Amoroso Anthony, Gilliam Bruce L, Talwani Rohit, Boyce Colleen, Redfield Robert R, Davis Charles E
Institute of Human Virology, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA.
HIV Clin Trials. 2009 Sep-Oct;10(5):320-3. doi: 10.1310/hct1005-320.
The once-daily nucleoside reverse transcriptase inhibitor backbone of tenofovir and emtricitabine has been proven effective in combination with efavirenz and protease inhibitors in large clinical trials. This study evaluated tenofovir and emtricitabine in combination with nevirapine.
Viral load was assessed at baseline, Day 3, and Day 7 in addition to Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84 in 10 antiretroviral-naïve patients participating in an open-label clinical trial of tenofovir and emtricitabine once daily in combination with nevirapine twice daily.
All patients achieved viral decay with this combination. Two patients discontinued prior to virologic suppression, one with a viral load of 55 copies/mL. Virologic suppression (<50 copies/mL) was achieved by Week 24 in the remaining 8 patients. An undetectable viral load was maintained during > or =60 weeks follow-up.
In this study of treatment-naïve patients, the combination of tenofovir and emtricitabine plus twice-daily nevirapine produced sustained viral load decay in patients including those with a high baseline viral load.
在大型临床试验中，每日一次的替诺福韦和恩曲他滨核苷类逆转录酶抑制剂骨干药物已被证明与依非韦伦和蛋白酶抑制剂联合使用有效。本研究评估了替诺福韦和恩曲他滨与奈韦拉平联合使用的情况。
在一项开放标签临床试验中，对10名初治抗逆转录病毒患者进行研究，这些患者每日一次服用替诺福韦和恩曲他滨，并每日两次服用奈韦拉平。除了在基线、第3天和第7天评估病毒载量外，还在第2、4、8、12、16、24、32、40、48、60、72和84周进行评估。
所有患者使用该联合方案均实现了病毒载量下降。两名患者在病毒学抑制之前停药，其中一名患者的病毒载量为55拷贝/毫升。其余8名患者在第24周时实现了病毒学抑制（<50拷贝/毫升）。在≥60周的随访期间，病毒载量一直保持不可检测。
在这项针对初治患者的研究中，替诺福韦和恩曲他滨联合每日两次服用奈韦拉平的方案在包括基线病毒载量较高的患者中产生了持续的病毒载量下降。
