Background

We report the long-term impact of ART in women of reproductive age (15–49 years) in Africa who have been using ART for up to 10 years. We assess outcomes of retention, adherence, maternal health, fertility intentions, and safety.

Methods

This longitudinal, multicountry study (PROMOTE) enrolled women who initiated ART in an earlier perinatal clinical trial, PROMISE. PROMISE occurred from 2011 to 2016 and PROMOTE follow-up started in 2016 and is ongoing. The PROMOTE study was done at eight sites in four countries: Malawi (Blantyre and Lilongwe), South Africa (Durban and Soweto), Uganda (Kampala), and Zimbabwe (Harare, Seke North, and St Mary's). After baseline enrolment, women and their children are followed up every 6 months to collect information on medical history, antiretroviral therapy (ART) use, adherence, and health information, and to do physical examinations and laboratory tests. Obesity was defined as a body-mass index of 30 kg/m² or more. Data analyses were restricted to summaries of the main long-term outcomes (retention, adherence, maternal health, fertility intentions, and safety). We used descriptive and stratified analyses, and estimated rates using person-years of follow-up and computed probabilities based on Kaplan-Meier methods.

Findings

PROMOTE enrolled 1987 mothers and 2522 children. The median follow-up time for mothers was 41·8 (IQR 35·8–42·0) months and for children was 35·7 (23·8–42·0) months. Overall retention rates were 96·5% for mothers and 94·3% for children at 12 months, and, at 42 months, were 88·9% for mothers and 85·4% for children. 1115 (89·1%) of 1252 women had an undetectable viral load at 42 months, which varied by site (81·7–93·8%). Reported maternal health improved over time, with the proportion of women with excellent to very good health increasing from 67·5% at baseline to 87·5% at 42 months, the proportion of unwell participants who visited a health centre declining from 14·7% to 2·8%, and the proportion of those admitted to hospital declining from 1·5% to 1·0%. The desire to have more children was consistently high at some sites. The proportion of women with obesity was high in South Africa and increased over time from 40·2% at baseline to 52·8% at 42 months. The overall pregnancy rate was 17·6 (95% CI 16·5–18·7) per 100 women-years, and mortality rates were 2·4 (1·4–3·9) per 1000 person-years for mothers and 3·4 (2·2–5·10) per 1000 person-years for children (0–9 years).

Interpretation

The findings from this multicountry study are reassuring. These findings show that African women can consistently use ART for a long period after initiation, and long-term benefits can be maintained. Services to support maternal HIV care, treatment, and reproductive health should be strengthened.

Funding

US President's Emergency Plan for AIDS Relief.

中文翻译：

---

长期抗逆转录病毒治疗对撒哈拉以南非洲育龄妇女的影响（PEPFAR PROMOTE 研究）：一项多国观察性队列研究

背景

我们报告了 ART 对非洲育龄妇女（15-49 岁）的长期影响，这些妇女已经使用 ART 长达 10 年。我们评估保留、依从性、孕产妇健康、生育意向和安全性的结果。

方法

这项纵向多国研究 (PROMOTE) 纳入了在早期围产期临床试验 PROMISE 中开始接受 ART 的女性。PROMISE 发生于 2011 年至 2016 年，PROMOTE 后续行动于 2016 年开始并正在进行中。PROMOTE 研究在四个国家的八个地点进行：马拉维（布兰太尔和利隆圭）、南非（德班和索韦托）、乌干达（坎帕拉）和津巴布韦（哈拉雷、塞克北和圣玛丽）。基线入组后，每 6 个月对妇女及其子女进行一次随访，收集病史、抗逆转录病毒治疗 (ART) 使用情况、依从性和健康信息，并进行体检和实验室检查。肥胖被定义为体重指数为30 kg/m ²或以上。数据分析仅限于主要长期结果（保留、依从性、孕产妇健康、生育意向和安全性）的总结。我们使用描述性和分层分析，并使用人年随访估计率，并根据卡普兰-迈耶方法计算概率。

发现

PROMOTE 招募了 1987 名母亲和 2522 名儿童。母亲的中位随访时间为 41·8 (IQR 35·8–42·0) 个月，儿童为 35·7 (23·8–42·0) 个月。12 个月时，母亲的总体保留率为 96·5%，儿童的总体保留率为 94·3%；42 个月时，母亲的总体保留率为 88·9%，儿童的总体保留率为 85·4%。1252 名女性中有 1115 名 (89·1%) 在 42 个月时病毒载量无法检测到，具体情况因地点而异 (81·7–93·8%)。据报告，孕产妇健康状况随着时间的推移而有所改善，健康状况良好至非常好的女性比例从基线时的 67·5% 增加到 42 个月时的 87·5%，前往医疗中心就诊的身体不适的参与者比例从 14·7 下降%下降到2·8%，入院比例从1·5%下降到1·0%。在一些地方，想要更多孩子的愿望一直很高。南非女性肥胖的比例很高，并且随着时间的推移，从基线时的 40·2% 增加到 42 个月时的 52·8%。总体妊娠率为每 100 名女性年 17·6 (95% CI 16·5–18·7)，母亲和婴儿的死亡率为每 1000 人年 2·4 (1·4–3·9)。儿童（0-9 岁）每 1000 人年 3·4 (2·2–5·10)。

解释

这项多国研究的结果令人欣慰。这些研究结果表明，非洲女性在开始接受ART后可以长期持续使用ART，并且可以保持长期获益。应加强支持孕产妇艾滋病毒护理、治疗和生殖健康的服务。

资金

美国总统艾滋病紧急救援计划。