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Article ; Online: Promoting tuberculosis preventive therapy in HIV.

LaCourse, Sylvia M / Onyango, Dickens

The lancet. HIV

2022 Volume 9, Issue 9, Page(s) e596–e597

MeSH term(s)	Antitubercular Agents/therapeutic use ; HIV Infections/drug therapy ; HIV Infections/prevention & control ; Humans ; Isoniazid ; Tuberculosis/drug therapy ; Tuberculosis/epidemiology ; Tuberculosis/prevention & control
Chemical Substances	Antitubercular Agents ; Isoniazid (V83O1VOZ8L)
Language	English
Publishing date	2022-07-28
Publishing country	Netherlands
Document type	Journal Article ; Comment
ISSN	2352-3018
ISSN (online)	2352-3018
DOI	10.1016/S2352-3018(22)00197-7
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Article ; Online: TB prevention strategies and unanswered questions for pregnant and postpartum women living with HIV: the need for improved evidence.

Mathad, Jyoti S / LaCourse, Sylvia M / Gupta, Amita

Journal of the International AIDS Society

2020 Volume 23, Issue 3, Page(s) e25481

Language	English
Publishing date	2020-03-22
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2467110-1
ISSN	1758-2652 ; 1758-2652
ISSN (online)	1758-2652
ISSN	1758-2652
DOI	10.1002/jia2.25481
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Article ; Online: Notes from the Field: Undiagnosed Tuberculosis During Pregnancy Resulting in a Neonatal Death - United States, 2021.

Miele, Kathryn / Rock, R Bryan / LaCourse, Sylvia M / Ashkin, David / Armitige, Lisa Y / Pomputius, William / Goswami, Neela D

MMWR. Morbidity and mortality weekly report

2023 Volume 72, Issue 49, Page(s) 1331–1332

MeSH term(s)	Infant, Newborn ; Pregnancy ; Female ; Humans ; United States/epidemiology ; Perinatal Death ; Tuberculosis/diagnosis ; Tuberculosis/epidemiology
Language	English
Publishing date	2023-12-08
Publishing country	United States
Document type	Journal Article
ZDB-ID	412775-4
ISSN	1545-861X ; 0149-2195
ISSN (online)	1545-861X
ISSN	0149-2195
DOI	10.15585/mmwr.mm7249a4
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Article: Tuberculosis Infection in Pregnant People: Current Practices and Research Priorities.

Mathad, Jyoti S / Yadav, Sharan / Vaidyanathan, Arthi / Gupta, Amita / LaCourse, Sylvia M

Pathogens (Basel, Switzerland)

2022 Volume 11, Issue 12

Abstract: Women are significantly more likely to develop tuberculosis (TB) disease within the first 90 days after pregnancy than any other time in their lives. Whether pregnancy increases risk of progression from TB infection (TBI) to TB disease is unknown and is ... ...

Abstract	Women are significantly more likely to develop tuberculosis (TB) disease within the first 90 days after pregnancy than any other time in their lives. Whether pregnancy increases risk of progression from TB infection (TBI) to TB disease is unknown and is an active area of investigation. In this review, we discuss the epidemiology of TB and TBI in pregnancy, TBI diagnostics, and prevalence in pregnancy. We also review TBI treatment and highlight research priorities, such as short-course TB prevention regimens, drug-resistant TB prevention, and additional considerations for safety, tolerability, and pharmacokinetics that are unique to pregnant and postpartum people.
Language	English
Publishing date	2022-12-06
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2695572-6
ISSN	2076-0817
ISSN	2076-0817
DOI	10.3390/pathogens11121481
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Article: Isoniazid preventive therapy during infancy does not adversely effect growth among HIV-exposed uninfected children: secondary analysis of data from a randomized controlled trial.

Cherkos, Ashenafi S / LaCourse, Sylvia M / Enquobahrie, Daniel A / Escudero, Jaclyn N / Mecha, Jerphason / Matemo, Daniel / Kinuthia, John / John-Stewart, Grace

medRxiv : the preprint server for health sciences

2023

Abstract: Background: Isoniazid preventive therapy (IPT) decreases risk of tuberculosis (TB) disease; impact on long-term infant growth is unknown. In a recent randomized trial (RCT), we assessed IPT effects on infant growth without known TB exposure.: Methods!# ...

Abstract	Background: Isoniazid preventive therapy (IPT) decreases risk of tuberculosis (TB) disease; impact on long-term infant growth is unknown. In a recent randomized trial (RCT), we assessed IPT effects on infant growth without known TB exposure. Methods: The infant TB Infection Prevention Study (iTIPS) trial was a non-blinded RCT among HIV-exposed uninfected (HEU) infants in Kenya. Inclusion criteria included age 6-10 weeks, birthweight ≥2.5 kg, and gestation ≥37 weeks. Infants in the IPT arm received 10 mg/kg isoniazid daily for 12 months, while the control trial received no intervention; post-trial observational follow-up continued through 24 months of age. We used intent-to-treat linear mixed-effects models to compare growth rates (weight-for-age z-score [WAZ] and height-for-age z-score [HAZ]) between trial arms. Results: Among 298 infants, 150 were randomized to IPT, 47.6% were females, median birthweight was 3.4 kg (interquartile range [IQR] 3.0-3.7), and 98.3% were breastfed. During the 12-month intervention period and 12-month post-RCT follow-up, WAZ and HAZ declined significantly in all children, with more HAZ decline in male infants. There were no growth differences between trial arms, including in sex-stratified analyses. In longitudinal linear analysis, mean WAZ (β=0.04 [95% CI:-0.14, 0.22]), HAZ (β=0.14 [95% CI:-0.06, 0.34]), and WHZ [β=-0.07 [95% CI: -0.26, 0.11]) z-scores were similar between arms as were WAZ and HAZ growth trajectories. Infants randomized to IPT had higher monthly WHZ increase (β to 24 months 0.02 [95% CI:0.01, 0.04]) than the no-IPT arm. Conclusion: IPT administered to HEU infants did not significantly impact growth outcomes in the first two years of life.
Language	English
Publishing date	2023-10-20
Publishing country	United States
Document type	Preprint
DOI	10.1101/2023.10.19.23297259
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Article ; Online: Maternal breastfeeding and education impact infant growth and development more than in-utero HIV/antiretroviral therapy exposure in context of universal antiretroviral therapy.

Cherkos, Ashenafi S / LaCourse, Sylvia M / Kinuthia, John / Mecha, Jerphason / Enquobahrie, Daniel A / Escudero, Jaclyn N / John-Stewart, Grace

AIDS (London, England)

2023 Volume 38, Issue 4, Page(s) 537–546

Abstract: Background: Exposure to HIV and antiretroviral therapy (ART) in utero may influence infant growth and development. Most available evidence predates adoption of universal ART (Option B+ ART regimens). In a recent cohort, we compared growth and ... ...

Abstract	Background: Exposure to HIV and antiretroviral therapy (ART) in utero may influence infant growth and development. Most available evidence predates adoption of universal ART (Option B+ ART regimens). In a recent cohort, we compared growth and development in HIV-exposed uninfected (HEU) to HIV-unexposed (HUU) infants. Design: Prospective cohort study: data from Impact of Maternal HIV on Mycobacterium Tuberculosis Infection among Peripartum Women and their Infants (MiTIPS) in Western Kenya. Methods: Women were enrolled during pregnancy. Mother-infant pairs were followed until 24 months postpartum. We used multivariable linear mixed-effects models to compare growth rates [weight-for-age z score (WAZ) and height-for-age z score (HAZ)] and multivariable linear regression to compare overall development between HEU and HUU children. Results: About 51.8% (184/355) of the infants were HEU, 3.9% low birthweight (<2.5 kg), and 8.5% preterm (<37 gestational weeks). During pregnancy, all mothers of HEU received ART; 67.9% started ART prepregnancy, and 87.3% received 3TC/FTC, TDF, and EFV. In longitudinal analyses, HEU children did not differ significantly from HUU in growth or development ( P > 0.05 for all). In the combined HEU/HUU cohort, higher maternal education was associated with significantly better growth and development: WAZ [ β = 0.18 (95% CI 0.01-0.34)], HAZ [ β = 0.26 (95% CI 0.04-0.48)], and development [ β = 0.24 (95% CI 0.02-0.46)]. Breastfeeding was associated with significantly better HAZ [ β =0.42 (95% CI 0.19-0.66)] and development [ β =0.31 (95% CI 0.08-0.53)]. Conclusion: HEU children in the setting of universal maternal ART had a similar growth trajectory and development to HUU children. Breastfeeding and maternal education improved children's weight, height, and overall development irrespective of maternal HIV status.
MeSH term(s)	Infant ; Infant, Newborn ; Pregnancy ; Child ; Humans ; Female ; Breast Feeding ; HIV Infections/drug therapy ; Prospective Studies ; Anti-Retroviral Agents/therapeutic use ; Growth and Development ; Pregnancy Complications, Infectious/drug therapy
Chemical Substances	Anti-Retroviral Agents
Language	English
Publishing date	2023-11-14
Publishing country	England
Document type	Journal Article
ZDB-ID	639076-6
ISSN	1473-5571 ; 0269-9370 ; 1350-2840
ISSN (online)	1473-5571
ISSN	0269-9370 ; 1350-2840
DOI	10.1097/QAD.0000000000003785
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Article ; Online: Hybrid Immunity to Severe Acute Respiratory Syndrome Coronavirus 2 During Pregnancy Provides More Durable Infant Antibody Responses Compared to Natural Infection or Vaccination Alone.

LaCourse, Sylvia M / Wetzler, Erica A / Aurelio, Morgan C / Escudero, Jaclyn N / Selke, Stacy S / Greninger, Alexander L / Goecker, Erin A / Barnes, Sarina R / Arnould, Isabel S / Pérez-Osorio, Ailyn C / Richardson, Barbra A / Kachikis, Alisa / Englund, Janet A / Drake, Alison L

The Journal of infectious diseases

2024 Volume 229, Issue 4, Page(s) 1241–1243

MeSH term(s)	Infant ; Female ; Pregnancy ; Humans ; SARS-CoV-2 ; Antibody Formation ; COVID-19/prevention & control ; Vaccination ; Antibodies, Viral
Chemical Substances	Antibodies, Viral
Language	English
Publishing date	2024-02-28
Publishing country	United States
Document type	Journal Article
ZDB-ID	3019-3
ISSN	1537-6613 ; 0022-1899
ISSN (online)	1537-6613
ISSN	0022-1899
DOI	10.1093/infdis/jiae046
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Article ; Online: Importance of Inclusion of Pregnant and Breastfeeding Women in COVID-19 Therapeutic Trials.

LaCourse, Sylvia / John-Stewart, Grace / Adams Waldorf, Kristina M

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2020 Volume 71, Issue 15, Page(s) 879–881

Abstract: Investigators are employing unprecedented innovation in the design of clinical trials to rapidly and rigorously assess potentially promising therapies for coronavirus disease 2019 (COVID-19); this is in stark contrast to the continued near-universal ... ...

Abstract	Investigators are employing unprecedented innovation in the design of clinical trials to rapidly and rigorously assess potentially promising therapies for coronavirus disease 2019 (COVID-19); this is in stark contrast to the continued near-universal regressive practice of exclusion of pregnant and breastfeeding women from these trials. The few trials that allow their inclusion focus on postexposure prophylaxis or outpatient treatment of milder disease, limiting the options available to pregnant women with severe COVID-19 to compassionate use of remdesivir, or off-label drug use of hydroxychloroquine or other therapies. These restrictions were put in place despite experience with these drugs in pregnant women. In this Viewpoint, we call attention to the need and urgency to engage pregnant women in COVID-19 treatment trials now in order to develop data-driven recommendations regarding the risks and benefits of therapies in this unique but not uncommon population.
MeSH term(s)	Antiviral Agents/therapeutic use ; Betacoronavirus/drug effects ; Breast Feeding ; COVID-19 ; Coronavirus Infections/drug therapy ; Coronavirus Infections/virology ; Drug Administration Schedule ; Female ; Humans ; Hydroxychloroquine/therapeutic use ; Off-Label Use ; Outpatients ; Pandemics ; Pneumonia, Viral/drug therapy ; Pneumonia, Viral/virology ; Post-Exposure Prophylaxis/methods ; Pregnancy ; Pregnancy Complications, Infectious/drug therapy ; Pregnancy Complications, Infectious/virology ; SARS-CoV-2 ; Time Factors
Chemical Substances	Antiviral Agents ; Hydroxychloroquine (4QWG6N8QKH)
Keywords	covid19
Language	English
Publishing date	2020-04-14
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciaa444
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Zs.MO 480: Show issues

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Article ; Online: Adverse pregnancy outcomes after in vitro fertilization due to undiagnosed urogenital tuberculosis and proposed screening algorithm for patients from tuberculosis-endemic countries.

McLaughlin, Stephanie E / Vora, Surabhi B / Church, E Chandler / Spitters, Christopher / Thyer, Angela / LaCourse, Sylvia / Herndon, Christopher N

F&S reports

2022 Volume 3, Issue 3, Page(s) 285–291

Abstract: Objective: To report 2 cases of adverse pregnancy outcomes due to delayed diagnosis of urogenital tuberculosis and propose a screening algorithm for patients from tuberculosis-endemic countries.: Design: Case report.: Setting: Academic medical ... ...

Abstract	Objective: To report 2 cases of adverse pregnancy outcomes due to delayed diagnosis of urogenital tuberculosis and propose a screening algorithm for patients from tuberculosis-endemic countries. Design: Case report. Setting: Academic medical center. Patients: Two patients with delayed diagnosis of urogenital tuberculosis leading to a fetal loss and a preterm delivery of an infant with congenital tuberculosis. Interventions: Endometrial biopsy, acid-fast bacilli culture of urine, and endometrium. Main outcome measures: Pregnancy outcomes. Results: Fetal loss at 19 weeks and preterm delivery of an infant with congenital tuberculosis before urogenital tuberculosis treatment. Conclusions: Patients who are at risk of urogenital tuberculosis should be screened in advance of infertility treatment to potentially prevent adverse pregnancy outcomes.
Language	English
Publishing date	2022-08-05
Publishing country	United States
Document type	Journal Article
ISSN	2666-3341
ISSN (online)	2666-3341
DOI	10.1016/j.xfre.2022.07.008
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Article ; Online: Biomarker-confirmed suboptimal adherence to isoniazid preventive therapy among children with HIV in western Kenya.

Onyango, Dickens Otieno / van der Sande, Marianne A B / Yuen, Courtney M / Were, Joyce / Mecha, Jerphason / Njagi, Lilian N / Panpradist, Nuttada / Matemo, Daniel / Leon, Daniel / Lutz, Barry / Kinuthia, John / John-Stewart, Grace / Lacourse, Sylvia M

AIDS (London, England)

2023 Volume 38, Issue 1, Page(s) 39–47

Abstract: Objectives: The aim of this study was to assess the level and correlates of biomarker-confirmed adherence to isoniazid (INH) preventive therapy (IPT) among children with HIV (CLHIV).: Design: This prospective cohort study assessed adherence among ... ...

Abstract	Objectives: The aim of this study was to assess the level and correlates of biomarker-confirmed adherence to isoniazid (INH) preventive therapy (IPT) among children with HIV (CLHIV). Design: This prospective cohort study assessed adherence among CLHIV on IPT in public sector HIV clinics from 2019 through 2020. Methods: Adherence was assessed by pill counts or caregiver or self-reports, and urine biomarkers (in-house dipstick and Isoscreen). Both urine biomarker tests detect INH metabolites within 48 h of ingestion. Consistent adherence was defined as having positive results on either biomarker at all visits. Correlates of biomarker-confirmed nonadherence at each visit were evaluated using generalized estimating equations. The in-house dipstick was validated using Isoscreen as the reference. Results: Among 97 CLHIV on IPT with adherence assessments, median age was 10 years (IQR 7-13). All were on ART at IPT initiation (median duration 46 months [IQR 4-89]); 81% were virally suppressed (<1000 copies/ml). At all visits, 59% ( n = 57) of CLHIV reported taking at least 80% of their doses, while 39% ( n = 38) had biomarker-confirmed adherence. Viral nonsuppression (adjusted risk ratio [aRR] = 1.65; 95% confidence interval [95% CI] 1.09-2.49) and the sixth month of IPT use (aRR = 2.49; 95% CI 1.34-4.65) were independent correlates of biomarker-confirmed nonadherence at each visit. Sensitivity and specificity of the in-house dipstick were 98.1% ( 94.7 - 99.6%) and 94.7% ( 88.1 - 98.3%) , respectively, versus Isoscreen. Conclusion: Biomarker-confirmed adherence to IPT was sub-optimal and was associated with viral nonsuppression and duration of IPT. Urine dipstick testing may be useful in assessing adherence to IPT in clinical care.
MeSH term(s)	Child ; Humans ; Isoniazid/therapeutic use ; Antitubercular Agents/therapeutic use ; Tuberculosis/diagnosis ; Tuberculosis/prevention & control ; Tuberculosis/drug therapy ; Prospective Studies ; Kenya ; HIV Infections/drug therapy ; HIV Infections/prevention & control ; Biomarkers
Chemical Substances	Isoniazid (V83O1VOZ8L) ; Antitubercular Agents ; Biomarkers
Language	English
Publishing date	2023-09-28
Publishing country	England
Document type	Journal Article
ZDB-ID	639076-6
ISSN	1473-5571 ; 0269-9370 ; 1350-2840
ISSN (online)	1473-5571
ISSN	0269-9370 ; 1350-2840
DOI	10.1097/QAD.0000000000003719
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