The Mortality of Congenital Syphilis.

OBJECTIVES: To document the case-fatality rate (CFR) of congenital syphilis diagnosed by molecular tools and rabbit infectivity testing (RIT) of clinical specimens in addition to standard evaluation and to compare that with the CFR using the Centers for Disease Control and Prevention (CDC) surveillance case definition. STUDY DESIGN: Prospective, single site, cohort study of all cases of syphilis among mothers and their infants from 1984 to 2002. The diagnosis of congenital syphilis was determined using IgM immunoblotting, polymerase chain reaction, and RIT of fetal or infant specimens in addition to clinical, laboratory, and radiographic criteria. Data were retrospectively reviewed to ascertain fetal and neonatal mortality. RESULTS: During the 18-year study, there were 191 cases of congenital syphilis confirmed by abnormalities on clinical, laboratory, or radiographic evaluation and/or positive serum IgM immunoblot, blood polymerase chain reaction, or blood/cerebrospinal fluid RIT. Of the 191 cases, 59 died for a CFR of 31%. Of the 59 deaths, 53 (90%) were stillborn and 6 (10%) died in the neonatal period. The majority (74%, 39/53) of stillbirths occurred in the third trimester. The CDC surveillance case definition correctly identified all infants with congenital syphilis, but the CDC CFR was 10% which underestimated the CFR by more than 300%. CONCLUSIONS: Our findings corroborate the high sensitivity of the CDC surveillance definition for congenital syphilis but highlight its poor estimation of its associated mortality. The CFR among infected progeny of pregnant women with syphilis was 31%, due mostly to demise in the third trimester and as such highlights the need for detection and appropriate treatment of syphilis during pregnancy.

Infant feeding for people living with HIV in high resource settings: a multi-disciplinary approach with best practices to maximise risk reduction.

Shared decision making for infant feeding in the context of HIV in high-resourced settings is necessary to acknowledge patient autonomy, meet increasing patient requests and address the changing reality of perinatal HIV care. In low-to middle-income countries (LMIC), where the majority of individuals living with HIV reside, persons with HIV are recommended to breastfeed their infants. In the setting of maternal anti-retroviral therapy (ART) use throughout pregnancy, viral suppression and appropriate neonatal post-exposure prophylaxis (PEP) use, updated information indicates that the risk of HIV transmission through breastmilk may be between 0.3 and 1%. While not endorsing or recommending breastfeeding, the United States' DHHS perinatal guidelines are similarly pivoting, stating that individuals should "receive patient-centred, evidence-based counselling on infant feeding options." Similar statements appear in the British, Canadian, Swiss, European, and Australasian perinatal guidelines. We assembled a multi-disciplinary group at our institution to develop a structured shared decision-making process and protocol for successful implementation of breastfeeding. We recommend early and frequent counselling about infant feeding options, which should include well known benefits of breastfeeding even in the context of HIV and the individual's medical and psychosocial circumstances, with respect and support for patient's autonomy in choosing their infant feeding option.

Women Living with Human Immunodeficiency Virus with Intended and Unintended Pregnancy: Characteristics and Patient Outcomes.

Background: Rates of unintended pregnancy may be higher in women living with human immunodeficiency virus (WLWH) than in the general population, and it is unclear how populations of WLWH with intended and unintended pregnancy differ. We compared baseline characteristics and outcomes between WLWH with intended and unintended pregnancy. Materials and Methods: We conducted a retrospective analysis of WLWH enrolled in a human immunodeficiency virus (HIV) and Pregnancy clinic from 2003 to 2014. Data were analyzed using descriptive statistics, chi-square test, Student's t-test, one-way analysis of variance, and linear and logistic regression analysis. Two-tailed p-value <0.05 was considered significant. The study was approved by the Johns Hopkins University School of Medicine Institutional Review Board. Results: Sixty-nine (27.1%) of 255 women reported an intended pregnancy. Women with intended pregnancy (WWIP) were more likely to be older, White, married, privately insured, and college educated. WWIP were less likely to use tobacco (15.9% vs. 44.2%, p < 0.001), alcohol (2.9% vs. 11.1%, p = 0.041), opiates (0.0% vs. 19.3%, p < 0.001), or cocaine (2.9% vs. 21.0%, p < 0.001) during pregnancy, more likely to disclose their HIV status to the father of the baby by delivery (100.0% vs. 15.8%, p < 0.001), and more likely to receive less effective contraception at delivery (condoms 14.9% vs. 4.8%, p = 0.024; sterilization 11.9% vs. 22.1%, p = 0.028). In multivariate regression analysis, pregnancy intendedness was an important predictor of nondetectable viral load at pregnancy entry but not at delivery. Conclusions: WLWH vary in their baseline characteristics and pregnancy outcomes depending on pregnancy intendedness, highlighting the need to improve pregnancy timing in WLWH and intensify interventions for women with unintended pregnancy.

Findings From Severe Maternal Morbidity Surveillance and Review in Maryland.

Importance: In the US, more than 50 000 women experience severe maternal morbidity (SMM) each year, and the SMM rate more than doubled during the past 25 years. In response, professional organizations called for birthing facilities to routinely identify and review SMM events and identify prevention opportunities. Objective: To examine SMM levels, primary causes, and factors associated with the preventability of SMM using Maryland's SMM surveillance and review program. Design, Setting, and Participants: This cross-sectional study included pregnant and postpartum patients at 42 days or less after delivery who were hospitalized at 1 of 6 birthing hospitals in Maryland between August 1, 2020, and November 30, 2021. Hospital-based SMM surveillance was conducted through a detailed review of medical records. Exposures: Hospitalization during pregnancy or within 42 days post partum. Main Outcomes and Measures: The main outcomes were admission to an intensive care unit, having at least 4 U of red blood cells transfused, and/or having COVID-19 infection requiring inpatient hospital care. Results: A total of 192 SMM events were identified and reviewed. Patients with SMM had a mean [SD] age of 31 [6.49] years; 9 [4.7%] were Asian, 27 [14.1%] were Hispanic, 83 [43.2%] were non-Hispanic Black, and 68 [35.4%] were non-Hispanic White. Obstetric hemorrhage was the leading primary cause of SMM (83 [43.2%]), followed by COVID-19 infection (57 [29.7%]) and hypertensive disorders of pregnancy (17 [8.9%]). The SMM rate was highest among Hispanic patients (154.9 per 10 000 deliveries), primarily driven by COVID-19 infection. The rate of SMM among non-Hispanic Black patients was nearly 50% higher than for non-Hispanic White patients (119.9 vs 65.7 per 10 000 deliveries). The SMM outcome assessed could have been prevented in 61 events (31.8%). Clinician-level factors and interventions in the antepartum period were most frequently cited as potentially altering the SMM outcome. Practices that were performed well most often pertained to hospitals' readiness and adequate response to managing pregnancy complications. Recommendations for care improvement focused mainly on timely recognition and rapid response to such. Conclusions and Relevance: The findings of this cross-sectional study, which used hospital-based SMM surveillance and review beyond the mere exploration of administrative data, offers opportunities for identifying valuable quality improvement strategies to reduce SMM. Immediate strategies to reduce SMM in Maryland should target its most common causes and address factors associated with preventability identified at individual hospitals.

Pulmonary Embolism and Amniotic Fluid Embolism.

Venous thromboembolism (VTE) as well as other embolic events including amniotic fluid embolism (AFE) remain a leading cause of maternal death in the United States and worldwide. The pregnant patient is at a higher risk of developing VTE including pulmonary embolism. In contrast, AFE is a rare, but catastrophic event that remains incompletely understood. Here the authors review the cause of VTE in pregnancy and look at contemporary and evidence-based practices for the evaluation, diagnosis, and management in pregnancy. Then the cause and diagnostic difficulty of AFE as well as what is known regarding the pathogenesis are reviewed.

Long-Term Fine Particulate Matter Concentrations and Prevalence of Severe Acute Respiratory Syndrome Coronavirus 2: Differential Relationships by Socioeconomic Status Among Pregnant Individuals in New York City.

We aimed to determine whether long-term ambient concentrations of fine particulate matter (particulate matter with an aerodynamic diameter less than or equal to 2.5 µm (PM2.5)) were associated with increased risk of testing positive for coronavirus disease 2019 (COVID-19) among pregnant individuals who were universally screened at delivery and whether socioeconomic status (SES) modified this relationship. We used obstetrical data collected from New-York Presbyterian Hospital/Columbia University Irving Medical Center in New York, New York, between March and December 2020, including data on Medicaid use (a proxy for low SES) and COVID-19 test results. We linked estimated 2018-2019 PM2.5 concentrations (300-m resolution) with census-tract-level population density, household size, income, and mobility (as measured by mobile-device use) on the basis of residential address. Analyses included 3,318 individuals; 5% tested positive for COVID-19 at delivery, 8% tested positive during pregnancy, and 48% used Medicaid. Average long-term PM2.5 concentrations were 7.4 (standard deviation, 0.8) µg/m3. In adjusted multilevel logistic regression models, we saw no association between PM2.5 and ever testing positive for COVID-19; however, odds were elevated among those using Medicaid (per 1-µg/m3 increase, odds ratio = 1.6, 95% confidence interval: 1.0, 2.5). Further, while only 22% of those testing positive showed symptoms, 69% of symptomatic individuals used Medicaid. SES, including unmeasured occupational exposures or increased susceptibility to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) due to concurrent social and environmental exposures, may explain the increased odds of testing positive for COVID-19 being confined to vulnerable pregnant individuals using Medicaid.

Improvement of Umbilical Cord Blood Gas Analysis with Implementation of Clot Catchers.

BACKGROUND: Umbilical cord blood gas testing is a key component of objective pre- and perinatal evaluation of fetal acid base status to determine presence of intrapartum asphyxia and risk of neonatal encephalopathy. Heparinized cord blood is more likely to form small clots than other blood sources, which can interfere with, or preclude, sample analysis. Cord blood samples are irreplaceable and cannot be recollected, thereby compromising clinical decision-making when analysis is not possible. We evaluated processes to prevent excessive rates of cord blood clotting and quantified their impact on successful testing of blood gas specimens. METHODS: Verified result and cancellation data were obtained retrospectively from the laboratory information system. Clot catchers were evaluated using noncord remnant specimens. Collection syringes were compared via collection from remnant cord sections. RESULTS: Prior to implementation of any interventions, retrospective analysis indicated a cancellation rate of 18.6% for umbilical cord blood gas specimens (arterial and venous) and 0.7% for noncord blood arterial and venous samples. Clot catchers were validated for clinical use, with a bias of <±4% for all analytes. After clot catchers were implemented for all cord specimens, cancellation rate decreased approximately 5-fold in the first month and remained <5% a year after implementation. A limited comparison of two heparin syringe types revealed a small difference in the overall rate of specimen clotting. CONCLUSIONS: Implementation of clot catchers was acceptable for analysis of cord blood samples, and when implemented resulted in a sustained 5-fold decrease in the rate of cord blood gas order cancellation.

Development of an Obstetric Hemorrhage Response Intervention: The Postpartum Hemorrhage Cart and Medication Kit.

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity in the United States, and timely treatment is imperative. Delay in treatment of PPH can lead to significant blood loss and increased morbidity and mortality. Supplies and medications essential for treating PPH are typically not located in close proximity to the hemorrhaging patient, leading to inefficiency and delay in timely response to hemorrhage. METHODS: An in situ hemorrhage simulation was created dictating the collection of a prespecified list of supplies commonly used in response to PPH on labor and delivery (L&D). Baseline data were collected, then Lean Six Sigma tools were used to construct a process map, including recording times and cumulative distance traveled for collection of each item. The simulation was repeated after development, creation, and deployment of each intervention. For the first intervention, a PPH cart was created containing the supplies most used in response to PPH. Second, a PPH medication kit was created consisting of a refrigerated box containing all medications typically administered during a PPH. RESULTS: The average time to collect a prespecified list of supplies and medications in response to a PPH scenario was 11 minutes 5 seconds (standard deviation [SD] = 3 minutes 33 seconds), with an average cumulative distance traveled of 4,092 feet. Following Intervention 1, the time decreased to 4 minutes 0 seconds, with 918 feet traveled (only one trial performed). Intervention 2 further reduced the average time and cumulative distance to 2 minutes 14 seconds (SD = 16 seconds) and 462 feet, respectively. This represents a 79.8% reduction in time and an 88.7% reduction in distance from baseline to postintervention. CONCLUSION: A PPH cart and medication kit can significantly reduce the amount of time and distance traveled to obtain materials necessary to treat hemorrhage, thus optimizing a team's ability to efficiently treat PPH.

Experience and Outcomes of Breastfed Infants of Women Living With HIV in the United States: Findings From a Single-Center Breastfeeding Support Initiative.

We assessed breastfeeding outcomes for a cohort of infants born to women living with HIV (WLHIV) at an urban health care center in the United States. Ten infants were exclusively breastfed for a mean duration of 4.4 (1.0-8.6) months. All had negative HIV RNA PCRs at a median age of 16 months.

Pregnancy alters interleukin-1 beta expression and antiviral antibody responses during severe acute respiratory syndrome coronavirus 2 infection.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2, the disease-causing pathogen of the coronavirus disease 2019 pandemic, has resulted in morbidity and mortality worldwide. Pregnant women are more susceptible to severe coronavirus disease 2019 and are at higher risk of preterm birth than uninfected pregnant women. Despite this evidence, the immunologic effects of severe acute respiratory syndrome coronavirus 2 infection during pregnancy remain understudied. OBJECTIVE: This study aimed to assess the impact of severe acute respiratory syndrome coronavirus 2 infection during pregnancy on inflammatory and humoral responses in maternal and fetal samples and compare antibody responses to severe acute respiratory syndrome coronavirus 2 among pregnant and nonpregnant women. STUDY DESIGN: Immune responses to severe acute respiratory syndrome coronavirus 2 were analyzed using samples from pregnant (n=33) and nonpregnant (n=17) women who tested either positive (pregnant, 22; nonpregnant, 17) or negative for severe acute respiratory syndrome coronavirus 2 (pregnant, 11) at Johns Hopkins Hospital. We measured proinflammatory and placental cytokine messenger RNAs, neonatal Fc receptor expression, and tetanus antibody transfer in maternal and cord blood samples. In addition, we evaluated antispike immunoglobulin G, antispike receptor-binding domain immunoglobulin G, and neutralizing antibody responses to severe acute respiratory syndrome coronavirus 2 in serum or plasma collected from nonpregnant women, pregnant women, and cord blood. RESULTS: Pregnant women with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 infection expressed more interleukin-1 beta, but not interleukin 6, in blood samples collected within 14 days vs >14 days after performing severe acute respiratory syndrome coronavirus 2 test. Pregnant women with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 infection also had reduced antispike receptor-binding domain immunoglobulin G titers and were less likely to have detectable neutralizing antibody than nonpregnant women. Although severe acute respiratory syndrome coronavirus 2 infection did not disrupt neonatal Fc receptor expression in the placenta, maternal transfer of severe acute respiratory syndrome coronavirus 2 neutralizing antibody was inhibited by infection during pregnancy. CONCLUSION: Severe acute respiratory syndrome coronavirus 2 infection during pregnancy was characterized by placental inflammation and reduced antiviral antibody responses, which may impact the efficacy of coronavirus disease 2019 treatment in pregnancy. In addition, the long-term implications of placental inflammation for neonatal health require greater consideration.

Evidence-based protocol decreases time to vaginal delivery in elective inductions.

BACKGROUND: Labor induction accounts for over 1 in 5 births in the United States. There is large variability in practices of induction of labor. Standardizing aspects of induction of labor has been shown to have beneficial maternal and fetal effects. OBJECTIVE: This study aimed to investigate the impact of the implementation of an evidence-based labor induction protocol on maternal and neonatal outcomes. STUDY DESIGN: In February 2018, a contemporary labor induction protocol composed of standardized cervical ripening and early amniotomy was implemented in the labor and delivery unit at a large academic center along with comprehensive training of staff. Maternal and fetal outcomes were compared between patients undergoing induction over a 9 month period following the implementation of the protocol and those undergoing induction 9 months earlier, excluding a 2 week washout period while training occurred. RESULTS: We studied 887 patients who underwent induction of labor of a live singleton at >24 weeks' gestation during our study period (387 patients before the implementation of the protocol and 500 patients after the implementation of the protocol). Baseline characteristics of maternal age, previous vaginal deliveries, and birthweight were similar in patients before and after the implementation of the protocol. There was a significant increase in the number of elective inductions occurring after the implementation of the protocol. There was a significant decrease in time from start of induction to rupture of membranes in all women under the protocol (13.3 hours before the implementation of the protocol vs 10.4 hours after the implementation of the protocol; P≤.001) and decrease in time from start of induction to delivery (21.2 hours before the implementation of the protocol vs 19.7 hours after the implementation of the protocol; P=.04). When the analysis was stratified by elective and nonelective inductions of labor, we found that time from induction of labor initiation to vaginal delivery was shortened after the implementation of the protocol for those undergoing elective induction (18.5 hours vs 14.6 hours; P=.03). There was no difference in cesarean delivery rate (P=.7), chorioamnionitis (P=.3), postpartum hemorrhage (P=.7), or newborn intensive care unit admission (P=.3). CONCLUSION: The implementation of an evidence-based labor induction protocol was associated with decreased time to delivery, primarily driven by decreased time to vaginal delivery among those undergoing elective inductions of labor, without compromise of maternal or neonatal outcomes.

Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response.

Zika virus, influenza, and Ebola have called attention to the ways in which infectious disease outbreaks can severely - and at times uniquely - affect the health interests of pregnant women and their offspring. These examples also highlight the critical need to proactively consider pregnant women and their offspring in vaccine research and response efforts to combat emerging and re-emerging infectious diseases. Historically, pregnant women and their offspring have been largely excluded from research agendas and investment strategies for vaccines against epidemic threats, which in turn can lead to exclusion from future vaccine campaigns amidst outbreaks. This state of affairs is profoundly unjust to pregnant women and their offspring, and deeply problematic from the standpoint of public health. To ensure that the needs of pregnant women and their offspring are fairly addressed, new approaches to public health preparedness, vaccine research and development, and vaccine delivery are required. This Guidance offers 22 concrete recommendations that provide a roadmap for the ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in the development and deployment of vaccines against emerging pathogens. The Guidance was developed by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group - a multidisciplinary, international team of 17 experts specializing in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research and policy - in consultation with a variety of external experts and stakeholders.

Compassionate Use of Remdesivir in Pregnant Women With Severe Coronavirus Disease 2019.

BACKGROUND: Remdesivir is efficacious for severe coronavirus disease 2019 (COVID-19) in adults, but data in pregnant women are limited. We describe outcomes in the first 86 pregnant women with severe COVID-19 who were treated with remdesivir. METHODS: The reported data span 21 March to 16 June 2020 for hospitalized pregnant women with polymerase chain reaction-confirmed severe acute respiratory syndrome coronavirus 2 infection and room air oxygen saturation ≤94% whose clinicians requested remdesivir through the compassionate use program. The intended remdesivir treatment course was 10 days (200 mg on day 1, followed by 100 mg for days 2-10, given intravenously). RESULTS: Nineteen of 86 women delivered before their first dose and were reclassified as immediate "postpartum" (median postpartum day 1 [range, 0-3]). At baseline, 40% of pregnant women (median gestational age, 28 weeks) required invasive ventilation, in contrast to 95% of postpartum women (median gestational age at delivery 30 weeks). By day 28 of follow-up, the level of oxygen requirement decreased in 96% and 89% of pregnant and postpartum women, respectively. Among pregnant women, 93% of those on mechanical ventilation were extubated, 93% recovered, and 90% were discharged. Among postpartum women, 89% were extubated, 89% recovered, and 84% were discharged. Remdesivir was well tolerated, with a low incidence of serious adverse events (AEs) (16%). Most AEs were related to pregnancy and underlying disease; most laboratory abnormalities were grade 1 or 2. There was 1 maternal death attributed to underlying disease and no neonatal deaths. CONCLUSIONS: Among 86 pregnant and postpartum women with severe COVID-19 who received compassionate-use remdesivir, recovery rates were high, with a low rate of serious AEs.

Dysregulated immunity in SARS-CoV-2 infected pregnant women.

IMPORTANCE: The effects of SARS-CoV-2 infection on immune responses during pregnancy have not been systematically evaluated. OBJECTIVE: To assess the impact of SARS-CoV-2 infection during pregnancy on inflammatory and humoral responses in maternal and fetal samples and compare antibody responses to SARS-CoV-2 among pregnant and non-pregnant women. DESIGN: Immune responses to SARS-CoV-2 were analyzed using samples from pregnant and non-pregnant women who had either tested positive or negative for SARS-CoV-2. We measured, proinflammatory and placental cytokine mRNAs, neonatal Fc receptor (FcRn) receptor expression, and tetanus antibody transfer in maternal and cord blood samples. Additionally, we measured anti-spike (S) IgG, anti-S-receptor binding domain (RBD) IgG, and neutralizing antibody (nAb) responses to SARS-CoV-2 in serum or plasma collected from non-pregnant women, pregnant women, and cord blood. SETTING: Johns Hopkins Hospital (JHH). PARTICIPANTS: Pregnant women were recruited through JHH outpatient obstetric clinics and the JHH Labor & Delivery unit. Non-pregnant women were recruited after receiving outpatient SARS-CoV-2 testing within Johns Hopkins Health System, USA. Adult non-pregnant women with positive RT-PCR results for SARS-CoV-2, within the age range of 18-48 years, were included in the study. EXPOSURES: SARS-CoV-2. MAIN OUTCOMES AND MEASURES: Participant demographic characteristics, antibody titers, cytokine mRNA expression, and FcRn receptor expression. RESULTS: SARS-COV-2 positive pregnant women expressed more IL1ß , but not IL6 , in blood samples collected within 14 days versus > 14 days after a confirmed SARS-CoV-2 test, with similar patterns observed in the fetal side of placentas, particularly among asymptomatic pregnant women. Pregnant women with confirmed SARS-CoV-2 infection also had reduced anti-S-RBD IgG titers and were less likely to have detectable nAb as compared with non-pregnant women. Although SARS-CoV-2 infection did not disrupt FcRn expression in the placenta, maternal transfer of nAb was inhibited by SARS-CoV-2 infection during pregnancy. CONCLUSIONS AND RELEVANCE: SARS-CoV-2 infection during pregnancy was characterized by placental inflammation and reduced antiviral antibody responses, which may impact the efficacy of COVID-19 therapeutics in pregnancy. The long-term implications of placental inflammation for neonatal health also requires greater consideration.

Severity of COVID-19 in pregnancy: A review of current evidence.

Coronavirus disease 19 (COVID-19) has recently emerged as a major threat to human health. Infections range from asymptomatic to severe (increased respiratory rate, hypoxia, significant lung involvement on imaging) or critical (multi-organ failure or dysfunction or respiratory failure requiring mechanical ventilation or high-flow nasal cannula). Current evidence suggests that pregnancy women are at increased risk of severe disease, specifically the need for hospitalization, ICU admission, and mechanical ventilation, and the already complex management of infection with an emerging pathogen may be further complicated by pregnancy. The goal of this review is to provide an overview of what is known about the clinical course of COVID-19 in pregnancy, drawing on (a) experience with other coronaviruses such as SARS and MERS, (b) knowledge of immunologic and physiologic changes in pregnancy and how these might impact infection with SARS-CoV-2, and (c) the current literature reporting outcomes in pregnant women with SARS-CoV-2. We also briefly summarize considerations in management of severe COVID-19 in pregnancy.

Tenofovir alafenamide use in pregnant and lactating women living with HIV.

Introduction: Tenofovir alafenamide (TAF)-containing fixed-dose drug combinations (FDCs) are increasingly being used in managing pregnant women living with HIV. However, TAF is not currently recommended during pregnancy due to limited pharmacokinetic and safety data. TAF, a newer nucleotide phosphonamidate prodrug of tenofovir (TFV), achieves high levels of tenofovir-diphosphate in lymphoid cells and hepatocytes, and 90% lower systemic concentrations of TFV compared to tenofovir disoproxil fumarate (TDF), thereby maximizing TAF's antiviral efficacy, potency and clinical safety.Areas covered: This review discusses the currently available information on the pharmacology of TAF in pregnant women living with HIV. Pharmacokinetic studies with TAF during pregnancy have yielded varying results compared to postpartum, but TAF exposures during pregnancy have been within the range of those typically observed in non-pregnant adults. The efficacy and safety of TAF in treatment-naïve pregnant women living with HIV is currently being evaluated in the VESTED study, a phase-III NIH randomized clinical trial.Expert opinion: Initial pregnancy data suggest that TAF-based FDCs have high efficacy and low risk of adverse effects during pregnancy. TAF is likely to become part of first-line regimens for use in pregnant women living with HIV once additional pregnancy data from phase III trials are available.