Viral Suppression and HIV Drug Resistance at 6 Months Among Women in Malawi's Option B+ Program: Results From the PURE Malawi Study.
Viral Suppression and HIV Drug Resistance at 6 Months Among Women in Malawi's Option B+ Program: Results From the PURE Malawi Study.
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DOI：
10.1097/qai.0000000000001368
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发表时间：
2017-06-01
期刊：
影响因子：
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通讯作者：
PURE Malawi Consortium
中科院分区：
文献类型：
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作者：
Hosseinipour M;Nelson JAE;Trapence C;Rutstein SE;Kasende F;Kayoyo V;Kaunda-Khangamwa B;Compliment K;Stanley C;Cataldo F;van Lettow M;Rosenberg NE;Tweya H;Gugsa S;Sampathkumar V;Schouten E;Eliya M;Chimbwandira F;Chiwaula L;Kapito-Tembo A;Phiri S;PURE Malawi Consortium
2011年，马拉维启动了备选方案B+，这是一个为孕妇和哺乳期妇女提供普遍抗逆转录病毒治疗的方案，以优化孕产妇健康，预防儿童感染艾滋病毒。为了获得最佳结果，女性需要实现HIVRNA抑制。我们在PURE研究中报告了6个月的HIVRNA抑制和HIV耐药性。PURE研究是一项随机分组对照试验，评估了促进吸收和保留的三种策略;第1组：标准治疗，第2组：设施同伴支持和第3组：社区同伴支持。根据马拉维抗逆转录病毒疗法指南，对孕妇和哺乳期母亲进行登记和随访。在6个月时收集用于HIVRNA检测的干血斑。抗逆转录病毒治疗失败（HIV RNA ≥1000拷贝/ml）的样本进行耐药性检测。我们使用广义估计方程，结合logit连接和二项分布计算ART失败的比值比。我们在马拉维南部和中部的21个地点招募了1 269名妇女。大多数患者在妊娠期间入组（86%），且为WHO第1阶段（95%）。在6个月时，950/1269（75%）被保留; 833/950（88%）进行了HIVRNA检测，699/833（84%）被抑制。在成功扩增的HIV RNA ≥1000拷贝/ml的患者中（N=55，所有VL> 1000拷贝/ml的41%），在35%（19/55）中发现确认的HIV耐药，主要是对非核苷类逆转录酶抑制剂（NNRTI）类药物。ART失败与治疗失败相关，但与研究组、年龄、WHO分期或母乳喂养状态无关。6个月时的病毒学抑制目标<90%，但观察到的确认耐药率表明依从性支持应是选项B+早期失败的主要方法。
In 2011, Malawi launched Option B+, a program of universal ART treatment for pregnant and lactating women to optimize maternal health and prevent pediatric HIV infection. For optimal outcomes, women need to achieve HIVRNA suppression. We report 6 month HIVRNA suppression and HIV drug resistance in the PURE study. PURE study was a cluster-randomized controlled trial evaluating three strategies for promoting uptake and retention; Arm 1: Standard of Care, Arm 2: Facility Peer Support and Arm 3: Community Peer support. Pregnant and breastfeeding mothers were enrolled and followed according to Malawi ART guidelines. Dried blood spots for HIVRNA testing were collected at 6 months. Samples with ART failure (HIVRNA ≥1000 copies/ml) had resistance testing. We calculated odds ratios for ART failure using generalized estimating equations with a logit link and binomial distribution. We enrolled 1269 women across 21 sites in Southern and Central Malawi. Most enrolled while pregnant(86%) and were WHO Stage 1(95%). At 6 months, 950/1269 (75%) were retained; 833/950 (88%) had HIVRNA testing conducted and 699/833(84%) were suppressed. Among those with HIVRNA ≥1000 copies/ml with successful amplification (N=55, 41% of all VL> 1000 copies/ml), confirmed HIV resistance was found in 35% (19/55), primarily to the Non-nucleoside reverse transcriptase inhibitors(NNRTI) class of drugs. ART failure was associated with treatment default but not study arm, age, WHO stage, or breastfeeding status. Virologic suppression at 6 months was <90% targets, but the observed confirmed resistance rates suggest adherence support should be the primary approach for early failure in Option B+.