894 results on '"Mofenson, Lynne M."'
Search Results
2. Clinical and population‐based study design considerations to accelerate the investigation of new antiretrovirals during pregnancy
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Brummel, Sean S, Stringer, Jeff, Mills, Ed, Tierney, Camlin, Caniglia, Ellen C, Colbers, Angela, H., Benjamin, Best, Brookie M, Gaaloul, Myriam El, Hillier, Sharon, Jourdain, Gonzague, Khoo, Saye H, Mofenson, Lynne M, Myer, Landon, Nachman, Sharon, Stranix‐Chibanda, Lynda, Clayden, Polly, Sachikonye, Memory, and Lockman, Shahin
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Reproductive Medicine ,Biomedical and Clinical Sciences ,Infectious Diseases ,Women's Health ,Perinatal Period - Conditions Originating in Perinatal Period ,Pediatric ,Clinical Research ,Sexually Transmitted Infections ,Clinical Trials and Supportive Activities ,Maternal Health ,HIV/AIDS ,Pregnancy ,Preterm ,Low Birth Weight and Health of the Newborn ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Reproductive health and childbirth ,Good Health and Well Being ,Anti-Retroviral Agents ,Female ,HIV Infections ,Humans ,Pregnancy Complications ,Infectious ,Randomized Controlled Trials as Topic ,ARV ,clinical trials ,intervention ,paediatrics ,treatment ,viral suppression ,Clinical Sciences ,Public Health and Health Services ,Other Medical and Health Sciences ,Clinical sciences ,Epidemiology ,Public health - Abstract
IntroductionPregnant women are routinely excluded from clinical trials, leading to the absence or delay in even the most basic pharmacokinetic (PK) information needed for dosing in pregnancy. When available, pregnancy PK studies use a small sample size, resulting in limited safety information. We discuss key study design elements that may enhance the timely availability of pregnancy data, including the role and timing of randomized controlled trials (RCTs) to evaluate pregnancy safety; efficacy and safety outcome measures; stand-alone protocols, platform trials, single arm studies, sample size and the effect that follow-up time during gestation has on analysis interpretations; and observational studies.DiscussionPregnancy PK should be studied during drug development, after dosing in non-pregnant persons is established (unless non-clinical or other data raise pregnancy concerns). RCTs should evaluate the safety during pregnancy of priority new HIV agents that are likely to be used by large numbers of females of childbearing age. Key endpoints for pregnancy safety studies include birth outcomes (prematurity, small for gestational age and stillbirth) and neonatal death, with traditional adverse events and infant growth also measured (congenital anomalies are best studied through surveillance). We recommend that viral efficacy be studied as a secondary endpoint of pregnancy RCTs, once PK studies confirm adequate drug exposure in pregnancy. RCTs typically use a stand-alone protocol for new agents. In contrast, master protocols using a platform design can add agents over time, possibly speeding safety data ascertainment. To speed accrual, stand-alone pregnancy trial protocols can include pre-specified starting rules based upon adequate PK levels in pregnancy; and seamless master protocols or platform trials can include a pregnancy PK and safety component. When RCTs are unethical or cost-prohibitive, observational studies should be conducted, preferably using target trial emulation to avoid bias.ConclusionsPregnancy PK needs to be obtained earlier in drug evaluation. Timely RCTs are needed to understand safety in pregnancy for high-priority new HIV agents. RCTs that enrol pregnant women should focus on outcomes unique to pregnancy, and observational studies should focus on questions that RCTs are not equipped to answer.
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- 2022
3. Impact of postpartum tenofovir-based antiretroviral therapy on bone mineral density in breastfeeding women with HIV enrolled in a randomized clinical trial
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Stranix-Chibanda, Lynda, Tierney, Camlin, Sebikari, Dorothy, Aizire, Jim, Dadabhai, Sufia, Zanga, Admire, Mukwasi-Kahari, Cynthia, Vhembo, Tichaona, Violari, Avy, Theron, Gerard, Moodley, Dhayandre, George, Kathleen, Fan, Bo, Sommer, Markus J, Browning, Renee, Mofenson, Lynne M, Shepherd, John, Nelson, Bryan, Fowler, Mary Glenn, and Siberry, George K
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Reproductive Medicine ,Biomedical and Clinical Sciences ,Clinical Sciences ,Clinical Research ,HIV/AIDS ,Infectious Diseases ,Pediatric ,Clinical Trials and Supportive Activities ,Prevention ,Osteoporosis ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Musculoskeletal ,Reproductive health and childbirth ,Good Health and Well Being ,Absorptiometry ,Photon ,Adult ,Anti-HIV Agents ,Bone Density ,Breast Feeding ,Drug Therapy ,Combination ,Emtricitabine ,Female ,HIV Infections ,Humans ,Lopinavir ,Postpartum Period ,Ritonavir ,Tenofovir ,Young Adult ,PROMISE P1084s study team ,General Science & Technology - Abstract
ObjectivesWe set out to evaluate the effect of postnatal exposure to tenofovir-containing antiretroviral therapy on bone mineral density among breastfeeding women living with HIV.DesignIMPAACT P1084s is a sub-study of the PROMISE randomized trial conducted in four African countries (ClinicalTrials.gov number NCT01066858).MethodsIMPAACT P1084s enrolled eligible mother-infant pairs previously randomised in the PROMISE trial at one week after delivery to receive either maternal antiretroviral therapy (Tenofovir disoproxil fumarate / Emtricitabine + Lopinavir/ritonavir-maternal TDF-ART) or administer infant nevirapine, with no maternal antiretroviral therapy, to prevent breastmilk HIV transmission. Maternal lumbar spine and hip bone mineral density were measured using dual-energy x-ray absorptiometry (DXA) at postpartum weeks 1 and 74. We studied the effect of the postpartum randomization on percent change in maternal bone mineral density in an intention-to-treat analysis with a t-test; mean and 95% confidence interval (95%CI) are presented.ResultsAmong 398/400 women included in this analysis, baseline age, body-mass index, CD4 count, mean bone mineral density and alcohol use were comparable between study arms. On average, maternal lumbar spine bone mineral density declined significantly through week 74 in the maternal TDF-ART compared to the infant nevirapine arm; mean difference (95%CI) -2.86 (-4.03, -1.70) percentage points (p-value
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- 2021
4. Long-acting antiretrovirals and HIV treatment adherence
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Nachega, Jean B, Scarsi, Kimberly K, Gandhi, Monica, Scott, Rachel K, Mofenson, Lynne M, Archary, Moherndran, Nachman, Sharon, Decloedt, Eric, Geng, Elvin H, Wilson, Lindsay, Rawat, Angeli, and Mellors, John W
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- 2023
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5. Defining gaps in pre-exposure prophylaxis delivery for pregnant and post-partum women in high-burden settings using an implementation science framework
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Pintye, Jillian, Davey, Dvora L Joseph, Wagner, Anjuli D, John-Stewart, Grace, Baggaley, Rachel, Bekker, Linda-Gail, Celum, Connie, Chi, Benjamin H, Coates, Thomas J, Groves, Allison K, Haberer, Jessica E, Heffron, Renee, Kinuthia, John, Matthews, Lynn T, McIntyre, James A, Moodley, Dhayendre, Mofenson, Lynne M, Mugo, Nelly, Mujugira, Andrew, Myer, Landon, Shoptaw, Steven, Stranix-Chibanda, Lynda, Baeten, Jared M, and Group, for the PrEP in Pregnancy Working
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Reproductive Medicine ,Biomedical and Clinical Sciences ,Public Health ,Health Sciences ,Behavioral and Social Science ,Infectious Diseases ,Prevention ,Pediatric AIDS ,Clinical Research ,Pediatric ,HIV/AIDS ,Infection ,Reproductive health and childbirth ,Good Health and Well Being ,Anti-HIV Agents ,Female ,HIV Infections ,Health Plan Implementation ,Humans ,Infectious Disease Transmission ,Vertical ,Male ,Postnatal Care ,Pre-Exposure Prophylaxis ,Pregnancy ,PrEP in Pregnancy Working Group ,Medical and Health Sciences ,Biomedical and clinical sciences ,Health sciences - Abstract
Pregnancy is a high-risk period for HIV acquisition in African women, and pregnant women who become acutely infected with HIV account for up to a third of vertical HIV transmission cases in African settings. To protect women and eliminate vertical transmission, WHO recommends offering oral pre-exposure prophylaxis (PrEP) based on tenofovir to HIV-negative pregnant and post-partum women with a substantial risk of HIV acquisition. PrEP implementation for pregnant and post-partum women lags behind implementation for other high-risk populations. Unique considerations for PrEP implementation arise during pregnancy and post partum, including the integration of provider training with clinical delivery and monitoring of PrEP exposure and outcomes within existing maternal health systems, yet scarce implementation data are available to generate evidence in this context.
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- 2020
6. Safety, Tolerability, and Pharmacokinetics of the Broadly Neutralizing Human Immunodeficiency Virus (HIV)-1 Monoclonal Antibody VRC01 in HIV-Exposed Newborn Infants
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Cunningham, Coleen K, McFarland, Elizabeth J, Morrison, R Leavitt, Capparelli, Edmund V, Safrit, Jeffrey T, Mofenson, Lynne M, Mathieson, Bonnie, Valentine, Megan E, Perlowski, Charlotte, Smith, Betsy, Hazra, Rohan, Purdue, Lynette, Muresan, Petronella, Harding, Paul A, Mbengeranwa, Tapiwa, Robinson, Lisa-Gaye, Wiznia, Andrew, Theron, Gerhard, Lin, Bob, Bailer, Robert T, Mascola, John R, Graham, Barney S, Aldrovandi, Grace, Bone, Frederic, Dayton, Dale, Johnston, Benjamin, Morgan, Patricia, Myers, Kathryn, Tobin, Nicole, Zimmer, Bonnie, Rossouw, Magdel, Rossouw, Lindie, Louw, Jeanne, Dobroszycki, Joanna, Burey, Marlene, Auguste, Raphaelle, Graham, Kathleen K, Major-Wilson, Hanna, Mhembere, Tsungai, Maturure, Sukunena, Bwakura-Dangarembizi, Mutsa, Barr, Emily, Dunn, Jennifer, Glenny, Carrie, Chambers, Carrie, Baig, Mahboobullah Mirza, Purswani, Murli, Deville, Jaime G, Nielsen-Saines, Karin, Shin, Christina, Carter, Michele F, Chahroudi, Ann, Ahonen, Alexis, Badell, Martina, Chakraborty, Rana, Agwu, Allison, Golden, W Christopher, Anderson, Thuy, Collinson-Streng, Aleisha, Diaz-Velasco, Rodrigo, Rosario, Nicolas, Pérez, Elvia, Marrero, Wanda I, Febo, Irma, Santos, Ruth, and Zorrilla, Carmen D
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Medical Microbiology ,Biomedical and Clinical Sciences ,Immunology ,Infectious Diseases ,Prevention ,Perinatal Period - Conditions Originating in Perinatal Period ,Pediatric AIDS ,HIV/AIDS ,Pediatric ,Clinical Research ,Immunization ,Vaccine Related ,Clinical Trials and Supportive Activities ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Infection ,Reproductive health and childbirth ,Good Health and Well Being ,Africa ,Antibodies ,Monoclonal ,Broadly Neutralizing Antibodies ,Female ,HIV Antibodies ,HIV Infections ,HIV-1 ,Humans ,Infant ,Newborn ,Infectious Disease Transmission ,Vertical ,Injections ,Subcutaneous ,Linear Models ,Male ,United States ,broadly neutralizing antibodies ,mother-to-child transmission of HIV ,neonates ,VRC01 ,IMPAACT P1112 team ,Biological Sciences ,Medical and Health Sciences ,Microbiology ,Biological sciences ,Biomedical and clinical sciences ,Health sciences - Abstract
BackgroundAlthough mother-to-child human immunodeficiency virus (HIV) transmission has dramatically decreased with maternal antiretroviral therapy, breast milk transmission accounts for most of the 180 000 new infant HIV infections annually. Broadly neutralizing antibodies (bNAb) may further reduce transmission.MethodsA Phase 1 safety and pharmacokinetic study was conducted: a single subcutaneous (SC) dose of 20 or 40 mg/kg (Dose Groups 1 and 2, respectively) of the bNAb VRC01 was administered to HIV-exposed infants soon after birth. Breastfeeding infants (Dose Group 3) received 40 mg/kg SC VRC01 after birth and then 20 mg/kg/dose SC monthly. All infants received appropriate antiretroviral prophylaxis.ResultsForty infants were enrolled (21 in the United States, 19 in Africa). Subcutaneous VRC01 was safe and well tolerated with only mild-to-moderate local reactions, primarily erythema, which rapidly resolved. For multiple-dose infants, local reactions decreased with subsequent injections. VRC01 was rapidly absorbed after administration, with peak concentrations 1-6 days postdose. The 40 mg/kg dose resulted in 13 of 14 infants achieving the serum 50 micrograms (mcg)/mL target at day 28. Dose Group 3 infants maintained concentrations greater than 50 mcg/mL throughout breastfeeding.ConclusionsSubcutaneous VRC01 as single or multiple doses is safe and well tolerated in very young infants and is suitable for further study to prevent HIV transmission in infants.
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- 2020
7. Emerging evidence from a systematic review of safety of pre-exposure prophylaxis for pregnant and postpartum women: where are we now and where are we heading?
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Joseph Davey, Dvora L, Pintye, Jillian, Baeten, Jared M, Aldrovandi, Grace, Baggaley, Rachel, Bekker, Linda-Gail, Celum, Connie, Chi, Benjamin H, Coates, Thomas J, Haberer, Jessica E, Heffron, Renee, Kinuthia, John, Matthews, Lynn T, McIntyre, James, Moodley, Dhayendre, Mofenson, Lynne M, Mugo, Nelly, Myer, Landon, Mujugira, Andrew, Shoptaw, Steven, Stranix-Chibanda, Lynda, John-Stewart, Grace, and PrEP in Pregnancy Working Group
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PrEP in Pregnancy Working Group ,Humans ,HIV-1 ,Pregnancy Complications ,Infectious ,HIV Infections ,Anti-HIV Agents ,Postnatal Care ,Breast Feeding ,Pregnancy ,Adult ,Female ,Young Adult ,Pre-Exposure Prophylaxis ,Tenofovir ,HIV ,PMTCT ,PrEP ,breastfeeding ,preexposure prophylaxis ,pregnancy ,prevention of mother to child transmission ,Pregnancy Complications ,Infectious ,Clinical Sciences ,Public Health and Health Services ,Other Medical and Health Sciences - Abstract
IntroductionHIV incidence is high during pregnancy and breastfeeding with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are not pregnant. The World Health Organization recommends offering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV infection. However, maternal PrEP national guidelines differ and most countries with high maternal HIV incidence are not offering PrEP. We conducted a systematic review of recent research on PrEP safety in pregnancy to inform national policy and rollout.MethodsWe used a standard Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) approach to conduct a systematic review by searching for completed, ongoing, or planned PrEP in pregnancy projects or studies from clinicaltrials.gov, PubMed and NIH RePORTER from 2014 to March 2019. We performed a systematic review of studies that assess tenofovir disoproxil fumarate (TDF)-based oral PrEP safety in pregnant and breastfeeding HIV-uninfected women.Results and discussionWe identified 14 completed (n = 5) and ongoing/planned (n = 9) studies that evaluate maternal and/or infant outcomes following PrEP exposure during pregnancy or breastfeeding. None of the completed studies found differences in pregnancy or perinatal outcomes associated with PrEP exposure. Nine ongoing studies, to be completed by 2022, will provide data on >6200 additional PrEP-exposed pregnancies and assess perinatal, infant growth and bone health outcomes, expanding by sixfold the data on PrEP safety in pregnancy. Research gaps include limited data on (1) accurately measured PrEP exposure within maternal and infant populations including drug levels needed for maternal protection; (2) uncommon perinatal outcomes (e.g. congenital anomalies); (3) infant outcomes such as bone growth beyond one year following PrEP exposure; (4) outcomes in HIV-uninfected women who use PrEP during pregnancy and/or lactation.ConclusionsExpanding delivery of PrEP is an essential strategy to reduce HIV incidence in pregnancy and breastfeeding women. Early safety studies of PrEP among pregnant women without HIV infection are reassuring and ongoing/planned studies will contribute extensive new data to bolster the safety profile of PrEP use in pregnancy. However, addressing research gaps is essential to expanding PrEP delivery for women in the context of pregnancy.
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- 2020
8. Emerging evidence from a systematic review of safety of pre‐exposure prophylaxis for pregnant and postpartum women: where are we now and where are we heading?
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Davey, Dvora L Joseph, Pintye, Jillian, Baeten, Jared M, Aldrovandi, Grace, Baggaley, Rachel, Bekker, Linda‐Gail, Celum, Connie, H, Benjamin, Coates, Thomas J, Haberer, Jessica E, Heffron, Renee, Kinuthia, John, Matthews, Lynn T, McIntyre, James, Moodley, Dhayendre, Mofenson, Lynne M, Mugo, Nelly, Myer, Landon, Mujugira, Andrew, Shoptaw, Steven, Stranix‐Chibanda, Lynda, John‐Stewart, Grace, and Group, for the PrEP in Pregnancy Working
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Biomedical and Clinical Sciences ,Midwifery ,Public Health ,Health Sciences ,Reproductive Medicine ,Breastfeeding ,Lactation and Breast Milk ,HIV/AIDS ,Sexually Transmitted Infections ,Prevention ,Pregnancy ,Maternal Health ,Infectious Diseases ,Maternal Morbidity and Mortality ,Pediatric ,Women's Health ,Perinatal Period - Conditions Originating in Perinatal Period ,Reproductive health and childbirth ,Infection ,Good Health and Well Being ,Adult ,Anti-HIV Agents ,Breast Feeding ,Female ,HIV Infections ,HIV-1 ,Humans ,Postnatal Care ,Pre-Exposure Prophylaxis ,Pregnancy Complications ,Infectious ,Tenofovir ,Young Adult ,preexposure prophylaxis ,PrEP ,pregnancy ,breastfeeding ,PMTCT ,prevention of mother to child transmission ,HIV ,PrEP in Pregnancy Working Group ,Clinical Sciences ,Public Health and Health Services ,Other Medical and Health Sciences ,Clinical sciences ,Epidemiology ,Public health - Abstract
IntroductionHIV incidence is high during pregnancy and breastfeeding with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are not pregnant. The World Health Organization recommends offering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV infection. However, maternal PrEP national guidelines differ and most countries with high maternal HIV incidence are not offering PrEP. We conducted a systematic review of recent research on PrEP safety in pregnancy to inform national policy and rollout.MethodsWe used a standard Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) approach to conduct a systematic review by searching for completed, ongoing, or planned PrEP in pregnancy projects or studies from clinicaltrials.gov, PubMed and NIH RePORTER from 2014 to March 2019. We performed a systematic review of studies that assess tenofovir disoproxil fumarate (TDF)-based oral PrEP safety in pregnant and breastfeeding HIV-uninfected women.Results and discussionWe identified 14 completed (n = 5) and ongoing/planned (n = 9) studies that evaluate maternal and/or infant outcomes following PrEP exposure during pregnancy or breastfeeding. None of the completed studies found differences in pregnancy or perinatal outcomes associated with PrEP exposure. Nine ongoing studies, to be completed by 2022, will provide data on >6200 additional PrEP-exposed pregnancies and assess perinatal, infant growth and bone health outcomes, expanding by sixfold the data on PrEP safety in pregnancy. Research gaps include limited data on (1) accurately measured PrEP exposure within maternal and infant populations including drug levels needed for maternal protection; (2) uncommon perinatal outcomes (e.g. congenital anomalies); (3) infant outcomes such as bone growth beyond one year following PrEP exposure; (4) outcomes in HIV-uninfected women who use PrEP during pregnancy and/or lactation.ConclusionsExpanding delivery of PrEP is an essential strategy to reduce HIV incidence in pregnancy and breastfeeding women. Early safety studies of PrEP among pregnant women without HIV infection are reassuring and ongoing/planned studies will contribute extensive new data to bolster the safety profile of PrEP use in pregnancy. However, addressing research gaps is essential to expanding PrEP delivery for women in the context of pregnancy.
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- 2020
9. Pharmacokinetics of Increased Nelfinavir Plasma Concentrations in Women During Pregnancy and Postpartum
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Eke, Ahizechukwu C, McCormack, Shelley A, Best, Brookie M, Stek, Alice M, Wang, Jiajia, Kreitchmann, Regis, Shapiro, David, Smith, Elizabeth, Mofenson, Lynne M, Capparelli, Edmund V, Mirochnick, Mark, and Team, IMPAACT P1026s Protocol
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Reproductive Medicine ,Biomedical and Clinical Sciences ,Clinical Research ,HIV/AIDS ,Pediatric ,Clinical Trials and Supportive Activities ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Infection ,Reproductive health and childbirth ,Good Health and Well Being ,Adult ,Anti-HIV Agents ,Female ,HIV Protease Inhibitors ,Humans ,Nelfinavir ,Postpartum Period ,Pregnancy ,Pregnancy Complications ,Infectious ,Prospective Studies ,nelfinavir ,pregnancy ,hydroxyl-tert-butylamide ,postpartum ,IMPAACT P1026s Protocol Team ,Pharmacology and Pharmaceutical Sciences ,Pharmacology & Pharmacy ,Pharmacology and pharmaceutical sciences - Abstract
This study aims to evaluate the safety, acceptability, and pharmacokinetics (PK) of an increased dose of nelfinavir (NFV) during the third trimester of pregnancy. The study was registered as part of the International Maternal Pediatric Adolescent AIDS Clinical Trials network (IMPAACT-P1026s), an ongoing multicenter prospective cohort study of antiretroviral PK during pregnancy (NCT00042289). NFV intensive PK evaluations were performed at steady state during the third trimester of pregnancy and 2-3 weeks postpartum. Plasma concentrations of NFV and its active metabolite, hydroxyl-tert-butylamide (M8) were measured using high-performance liquid chromatography with ultraviolet detection. A total of 18 women are included in the analysis. NFV area under the concentration-time curve (AUC) with the increased dose during the third trimester was nearly identical to the standard dose postpartum, with a geometric mean ratio for third trimester to postpartum AUC of 0.98 (90%CI 0.71-1.35). Despite the increased dose, M8 AUC was lower during the third trimester compared to postpartum (0.53, IQR [0.38-0.75]), as was the M8/NFV AUC ratio (0.51, IQR [0.42-0.63]). NFV AUC0-12 was above target in 15 of 18 (83%) of participants during the third trimester compared to 14 of 16 (88%) postpartum. No major safety concerns were noted. Increasing the NFV dose to 1875 mg twice daily during the third trimester achieved similar concentrations postpartum compared to standard dosing (1250 mg twice daily). Increased NFV dose regimens may still have some benefit to human immunodeficiency virus (HIV)-positive pregnant women living in countries where novel protease inhibitors are currently unavailable or in individuals who are intolerant to ritonavir-boosted HIV medications.
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- 2019
10. Congenital Cytomegalovirus and HIV Perinatal Transmission
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Adachi, Kristina, Xu, Jiahong, Ank, Bonnie, Watts, D Heather, Camarca, Margaret, Mofenson, Lynne M, Pilotto, Jose Henrique, Joao, Esau, Gray, Glenda, Theron, Gerhard, Santos, Breno, Fonseca, Rosana, Kreitchmann, Regis, Pinto, Jorge, Mussi-Pinhata, Marisa M, Machado, Daisy Maria, Ceriotto, Mariana, Morgado, Mariza G, Bryson, Yvonne J, Veloso, Valdilea G, Grinsztejn, Beatriz, Mirochnick, Mark, Moye, Jack, and Nielsen-Saines, Karin
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Reproductive Medicine ,Medical Microbiology ,Biomedical and Clinical Sciences ,HIV/AIDS ,Pediatric ,Perinatal Period - Conditions Originating in Perinatal Period ,Pediatric AIDS ,Clinical Research ,Infectious Diseases ,Conditions Affecting the Embryonic and Fetal Periods ,Aetiology ,2.2 Factors relating to the physical environment ,Infection ,Reproductive health and childbirth ,Good Health and Well Being ,Anti-Retroviral Agents ,Cohort Studies ,Cytomegalovirus ,Cytomegalovirus Infections ,DNA ,Viral ,Female ,HIV Infections ,Humans ,Infant ,Infant ,Newborn ,Infectious Disease Transmission ,Vertical ,Pregnancy ,Pregnancy Complications ,Infectious ,Real-Time Polymerase Chain Reaction ,Risk Factors ,Viral Load ,congenital CMV ,HIV MTCT ,HIV perinatal transmission ,MPH for the NICHD HPTN 040 Study Team ,Paediatrics and Reproductive Medicine ,Public Health and Health Services ,Pediatrics ,Clinical sciences ,Paediatrics - Abstract
BackgroundCongenital cytomegalovirus (CMV) infection (cCMV) is an important cause of hearing loss and cognitive impairment. Prior studies suggest that HIV-exposed children are at higher risk of acquiring cCMV. We assessed the presence, magnitude and risk factors associated with cCMV among infants born to HIV-infected women, who were not receiving antiretrovirals during pregnancy.MethodscCMV and urinary CMV load were determined in a cohort of infants born to HIV-infected women not receiving antiretrovirals during pregnancy. Neonatal urines obtained at birth were tested for CMV DNA by qualitative and reflex quantitative real-time polymerase chain reaction.ResultsUrine specimens were available for 992 (58.9%) of 1684 infants; 64 (6.5%) were CMV-positive. Mean CMV load (VL) was 470,276 copies/ml (range: < 200-2,000,000 copies/ml). Among 89 HIV-infected infants, 16 (18%) had cCMV versus 42 (4.9%) of 858 HIV-exposed, uninfected infants (P < 0.0001). cCMV was present in 23.2% of infants with in utero and 9.1% infants with intrapartum HIV infection (P < 0.0001). Rates of cCMV among HIV-infected infants were 4-fold greater (adjusted OR, 4.4; 95% CI: 2.3-8.2) and 6-fold greater among HIV in utero-infected infants (adjusted OR, 6; 95% CI: 3-12.1) compared with HIV-exposed, uninfected infants. cCMV was not associated with mode of delivery, gestational age, Apgar scores, 6-month infant mortality, maternal age, race/ethnicity, HIV viral load or CD4 count. Primary cCMV risk factors included infant HIV-infection, particularly in utero infection.ConclusionHigh rates of cCMV with high urinary CMV VL were observed in HIV-exposed infants. In utero HIV infection appears to be a major risk factor for cCMV in infants whose mothers have not received combination antiretroviral therapy in pregnancy.
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- 2018
11. Benefits and Risks of Antiretroviral Therapy for Perinatal HIV Prevention
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Fowler, Mary G, Qin, Min, Fiscus, Susan A, Currier, Judith S, Flynn, Patricia M, Chipato, Tsungai, McIntyre, James, Gnanashanmugam, Devasena, Siberry, George K, Coletti, Anne S, Taha, Taha E, Klingman, Karin L, Martinson, Francis E, Owor, Maxensia, Violari, Avy, Moodley, Dhayendre, Theron, Gerhard B, Bhosale, Ramesh, Bobat, Raziya, Chi, Benjamin H, Strehlau, Renate, Mlay, Pendo, Loftis, Amy J, Browning, Renee, Fenton, Terence, Purdue, Lynette, Basar, Michael, Shapiro, David E, and Mofenson, Lynne M
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Reproductive Medicine ,Biomedical and Clinical Sciences ,Infant Mortality ,Clinical Research ,Clinical Trials and Supportive Activities ,Preterm ,Low Birth Weight and Health of the Newborn ,Perinatal Period - Conditions Originating in Perinatal Period ,Pediatric ,Prevention ,HIV/AIDS ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Reproductive health and childbirth ,Infection ,Good Health and Well Being ,Adult ,Black or African American ,Anti-Retroviral Agents ,CD4 Lymphocyte Count ,Drug Therapy ,Combination ,Female ,Gestational Age ,HIV Infections ,Humans ,Infant ,Infant ,Low Birth Weight ,Infant ,Newborn ,Infant ,Premature ,Infectious Disease Transmission ,Vertical ,Nevirapine ,Perinatal Care ,Pregnancy ,Pregnancy Outcome ,Tenofovir ,Young Adult ,Zidovudine ,IMPAACT 1077BF/1077FF PROMISE Study Team ,Medical and Health Sciences ,General & Internal Medicine ,Biomedical and clinical sciences ,Health sciences - Abstract
BackgroundRandomized-trial data on the risks and benefits of antiretroviral therapy (ART) as compared with zidovudine and single-dose nevirapine to prevent transmission of the human immunodeficiency virus (HIV) in HIV-infected pregnant women with high CD4 counts are lacking.MethodsWe randomly assigned HIV-infected women at 14 or more weeks of gestation with CD4 counts of at least 350 cells per cubic millimeter to zidovudine and single-dose nevirapine plus a 1-to-2-week postpartum "tail" of tenofovir and emtricitabine (zidovudine alone); zidovudine, lamivudine, and lopinavir-ritonavir (zidovudine-based ART); or tenofovir, emtricitabine, and lopinavir-ritonavir (tenofovir-based ART). The primary outcomes were HIV transmission at 1 week of age in the infant and maternal and infant safety.ResultsThe median CD4 count was 530 cells per cubic millimeter among 3490 primarily black African HIV-infected women enrolled at a median of 26 weeks of gestation (interquartile range, 21 to 30). The rate of transmission was significantly lower with ART than with zidovudine alone (0.5% in the combined ART groups vs. 1.8%; difference, -1.3 percentage points; repeated confidence interval, -2.1 to -0.4). However, the rate of maternal grade 2 to 4 adverse events was significantly higher with zidovudine-based ART than with zidovudine alone (21.1% vs. 17.3%, P=0.008), and the rate of grade 2 to 4 abnormal blood chemical values was higher with tenofovir-based ART than with zidovudine alone (2.9% vs. 0.8%, P=0.03). Adverse events did not differ significantly between the ART groups (P>0.99). A birth weight of less than 2500 g was more frequent with zidovudine-based ART than with zidovudine alone (23.0% vs. 12.0%, P
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- 2016
12. The Antiretroviral Pregnancy Registry: Three decades of prospective monitoring for birth defects.
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Albano, Jessica D., Scheuerle, Angela E., Watts, D. Heather, Beckerman, Karen P., Mofenson, Lynne M., Pikis, Andreas, Vannappagari, Vani, Seekins, Daniel, Cook, Taylor S., and Tilson, Hugh
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Purpose: Antiretrovirals (ARVs) are life‐saving drugs used for the treatment and prevention of HIV infection and antiviral drugs (AVs) for the treatment of chronic HBV infection. ARVs have proven highly effective in reducing perinatal HIV transmission, however the risk of birth defects from prenatal exposure to ARVs/AVs is an ongoing concern. The Antiretroviral Pregnancy Registry (APR), an international, prospective exposure‐registration cohort study, monitors ARV and AV use in pregnancy for early signals of teratogenicity. This communication reports results of 30‐years' experience of ARV/AV exposure during pregnancy and lessons learned through continuous quality improvement. Methods and Results: Birth defect prevalence is estimated and compared to internal and external groups. Statistical inference is based on exact methods for binomial proportions. Between 2006 and 2023, cumulative enrollment more than tripled from 6893 to 25 960 pregnancies and ARVs/AVs monitored increased from 29 to 222. Through January 2023, there were 21 636 live births and 631 outcomes with birth defects, for overall prevalence of 2.9/100 live births (95% CI 2.7, 3.2). The birth defect prevalence was 3.0% (95% CI 2.7%, 3.3%) among first trimester exposures and 2.8% (95% CI 2.5%, 3.2%) among second/third trimester exposures (prevalence ratio 1.04 [95% CI 0.89, 1.21]). Conclusions: Birth defect prevalence is not statistically significantly different between first trimester ARV/AV pregnancy exposures compared to second/third trimester exposures and is also not different from two population‐based surveillance systems: 2.72/100 live births reported in the Metropolitan Atlanta Congenital Defects Program (MACDP); and 4.17/100 live births from the Texas Birth Defects Registry (TBDR). [ABSTRACT FROM AUTHOR]
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- 2024
- Full Text
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13. Toward Earlier Inclusion of Pregnant and Postpartum Women in Tuberculosis Drug Trials: Consensus Statements From an International Expert Panel
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Gupta, Amita, Mathad, Jyoti S, Abdel-Rahman, Susan M, Albano, Jessica D, Botgros, Radu, Brown, Vikki, Browning, Renee S, Dawson, Liza, Dooley, Kelly E, Gnanashanmugam, Devasena, Grinsztejn, Beatriz, Hernandez-Diaz, Sonia, Jean-Philippe, Patrick, Kim, Peter, Lyerly, Anne D, Mirochnick, Mark, Mofenson, Lynne M, Montepiedra, Grace, Piper, Jeanna, Sahin, Leyla, Savic, Radojka, Smith, Betsy, Spiegel, Hans, Swaminathan, Soumya, Watts, D Heather, and White, Amina
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Reproductive Medicine ,Biomedical and Clinical Sciences ,Clinical Trials and Supportive Activities ,Prevention ,Infectious Diseases ,Rare Diseases ,Tuberculosis ,Orphan Drug ,Clinical Research ,Development of treatments and therapeutic interventions ,5.1 Pharmaceuticals ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Infection ,Reproductive health and childbirth ,Good Health and Well Being ,Adult ,Antitubercular Agents ,Clinical Trials as Topic ,Female ,HIV Infections ,Humans ,Latent Tuberculosis ,Postpartum Period ,Pregnancy ,Tuberculosis ,Multidrug-Resistant ,United States ,tuberculosis ,MDR tuberculosis ,latent tuberculosis infection ,pregnancy ,clinical trials ,Biological Sciences ,Medical and Health Sciences ,Microbiology ,Clinical sciences - Abstract
Tuberculosis is a major cause of morbidity and mortality in women of childbearing age (15-44 years). Despite increased tuberculosis risk during pregnancy, optimal clinical treatment remains unclear: safety, tolerability, and pharmacokinetic data for many tuberculosis drugs are lacking, and trials of promising new tuberculosis drugs exclude pregnant women. To advance inclusion of pregnant and postpartum women in tuberculosis drug trials, the US National Institutes of Health convened an international expert panel. Discussions generated consensus statements (>75% agreement among panelists) identifying high-priority research areas during pregnancy, including: (1) preventing progression of latent tuberculosis infection, especially in women coinfected with human immunodeficiency virus; (2) evaluating new agents/regimens for treatment of multidrug-resistant tuberculosis; and (3) evaluating safety, tolerability and pharmacokinetics of tuberculosis drugs already in use during pregnancy and postpartum. Incorporating pregnant women into clinical trials would extend evidence-based tuberculosis prevention and treatment standards to this special population.
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- 2016
14. Reply to Kojima and Klausner
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Nachega, Jean B., Sam-Agudu, Nadia A., Mofenson, Lynne M., Schechter, Mauro, and Mellors, John W.
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- 2018
15. Surveillance of ARV safety in pregnancy and breastfeeding: towards a new framework
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Renaud, Françoise, Mofenson, Lynne M., Bakker, Charlotte, Dolk, Helen, Leroy, Valeriane, Namiba, Angelina, Sahin, Leyla, Shapiro, Roger, Slogrove, Amy, Thorne, Claire, Vicari, Marissa, Low?Beer, Daniel, and Doherty, Meg
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Safety regulations -- Evaluation ,Birth defects -- Prevention ,Breast feeding -- Health aspects ,Antiviral agents -- Testing -- Complications and side effects ,Sentinel health events -- Methods -- Standards ,Clinical trials -- Methods -- Standards ,Data entry -- Methods -- Standards ,Pharmaceutical research -- Standards ,Pregnant women -- Drug therapy ,HIV infection -- Drug therapy ,Health - Abstract
: Introduction: As new antiretrovirals (ARVs), including long‐acting ARVs for treatment and prevention, are approved and introduced, surveillance during pregnancy must become the safety net for evaluating birth outcomes, especially those that are rare and require large numbers of observations. Historically, drug pharmacovigilance in pregnancy has been limited and fragmented between different data sources, resulting in inadequate data to assess risk. The International Maternal Pediatric Adolescent AIDS Clinical Trials Network and World Health Organization convened a Workshop which reviewed strengths and weaknesses of existing programs and discussed an improved framework to integrate existing safety data sources and promote harmonization and digitalization. Discussion: This paper highlights that although robust sources of safety data and surveillance programs exist, key challenges remain, including unknown denominators, reporting bias, under‐reporting (e.g. in voluntary registries), few data sources from resource‐limited settings (most are in North America and Europe), incomplete or inaccurate data (e.g. within routine medical records). However, recent experiences (e.g. with safety signals) and current innovations (e.g. electronic record use in resource‐limited settings and defining adverse outcomes) provide momentum and building blocks for a new framework for active surveillance of ARV safety in pregnancy. A public health approach should be taken using data from existing sources, including registries of pregnancy ARV exposure and birth defects; observational surveillance and cohort studies; clinical trials; and real‐world databases. Key facilitators are harmonization and standardization of outcomes, sharing of materials and tools, and data linkages between programs. Other key facilitators include the development of guidance to estimate sample size and duration of surveillance, ensuring strategic geographic diversity, bringing partners together to share information and engaging the community of women living with HIV. Conclusions: Looking ahead, critical steps to safely introduce new ARVs include (1) adopting harmonized standards for measuring adverse maternal, birth and infant outcomes; (2) establishing surveillance centres of excellence in areas with high HIV prevalence with harmonized data collection and optimized electronic health records linking maternal/infant data; and (3) creating targets and evaluation goals for reporting progress on implementation and quality of surveillance in pregnancy. The platform will be leveraged to ensure that appropriate contributions and strategic actions by relevant stakeholders are implemented., INTRODUCTION Data on new antiretroviral (ARV) drugs in pregnancy are often delayed until years after initial approval [1, 2]. Additionally, the most vulnerable period for adverse foetal effects is in [...]
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- 2022
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16. Pregnancy and medicines: time for paradigm change
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Saint?Raymond, Agnes and Mofenson, Lynne M.
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Drug approval -- Laws, regulations and rules -- Ethical aspects ,Pregnant women -- Drug therapy ,Government regulation ,Health - Abstract
There is a persistent scarcity of data to support clinical decision making regarding approval and use of drugs, biologics and vaccines in pregnant people, putting them at risk of inadequate, [...]
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- 2022
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17. Accelerating progress towards the elimination of mother-to-child transmission of HIV: a narrative review
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Chi, Benjamin H., Mbori-Ngacha, Dorothy, Essajee, Shaffiq, Mofenson, Lynne M., Tsiouris, Fatima, Mahy, Mary, and Luo, Chewe
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AIDS treatment ,Infants ,Highly active antiretroviral therapy ,Evidence-based medicine ,Disease transmission -- Prevention -- Care and treatment ,HIV tests ,Child health ,HIV -- Care and treatment -- Prevention ,Sexually transmitted disease prevention ,Pregnant women -- Care and treatment ,Breast feeding ,Health ,World Health Organization ,United Nations. Children's Fund - Abstract
Introduction: Findings from biomedical, behavioural and implementation studies provide a rich foundation to guide programmatic efforts for the prevention of mother-to-child HIV transmission (PMTCT). Methods: We summarized the current evidence base to support policy makers, programme managers, funding agencies and other stakeholders in designing and optimizing PMTCT programmes. We searched the scientific literature for PMTCT interventions in the era of universal antiretroviral therapy for pregnant and breastfeeding women (i.e. 2013 onward). Where evidence was sparse, relevant studies from the general HIV treatment literature or from prior eras of PMTCT programme implementation were also considered. Studies were organized into six categories: HIV prevention services for women, timely access to HIV testing, timely access to ART, programme retention and adherence support, timely engagement in antenatal care and services for infants at highest risk of HIV acquisition. These were mapped to specific missed opportunities identified by the UNAIDS Spectrum model and embedded in UNICEF operational guidance to optimize PMTCT services. Results and discussion: From May to November 2019, we identified numerous promising, evidence-based strategies that, properly tailored and adopted, could contribute to population reductions in vertical HIV transmission. These spanned the HIV and maternal and child health literature, emphasizing the importance of continued alignment and integration of services. We observed overlap between several intervention domains, suggesting potential for synergies and increased downstream impact. Common themes included integration of facility-based healthcare; decentralization of health services from facilities to communities; and engagement of partners, peers and lay workers for social support. Approaches to ensure early HIV diagnosis and treatment prior to pregnancy would strengthen care across the maternal lifespan and should be promoted in the context of PMTCT. Conclusions: A wide range of effective strategies exist to improve PMTCT access, uptake and retention. Programmes should carefully consider, prioritize and plan those that are most appropriate for the local setting and best address existing gaps in PMTCT health services. Keywords: HIV prevention; children; elimination of mother-to-child transmission; prevention of mother-to-child transmission; globa, 1 | INTRODUCTION Significant achievements have been made in the prevention of mother-to-child HIV transmission (PMTCT), transforming the paediatric HIV epidemic globally. With new innovations, strong political will and rapid [...]
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- 2020
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18. Emerging evidence from a systematic review of safety of preexposure prophylaxis for pregnant and postpartum women: where are we now and where are we heading?
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Davey, Dvora L. Joseph, Pintye, Jillian, Baeten, Jared M., Aldrovandi, Grace, Baggaley, Rachel, Bekker, Linda-Gail, Celum, Connie, Chi, Benjamin H., Coates, Thomas J., Haberer, Jessica E., Heffron, Renee, Kinuthia, John, Matthews, Lynn T., McIntyre, James, Moodley, Dhayendre, Mofenson, Lynne M., Mugo, Nelly, Myer, Landon, Mujugira, Andrew, Shoptaw, Steven, Stranix-Chibanda, Lynda, and John-Stewart, Grace
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United States. National Institutes of Health ,Infants -- Comparative analysis ,Prophylaxis -- Comparative analysis ,HIV infections -- Prevention ,Child development -- Comparative analysis ,Medical research -- Comparative analysis ,HIV -- Prevention ,Infection -- Prevention ,Tenofovir -- Comparative analysis ,Pregnancy -- Comparative analysis ,Pregnant women -- Comparative analysis ,Genetic disorders -- Prevention ,Breast feeding -- Comparative analysis ,Health ,World Health Organization - Abstract
Introduction: HIV incidence is high during pregnancy and breastfeeding with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are not pregnant. The World Health Organization recommends offering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV infection. However, maternal PrEP national guidelines differ and most countries with high maternal HIV incidence are not offering PrEP. We conducted a systematic review of recent research on PrEP safety in pregnancy to inform national policy and rollout. Methods: We used a standard Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) approach to conduct a systematic review by searching for completed, ongoing, or planned PrEP in pregnancy projects or studies from clinicaltrials.gov, PubMed and NIH RePORTER from 2014 to March 2019. We performed a systematic review of studies that assess tenofovir disoproxil fumarate (TDF)-based oral PrEP safety in pregnant and breastfeeding HIV-uninfected women. Results and discussion: We identified 14 completed (n = 5) and ongoing/planned (n = 9) studies that evaluate maternal and/or infant outcomes following PrEP exposure during pregnancy or breastfeeding. None of the completed studies found differences in pregnancy or perinatal outcomes associated with PrEP exposure. Nine ongoing studies, to be completed by 2022, will provide data on >6200 additional PrEP-exposed pregnancies and assess perinatal, infant growth and bone health outcomes, expanding by sixfold the data on PrEP safety in pregnancy. Research gaps include limited data on (1) accurately measured PrEP exposure within maternal and infant populations including drug levels needed for maternal protection; (2) uncommon perinatal outcomes (e.g. congenital anomalies); (3) infant outcomes such as bone growth beyond one year following PrEP exposure; (4) outcomes in HIV-uninfected women who use PrEP during pregnancy and/or lactation. Conclusions: Expanding delivery of PrEP is an essential strategy to reduce HIV incidence in pregnancy and breastfeeding women. Early safety studies of PrEP among pregnant women without HIV infection are reassuring and ongoing/planned studies will contribute extensive new data to bolster the safety profile of PrEP use in pregnancy. However, addressing research gaps is essential to expanding PrEP delivery for women in the context of pregnancy. Keywords: preexposure prophylaxis; PrEP; pregnancy; breastfeeding; PMTCT; prevention of mother to child transmission; HIV, 1 | INTRODUCTION HIV incidence is high during pregnancy and breastfeeding [1] with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are [...]
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- 2020
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19. Pharmacokinetics of Once Versus Twice Daily Darunavir in Pregnant HIV-Infected Women.
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Stek, Alice, Best, Brookie M, Wang, Jiajia, Capparelli, Edmund V, Burchett, Sandra K, Kreitchmann, Regis, Rungruengthanakit, Kittipong, Cressey, Tim R, Mofenson, Lynne M, Smith, Elizabeth, Shapiro, David, and Mirochnick, Mark
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Plasma ,Humans ,Pregnancy Complications ,Infectious ,HIV Infections ,Sulfonamides ,Ritonavir ,Anti-HIV Agents ,Chromatography ,High Pressure Liquid ,Cohort Studies ,Prospective Studies ,Pregnancy ,Adolescent ,Adult ,Female ,Young Adult ,Darunavir ,Pregnancy Complications ,Infectious ,Chromatography ,High Pressure Liquid ,Virology ,Clinical Sciences ,Public Health and Health Services - Abstract
ObjectiveTo describe darunavir (DRV) pharmacokinetics with once-and twice-daily dosing during pregnancy and postpartum in HIV-infected women.DesignWomen were enrolled in International Maternal Pediatric Adolescent AIDS Clinical Trials Network Protocol P1026s, a prospective nonblinded study of antiretroviral pharmacokinetics in HIV-infected pregnant women that included separate cohorts receiving DRV/ritonavir dosed at either 800 mg/100 mg once daily or 600 mg/100 mg twice daily.MethodsIntensive steady-state 12- or 24-hour pharmacokinetic profiles were performed during the second trimester, third trimester, and postpartum. DRV was measured using high-performance liquid chromatography (detection limit: 0.09 μg/mL).ResultsPharmacokinetic data were available for 64 women (30 once daily and 34 twice daily dosing). Median DRV area under the concentration-time curve (AUC) and maximum concentration were significantly reduced during pregnancy with both dosing regimens compared with postpartum, whereas the last measurable concentration (Clast) was also reduced during pregnancy with once daily DRV. DRV AUC with once daily dosing was reduced by 38% during the second trimester and by 39% during the third trimester. With twice daily dosing, DRV AUC was reduced by 26% in both trimesters. The median (range) ratio of cord blood/maternal delivery DRV concentration in 32 paired samples was 0.18 (range: 0-0.82).ConclusionsDRV exposure is reduced by pregnancy. To achieve DRV plasma concentrations during pregnancy equivalent to those seen in nonpregnant adults, an increased twice daily dose may be necessary. This may be especially important for treatment-experienced women who may have developed antiretroviral resistance mutations.
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- 2015
20. COVID-19 in pregnant women: a systematic review and meta-analysis on the risk and prevalence of pregnancy loss.
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Baar, Janneke A C van, Kostova, Elena B, Allotey, John, Thangaratinam, Shakila, Zamora, Javier R, Bonet, Mercedes, Kim, Caron Rahn, Mofenson, Lynne M, Kunst, Heinke, Khalil, Asma, Leeuwen, Elisabeth van, Keijzer, Julia, Strikwerda, Marije, Clark, Bethany, Verschuuren, Maxime, Coomarasamy, Arri, Goddijn, Mariëtte, Wely, Madelon van, and Consortium, PregCOV-19 Living Systematic Review
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MISCARRIAGE ,SARS-CoV-2 ,PREGNANT women ,COVID-19 ,ABORTION - Abstract
BACKGROUND Pregnant women infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are more likely to experience preterm birth and their neonates are more likely to be stillborn or admitted to a neonatal unit. The World Health Organization declared in May 2023 an end to the coronavirus disease 2019 (COVID-19) pandemic as a global health emergency. However, pregnant women are still becoming infected with SARS-CoV-2 and there is limited information available regarding the effect of SARS-CoV-2 infection in early pregnancy on pregnancy outcomes. OBJECTIVE AND RATIONALE We conducted this systematic review to determine the prevalence of early pregnancy loss in women with SARS-Cov-2 infection and compare the risk to pregnant women without SARS-CoV-2 infection. SEARCH METHODS Our systematic review is based on a prospectively registered protocol. The search of PregCov19 consortium was supplemented with an extra electronic search specifically on pregnancy loss in pregnant women infected with SARS-CoV-2 up to 10 March 2023 in PubMed, Google Scholar, and LitCovid. We included retrospective and prospective studies of pregnant women with SARS-CoV-2 infection, provided that they contained information on pregnancy losses in the first and/or second trimester. Primary outcome was miscarriage defined as a pregnancy loss before 20 weeks of gestation, however, studies that reported loss up to 22 or 24 weeks were also included. Additionally, we report on studies that defined the pregnancy loss to occur at the first and/or second trimester of pregnancy without specifying gestational age, and for second trimester miscarriage only when the study presented stillbirths and/or foetal losses separately from miscarriages. Data were stratified into first and second trimester. Secondary outcomes were ectopic pregnancy (any extra-uterine pregnancy), and termination of pregnancy. At least three researchers independently extracted the data and assessed study quality. We calculated odds ratios (OR) and risk differences (RDs) with corresponding 95% CI and pooled the data using random effects meta-analysis. To estimate risk prevalence, we performed meta-analysis on proportions. Heterogeneity was assessed by I
2 . OUTCOMES We included 120 studies comprising a total of 168 444 pregnant women with SARS-CoV-2 infection; of which 18 233 women were in their first or second trimester of pregnancy. Evidence level was considered to be of low to moderate certainty, mostly owing to selection bias. We did not find evidence of an association between SARS-CoV-2 infection and miscarriage (OR 1.10, 95% CI 0.81–1.48; I2 = 0.0%; RD 0.0012, 95% CI −0.0103 to 0.0127; I2 = 0%; 9 studies, 4439 women). Miscarriage occurred in 9.9% (95% CI 6.2–14.0%; I2 = 68%; 46 studies, 1797 women) of the women with SARS CoV-2 infection in their first trimester and in 1.2% (95% CI 0.3–2.4%; I2 = 34%; 33 studies; 3159 women) in the second trimester. The proportion of ectopic pregnancies in women with SARS-CoV-2 infection was 1.4% (95% CI 0.02–4.2%; I2 = 66%; 14 studies, 950 women). Termination of pregnancy occurred in 0.6% of the women (95% CI 0.01–1.6%; I2 = 79%; 39 studies; 1166 women). WIDER IMPLICATIONS Our study found no indication that SARS-CoV-2 infection in the first or second trimester increases the risk of miscarriages. To provide better risk estimates, well-designed studies are needed that include pregnant women with and without SARS-CoV-2 infection at conception and early pregnancy and consider the association of clinical manifestation and severity of SARS-CoV-2 infection with pregnancy loss, as well as potential confounding factors such as previous pregnancy loss. For clinical practice, pregnant women should still be advised to take precautions to avoid risk of SARS-CoV-2 exposure and receive SARS-CoV-2 vaccination. [ABSTRACT FROM AUTHOR]- Published
- 2024
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21. Risk of HIV Acquisition During Pregnancy and Postpartum : A Call for Action
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Mofenson, Lynne M.
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- 2018
22. Achieving Viral Suppression in 90% of People Living With Human Immunodeficiency Virus on Antiretroviral Therapy in Low- and Middle-Income Countries : Progress, Challenges, and Opportunities
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Nachega, Jean B., Sam-Agudu, Nadia A., Mofenson, Lynne M., Schechter, Mauro, and Mellors, John W.
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- 2018
23. Enhanced and timely investigation of ARVs for use in pregnant women
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Abrams, Elaine J, Mofenson, Lynne M, Pozniak, Anton, Lockman, Shahin, Colbers, Angela, Belew, Yodit, Clayden, Polly, Mirochnick, Mark, Siberry, George K, Ford, Nathan, Khoo, Saye, Renaud, Francoise, Vitoria, Marco, Francois Venter, Willem Daniel, Doherty, Meg, and Penazzato, Martina
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- 2020
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24. Enhanced and Timely Investigation of ARVs for Use in Pregnant Women
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Abrams, Elaine J., Mofenson, Lynne M., Pozniak, Anton, Lockman, Shahin, Colbers, Angela, Belew, Yodit, Clayden, Polly, Mirochnick, Mark, Siberry, George K., Ford, Nathan, Khoo, Saye, Renaud, Francoise, Vitoria, Marco, Venter, Willem D. F., Doherty, Meg, and Penazzato, Martina
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- 2021
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25. Cognitive Function and Neurodevelopmental Outcomes in HIV-infected Children Older Than 1 Year of Age Randomized to Early Versus Deferred Antiretroviral Therapy
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Puthanakit, Thanyawee, Ananworanich, Jintanat, Vonthanak, Saphonn, Kosalaraksa, Hansudewechakul, Rawiwan, van der Lugt, Jasper, Kerr, Stephen J, Kanjanavanit, Suparat, Ngampiyaskul, Chaiwat, Wongsawat, Jurai, Luesomboon, Wicharn, Vibol, Ung, Pruksakaew, Kanchana, Suwarnlerk, Tulathip, Apornpong, Tanakorn, Ratanadilok, Kattiya, Paul, Robert, Mofenson, Lynne M, Fox, Lawrence, Valcour, Victor, Brouwers, Pim, and Ruxrungtham, Kiat
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Prevention ,Pediatric ,Mental Health ,Neurosciences ,HIV/AIDS ,Clinical Trials and Supportive Activities ,Behavioral and Social Science ,Infectious Diseases ,Clinical Research ,Good Health and Well Being ,Anti-HIV Agents ,Cambodia ,Child ,Child ,Preschool ,Cognitive Dysfunction ,Cohort Studies ,Drug Administration Schedule ,Female ,HIV Infections ,Humans ,Infant ,Intelligence Tests ,Male ,Thailand ,Treatment Outcome ,HIV ,children ,antiretroviral therapy ,neurodevelopment ,resource-limited settings ,PREDICT Study Group ,Paediatrics and Reproductive Medicine ,Public Health and Health Services ,Pediatrics - Abstract
BackgroundWe previously reported similar AIDS-free survival at 3 years in children who were >1 year old initiating antiretroviral therapy (ART) and randomized to early versus deferred ART in the Pediatric Randomized to Early versus Deferred Initiation in Cambodia and Thailand (PREDICT) study. We now report neurodevelopmental outcomes.MethodsTwo hundred eighty-four HIV-infected Thai and Cambodian children aged 1-12 years with CD4 counts between 15% and 24% and no AIDS-defining illness were randomized to initiate ART at enrollment ("early," n = 139) or when CD4 count became
- Published
- 2013
26. ‘There are no more secrets’: acceptability of a family-centered model of care for HIV positive children in Eswatini
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Khumalo, Philisiwe N., Katirayi, Leila, Ashburn, Kim, Chouraya, Caspian, Mpango, Lydia, Mthethwa, Nobuhle, and Mofenson, Lynne M.
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- 2020
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27. Cytomegalovirus Urinary Shedding in HIV-infected Pregnant Women and Congenital Cytomegalovirus Infection
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NICHD HPTN 040 Study Team, Adachi, Kristina, Xu, Jiahong, Ank, Bonnie, Watts, D. Heather, Mofenson, Lynne M., Pilotto, Jose Henrique, Joao, Esau, Santos, Breno, Fonseca, Rosana, Kreitchmann, Regis, Pinto, Jorge, Mussi-Pinhata, Marisa M., Gray, Glenda, Theron, Gerhard, Morgado, Mariza G., Bryson, Yvonne J., Veloso, Valdilea G., Klausner, Jeffrey D., Moye, Jack, and Nielsen-Saines, Karin
- Published
- 2017
28. Antiretroviral Treatment of HIV/AIDS During Pregnancy
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Eke, Ahizechukwu C., primary, Lockman, Shahin, additional, and Mofenson, Lynne M., additional
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- 2023
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29. Diagnosis of HIV Infection During Early Infancy: How Early Is Early Enough?
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Mofenson, Lynne M.
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- 2016
30. Timing of initiation of antiretroviral therapy and adverse pregnancy outcomes: a systematic review and meta-analysis
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Uthman, Olalekan A, Nachega, Jean B, Anderson, Jean, Kanters, Steve, Mills, Edward J, Renaud, Françoise, Essajee, Shaffiq, Doherty, Meg C, and Mofenson, Lynne M
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- 2017
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31. SARS-COV-2 Maternal–Child Transmission: Can It Occur Before Delivery and How Do We Prove It?
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Siberry, George K., Reddy, Uma M., and Mofenson, Lynne M.
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- 2020
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32. Public Health Service Task Force Recommendations for the Use of Antiretroviral Drugs in Pregnant Women Infected with HIV-1 for Maternal Health and for Reducing Perinatal HIV-1 Transmission in the United States
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Mofenson, Lynne M.
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- 1998
33. Recent progress in immune-based interventions to prevent HIV-1 transmission to children
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Voronin, Yegor, Jani, Ilesh, Graham, Barney S., Cunningham, Coleen K., Mofenson, Lynne M., Musoke, Philippa M., Permar, Sallie R., and Scarlatti, Gabriella
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Health - Abstract
Globally, 150,000 new paediatric human immunodeficiency virus type 1 (HIV-1) infections occurred in 2015. There remain complex challenges to the global elimination of paediatric HIV-1 infection. Thus, for the global community to achieve elimination of new paediatric HIV-1 infections, innovative approaches need to be explored. Immune-based approaches to prevention of mother-to-child transmission (MTCT) may help fill some of the remaining gaps and provide new opportunities to achieve an AIDS-free generation. Immune-based interventions to prevent MTCT of HIV-1 may include paediatric HIV vaccines and passive immunization approaches. Recent discoveries providing evidence of robust immune responses to HIV in infants open new and exciting prospects for paediatric HIV vaccines. Moreover, successful vaccination of infants has a different set of requirements than vaccination of adults and may be easier to achieve. Proof-of-concept has been established over the last two decades that passively administered HIV-1 Env-specific monoclonal antibody (mAbs) can prevent chimeric simian human immunodeficiency virus (SHIV) transmission to newborn nonhuman primates. There has been tremendous progress in isolating and characterizing broadly neutralizing antibodies to HIV, and clinical testing of these antibodies for treatment and prevention in both infants and adults is a major effort in the field. Immune-based interventions need to be actively explored as they can provide critically important tools to address persistent challenges in MTCT prevention. It is a pivotal time for the field with active discussions on the best strategy to further reduce HIV infection of infants and accomplish the World Health Organization Fast-Track 2030 goals to eliminate new paediatric HIV infections.Keywords: mother-to-child transmission; passive immunization; paediatric vaccine; adolescents; antibodies; HIV, 1 | CHALLENGES IN PREVENTING MOTHER-TO-CHILD HIV-1 TRANSMISSIONGlobally, 150,000 new paediatric human immunodeficiency virus type 1 (HIV-1) infections occurred in 2015 [1]. This number represents a remarkable 70% decrease since [...]
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- 2017
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34. Prioritizing Pregnant Women for Coronavirus Disease 2019 Vaccination in African Countries
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Nachega, Jean B, Sam-Agudu, Nadia A, Siedner, Mark J, Rosenthal, Philip J, Mellors, John W, Zumla, Alimuddin, Hermans, Michel, Ntakwinja, Mukanire B, Mukwege, Denis M, Langenegger, Eduard, Mofenson, Lynne M, African Forum for Research and Education in Health (AFREhealth) Research Collaboration on COVID-19 and Pregnancy, UCL - SSS/IREC/EDIN - Pôle d'endocrinologie, diabète et nutrition, and UCL - (SLuc) Service d'endocrinologie et de nutrition
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sub-Saharan Africa ,Microbiology (medical) ,COVID-19 Vaccines ,SARS-CoV-2 ,Vaccination ,COVID-19 ,Infant ,Infectious Diseases ,Pregnancy ,Humans ,Female ,Pregnant Women ,Prospective Studies - Abstract
Coronavirus disease 2019 (COVID-19) in pregnancy is associated with excess maternal and infant morbidity and mortality in both African and higher-resource settings. Furthermore, mounting evidence demonstrates the safety and efficacy of COVID-19 vaccination for pregnant women and infants. However, national guidelines in many African countries are equivocal or lack recommendations on COVID-19 vaccine in pregnancy. We summarize key data on COVID-19 epidemiology and vaccination among pregnant African women to highlight major barriers to vaccination and recommend 4 interventions. First, policymakers should prioritize pregnant women for COVID-19 vaccination, with a target of 100% coverage. Second, empirically supported public health campaigns should be sustainably implemented to inform and support pregnant women and their healthcare providers in overcoming vaccine hesitancy. Third, COVID-19 vaccination for pregnant women should be expanded to include antenatal care, obstetrics/gynecology, and targeted mass vaccination campaigns. Fourth, national monitoring and evaluation of COVID-19 vaccine uptake, safety, surveillance, and prospective outcomes assessment should be conducted.
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- 2022
35. Antiretroviral Therapy and Adverse Pregnancy Outcome: The Elephant in the Room?
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Mofenson, Lynne M.
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- 2016
36. Chlamydia and Gonorrhea in HIV-Infected Pregnant Women and Infant HIV Transmission
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Adachi, Kristina, Klausner, Jeffrey D., Bristow, Claire C., Xu, Jiahong, Ank, Bonnie, Morgado, Mariza G., Watts, D. Heather, Weir, Fred, Persing, David, Mofenson, Lynne M., Veloso, Valdilea G., Pilotto, Jose Henrique, Joao, Esau, and Nielsen-Saines, Karin
- Published
- 2015
37. Crucial need for improved pharmacovigilance in pregnancy
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Mofenson, Lynne M and Abrams, Elaine J
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- 2023
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38. Association of Antiretroviral Drug Regimen With Viral Suppression in HIV-positive Children on Antiretroviral Therapy in Eswatini
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Chouraya, Caspian, Ashburn, Kim, Khumalo, Philisiwe, Mpango, Lydia, Mthethwa, Nobuhle, Machekano, Rhoderick, Guay, Laura, and Mofenson, Lynne M.
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- 2019
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39. Intramuscular 17-hydroxyprogesterone caproate to prevent preterm birth among HIV-infected women in Zambia: study protocol of the IPOP randomized trial
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Price, Joan T., Vwalika, Bellington, Freeman, Bethany L., Cole, Stephen R., Mulenga, Helen B., Winston, Jennifer, Mbewe, Felistas M., Chomba, Elwyn, Mofenson, Lynne M., Rouse, Dwight J., Goldenberg, Robert L., and Stringer, Jeffrey S. A.
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- 2019
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40. Lower Newborn Bone Mineral Content Associated With Maternal Use of Tenofovir Disoproxil Fumarate During Pregnancy
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Pediatric HIV/AIDS Cohort Study, Siberry, George K., Jacobson, Denise L., Kalkwarf, Heidi J., Wu, Julia W., DiMeglio, Linda A., Yogev, Ram, Knapp, Katherine M., Wheeler, Justin J., Butler, Laurie, Hazra, Rohan, Miller, Tracie L., Seage, George R., Van Dyke, Russell B., Barr, Emily, Davtyan, Mariam, Mofenson, Lynne M., and Rich, Kenneth C.
- Published
- 2015
41. EDITORIAL COMMENTARY: New Challenges in the Elimination of Pediatric HIV Infection: The Expanding Population of HIV-Exposed but Uninfected Children
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Mofenson, Lynne M.
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- 2015
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42. Use of Ritonavir-Boosted Nirmatrelvir in Pregnancy
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Siberry, George K, primary, Mofenson, Lynne M, additional, Calmy, Alexandra, additional, Reddy, Uma M, additional, and Abrams, Elaine J, additional
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- 2022
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43. The Need to Study Clinical Outcomes in Children and Adolescents With COVID-19 From Middle- and Low-Income Regions
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Nachega, Jean B., primary, Machekano, Rhoderick N., additional, and Mofenson, Lynne M., additional
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- 2022
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44. 24-month HIV-free survival among infants born to HIV-positive women enrolled in Option B+ program in Kigali, Rwanda: The Kabeho Study
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Gill, Michelle M., Hoffman, Heather J., Ndatimana, Dieudonne, Mugwaneza, Placidie, Guay, Laura, Ndayisaba, Gilles F., Bobrow, Emily A., Asiimwe, Anita, and Mofenson, Lynne M.
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- 2017
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45. Maternal Highly Active Antiretroviral Therapy and Child HIV-Free Survival in Malawi, 2004-2009
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Schwartz, Sheree R., Kumwenda, Newton, Kumwenda, Johnstone, Chen, Shu, Mofenson, Lynne M., Taylor, Allan W., Fowler, Mary Glenn, and Taha, Taha E.
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HIV patients -- Research -- Health aspects ,HIV infections -- Research -- Development and progression -- Care and treatment -- Prevention ,Health care industry - Abstract
Objectives Highly active antiretroviral therapy (HAART) provision to eligible HIV-infected pregnant and post-partum women is critical for optimizing maternal health. We assessed the impact of maternal HAART on HIV-free survival of breastfed infants in Malawi. Methods The post-exposure prophylaxis of infants-Malawi trial (2004-2009) enrolled mothers/infants during labor or immediately post-partum to evaluate 14-week extended infant antiretroviral prophylaxis for preventing HIV transmission through breastfeeding. Mothers meeting national HAART guidelines were referred for therapy. Child HIV-free survival-survival without HIV infection-was compared by maternal HAART status. Results Overall, 3022 mother-infant pairs contributed 4214 infant/person-years (PY) at-risk for HIV infection or death, with 532 events (incidence 12.6/100 PY, 95 % confidence interval [CI] 11.6-13.7). During follow-up, 349 mothers were HAART initiated; 581 remained HAART naïve with CD4 cell counts Clinical Trials Registration This study is registered at http://clinicaltrials.gov/ http://clinicaltrials.gov/ under trial number NCT00115648., Author(s): Sheree R. Schwartz[sup.1] , Newton Kumwenda[sup.1] , Johnstone Kumwenda[sup.2] , Shu Chen[sup.1] , Lynne M. Mofenson[sup.3] , Allan W. Taylor[sup.4] , Mary Glenn Fowler[sup.5] , Taha E. Taha[sup.1] Author [...]
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- 2016
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46. Combination Antiretroviral Use and Preterm Birth
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Pediatric HIV/AIDS Cohort Study, Watts, D. Heather, Williams, Paige L., Kacanek, Deborah, Griner, Raymond, Rich, Kenneth, Hazra, Rohan, Mofenson, Lynne M., and Mendez, Hermann A.
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- 2013
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47. Pooled Individual Data Analysis of 5 Randomized Trials of Infant Nevirapine Prophylaxis to Prevent Breast-Milk HIV-1 Transmission
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Hudgens, Michael G., Taha, Taha E., Omer, Saad B., Jamieson, Denise J., Lee, Hana, Mofenson, Lynne M., Chasela, Charles, Kourtis, Athena P., Kumwenda, Newton, Ruff, Andrea, Bedri, Abubaker, Jackson, J. Brooks, Musoke, Philippa, Bollinger, Robert C., Gupte, Nikhil, Thigpen, Michael C., Taylor, Allan, and van der Horst, Charles
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- 2013
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48. Assessment of Clinical Outcomes Among Children and Adolescents Hospitalized With COVID-19 in 6 Sub-Saharan African Countries
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Nachega, Jean B, Sam-Agudu, Nadia A, Machekano, Rhoderick N, Rabie, Helena, van der Zalm, Marieke M, Redfern, Andrew, Dramowski, Angela, O'Connell, Natasha, Pipo, Michel Tshiasuma, Tshilanda, Marc B, Byamungu, Liliane Nsuli, Masekela, Refiloe, Jeena, Prakash Mohan, Pillay, Ashendri, Gachuno, Onesmus W, Kinuthia, John, Ishoso, Daniel Katuashi, Amoako, Emmanuella, Agyare, Elizabeth, Agbeno, Evans K, Martyn-Dickens, Charles, Sylverken, Justice, Enimil, Anthony, Jibril, Aishatu Mohammed, Abdullahi, Asara M, Amadi, Oma, Umar, Umar Mohammed, Sigwadhi, Lovemore Nyasha, Hermans, Michel, Otokoye, John Otshudiema, Mbala-Kingebeni, Placide, Muyembe-Tamfum, Jean-Jacques, Zumla, Alimuddin, Sewankambo, Nelson K, Aanyu, Hellen Tukamuhebwa, Musoke, Philippa, Suleman, Fatima, Adejumo, Prisca, Noormahomed, Emilia V, Deckelbaum, Richard J, Fowler, Mary Glenn, Tshilolo, Léon, Smith, Gerald, Mills, Edward J, Umar, Lawal W, Siedner, Mark J, Kruger, Mariana, Rosenthal, Philip J, Mellors, John W, Mofenson, Lynne M, African Forum for Research and Education in Health (AFREhealth) COVID-19 Research Collaboration on Children and Adolescents, UCL - SSS/IREC/EDIN - Pôle d'endocrinologie, diabète et nutrition, UCL - (SLuc) Centre de pathologie sexuelle masculine, and UCL - (SLuc) Service d'endocrinologie et de nutrition
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Male ,Adolescent ,SARS-CoV-2 ,Pneumonia, Viral ,Oxygen Inhalation Therapy ,COVID-19 ,Infant ,Length of Stay ,Respiration, Artificial ,Child, Preschool ,Pediatrics, Perinatology and Child Health ,Outcome Assessment, Health Care ,Humans ,Female ,Child ,Child, Hospitalized ,Pandemics ,Africa South of the Sahara - Abstract
IMPORTANCE: Little is known about COVID-19 outcomes among children and adolescents in sub-Saharan Africa, where preexisting comorbidities are prevalent. OBJECTIVE: To assess the clinical outcomes and factors associated with outcomes among children and adolescents hospitalized with COVID-19 in 6 countries in sub-Saharan Africa. DESIGN, SETTING, AND PARTICIPANTS: This cohort study was a retrospective record review of data from 25 hospitals in the Democratic Republic of the Congo, Ghana, Kenya, Nigeria, South Africa, and Uganda from March 1 to December 31, 2020, and included 469 hospitalized patients aged 0 to 19 years with SARS-CoV-2 infection. EXPOSURES: Age, sex, preexisting comorbidities, and region of residence. MAIN OUTCOMES AND MEASURES: An ordinal primary outcome scale was used comprising 5 categories: (1) hospitalization without oxygen supplementation, (2) hospitalization with oxygen supplementation, (3) ICU admission, (4) invasive mechanical ventilation, and (5) death. The secondary outcome was length of hospital stay. RESULTS: Among 469 hospitalized children and adolescents, the median age was 5.9 years (IQR, 1.6-11.1 years); 245 patients (52.4%) were male, and 115 (24.5%) had comorbidities. A total of 39 patients (8.3%) were from central Africa, 172 (36.7%) from eastern Africa, 208 (44.3%) from southern Africa, and 50 (10.7%) from western Africa. Eighteen patients had suspected (n = 6) or confirmed (n = 12) multisystem inflammatory syndrome in children. Thirty-nine patients (8.3%) died, including 22 of 69 patients (31.9%) who required intensive care unit admission and 4 of 18 patients (22.2%) with suspected or confirmed multisystem inflammatory syndrome in children. Among 468 patients, 418 (89.3%) were discharged, and 16 (3.4%) remained hospitalized. The likelihood of outcomes with higher vs lower severity among children younger than 1 year expressed as adjusted odds ratio (aOR) was 4.89 (95% CI, 1.44-16.61) times higher than that of adolescents aged 15 to 19 years. The presence of hypertension (aOR, 5.91; 95% CI, 1.89-18.50), chronic lung disease (aOR, 2.97; 95% CI, 1.65-5.37), or a hematological disorder (aOR, 3.10; 95% CI, 1.04-9.24) was associated with severe outcomes. Age younger than 1 year (adjusted subdistribution hazard ratio [asHR], 0.48; 95% CI, 0.27-0.87), the presence of 1 comorbidity (asHR, 0.54; 95% CI, 0.40-0.72), and the presence of 2 or more comorbidities (asHR, 0.26; 95% CI, 0.18-0.38) were associated with reduced rates of hospital discharge. CONCLUSIONS AND RELEVANCE: In this cohort study of children and adolescents hospitalized with COVID-19 in sub-Saharan Africa, high rates of morbidity and mortality were observed among infants and patients with noncommunicable disease comorbidities, suggesting that COVID-19 vaccination and therapeutic interventions are needed for young populations in this region.
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- 2022
49. Antiretrovirals in Pregnancy: A Note of Caution
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Watts, D. Heather and Mofenson, Lynne M.
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- 2012
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50. Safety of Tenofovir Disoproxil Fumarate–Based Antiretroviral Therapy Regimens in Pregnancy for HIV-Infected Women and Their Infants: A Systematic Review and Meta-Analysis
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Nachega, Jean B., Uthman, Olalekan A., Mofenson, Lynne M., Anderson, Jean R., Kanters, Steve, Renaud, Francoise, Ford, Nathan, Essajee, Shaffiq, Doherty, Meg C., and Mills, Edward J.
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- 2017
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