Combination antiretroviral treatment for women previously treated only in pregnancy: week 24 results of AIDS clinical trials group protocol a5227.
Combination antiretroviral treatment for women previously treated only in pregnancy: week 24 results of AIDS clinical trials group protocol a5227.
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DOI：
10.1097/qai.0000000000000072
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发表时间：
2014-04-15
期刊：
影响因子：
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通讯作者：
Johnson VA
中科院分区：
文献类型：
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作者：
Vogler MA;Smeaton LM;Wright RL;Cardoso SW;Sanchez J;Infante R;Moran LE;Godfrey C;Demeter LM;Johnson VA
患有艾滋病毒且先前接受过仅用于预防母婴传播的联合抗逆转录病毒疗法(CART)的妇女需要知道，她们稍后是否可以成功地使用常用方案伊法韦仑(EFV)、联合配方恩曲他滨(FTC)和富马酸替诺福韦双丙酯(TDF)进行治疗。非怀孕妇女的血浆HIV-1RNA含量为500拷贝/毫升，以前仅接受CART治疗，如果她们在入选前24周停止≥治疗，在标准基因分型上没有耐药性证据，并准备开始EFV加FTC/TDF治疗，她们就有资格获得治疗。主要终点是24周时的病毒学应答(定义为血浆HIVRNA和400拷贝/毫升)。54名妇女在2007年10月至2009年12月期间登记；52/54人完成了24周的随访。基线CD4+T细胞计数中位数为265个/mm3，基线血浆HIV-1RNA为4.6log10拷贝/毫升。之前接受CART的中位数为14周，从最后一次PMTCT剂量到进入的中位数时间为22个月。在24周时观察到42/52名妇女或81%的病毒学应答(确切95%可信区间：68%-90%)。不同国家、先前接触过的防止母婴传播的数量或类别的反应没有差异。虽然在8名妇女中发生了确认的病毒学失败，但在报告完全早期依从性的妇女中没有观察到病毒学失败。在这项首次对有妊娠受限CART病史的妇女进行联合抗逆转录病毒再治疗的前瞻性临床试验中，观察到24周时对TDF/FTC和EFV的病毒学应答为81%。病毒学失败发生，并与自我报告的未坚持相关。
Women with HIV and prior exposure to combination antiretroviral therapy (cART) solely for prevention of Mother to Child Transmission (pMTCT) need to know whether they can later be treated successfully with a commonly used regimen of efavirenz (EFV) and co-formulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) Non-pregnant women with plasma HIV-1 RNA of ≥ 500 copies/mL, previously cART- exposed for pMTCT only, were eligible if they were off ART for ≥ 24 weeks prior to entry, were without evidence of drug resistance on standard genotyping, and were ready to start EFV plus FTC/TDF. The primary endpoint was virologic response (defined as plasma HIV RNA <400 copies/mL) at 24 weeks. 54 women were enrolled between 10/07 and 12/09; 52/54 completed 24 weeks of follow- up. Median baseline CD4+ T-cell count was 265/mm3 and baseline plasma HIV-1 RNA was 4.6 log10 copies/mL. Median prior cART duration was 14 weeks, and median time elapsed from the last pMTCT dose to entry was 22 months. Virologic response at 24 weeks was observed in 42/52 women or 81% (exact 95% CI: 68%–90%). There were no differences in response by country, by number or class of prior pMTCT exposures. While confirmed virologic failure occurred in 8 women, no virologic failures were observed in women reporting perfect early adherence. In this first prospective clinical trial studying combination antiretroviral re- treatment in women with a history of pregnancy-limited cART, the observed virologic response to TDF/FTC and EFV at 24 weeks was 81%. Virologic failures occurred and correlated with self-reported non-adherence.