Menezes Prema, Mollan Katie, Hoffman Erin, Xie Zimeng, Wills Jennifer, Marcus Cheryl, Rublein John, Hudgens Michael, Eron Joseph J
1 Division of Infectious Diseases, School of Medicine, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina.
2 Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina.
AIDS Res Hum Retroviruses. 2018 Jun;34(6):481-485. doi: 10.1089/AID.2016.0311. Epub 2018 May 2.
Benefits of switching to a single-tablet regimen (STR) of emtricitabine/rilpivirine/tenofovir (FTC/RPV/TDF) in virologically suppressed antiretroviral treatment (ART) experienced HIV-positive women include pregnancy category B rating and lack of clinically significant drug interactions between RPV and oral contraceptives. Unfortunately, studies involving switching to FTC/RPV/TDF enrolled fewer than 25% women. We undertook this 48-week study to assess the ability of virologically suppressed HIV-positive women switching to RPV STR to remain virologically suppressed and comply with the caloric intake requirement. HIV-positive women on ART with viral load <50 c/mL for 6 months before study entry and no known resistance to FTC, TDF, or RPV were enrolled and switched to STR RPV/FTC/TDF. Caloric intake (≥400 kcal) compliance and concurrency with oral STR RPV/FTC/TDF were evaluated with a 3-day food diary, which was validated by obtaining participant's caloric consumption through phone calls on randomly chosen dates. For each 3-day food diary, the daily median caloric intake and median value for each macronutrient consumed concurrent with FTC/RPV/TDF were computed. Medication adherence was measured using a visual analog scale. We enrolled 33 women, 73% of whom were African American. At week 48, virologic suppression (HIV RNA <40 c/mL) was maintained in 96% of women, including those (n = 4) who reported imperfect ART adherence. The daily median caloric intake concurrent with FTC/RPV/TDF was 820 kcal by food diary and 677 kcal by random phone call. Median kcal intake (food diary) did not change significantly from baseline (684 kcal) to week 48 (820 kcal); median change 102 kcal, p = .15. Women who reported noncompliance with a ≥400 kcal meal did not experience virologic failure. Significant concordance between caloric adherence and virologic suppression was not detected. Our study demonstrated that HIV-positive women who switched to STR FTC/RPV/TDF continued to experience virologic suppression and were readily able to comply with the recommended caloric intake requirement.
对于接受抗逆转录病毒治疗（ART）且病毒得到抑制的HIV阳性女性，换用恩曲他滨/利匹韦林/替诺福韦（FTC/RPV/TDF）单片治疗方案（STR）的益处包括妊娠分级为B级，以及RPV与口服避孕药之间不存在具有临床意义的药物相互作用。遗憾的是，涉及换用FTC/RPV/TDF的研究纳入的女性不到25%。我们开展了这项为期48周的研究，以评估病毒得到抑制的HIV阳性女性换用含RPV的STR后保持病毒抑制及符合热量摄入要求的能力。入组了在研究入组前接受ART且病毒载量<50拷贝/mL达6个月、对FTC、TDF或RPV无已知耐药的HIV阳性女性，并将其换用STR RPV/FTC/TDF。通过一份3天的食物日记评估热量摄入（≥400千卡）的依从性以及与口服STR RPV/FTC/TDF的同步性，该食物日记通过在随机选择的日期打电话获取参与者的热量消耗情况进行验证。对于每份3天的食物日记，计算与FTC/RPV/TDF同时摄入的每日热量摄入中位数以及每种宏量营养素的中位数。使用视觉模拟量表测量药物依从性。我们纳入了33名女性，其中73%为非裔美国人。在第48周时，96%的女性维持了病毒抑制（HIV RNA<40拷贝/mL），包括那些报告ART依从性不佳的女性（n = 4）。通过食物日记得出与FTC/RPV/TDF同时摄入的每日热量摄入中位数为820千卡，通过随机电话得出为677千卡。热量摄入中位数（食物日记）从基线（684千卡）到第48周（820千卡）无显著变化；中位数变化为102千卡，p = 0.15。报告未遵守每餐≥400千卡的女性未出现病毒学失败。未检测到热量依从性与病毒抑制之间存在显著一致性。我们的研究表明，换用STR FTC/RPV/TDF的HIV阳性女性继续保持病毒抑制，并且能够轻易符合推荐的热量摄入要求。
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