Byramjee Jeejeebhoy Government Medical College- Johns Hopkins University Clinical Research Site, Pune, India.
Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.
J Acquir Immune Defic Syndr. 2023 Jan 1;92(1):76-83. doi: 10.1097/QAI.0000000000003102. Epub 2022 Sep 28.
Optimal adherence to antiretroviral therapy (ART) is crucial to promoting maternal-infant health.
Fourteen sites in 7 countries within sub-Saharan Africa and India.
The multicomponent, open-label strategy PROMISE trial enrolled breastfeeding mother-infant pairs not meeting in-country criteria for maternal ART (mART) initiation in the postpartum component within 5 days of delivery. Randomization was to mART versus infant NVP (iNVP) prophylaxis. Infants in the mART arm also received 6 weeks of iNVP. Self-reported adherence was assessed in a secondary analysis. Time-to-event analyses were performed to explore the association between adherence and maternal viral load (mVL) in the mART arm.
Two thousand four hundred thirty-one mother-infant pairs were enrolled between 2011 and 2014; the baseline maternal median CD4 was 686 (IQR 553-869), and the median mVL was 322 copies/mL (IQR 40-1422). Self-reported adherence was lower in the mART arm compared with the iNVP arm (no missed doses within 4 weeks of all study visits: 66% vs 83%; within 2 weeks: 71% vs 85%; P < 0.0001). The iNVP adherence at week 6 was high in both arms: 97% in mART arm; 95% in iNVP arm. Time-to-event analyses showed that adherence to mART was associated with time to first mVL ≥400 copies/mL ( P < 0.0001). Missing 1 full day of doses over 3 days was associated with a 66% risk of mVL ≥1000 copies/mL (HR: 1.66; 95% CI: 1.37, 1.99).
Postpartum women were less adherent to their own ART than mothers providing their infant's nevirapine prophylaxis. The self-reported missed mART doses were associated with high mVL. Strategies to optimize postpartum mART adherence are urgently needed.
ClinicalTrials.gov: NCT01061151; closed to follow-up.
抗逆转录病毒疗法（ART）的最佳依从性对于促进母婴健康至关重要。
撒哈拉以南非洲和印度的 7 个国家的 14 个地点。
多组分、开放标签策略 PROMISE 试验招募了在产后部分不符合本国启动孕产妇 ART（mART）标准的母乳喂养母婴对，在分娩后 5 天内。随机分为 mART 与婴儿 NVP（iNVP）预防。mART 组的婴儿还接受了 6 周的 iNVP。在二次分析中评估了自我报告的依从性。进行时间事件分析以探索 mART 臂中依从性与母婴病毒载量（mVL）之间的关联。
2011 年至 2014 年间共纳入 2431 对母婴对；基线时产妇中位数 CD4 为 686（IQR 553-869），中位数 mVL 为 322 拷贝/ml（IQR 40-1422）。与 iNVP 组相比，mART 组的自我报告依从性较低（所有研究访视的 4 周内无漏服剂量：66%比 83%；2 周内：71%比 85%；P<0.0001）。在两个手臂中，第 6 周的 iNVP 依从性都很高：mART 手臂 97%；iNVP 手臂 95%。时间事件分析表明，mART 的依从性与首次 mVL≥400 拷贝/ml的时间有关（P<0.0001）。在 3 天内漏服 1 天的剂量与 mVL≥1000 拷贝/ml的风险增加 66%相关（HR：1.66；95%CI：1.37，1.99）。
产后妇女对自己的 ART 依从性低于为婴儿提供奈韦拉平预防的母亲。自我报告的漏服 mART 剂量与高 mVL 相关。迫切需要优化产后 mART 依从性的策略。
ClinicalTrials.gov：NCT01061151；已关闭随访。
