patient/physician choice. There were no significant differences in the incidence of non-AIDS-related events, worsening anaemia, severe weight loss, increased aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels or increased total cholesterol. Compared with patients on nevirapine, those on lopinavir had an 80% higher incidence of high-density lipoprotein (HDL) cholesterol decreasing below 0.9 mmol/L (P=0.003), but there was no significant difference in this variable between those on nevirapine and those on efavirenz (P=0.39).
The long-term durability of nevirapine-based cART, based on risk of all-cause discontinuation and development of long-term adverse events, was comparable to that of efavirenz or lopinavir, in patients in routine clinical practice across Europe who initially tolerated and virologically responded to their regimen.
联合抗逆转录病毒疗法(cART)方案的耐久性可以通过因毒性或治疗失败、临床疾病发展或严重长期不良事件而停药的时间来衡量。本分析的目的是基于这些指标比较奈韦拉平、依非韦伦和洛匹那韦方案的耐久性。
本分析纳入了 2000 年 1 月 1 日后首次开始使用奈韦拉平、依非韦伦或洛匹那韦为基础的 cART 方案的患者。如果病毒载量<500 HIV-1 RNA 拷贝/mL,则在治疗开始后≥3 个月开始随访。耐久性通过停药率或临床标志物的发展/恶化来衡量。
共有 603 例(21%)患者开始使用奈韦拉平为基础的 cART,1465 例(51%)患者使用依非韦伦,818 例(28%)患者使用洛匹那韦。调整后,奈韦拉平组与依非韦伦组(P=0.43)或洛匹那韦组(P=0.13)之间因任何原因停药的风险无显著差异。与奈韦拉平组相比,依非韦伦组因治疗失败停药的风险降低 48%(P=0.0002),因毒性或患者/医生选择停药的风险分别增加 31%(P=0.01)和 66%(P<0.0001);洛匹那韦组因治疗失败停药的风险降低 63%(P<0.0001),因毒性或患者/医生选择停药的风险分别增加 31%(P=0.01)和 66%(P<0.0001)。非艾滋病相关事件、贫血恶化、严重体重减轻、天门冬氨酸氨基转移酶(AST)/丙氨酸氨基转移酶(ALT)水平升高或总胆固醇升高的发生率无显著差异。与奈韦拉平组相比,洛匹那韦组高密度脂蛋白(HDL)胆固醇降低至<0.9mmol/L 的发生率增加 80%(P=0.003),但奈韦拉平组与依非韦伦组之间该变量无显著差异(P=0.39)。
在欧洲常规临床实践中,初始耐受并对方案病毒学应答的患者中,基于全因停药风险和长期不良事件发生情况,奈韦拉平为基础的 cART 的长期耐久性与依非韦伦或洛匹那韦相当。