Standardized Definitions of In Utero Human Immunodeficiency Virus and Antiretroviral Drug Exposure Among Children

Slogrove, Amy L.; Burmen, Barbara; Davies, Mary‐Ann; Edmonds, Andrew; Abrams, Elaine J.; Chadwick, Ellen G.; Goetghebuer, Tessa; Mofenson, Lynne M.; Paul, Mary E.; Thorne, Claire; Williams, Paige L.; Vicari, Marissa; Powis, Kathleen M.

doi:10.1093/cid/ciab974

Cited by 8 publications

(7 citation statements)

References 27 publications

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“…The primary exposure variable of combined HIV/ART status during pregnancy was defined as no HIV (no evidence of HIV during pregnancy up until the time of delivery), HIV – no ART (evidence of an HIV diagnosis but no evidence of ART received or only started at delivery or later), HIV – preconception ART (evidence of ART started ≥294 days (≥42 weeks) prior to pregnancy outcome date; corresponds to DECIPHER high-level certainty of preconception ART [ 24 ]), or HIV – pregnancy ART (evidence of ART started >0 and <294 days prior to current pregnancy outcome date). Additional exposure variables included maternal age, multiparity, multigestation pregnancy.…”

Section: Methodsmentioning

confidence: 99%

Hypertensive disorders of pregnancy and HIV: analysis of a province-wide cohort during 2018 and 2019

Slogrove

Davies

Phelanyane

et al. 2023

Aids

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Objective: We evaluated the prevalence of de novo hypertensive disorders of pregnancy (dnHDP) in pregnant people with HIV (PPHIV) in the Western Cape Province, South Africa in 2018–2019 by HIV and antiretroviral therapy (ART) status. Methods: All people with a pregnancy outcome from 1 January 2018 to 31 December 2019 in the Western Cape Provincial Health Data Centre (WCPHDC) were included. The WCPHDC integrates data from multiple electronic platforms according to unique identifiers. dnHDP was classified by ICD-10 code or first-time prescription of antihypertensive drugs less than 140 days before delivery. Pregnant people with preexisting hypertension without superimposed preeclampsia/eclampsia were not considered to have dnHDP. Adjusted prevalence ratios (aPR) for dnHDP by HIV/ART status were calculated using Poisson regression with robust variance. Results: Among 180 553 pregnant people studied, 13 677 (7.6%) had dnHDP and 33 978 (18.8%) were PPHIV. Among PPHIV, 11.3% ( N = 3827) had no evidence of ART, 59.7% ( N = 20 283) initiated ART preconception and 29.0% ( N = 9868) had ART initiated during pregnancy. Compared to those without HIV (7.7%), dnHDP prevalence was lower in PPHIV with preconception [6.9%; aPR 0.78; 95% confidence interval (CI) 0.74–0.83] or pregnancy-initiated ART (7.0%; aPR 0.83; 95% CI 0.75–0.92) and higher in PPHIV without ART (9.8%; aPR 1.17; 95% CI 1.06–1.29) adjusted for maternal age, multiparity, multigestation pregnancy and preexisting hypertension. ART duration by delivery of at least 100 weeks versus pregnancy-initiated ART of 20–<40 weeks was protective (aPR 0.88; 95% CI 0.78–0.98). Conclusions: In the context of universal ART, these findings are reassuring for most PPHIV. ART was not associated with increased dnHDP prevalence and longer ART duration was protective.

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Section: Methodsmentioning

confidence: 99%

Hypertensive disorders of pregnancy and HIV: analysis of a province-wide cohort during 2018 and 2019

Slogrove

Davies

Phelanyane

et al. 2023

Aids

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“…Breastfeeding duration is a major determinant of postnatal VT [ 50 ] but breastfeeding data were not available. Because breastfeeding data, PNP data and infant HIV testing at ≥6 weeks were incomplete, the level of certainty at study closure that HIV‐exposed children were uninfected ranged from moderate (76%) to low (17%) to no certainty (7%), based on whether infants had any negative test at ≥6 weeks; a negative HIV‐PCR at <6 weeks but were not tested at ≥6 weeks; or were never tested, respectively (DECIPHER definitions) [ 51 ]. A high level of certainty requires more detailed information on the timing of tests at ≥6 weeks in relation to cessation of breastfeeding and PNP duration.…”

Section: Discussionmentioning

confidence: 99%

Factors associated with vertical transmission of HIV in the Western Cape, South Africa: a retrospective cohort analysis

Anderson,

Kalk,

Heekes

et al. 2024

J Int AIDS Soc.

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IntroductionMonitoring mother‐infant pairs with HIV exposure is needed to assess the effectiveness of vertical transmission (VT) prevention programmes and progress towards VT elimination.MethodsWe used routinely collected data on infants with HIV exposure, born May 2018–April 2021 in the Western Cape, South Africa, with follow‐up through mid‐2022. We assessed the proportion of infants diagnosed with HIV at birth (≤7 days), 10 weeks (>1 to 14 weeks) and >14 weeks as proxies for intrauterine, intrapartum/early breastfeeding and late breastfeeding transmission, respectively. We used mixed‐effects Poisson regression to assess factors associated with VT in mothers known with HIV by delivery.ResultsWe included 50,461 infants born to mothers known with HIV by delivery. HIV was diagnosed in 894 (1.8%) infants. Among mothers, 51% started antiretroviral treatment (ART) before and 27% during pregnancy; 17% restarted during pregnancy after ≥6 months interruption; and 6% had no recorded ART during pregnancy. Most pregnancy ART regimens included non‐nucleoside reverse transcriptase inhibitors (83%). Of mothers with available results (90% with viral load [VL]; 70% with CD4), VL nearest delivery was <100 copies/ml in 78% and CD4 count ≥350 cells/μl in 62%. HIV‐PCR results were available for 86%, 67% and 48% of eligible infants at birth, 10 weeks and >14 weeks. Among these infants, 0.9%, 0.4% and 1.5% were diagnosed positive at birth, 10 weeks and >14 weeks, respectively. Among infants diagnosed with HIV, 43%, 16% and 41% were diagnosed at these respective time periods. Among mothers with VL<100, 100–999, 1000–99,000 and ≥100,000 copies/ml nearest delivery, infant HIV diagnosis incidence was 0.4%, 2.3%, 6.6% and 18.4%, respectively. Increased VT was strongly associated with recent elevated maternal VL with a seven‐fold increased rate with even modestly elevated VL (100–999 vs. <100 copies/ml). VT was also associated with unknown/low maternal CD4, maternal age <20 years, no antenatal ART, later maternal ART start/restart in pregnancy and ART gaps.ConclusionsDespite high maternal ART coverage and routine postnatal prophylaxis, ongoing VT remains a concern. Timing of infant HIV diagnoses suggests intrapartum and/or breastfeeding transmission in nearly 60%. Interventions to ensure retention on ART and sustained maternal viral suppression are needed to reduce VT.

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“…The DECIPHER Project (Data Evaluation and CIPHER Preparation for an HIV‐Exposed Uninfected Child Cohort) Project of the CIPHER Program of the International AIDS Society has completed development of in utero HIV and ARV exposure definitions that can be used globally, and is working on harmonization of birth outcome and neonatal morbidity and mortality definitions. The DECIPHER definitions incorporate a “level of certainty” approach, initially proposed by the Brighton Collaboration [ 27 , 28 , 29 ].…”

Section: Discussionmentioning

confidence: 99%

Surveillance of ARV safety in pregnancy and breastfeeding: towards a new framework

et al. 2022

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Introduction As new antiretrovirals (ARVs), including long‐acting ARVs for treatment and prevention, are approved and introduced, surveillance during pregnancy must become the safety net for evaluating birth outcomes, especially those that are rare and require large numbers of observations. Historically, drug pharmacovigilance in pregnancy has been limited and fragmented between different data sources, resulting in inadequate data to assess risk. The International Maternal Pediatric Adolescent AIDS Clinical Trials Network and World Health Organization convened a Workshop which reviewed strengths and weaknesses of existing programs and discussed an improved framework to integrate existing safety data sources and promote harmonization and digitalization. Discussion This paper highlights that although robust sources of safety data and surveillance programs exist, key challenges remain, including unknown denominators, reporting bias, under‐reporting (e.g. in voluntary registries), few data sources from resource‐limited settings (most are in North America and Europe), incomplete or inaccurate data (e.g. within routine medical records). However, recent experiences (e.g. with safety signals) and current innovations (e.g. electronic record use in resource‐limited settings and defining adverse outcomes) provide momentum and building blocks for a new framework for active surveillance of ARV safety in pregnancy. A public health approach should be taken using data from existing sources, including registries of pregnancy ARV exposure and birth defects; observational surveillance and cohort studies; clinical trials; and real‐world databases. Key facilitators are harmonization and standardization of outcomes, sharing of materials and tools, and data linkages between programs. Other key facilitators include the development of guidance to estimate sample size and duration of surveillance, ensuring strategic geographic diversity, bringing partners together to share information and engaging the community of women living with HIV. Conclusions Looking ahead, critical steps to safely introduce new ARVs include (1) adopting harmonized standards for measuring adverse maternal, birth and infant outcomes; (2) establishing surveillance centres of excellence in areas with high HIV prevalence with harmonized data collection and optimized electronic health records linking maternal/infant data; and (3) creating targets and evaluation goals for reporting progress on implementation and quality of surveillance in pregnancy. The platform will be leveraged to ensure that appropriate contributions and strategic actions by relevant stakeholders are implemented.

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Standardized Definitions of In Utero Human Immunodeficiency Virus and Antiretroviral Drug Exposure Among Children

Cited by 8 publications

References 27 publications

Hypertensive disorders of pregnancy and HIV: analysis of a province-wide cohort during 2018 and 2019

Hypertensive disorders of pregnancy and HIV: analysis of a province-wide cohort during 2018 and 2019

Factors associated with vertical transmission of HIV in the Western Cape, South Africa: a retrospective cohort analysis

Surveillance of ARV safety in pregnancy and breastfeeding: towards a new framework

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