Dataset Information

Perinatal Antiretroviral Intensification to Prevent Intrapartum HIV Transmission When Antenatal Antiretroviral Therapy Is Initiated Less Than 8 Weeks Before Delivery.

ABSTRACT:

Introduction

Infants born to women living with HIV initiating combination antiretroviral therapy (cART) late in pregnancy are at high risk of intrapartum infection. Mother/infant perinatal antiretroviral intensification may substantially reduce this risk.

Methods

In this single-arm Bayesian trial, pregnant women with HIV receiving standard of care antiretroviral prophylaxis in Thailand (maternal antenatal lopinavir-based cART; nonbreastfed infants 4 weeks' postnatal zidovudine) were offered "antiretroviral intensification" (labor single-dose nevirapine plus infant zidovudine-lamivudine-nevirapine for 2 weeks followed by zidovudine-lamivudine for 2 weeks) if their antenatal cART was initiated ≤8 weeks before delivery. A negative birth HIV-DNA polymerase chain reaction (PCR) followed by a confirmed positive PCR defined intrapartum transmission. Before study initiation, we modeled intrapartum transmission probabilities using data from 3738 mother/infant pairs enrolled in our previous trials in Thailand using a logistic model, with perinatal maternal/infant antiretroviral regimen and predicted viral load at delivery as main covariates. Using the characteristics of the women enrolled who received intensification, prior intrapartum transmission probabilities (credibility intervals) with/without intensification were estimated. After including the transmission data observed in the current study, the corresponding Bayesian posterior transmission probability was derived.

Results

No intrapartum transmission of HIV was observed among the 88 mother/infant pairs receiving intensification. The estimated intrapartum transmission probability was 2·2% (95% credibility interval 0·5-6·1) without intensification versus 0·3% (0·0-1·6) with intensification. The probability of superiority of intensification over standard of care was 94·4%. Antiretroviral intensification appeared safe.

Conclusion

Mother/infant antiretroviral intensification was effective in preventing intrapartum transmission of HIV in pregnant women receiving ≤8 weeks antepartum cART.

SUBMITTER: Lallemant M

PROVIDER: S-EPMC9741956 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Publications

Perinatal Antiretroviral Intensification to Prevent Intrapartum HIV Transmission When Antenatal Antiretroviral Therapy Is Initiated Less Than 8 Weeks Before Delivery.

Lallemant Marc M Amzal Billy B Sripan Patumrat P Urien Saïk S Cressey Tim R TR Ngo-Giang-Huong Nicole N Klinbuayaem Virat V Rawangban Boonsong B Sabsanong Prapan P Siriwachirachai Thitiporn T Jarupanich Tapnarong T Kanjanavikai Prateep P Wanasiri Phaiboon P Koetsawang Suporn S Jourdain Gonzague G Le Coeur Sophie S

Journal of acquired immune deficiency syndromes (1999) 20200701 3

<h4>Introduction</h4>Infants born to women living with HIV initiating combination antiretroviral therapy (cART) late in pregnancy are at high risk of intrapartum infection. Mother/infant perinatal antiretroviral intensification may substantially reduce this risk.<h4>Methods</h4>In this single-arm Bayesian trial, pregnant women with HIV receiving standard of care antiretroviral prophylaxis in Thailand (maternal antenatal lopinavir-based cART; nonbreastfed infants 4 weeks' postnatal zidovudine) we ...[more]

PMID: 32205720

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Project description:BackgroundThe safety and efficacy of adding antiretroviral drugs to standard zidovudine prophylaxis in infants of mothers with human immunodeficiency virus (HIV) infection who did not receive antenatal antiretroviral therapy (ART) because of late identification are unclear. We evaluated three ART regimens in such infants.MethodsWithin 48 hours after their birth, we randomly assigned formula-fed infants born to women with a peripartum diagnosis of HIV type 1 (HIV-1) infection to one of three regimens: zidovudine for 6 weeks (zidovudine-alone group), zidovudine for 6 weeks plus three doses of nevirapine during the first 8 days of life (two-drug group), or zidovudine for 6 weeks plus nelfinavir and lamivudine for 2 weeks (three-drug group). The primary outcome was HIV-1 infection at 3 months in infants uninfected at birth.ResultsA total of 1684 infants were enrolled in the Americas and South Africa (566 in the zidovudine-alone group, 562 in the two-drug group, and 556 in the three-drug group). The overall rate of in utero transmission of HIV-1 on the basis of Kaplan-Meier estimates was 5.7% (93 infants), with no significant differences among the groups. Intrapartum transmission occurred in 24 infants in the zidovudine-alone group (4.8%; 95% confidence interval [CI], 3.2 to 7.1), as compared with 11 infants in the two-drug group (2.2%; 95% CI, 1.2 to 3.9; P=0.046) and 12 in the three-drug group (2.4%; 95% CI, 1.4 to 4.3; P=0.046). The overall transmission rate was 8.5% (140 infants), with an increased rate in the zidovudine-alone group (P=0.03 for the comparisons with the two- and three-drug groups). On multivariate analysis, zidovudine monotherapy, a higher maternal viral load, and maternal use of illegal substances were significantly associated with transmission. The rate of neutropenia was significantly increased in the three-drug group (P<0.001 for both comparisons with the other groups).ConclusionsIn neonates whose mothers did not receive ART during pregnancy, prophylaxis with a two- or three-drug ART regimen is superior to zidovudine alone for the prevention of intrapartum HIV transmission; the two-drug regimen has less toxicity than the three-drug regimen. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development [NICHD] and others; ClinicalTrials.gov number, NCT00099359.).

Project description:IntroductionIn high mortality settings, prophylactic azithromycin has been shown to improve birth weight and gestational age at birth when administered antenatally, to reduce the incidence of neonatal infections when administered intrapartum, and to improve survival when administered in infancy. Questions remain regarding whether azithromycin can prevent stillbirths, and regarding the optimal strategy for the delivery of azithromycin to pregnant women and their infants.Methods and analysisSauver avec l'Azithromycine en Traitant les Femmes Enceintes et les Enfants (SANTE) is a 2×2 factorial, individually randomised, placebo-controlled, double-masked trial in rural Mali. The primary aims are: (1A) to assess the efficacy of antenatal and intrapartum azithromycin on a composite outcome of stillbirths and infant mortality through 6-12 months and (1B) to assess the efficacy of azithromycin administered concurrently with the first and third doses of pentavalent vaccines (Penta-1/3) on infant mortality through 6-12 months. Pregnant participants (n=49 600) and their infants are randomised 1:1:1:1 to one of four treatment arms: (1) mother and infant receive azithromycin, (2) mother and infant receive placebo, (3) mother receives azithromycin and infant receives placebo or (4) mother receives placebo and infant receives azithromycin. Pregnant participants receive three single 2 g doses: two antepartum and one intrapartum. Infants receive a single 20 mg/kg dose at the Penta-1 and 3 visits. An additional cohort of 12 000 infants is recruited at the Penta-1 visit and randomised 1:1 to receive azithromycin or placebo at the same time points. The SANTE trial will inform guidelines and policies regarding the administration of antenatal and infant azithromycin using routine healthcare delivery platforms.Ethics and disseminationThis trial was approved by the Institutional Review Board at the University of Maryland School of Medicine (Protocol #HP-00084242) and the Faculté de Médecine et d'Odonto-Stomatologie in Mali. The findings of this trial will be published in open access peer-reviewed journals.Trial registration numberNCT03909737.

Project description:ObjectiveTo identify current and emerging self-care interventions to improve maternity healthcare.DesignScoping review.Data sourcesMEDLINE, Embase, EmCare, PsycINFO, Cochrane CENTRAL/CDSR, CINAHL Plus (last searched on 17 October 2021).Eligibility criteriaEvidence syntheses, interventional or observational studies describing any tool, resource or strategy to facilitate self-care in women preparing to get pregnant, currently pregnant, giving birth or post partum.Data extraction/synthesisScreening and data collection were conducted independently by two reviewers. Self-care interventions were identified based on predefined criteria and inductively organised into 11 categories. Characteristics of study design, interventions, participants and outcomes were recorded.ResultsWe identified eligible 580 studies. Many included studies evaluated interventions in high-income countries (45%) and during antenatal care (76%). Self-care categories featuring highest numbers of studies were diet and nutrition (26% of all studies), physical activity (24%), psychosocial strategies (18%) and other lifestyle adjustments (17%). Few studies featured self-care interventions for sexual health and postpartum family planning (2%), self-management of medication (3%) and self-testing/sampling (3%). Several venues to introduce self-care were described: health facilities (44%), community venues (14%), digital platforms (18%), partner/peer support (7%) or over-the-counter products (13%). Involvement of health and community workers were described in 38% and 8% of studies, who supported self-care interventions by providing therapeutics for home use, training or counselling. The most common categories of outcomes evaluated were neonatal outcomes (eg, birth weight) (31%), maternal mental health (26%) and labour outcomes (eg, duration of labour) (22%).ConclusionSelf-care interventions in maternal care are diverse in their applications, implementation characteristics and intended outcomes. Many self-care interventions were implemented with support from the health system at initial stages of use and uptake. Some promising self-care interventions require further primary research, though several are matured and up-to-date evidence syntheses are needed. Research on self-care in the preconception period is lacking.

Project description:IntroductionNear-term and intrapartum care play pivotal roles in ensuring a safe childbirth experience and are essential components of a comprehensive approach to maternal and neonatal health.MethodsThe following interventions were identified: antibiotics for preterm premature rupture of membrane, antenatal corticosteroids for fetal lung maturation, partograph use during labor and delivery, induction of labor at or post-term, skilled birth care and safe childbirth checklist during labor and delivery. A scoping exercise was conducted to ascertain the most up-to-date evidence, and reviews of topics of interest were updated in case the evidence was not recent, with a focus on low- and middle-income countries (LMICs).ResultsAntibiotics reduced the overall risk of neonatal infection including pneumonia (RR 0.67 [0.52 to 0.85]). LMIC evidence showed a significant effect of antenatal steroids on the risk of neonatal mortality (RR 0.64 [0.43 to 0.97]) and respiratory distress syndrome (RR 0.65 [0.44 to 0.96]). Induction of labor practices at term or post-term reduced the risk of meconium aspiration syndrome (RR 0.51 [0.34 to 0.76]). The use of the WHO childbirth checklist significantly raised the standard of preeclampsia care (OR 8.09 [2.55 to 25.63]) as well as of maternal infection management (OR 25.44 [4.09 to 158.08]). LMIC-specific evidence also demonstrated a significant reduction in the risk of stillbirth (OR 0.92 [0.87 to 0.96]).ConclusionFurther research initiatives pertaining to health interventions delivered to expectant mothers near-term or during the intrapartum period can contribute to a more inclusive understanding of health challenges in LMICs.IntroductionNear-term and intrapartum care play pivotal roles in ensuring a safe childbirth experience and are essential components of a comprehensive approach to maternal and neonatal health.MethodsThe following interventions were identified: antibiotics for preterm premature rupture of membrane, antenatal corticosteroids for fetal lung maturation, partograph use during labor and delivery, induction of labor at or post-term, skilled birth care and safe childbirth checklist during labor and delivery. A scoping exercise was conducted to ascertain the most up-to-date evidence, and reviews of topics of interest were updated in case the evidence was not recent, with a focus on low- and middle-income countries (LMICs).ResultsAntibiotics reduced the overall risk of neonatal infection including pneumonia (RR 0.67 [0.52 to 0.85]). LMIC evidence showed a significant effect of antenatal steroids on the risk of neonatal mortality (RR 0.64 [0.43 to 0.97]) and respiratory distress syndrome (RR 0.65 [0.44 to 0.96]). Induction of labor practices at term or post-term reduced the risk of meconium aspiration syndrome (RR 0.51 [0.34 to 0.76]). The use of the WHO childbirth checklist significantly raised the standard of preeclampsia care (OR 8.09 [2.55 to 25.63]) as well as of maternal infection management (OR 25.44 [4.09 to 158.08]). LMIC-specific evidence also demonstrated a significant reduction in the risk of stillbirth (OR 0.92 [0.87 to 0.96]).ConclusionFurther research initiatives pertaining to health interventions delivered to expectant mothers near-term or during the intrapartum period can contribute to a more inclusive understanding of health challenges in LMICs.

Project description:BackgroundAntenatal care strategies (ANC) play a pivotal role in ensuring a healthy gestational period for expectant mothers and promote optimal outcomes for their babies. Implementing these interventions can contribute to a supportive environment for pregnant women, resulting in positive perinatal and neonatal outcomes.SummaryWe summarize evidence for a total of twenty-seven interventions pertaining to ANC from Every Newborn Series published in The Lancet 2014 by identifying the most recent systematic reviews, extracting data from each review, and conducting a subgroup analysis for low-income and lower-middle-income countries (LMICs) for outcomes relevant to maternal and neonatal health. Findings from our paper suggest a paucity in evidence from LMICs, and consolidated efforts are required to narrow this gap to build on more inclusive evidence on ANC.Key messagesEvidence from LMICs suggests that antenatal multiple micronutrient supplementation when compared to iron and folic acid had a significant effect on stillbirth, small for gestational age, and low birthweight (LBW). Vitamin D supplementation reduced the risks of preterm birth and LBW. High-dose calcium supplementation, when compared to placebo in pregnancy, lowered the likelihood of developing high blood pressure, preeclampsia, and preterm birth. Antihypertensives significantly reduced the probability of developing severe hypertension, proteinuria/preeclampsia, and severe preeclampsia. Metformin for GDM reduced the risk of neonatal death or serious morbidity composite. Cervical cerclage had no effect on stillbirth, preterm birth, or perinatal and neonatal mortality. Data for anti-D administration for rhesus alloimmunization were limited to HICs.BackgroundAntenatal care strategies (ANC) play a pivotal role in ensuring a healthy gestational period for expectant mothers and promote optimal outcomes for their babies. Implementing these interventions can contribute to a supportive environment for pregnant women, resulting in positive perinatal and neonatal outcomes.SummaryWe summarize evidence for a total of twenty-seven interventions pertaining to ANC from Every Newborn Series published in The Lancet 2014 by identifying the most recent systematic reviews, extracting data from each review, and conducting a subgroup analysis for low-income and lower-middle-income countries (LMICs) for outcomes relevant to maternal and neonatal health. Findings from our paper suggest a paucity in evidence from LMICs, and consolidated efforts are required to narrow this gap to build on more inclusive evidence on ANC.Key messagesEvidence from LMICs suggests that antenatal multiple micronutrient supplementation when compared to iron and folic acid had a significant effect on stillbirth, small for gestational age, and low birthweight (LBW). Vitamin D supplementation reduced the risks of preterm birth and LBW. High-dose calcium supplementation, when compared to placebo in pregnancy, lowered the likelihood of developing high blood pressure, preeclampsia, and preterm birth. Antihypertensives significantly reduced the probability of developing severe hypertension, proteinuria/preeclampsia, and severe preeclampsia. Metformin for GDM reduced the risk of neonatal death or serious morbidity composite. Cervical cerclage had no effect on stillbirth, preterm birth, or perinatal and neonatal mortality. Data for anti-D administration for rhesus alloimmunization were limited to HICs.

Dataset Information

Perinatal Antiretroviral Intensification to Prevent Intrapartum HIV Transmission When Antenatal Antiretroviral Therapy Is Initiated Less Than 8 Weeks Before Delivery.

Introduction

Methods

Results

Conclusion

Publications

Perinatal Antiretroviral Intensification to Prevent Intrapartum HIV Transmission When Antenatal Antiretroviral Therapy Is Initiated Less Than 8 Weeks Before Delivery.

Similar Datasets

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