ABSTRACT
OBJECTIVES: In this study, we aimed to systematically review the literature of the prevalence of systemic antibacterial use during pregnancy and to perform a descriptive analysis focused on methodological characteristics. MATERIALS AND METHODS: This study was registered in PROSPERO under protocol number CRD42022376634. Medline, Embase, Scientific Electronic Library Online, Biblioteca Virtual em Saúde, Cumulative Index to Nursing and Allied Health Literature, and Web of Science databases were searched (published studies until November 3rd, 2022). Selected studies were population-based cross-sectional or cohort, carried out with pregnant women, and providing information about the prevalence of systemic antibacterial use at least in one trimester of pregnancy. Reviewers conducted in pairs the title and abstract screening, eligibility criteria check, and data extraction of selected studies. Quality appraisal was performed with an adapted version of the Joanna Briggs Institute Critical Appraisal Checklist for Prevalence Studies. Data of included studies were pooled into a graphical and tabular summary. RESULTS: A total of 16,251,280 pregnant women and 5,169,959 pregnancy registers were identified. The prevalence estimates of systemic antibacterial use during pregnancy ranged from 2.0% (95%CI 2.0-2.0) to 64.3% (95%CI not reported) in the 79 included studies. The majority were performed in high-income countries (91.5%). Overall, the studies revealed considerable prevalence heterogeneity in terms of study type and dataset used. The 95% confidence intervals were not reported in 41% of studies. CONCLUSION: The disparities in the prevalence of systemic antibacterial use during pregnancy can be related to methodological issues and different health policies. Lack of uniform databases and changes in data collection methods over time should be taken into account in public health strategy planning. The scarce evidence in low- and middle-income settings hampers the comprehensiveness of the global prevalence of antibacterial use during pregnancy.
Subject(s)
Anti-Bacterial Agents , Humans , Pregnancy , Female , Anti-Bacterial Agents/therapeutic use , Prevalence , Pregnancy Complications, Infectious/epidemiology , Pregnancy Complications, Infectious/drug therapyABSTRACT
BACKGROUND: A dolutegravir (DTG)-based antiretroviral regimen has been rolled out for pregnant women in low- and middle-income countries since 2020. However, available safety data are limited to a few clinical trials and observational studies. Hence, we present real-world pregnancy and birth outcome safety data from a large sample multicenter cohort study in Ethiopia. METHODS: A retrospective cohort study was conducted in fourteen hospitals across Ethiopia from 2017 to 2022. HIV-infected pregnant women were followed from the date of prevention of mother-to-child transmission (PMTCT) care enrolment until the infant was 6-8 weeks old. The primary safety outcome was a composite of adverse pregnancy events comprising spontaneous abortion, intrauterine fetal death (IUFD) before onset of labor, preterm birth, and maternal death. Additionally, a composite adverse birth outcome was assessed, comprising intrapartum fetal demise, low birth weight, and neonatal death. Finally, a composite of adverse pregnancy or birth outcome was also investigated. The exposure of interest was the antiretroviral treatment (ART) regimen used during pregnancy for PMTCT of HIV. RESULTS: During the study period, 2643 women were enrolled in routine PMTCT care. However, 2490 (92.2%) participants were eligible for the study. A total of 136/1724 (7.9%, 95% CI: 6.7-9.3%) women experienced adverse pregnancy outcomes. Fewer women in the DTG-based group (5.4%, 95% CI: 3.7-7.5%) had adverse pregnancy outcomes than in the Efavirenz (EFV)-based group (8.3%, 95% CI: 6.6-10.3%), P = 0.004. After controlling for baseline differences, the DTG group had a 43% lower risk of adverse pregnancy outcomes (adjusted odd ratio (AOR), 0.57; 95% CI, 0.32-0.96%) and a 53% lower risk of preterm birth (AOR, 0.47; 95% CI, 0.22-0.98%) compared to the EFV group. A total of 103/1616 (6.4%, 95% CI: 5.2-7.7%) women had adverse birth outcomes. Although the difference was not statistically significant, fewer women in the DTG group (30/548; 5.5%, 95% CI: 3.7-7.7%) than in the EFV group (57/830; 6.9%, 95% CI: 5.2-8.8%) had adverse birth outcomes. CONCLUSIONS: In this study, we observed that DTG-based regimens were associated with better pregnancy and birth outcome safety profiles, reaffirming the WHO recommendation. However, a prospective study is recommended to assess uncaptured maternal and perinatal adverse outcomes, such as congenital abnormalities, and infant growth and neurocognitive development.
Subject(s)
HIV Infections , Heterocyclic Compounds, 3-Ring , Infectious Disease Transmission, Vertical , Oxazines , Piperazines , Pregnancy Complications, Infectious , Pregnancy Outcome , Pyridones , Humans , Pregnancy , Female , Ethiopia/epidemiology , Heterocyclic Compounds, 3-Ring/therapeutic use , Heterocyclic Compounds, 3-Ring/adverse effects , Heterocyclic Compounds, 3-Ring/administration & dosage , HIV Infections/drug therapy , Adult , Retrospective Studies , Pregnancy Complications, Infectious/drug therapy , Infant, Newborn , Infectious Disease Transmission, Vertical/prevention & control , Young Adult , Cyclopropanes , Benzoxazines/therapeutic use , Benzoxazines/adverse effects , Anti-HIV Agents/therapeutic use , Anti-HIV Agents/adverse effects , Alkynes , Cohort Studies , Premature Birth/epidemiologyABSTRACT
BACKGROUND: Hepatitis B poses a significant global public health challenge, with mother-to-child transmission (MTCT) being the primary method of hepatitis B virus (HBV) transmission. The prevalence of HBV infection in China is the highest in Asia, and it carries the greatest burden globally. OBJECTIVE: This study aims to critically evaluate the existing local strategies for preventing MTCT and the proposed potential enhancements by analyzing the prevalence of hepatitis B among pregnant women and their neonates in Yinchuan. METHODS: From January 2017 to December 2021, 37,557 prenatal screening records were collected. Among them, 947 pregnant women who tested positive for hepatitis B surface antigen (HBsAg) near delivery and their 960 neonates were included in an HBV-exposed group, while 29 pregnant women who tested negative and their 30 neonates were included in an HBV-nonexposed group. HBV markers in maternal peripheral blood and neonatal cord blood were analyzed using the least absolute shrinkage and selection operator (LASSO) regression, logistic regression, chi-square test, t-test, and U-test. Additionally, to further evaluate the diagnostic value of HBsAg positivity in cord blood, we conducted an additional follow-up study on 103 infants who tested positive for HBsAg in their cord blood. RESULTS: The prevalence of HBV among pregnant women was 2.5% (947/37,557), with a declining trend every year (χ²4=19.7; P=.001). From 2018 to 2020, only 33.0% (35/106) of eligible pregnant women received antiviral medication treatment. Using LASSO regression to screen risk factors correlated with HBsAg positivity in cord blood (when log [λ] reached a minimum value of -5.02), 5 variables with nonzero coefficients were selected, including maternal hepatitis B e-antigen (HBeAg) status, maternal hepatitis B core antibody (HBcAb) status, maternal HBV DNA load, delivery method, and neonatal birth weight. Through univariate and multivariate logistic regression, delivery by cesarean section (adjusted odds ratio [aOR] 0.52, 95% CI 0.31-0.87), maternal HBeAg positivity (aOR 2.05, 95% CI 1.27-3.33), low maternal viral load (aOR 2.69, 95% CI 1.33-5.46), and high maternal viral load (aOR 2.69, 95% CI 1.32-5.51) were found to be strongly associated with cord blood HBsAg positivity. In the additional follow-up study, 61 infants successfully completed the follow-up, and only 2 were found to be infected with HBV. The mothers of both these infants had detectable HBV DNA levels and should have received standard antiviral therapy. The results of the hepatitis B surface antibody (HBsAb) positivity rate and titer test indicated a gradual decline in the immunity of vaccinated infants as the interval after vaccination increased. CONCLUSIONS: The clinical relevance of HBV marker detection in cord blood is restricted within the current prevention measures for MTCT. There is an emphasis on the significance of public education regarding hepatitis B and the reinforcement of postnatal follow-up for the prevention of MTCT.
Subject(s)
Hepatitis B , Infectious Disease Transmission, Vertical , Humans , Infectious Disease Transmission, Vertical/statistics & numerical data , Infectious Disease Transmission, Vertical/prevention & control , Female , China/epidemiology , Pregnancy , Cross-Sectional Studies , Hepatitis B/epidemiology , Hepatitis B/transmission , Adult , Infant, Newborn , Prevalence , Pregnancy Complications, Infectious/epidemiology , Pregnancy Complications, Infectious/drug therapy , Hepatitis B Surface Antigens/bloodABSTRACT
BACKGROUND: Antiretroviral therapy (ART) use during pregnancy is essential to prevent vertical transmission of HIV, but it may also increase the risk of adverse birth outcomes. This study investigated the impact of both maternal HIV infection and the timing of ART initiation on birth outcomes in women living with HIV in South Africa. METHODS: This secondary data analysis examined the dataset from an earlier cohort study involving 1709 pregnant women living with HIV who delivered their babies at three major maternity centres in the Eastern Cape province of South Africa between September 2015 and May 2018. The associations between adverse birth outcomes (stillbirth, preterm birth, very preterm birth, and low birth weight) and the timing of maternal ART initiation, peripartum CD4 count, and HIV viral load were examined using logistic regression analysis. RESULTS: The observed rates of stillbirth, preterm birth, very preterm birth, and low birth weight were 1.4%, 33.5%, 5.4% and 18.0%, respectively. In the multivariable analysis, low birth weight was associated with ART initiated during the second trimester (adjusted odds ratio [aOR] 1.38; 95% confidence interval [CI], 1.03-1.85), low-level viraemia (21-999 copies/ml) (aOR, 1.62; 95% CI, 1.17-2.22), and high-level viraemia (≥1000 copies/ml) (aOR, 1.66; 95% CI, 1.66-2.38) during the peripartum period. Preterm birth was associated with low-level viraemia (aOR, 1.44; 95% CI, 1.16-1.79) and a CD4 count of less than 200 cells/mm3 (aOR, 1.35; 95% CI, 1.01-1.82). Very preterm birth was associated with detectable maternal viraemia. CONCLUSION: Adverse birth outcomes are common among pregnant women living with HIV, especially those with unsuppressed viraemia. Clinicians and programme managers should prioritise timeous ART initiation and virological suppression in all pregnant women living with HIV.
Subject(s)
HIV Infections , Pregnancy Complications, Infectious , Pregnancy Outcome , Viral Load , Humans , Female , Pregnancy , South Africa/epidemiology , HIV Infections/drug therapy , HIV Infections/virology , Adult , CD4 Lymphocyte Count , Pregnancy Complications, Infectious/drug therapy , Pregnancy Complications, Infectious/virology , Infant, Newborn , Premature Birth/epidemiology , Infectious Disease Transmission, Vertical/prevention & control , Young Adult , Infant, Low Birth Weight , Anti-HIV Agents/therapeutic use , Stillbirth/epidemiology , Secondary Data AnalysisABSTRACT
INTRODUCTION: Refugee HIV positive mothers experience significant obstacles in accessing, utilizing and adhering to antiretroviral therapy (ART). Identifying ART non-adherence can help in the development of interventions aimed at improving adherence and subsequently effectiveness of ART among the refugee mothers. We describe the use and the factors associated with non-adherence to ART among Refugee HIV positive pregnant mothers aged 18-49 years in Kyangwali Refugee Camp, Uganda. METHODS: We conducted a cross-sectional study among HIV positive pregnant mothers aged 18-49 years in Kyangwali refugee camp between May and June 2023. Using a structured questionnaire, we collected data on use, and factors associated with non-adherence to ART. We used modified Poisson regression analysis to determine factors associated with non-adherence to ART. RESULTS: Of the 380 participants enrolled, 192 (50.5%) were married, mean age 32.1 years. Overall, 98.7; 95% Confidence Interval (CI) [97.5-99.8%] were using ART and 27.4; 95% CI [22.9-31.9%] were non-adherent. Non-adherence was associated with: Initiating Prevention of Mother to Child Transmission (PMTCT) care in the third trimester of pregnancy (adjusted Prevalence ration(aPR): 2.06; 95% CI: 1.27-3.35), no need to get permission to seek PMTCT services aPR 1.61; 95% CI [1.07-2.42] and poor attitude of PMTCT providers aPR 1.90; 95% CI [1.20-3.01]. CONCLUSION AND RECOMMENDATIONS: Non-adherence to ART was generally high; therefore limiting the effectiveness of the PMTCT program in this setting. Refugee context specific education interventional programs aimed at early initiation into HIV care, strong social and psychological support from families, communities and health care providers are vital to improve adherence in this setting.
Subject(s)
HIV Infections , Medication Adherence , Pregnancy Complications, Infectious , Refugee Camps , Refugees , Humans , Female , Uganda/epidemiology , Pregnancy , Adult , Cross-Sectional Studies , Adolescent , HIV Infections/drug therapy , HIV Infections/epidemiology , Young Adult , Medication Adherence/statistics & numerical data , Middle Aged , Pregnancy Complications, Infectious/drug therapy , Pregnancy Complications, Infectious/virology , Anti-HIV Agents/therapeutic use , Surveys and Questionnaires , Mothers/psychology , Infectious Disease Transmission, Vertical/prevention & controlABSTRACT
While research involving pregnant women with HIV has largely focused on the antepartum and intrapartum periods, few studies in Nigeria have examined the clinical outcomes of these women postpartum. This study aimed to evaluate antiretroviral therapy retention, adherence, and viral suppression among postpartum women in Nigeria. This retrospective clinical data analysis included women with a delivery record at the antenatal HIV clinic at Jos University Teaching Hospital between 2013 and 2017. Descriptive statistics quantified proportions retained, adherent (≥95% medication possession ratio), and virally suppressed up to 24 months postpartum. Among 1535 included women, 1497 met the triple antiretroviral therapy eligibility criteria. At 24 months, 1342 (89.6%) women remained in care, 51 (3.4%) reported transferring, and 104 (7.0%) were lost to follow-up. The proportion of patients with ≥95% medication possession ratio decreased from 79.0% to 69.1% over the 24 months. Viral suppression among those with results was 88.7% at 24 months, but <62% of those retained had viral load results at each time point. In multiple logistic regression, predictors of loss to follow-up included having a more recent HIV diagnosis, higher gravidity, fewer antenatal care visits, and a non-hospital delivery. Predictors of viral non-suppression included poorer adherence, unsuppressed/missing baseline viral load, lower baseline CD4+ T-cell count, and higher gravidity. Loss to follow-up rates were lower and antiretroviral therapy adherence rates similar among postpartum women at our study hospital compared with other sub-Saharan countries. Longer follow-up time and inclusion of multiple facilities for a nationally representative sample would be beneficial in future studies.
Subject(s)
Anti-HIV Agents , HIV Infections , Medication Adherence , Postpartum Period , Viral Load , Humans , Female , Nigeria/epidemiology , HIV Infections/drug therapy , HIV Infections/epidemiology , HIV Infections/virology , Adult , Medication Adherence/statistics & numerical data , Pregnancy , Retrospective Studies , Anti-HIV Agents/therapeutic use , Pregnancy Complications, Infectious/drug therapy , Pregnancy Complications, Infectious/virology , Young Adult , CD4 Lymphocyte Count , Treatment OutcomeABSTRACT
INTRODUCTION: Dolutegravir (DTG)-based antiretroviral therapy is the World Health Organization's preferred first-line regimen for all persons with HIV, including pregnant women. While DTG has been implicated as an obesogen associated with greater weight gain compared to other antiretrovirals, there is a paucity of data in pregnant women and their children. The Obesogenic oRigins of maternal and Child metabolic health Involving Dolutegravir (ORCHID) study is investigating associations between DTG, weight gain, and metabolic outcomes in the context of HIV. MATERIALS & METHODS: ORCHID is a prospective observational study taking place in Cape Town, South Africa (NCT04991402). A total of 1920 pregnant women with and without HIV infection are being followed from ≤18 weeks gestational age to 24 months postpartum with their children. Participants attend eleven study visits: 3 antenatal, delivery, and 7 postnatal visits. Several embedded sub-studies address specific scientific aims. Primary outcome measurements in mothers include anthropometry, blood pressure, body composition, dysglycemia, insulin resistance (IR), and dyslipidemia. Other maternal measures include demographics, resting energy expenditure, viral load, physical activity, dietary intake, hepatic steatosis, and repository specimens. Sub-study measurements include markers of adipose inflammation, gut integrity, and satiety/hunger, subcutaneous adipose tissue morphology and mitochondrial function, and metabolomics. Primary outcome measurements in children include anthropometry, adipose tissue mass, dysglycemia, IR, and dyslipidemia. Other variables include fetal growth, birth outcomes, medical/breastfeeding history, caloric intake, neurodevelopment, and repository specimens. Sub-study measurements include metabolites/lipid subspecies in umbilical cord blood, as well as breast milk composition and DTG exposure. DISCUSSION: ORCHID will play a pivotal role in defining obesogenic mechanisms and clinical consequences of DTG use in pregnancy in women with HIV and their children. It will provide insights into metabolic disease risk reduction in the context of HIV/DTG, identify intervention targets, and inform public health approaches to diminish chronic metabolic co-morbidities for women and children.
Subject(s)
HIV Infections , Heterocyclic Compounds, 3-Ring , Oxazines , Piperazines , Pyridones , Humans , Female , Pregnancy , HIV Infections/drug therapy , Heterocyclic Compounds, 3-Ring/adverse effects , Heterocyclic Compounds, 3-Ring/therapeutic use , Piperazines/adverse effects , Piperazines/therapeutic use , Adult , Pregnancy Complications, Infectious/drug therapy , Pregnancy Complications, Infectious/virology , Prospective Studies , HIV Integrase Inhibitors/adverse effects , HIV Integrase Inhibitors/therapeutic use , Child, Preschool , Infant , Infant, Newborn , Obesity/chemically induced , Obesity/epidemiology , Insulin Resistance , Male , Weight Gain/drug effects , Cohort Studies , South Africa/epidemiologyABSTRACT
Introduction: VESTED (NCT03048422) compared the safety and efficacy of three antiretroviral treatment (ART) regimens in pregnant and postpartum women: dolutegravir+emtricitabine/tenofovir alafenamide fumarate; dolutegravir+emtricitabine/tenofovir disoproxil fumarate (TDF); efavirenz/emtricitabine/TDF. Vertical HIV transmission (VT) occurred to 4/617 (0.60%) live-born infants, who were evaluated for HIV drug resistance (HIVDR) and other risk factors. Setting: In 2018-2020, pregnant (weeks-14-28) women living with HIV and ≤14 days of ART were enrolled at 22 international sites and followed with their infants through 50 weeks postpartum. Methods: HIV sequences derived by single genome amplification (SGA) from longitudinally collected specimens were assessed from VT Cases for HIVDR in protease, reverse transcriptase, integrase, and the nef 3'polypurine tract (3'PPT). Results: The four Case mothers were prescribed efavirenz-based-ART for 1-7 days prior to randomization to study ART. Their infants received postnatal nevirapine+/-zidovudine prophylaxis and were breastfed. A total of 833 SGA sequences were derived. The "major" (Stanford HIVDR Score ≥60) non-nucleoside reverse transcriptase inhibitor (NNRTI) mutation (K103N) was detected persistently in one viremic mother, and likely contributed to VT of HIVDR. Major NNRTI HIVDR mutations were detected in all three surviving infants. No integrase, nor high frequencies of 3'PPT mutations conferring dolutegravir HIVDR were detected. The timing of HIV infant diagnosis, plasma HIV RNA levels and HIVDR suggests one in utero, one peripartum, one early, and one late breastfeeding transmission. Conclusions: VT was rare. New-onset NNRTI HIVDR in Case mothers was likely from efavirenz-ART prescribed prior to study dolutegravir-ART, and in one case appeared transmitted to the infant despite nevirapine prophylaxis.
Subject(s)
Anti-HIV Agents , Drug Resistance, Viral , HIV Infections , Infectious Disease Transmission, Vertical , Humans , Female , HIV Infections/drug therapy , HIV Infections/transmission , HIV Infections/virology , Infectious Disease Transmission, Vertical/prevention & control , Drug Resistance, Viral/genetics , Pregnancy , Anti-HIV Agents/therapeutic use , Adult , Infant, Newborn , Piperazines/therapeutic use , Cyclopropanes , HIV-1/genetics , HIV-1/drug effects , Tenofovir/therapeutic use , Heterocyclic Compounds, 3-Ring/therapeutic use , Alkynes , Pyridones/therapeutic use , Emtricitabine/therapeutic use , Pregnancy Complications, Infectious/drug therapy , Pregnancy Complications, Infectious/virology , Benzoxazines/therapeutic use , Oxazines/therapeutic useABSTRACT
INTRODUCTION: Vertical transmission of HIV remains a major challenge in Guinea, especially, in low-resource rural areas. This paper presents the results of a pilot project designed to enhance the prevention of vertical transmission through a comprehensive improvement plan implemented across 66 large-cohort sites. METHODS: Data from 66 large-cohort of mother to child transmission prevention (PMTCT) sites from 2019 to 2022 were analysed to compare PMTCT metrics before (2019-2020) and after (2021-2022) the improvement initiative. Key indicators were reviewed, and trends were statistically analysed using MannâWhitney tests, with a p value less than 0.05 indicating statistical significance. RESULTS: The implementation of this strategy significantly increased the antiretroviral therapy rate among HIV-positive pregnant women from 66 to 94%, and full antiretroviral prophylaxis coverage was achieved in infants. However, early infant diagnosis via polymerase chain reaction testing falls short of the national target, highlighting deficiencies in laboratory and specimen transport capacities. The study also revealed regional disparities in the use of PMTCT services. CONCLUSION: The improvement plan effectively enhanced antiretroviral therapy and prophylaxis use, demonstrating the benefits of structured interventions and capacity development. Despite improvements, challenges such as insufficient polymerase chain reaction (PCR) testing and uneven access to services remain. Future initiatives should aim to equip PMTCT sites with essential resources and promote community-driven health-seeking behaviours in underserved areas.
Subject(s)
HIV Infections , Infectious Disease Transmission, Vertical , Pregnancy Complications, Infectious , Humans , Infectious Disease Transmission, Vertical/prevention & control , HIV Infections/prevention & control , HIV Infections/transmission , HIV Infections/drug therapy , Female , Pregnancy , Guinea/epidemiology , Pilot Projects , Pregnancy Complications, Infectious/drug therapy , Pregnancy Complications, Infectious/prevention & control , Infant , Anti-HIV Agents/therapeutic use , Cohort Studies , Infant, Newborn , AdultABSTRACT
BACKGROUND: A paucity of data exists to inform the use of interleukin (IL)-6 receptor antibodies (anti-IL-6) in pregnancy, particularly in the third trimester. This study aimed to describe outcomes of pregnant women and their neonates exposed to these medications given after the first trimester to treat COVID-19. METHODS: In this retrospective cohort study, we included all women with COVID-19 who were treated with an anti-IL-6 during pregnancy at two tertiary hospitals in London, UK-Guy's and St Thomas' NHS Foundation Trust and Imperial College Healthcare NHS Trust-between March 1, 2020, and Sept 30, 2022. Maternal demographics, clinical data, administered medications, and maternal and neonatal outcomes were assessed for all included women via a review of medical records and through maternal medicine networks. FINDINGS: 25 women received an anti-IL-6 for COVID-19 in pregnancy during the study period and were followed up for 12 months. The group described were a population at high risk, with 24 requiring level two or three critical care. 24 women received tocilizumab and one received sarilumab. All women were prescribed at least three concomitant medications. 16 received the anti-IL-6 in the third trimester of pregnancy and nine during the seocnd trimester. There were no women with maternal neutropenia or pancytopenia; increases in liver enzymes in 16 of 20 women with available alanine aminotransferase data were in keeping with the severity of COVID-19 reported and all three women who developed a secondary bacterial infection mounted a C-reactive protein response. There was one maternal death due to COVID-19. All pregnancies resulted in livebirths and there was one twin pregnancy. 16 of 26 babies were born preterm. One baby died at age 6 months due to complications of extreme prematurity. A transient neonatal cytopenia was described in six of 19 babies in whom a full blood count was performed. Although these findings are likely to be in keeping with prematurity alone, we cannot exclude the possibility that transplacental transfer of anti-IL-6 was contributory. INTERPRETATION: We report further data on the use of anti-IL-6 in the second and third trimesters of pregnancy for the management of COVID-19. When extrapolated, our data can inform shared decision making for individuals who would benefit from the use of anti-IL-6 into the third trimester of pregnancy for management of rheumatological disease. FUNDING: None.
Subject(s)
Antibodies, Monoclonal, Humanized , COVID-19 Drug Treatment , Pregnancy Complications, Infectious , Pregnancy Trimester, Second , Pregnancy Trimester, Third , Adult , Female , Humans , Infant, Newborn , Pregnancy , Antibodies, Monoclonal, Humanized/therapeutic use , COVID-19/immunology , Pregnancy Complications, Infectious/drug therapy , Pregnancy Outcome/epidemiology , Receptors, Interleukin-6/antagonists & inhibitors , Receptors, Interleukin-6/immunology , Retrospective Studies , SARS-CoV-2/immunologyABSTRACT
In 2018, a significant neural tube defects (NTD) signal was reported after pre-conceptional exposure to dolutegravir, but was not confirmed in further analysis. Since 2019, dolutegravir-based regimen, an integrase inhibitor (INI), is recommended by WHO as the most-effective first-line therapy in all patients living with HIV. To explore the potential INI-related teratogenic effect, we searched disproportionate signals between exposure to INI-class drugs and congenital anomalies, compared to non-INI drugs, using the international pharmacovigilance database, VigiBase®. We selected all the reports registered in VigiBase® between 01/01/2007 and 30/03/2021 on any antiretroviral drug-related fetal or neonatal adverse drug reactions, declared either in children (<2 years) exposed in utero or in pregnant women (12-50 years). A case/non-case study was conducted to detected signals between congenital anomalies and prenatal exposure to any INI-class drug, compared to non-INI drugs, by estimating adjusted reporting odds ratios (aROR) with 95% confidence intervals (95%CI). We identified 2521 unique reports, among which 664 (26.3%) were related to INI-class use. Overall, 520 congenital anomalies were cited from 327 unique reports, of whom 31.0% were INI-related. Compared to non-INI drugs, no significant disproportionate reporting signal between prenatal exposure to INI-class drugs and congenital anomalies was found (aROR 1.13; 95% CI:0.85-1.51). However, specific significant signals were reported for raltegravir/elvitegravir/dolutegravir drug exposure and urinary malformations (aROR 2.43; 95%CI:1.08-5.43), digestive malformations (aROR 3.09; 95%CI:1.22-7.84), and NTDs (aROR 3.02; 95%CI:1.09-8.37). Although specific congenital anomalies signals associated with raltegravir/elvitegravir/dolutegravir exposure were notified, causal relationship needs to be further investigated in prospective studies.
Subject(s)
Abnormalities, Drug-Induced , Databases, Factual , Heterocyclic Compounds, 3-Ring , Pharmacovigilance , Pyridones , Humans , Pregnancy , Female , Adult , Adolescent , Abnormalities, Drug-Induced/epidemiology , Heterocyclic Compounds, 3-Ring/adverse effects , Heterocyclic Compounds, 3-Ring/therapeutic use , Pyridones/adverse effects , Young Adult , Infant, Newborn , Child , Piperazines/adverse effects , Middle Aged , HIV Infections/drug therapy , HIV Integrase Inhibitors/adverse effects , HIV Integrase Inhibitors/therapeutic use , Oxazines/adverse effects , Raltegravir Potassium/adverse effects , Raltegravir Potassium/therapeutic use , Child, Preschool , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Pregnancy Complications, Infectious/drug therapy , QuinolonesABSTRACT
BACKGROUND: The number of perinatal HIV cases have continued to decline since the United States achieved the goal of perinatal HIV elimination in 2019. We aimed to evaluate dynamics in perinatal HIV transmission in the metropolitan District of Columbia (DC) area during 2018-2022. SETTING: Children's National Hospital's (CNH) is a major referral site for the metropolitan DC area, including suburban Maryland and Virginia, and evaluates >95% of HIV-exposed infants (HEI) in the region. METHODS: A retrospective cohort study of mother-infant pairs with perinatal HIV exposure seen at CNH during 2018-2022. We describe the demographics, intrapartum/postpartum management, and outcomes among mothers and HEI. RESULTS: We analyzed 503 HEI; most (78.9%) were at low risk for perinatal HIV. Most mothers were African or African American (87.1%) and had HIV RNA <50 copies/mL around delivery (78.1%). The proportion of HEI at high risk for perinatal HIV decreased from 28.2% to 15.5% in 2018 and 2020, respectively, but increased to 24.8% in 2022. Most HEI received postnatal antiretroviral drugs for at least 4 weeks (95.3%). Seventy-nine infants (15.7%) were born to mothers diagnosed with HIV during pregnancy. Two infants (0.4%) were diagnosed with perinatally acquired HIV. CONCLUSIONS: We report high rates of antiretroviral drugs use among mother-infant pairs and a low rate of perinatal HIV transmission in metropolitan DC. Despite a 1.8-fold decrease in the number of high-risk perinatal HIV exposures since 2018, this rate rebounded in 2022. There remain opportunities to optimize maternal care and reduce the number of high-risk HEI.
Subject(s)
HIV Infections , Infectious Disease Transmission, Vertical , Pregnancy Complications, Infectious , Humans , HIV Infections/transmission , HIV Infections/drug therapy , HIV Infections/prevention & control , HIV Infections/epidemiology , Infectious Disease Transmission, Vertical/prevention & control , Female , Retrospective Studies , Pregnancy , District of Columbia/epidemiology , Adult , Infant, Newborn , Pregnancy Complications, Infectious/drug therapy , Pregnancy Complications, Infectious/epidemiology , Young Adult , Infant , Male , Anti-HIV Agents/therapeutic useABSTRACT
Group B Streptococcus (GBS) is the leading cause of bacterial neonatal sepsis. This study aimed to confirm the effect of Ligilactobacillus salivarius V4II-90 on GBS colonisation during pregnancy. A randomised, multicentre, double-blind, placebo-controlled, parallel-group study was conducted in seven hospitals in Madrid, Spain. The sample was broken down into two groups with 20 participants each (n = 40) in order to show reduced GBS colonisation frequency in the probiotic versus the placebo group. Pregnant participants positive for vaginal-rectal colonisation before or during the 13th week of gestation were randomly assigned to either the placebo or the probiotic group. The probiotic, L. salivarius V4II-90 at 1 × 109 cfu/day was administered for 12 weeks, starting at week 21-23 of gestation. The primary outcome was the percentage of participants with vaginal and/or rectal GBS colonisation at the end of the intervention period (35 weeks of gestation). Secondary outcomes were changes in the microbial composition of vaginal and rectal exudates; premature delivery; premature rupture of membranes; intrapartum antibiotics; new-borns with early or late-onset GBS sepsis; adverse events (AEs); and GBS test results performed at the hospital at week 35 of gestation. Of the 481 participants included, 44 were vaginal-rectal colonised with GBS and randomised. 43 completed the study (20 in the probiotic group and 23 in the placebo group). After intervention, GBS was eradicated in six participants (27%) from the placebo group and in twelve participants (63%) from the probiotic group ( P = 0.030). None of the 185 AEs reported were identified as possibly, probably, or definitely related to the investigational product. In conclusion, oral administration of L. salivarius V4II-90 is a safe and successful strategy to significantly decrease the rates of GBS colonisation at the end of pregnancy and, therefore, to reduce the exposure of subjects and their infants to intrapartum antibiotic prophylaxis. Trial registered at ClinicalTrials.gov: number NCT03669094.
Subject(s)
Ligilactobacillus salivarius , Pregnancy Complications, Infectious , Probiotics , Rectum , Streptococcal Infections , Streptococcus agalactiae , Vagina , Humans , Female , Pregnancy , Probiotics/administration & dosage , Double-Blind Method , Streptococcus agalactiae/growth & development , Streptococcus agalactiae/drug effects , Streptococcal Infections/prevention & control , Streptococcal Infections/microbiology , Streptococcal Infections/drug therapy , Adult , Vagina/microbiology , Rectum/microbiology , Ligilactobacillus salivarius/physiology , Pregnancy Complications, Infectious/microbiology , Pregnancy Complications, Infectious/prevention & control , Pregnancy Complications, Infectious/drug therapy , Infant, Newborn , Spain , Young AdultABSTRACT
The focus of this case study is the delayed diagnosis of a perinatal HIV transmission, which was identified when the infant reached 4 months of age, and the social conditions and structural determinants that contributed to the increased transmission risk. Despite adhering to the diagnostic testing protocols and neonatal antiretroviral (ARV) guidelines of the New York State Department of Health, this transmission still occurred. This transmission event prompted strategies to address criminalization of substance use during pregnancy and a reevaluation of the HIV testing and treatment protocols, including the timing of testing. Obtaining a diagnostic specimen at birth before initiating prophylactic or presumptive therapy, without causing delays in therapy, and incorporating HIV-1 DNA or RNA testing 2 to 6 weeks after discontinuing ARV therapy might have facilitated earlier detection and a quicker resumption of ARV therapy for this high-risk infant. Subsequently, the New York State HIV perinatal testing guidelines were updated. These changes included the recommendation to obtain a diagnostic specimen at birth before initiating ARV medications, whenever feasible, without causing delays in ARV initiation. Additionally, an extra virologic diagnostic test is recommended at 2 to 6 weeks after discontinuing ARVs for infants at high risk of perinatal HIV transmission, especially those with possible DNA or RNA suppression due to ARV prophylaxis or presumptive HIV therapy.
Subject(s)
HIV Infections , Infectious Disease Transmission, Vertical , Humans , HIV Infections/transmission , HIV Infections/drug therapy , HIV Infections/diagnosis , Infectious Disease Transmission, Vertical/prevention & control , Female , Pregnancy , New York/epidemiology , Infant, Newborn , Infant , Pregnancy Complications, Infectious/drug therapy , Pregnancy Complications, Infectious/diagnosisABSTRACT
Group B Streptococcus (GBS) disease in neonates occurs in two forms: early-onset disease (EOD), (day 0-6), and late-onset disease (LOD), (day 7-90). This review investigates that risk-based intrapartum screening and antibiotics have reduced the incidence of EOD, but not LOD, in Denmark. No clinical or laboratory tests can rule out GBS disease at symptom onset. Thus, a high proportion of uninfected infants receive antibiotics, although this varies widely, and may be reduced by strategies of antibiotic stewardship. A future GBS vaccine for pregnant women may potentially reduce disease burden and antibiotic exposure.
Subject(s)
Anti-Bacterial Agents , Streptococcal Infections , Streptococcus agalactiae , Humans , Streptococcal Infections/diagnosis , Streptococcal Infections/prevention & control , Streptococcal Infections/drug therapy , Infant, Newborn , Streptococcus agalactiae/isolation & purification , Anti-Bacterial Agents/therapeutic use , Anti-Bacterial Agents/administration & dosage , Female , Pregnancy , Denmark/epidemiology , Pregnancy Complications, Infectious/diagnosis , Pregnancy Complications, Infectious/microbiology , Pregnancy Complications, Infectious/prevention & control , Pregnancy Complications, Infectious/drug therapy , Infant , Streptococcal Vaccines/administration & dosage , Infectious Disease Transmission, Vertical/prevention & controlABSTRACT
This case report describes a pregnant patient with recent diagnosis of Human Immuno-Deficiency Virus (HIV) infection initiated on Anti-Retroviral Therapy (ART) in the second trimester, as well as high dose acyclovir high for large infected genital warts. She had no other HIV related opportunistic infections, and no prior anti tuberculosis treatment or preventive medication. Despite little response to acyclovir, patient was continuing on acyclovir for over 4 months. She subsequently developed recurrent anemia requiring frequent transfusion (14 units in total) over a 6-week period. On stopping acyclovir, the anemia subsided, a few weeks later she had a normal delivery, followed by surgical removal of the warts. At a follow-up 8 months later, she was well, with a healthy baby, and reported no other episodes of blood transfusion.
Subject(s)
Acyclovir , Anemia , Antiviral Agents , HIV Infections , Pregnancy Complications, Infectious , Recurrence , Humans , Female , Pregnancy , Acyclovir/therapeutic use , Acyclovir/adverse effects , Acyclovir/administration & dosage , HIV Infections/drug therapy , HIV Infections/complications , Pregnancy Complications, Infectious/drug therapy , Antiviral Agents/adverse effects , Antiviral Agents/therapeutic use , Adult , Uganda , Treatment Outcome , Herpes Genitalis/drug therapy , Blood TransfusionABSTRACT
BACKGROUND: Nevirapine prophylaxis has been found to lower the risk of HIV transmission in breastfed infants. While about 95% of HIV positive pregnant and lactating mothers use Antiretroviral therapy in Uganda, a smaller percentage of HIV exposed infants (HEI) receive nevirapine (NVP) prophylaxis. This study aimed to determine the proportion of HEI who missed NVP prophylaxis and associated factors. METHODS: This was a cross-sectional study done using quantitative methods, conducted at Mulago National Referral Hospital (MNRH). A total of 228 mother-infant pairs were enrolled. The proportion of HEI who missed NVP, maternal, infant and health facility factors associated were determined using a pre-tested questionnaire. Bivariate analysis and binary logistic regression model were used to determine the proportion and factors associated with missing NVP prophylaxis. RESULTS: The proportion of HEI who missed NVP prophylaxis was 50/228 (21.9%). Factors significantly associated with HEI missing NVP prophylaxis included delivery from outside government health facilities (AOR = 8.41; P = 0.001), mothers not undergoing PMTCT counselling (AOR = 12.01; P = 0.001), not on ART (AOR = 8.47; P = 0.003) and not having disclosed their HIV status to their partners (AOR = 2.80; P = 0.001). The HEI that missed nevirapine and were HIV positive were 35 (70.0%). The HEI that were HIV infected despite receiving nevirapine prophylaxis were 5 out of 40(12.5%). CONCLUSION: One in five HEI missed NVP prophylaxis and nearly three quarters of those who missed NVP prophylaxis were HIV infected. Improving uptake of nevirapine by HEI will require interventions that can aid to strengthen PMTCT counselling.
Subject(s)
Anti-HIV Agents , HIV Infections , Infectious Disease Transmission, Vertical , Nevirapine , Humans , Nevirapine/therapeutic use , Cross-Sectional Studies , Uganda , Female , HIV Infections/prevention & control , HIV Infections/drug therapy , Infant , Infectious Disease Transmission, Vertical/prevention & control , Anti-HIV Agents/therapeutic use , Adult , Infant, Newborn , Male , Young Adult , Pregnancy , Medication Adherence/statistics & numerical data , Pregnancy Complications, Infectious/drug therapy , Pregnancy Complications, Infectious/prevention & controlABSTRACT
BACKGROUND: Globally, the rate of antiretroviral therapy coverage for pregnant women living with human immunodeficiency virus (HIV) increased by 38% between 2010 and 2015 but only by 2% between 2016 and 2020. OBJECTIVES: We aimed to determine the prevalence of vertical transmission of HIV among infants from mothers living with HIV and associated factors in the Eastern Lake Zone and Southern Highland of Tanzania from January to December 2022. METHODS: This retrospective cross-sectional study extracted data from the Open Laboratory Data Repository database collected from January to December 2022 at 93 health facilities. A total of 1,411 infants exposed to HIV from the Mbeya (851), Songwe (304), and Mara regions (256) were enrolled. RESULTS: The prevalence for vertical transmission of HIV was 2.48% (35/1411). We observed a non-significant difference in the prevalence of vertical transmission in children whose first test was done below six weeks of life (1.89%) and other age groups (2.52-2.62%) (p < 0.917). Children not given antiretroviral prophylaxis had eleven times higher odds of acquiring infection (AOR 11.39, 95% CI: 3.61-35.97). Mothers who were not on ART during pregnancy had three times the odds of transmitting HIV to their infants (AOR 3.03, 95%CI: 0.91-10.15). CONCLUSIONS: We found a low prevalence of vertical transmission of HIV compared to previous studies done in Tanzania. The use of ART prophylaxis for infants exposed to HIV is significantly associated with the low rate of HIV transmission.
Subject(s)
HIV Infections , Infectious Disease Transmission, Vertical , Pregnancy Complications, Infectious , Humans , Infectious Disease Transmission, Vertical/statistics & numerical data , Tanzania/epidemiology , HIV Infections/transmission , HIV Infections/epidemiology , HIV Infections/drug therapy , Cross-Sectional Studies , Female , Prevalence , Retrospective Studies , Infant , Adult , Pregnancy , Male , Infant, Newborn , Pregnancy Complications, Infectious/epidemiology , Pregnancy Complications, Infectious/virology , Pregnancy Complications, Infectious/drug therapy , Young Adult , Risk FactorsABSTRACT
Intraamniotic inflammation and infection complicate 2% to 5% of term deliveries. Group B Streptococcus (GBS) is a common cause of intraamniotic infection associated with invasive neonatal disease and maternal morbidity. Universal vaginal-rectal screening for GBS colonization is recommended between 36 and 37 weeks. Intrapartum antibiotic prophylaxis is recommended for individuals with positive GBS screens and other risk factors. Intravenous penicillin is the preferred antimicrobial agent. Individuals with penicillin allergies may receive cefazolin for low-risk allergies and either clindamycin or vancomycin for high-risk allergies, depending on their antimicrobial susceptibilities. Clinical trials are underway to evaluate the safety and immunogenicity of maternal anti-GBS vaccine candidates.
Subject(s)
Anti-Bacterial Agents , Antibiotic Prophylaxis , Chorioamnionitis , Pregnancy Complications, Infectious , Streptococcal Infections , Streptococcus agalactiae , Humans , Pregnancy , Streptococcal Infections/diagnosis , Streptococcal Infections/drug therapy , Streptococcal Infections/prevention & control , Female , Antibiotic Prophylaxis/methods , Pregnancy Complications, Infectious/drug therapy , Pregnancy Complications, Infectious/microbiology , Pregnancy Complications, Infectious/prevention & control , Anti-Bacterial Agents/therapeutic use , Chorioamnionitis/microbiology , Chorioamnionitis/drug therapy , Streptococcal Vaccines , Infant, NewbornABSTRACT
There is limited evidence about the use of medications among pregnant women with COVID-19, as well as risk factors for hospitalization due to COVID-19 in pregnancy. We aimed to describe the use of medications among SARS-CoV-2-positive pregnant women at the time around infection and identify predictors for hospitalization due to COVID-19 in two hospitals in Brazil. This is a hospital record-based study among pregnant women with positive SARS-CoV-2 tests between March 2020 and August 2022 from two Brazilian hospitals. Characteristics of sociodemographic, obstetrical, and COVID-19 symptoms were extracted retrospectively. The prevalence use of medications was based on self-reported use, and this was administered at the hospital. Logistic regression was used to estimate predictors of hospitalization due to COVID-19. There were 278 pregnant women included in the study, of which 41 (14.7%) required hospitalization due to COVID-19. The remaining 237 (85.3%) had mild symptoms or were asymptomatic. Most of the women had the infection in the third trimester (n = 149; 53.6%). The most prevalent medications used across all trimesters were analgesics (2.4% to 20.0%), antibacterials (15.0% to 23.1%), and corticosteroids (7.2% to 10.4%). Pre- or gestational hypertensive disorder (odds ratio (OR) 4.94, 95% confidence interval (CI) 1.65, 14.87) and having at least one dose of vaccine against SARS-CoV-2 (OR 0.13, 95% CI 0.04, 0.39) were associated with hospitalization due to COVID-19. Analgesics, antibacterials, and corticosteroids were the most frequently used medications among pregnant women with COVID-19. Women with hypertensive disorders have almost a five-fold increased risk of hospitalization due to COVID-19. Vaccination was the strongest protective factor for severe COVID-19. The COVID-19 vaccination among pregnant women should be promoted, and pregnant women diagnosed with COVID-19 who have hypertensive disorders should be closely monitored.