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Longterm Antiretroviral Treatment Effects in a Multi-country Observational Cohort of Reproductive Age Women in Sub-Saharan Africa: The PEPFAR PROMOTE Study Findings
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6 2022
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Source: Lancet HIV. 9(6):e394-e403
Details:
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Alternative Title:Lancet HIV
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Personal Author:
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Description:Background.
We report the long-term impact of ART in reproductive age African women 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, multi-country, study known as the PEPFAR PROMise Ongoing Treatment Evaluation (PROMOTE), enrolled women who initiated ART in an earlier perinatal clinical trial known as Promoting Maternal and Infant Survival Everywhere (PROMISE). PROMISE continued from 2010/2011 to 2016 and PROMOTE follow-up started in 2016 and is on-going. The PROMOTE study is conducted 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). Following baseline enrollment, women and their children are followed every six months to collect information on medical history, ART use, adherence, health information, and to conduct physical examinations and laboratory tests. Obesity is defined as body-mass index >30 kg/m2. Data analyses are restricted to summaries of the main long-term outcomes. We use descriptive and stratified analyses, and estimate rates using person-years of follow-up and compute probabilities based on Kaplan Meier methods.
Findings.
PROMOTE enrolled 1987 mothers and 2522 children. The median follow-up time for mothers was 41·8 months (IQR 35·8– 42·0) and for children 35·7 months (IQR 23·8–42·0). Overall retention rates for mothers and children, respectively, were 97% and 94% at 12 months, and 89% and 85% at 42 months. Undetectable viral load at 42 months was 89·1% among 1252 women and varied by site (81·7% to 93·8%). Reported maternal health improved over time; baseline vs 42 months, respectively: excellent/very good health 67·5% vs 86·9%; unwell and visited a health center 14·7% vs 2·8%; and admitted to hospital 1·5% vs 1·0%. Desire to have more children was consistently high at some sites (Uganda: 54·0%−64·0%). Obesity was high in South Africa and increased over time: 40·8% at baseline and 52·8% at 42 months. Overall, the pregnancy rate was 17·6 per 100 woman-years, and maternal and child (0–9 years) mortality rates were 2·4 and 3·4 per 1000 person-years, respectively.
Interpretation.
The findings from this multi-country study are re-assuring. It shows that African women can consistently use ART for a long period post initiation, and long-term benefits can be maintained. Services to support maternal HIV care and treatment and reproductive health should be strengthened.
Funding.
President’s Emergency Plan for AIDS Relief (PEPFAR).
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Pubmed ID:35489365
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Pubmed Central ID:PMC9639003
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