Antepartum Weight Gain And Adverse Pregnancy Outcomes In IMPAACT 2010

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Antepartum weight gain andadverse pregnancy outcomesin IMPAACT 2010Risa M. Hoffman, Associate Professor of MedicineDavid Geffen School of Medicine at the University of California, Los AngelesJune 23, 2021

Antepartum weight gain and adversepregnancy outcomes in IMPAACT 2010Risa M. Hoffman, Lauren Ziemba, Sean Brummel, Lameck Chinula,Teacler Nematadzira, Frances Nakayiwa, Jeff Stringer, Chelsea Krotje,Patrick Jean-Philippe, Anne Coletti, Rebecca Zash, Roger Shapiro, PaulSax, Judith S. Currier, Shahin Lockman on behalf of IMPAACT 2010 Team

3Background and Rationale ART containing dolutegravir (DTG) and/or tenofovir alafenamidefumarate (TAF) is associated greater weight gain in both nonpregnant and pregnant women1,2 Efavirenz (EFV) and tenofovir disoproxil fumarate (TDF) have beenassociated with low weight gain in pregnancy2 Both insufficient and excessive weight gain in pregnancy have beenassociated with adverse pregnancy outcomes3 IMPAACT 2010: pregnant women with HIV-1 randomized to starttreatment with DTG FTC/TAF, DTG FTC/TDF, or EFV/FTC/TDF Significantly lower rate of adverse pregnancy outcomes in women inDTG FTC/TAF arm than other two arms41-Venter WDF et al NEJM 2019; 2-Caniglia E et al, Eclinical Medicine 2020; 3-Ukah UV et al.PLOS Medicine 2019; 4-Primary outcomes presented at CROI 2020, Abstract 130

Objectives and Methods4 Estimated by-arm differences in average antepartum weeklyweight gain using generalized estimating equations Evaluated associations between weight gain and adversepregnancy outcomes using Cox-proportional hazards regression*: Composite outcome of stillbirth ( 20 wks GA), preterm delivery ( 37 wksGA) and small for gestational age (SGA: 10th percentile) Individual components of the composite outcome Neonatal death Weight categories: low weight gain 0.18 kg/week and highweight gain 0.59 kg/week (Institute of Medicine Guidelines)*Weight included as a time-varying covariate; analyses adjusted forgestational age at baseline

IMPAACT 2010 Study DesignArm 1: Maternal DTG FTC/TAF During Pregnancy and PostpartumKey Eligibility Criteria Pregnant women 14-28weeks gestation ART-naïve

6Enrollment and Weight Data AvailabilityScreened 810Enrolled 643 (79%)Jan 2018 – Feb 2019Participants were enrolled at22 sites in 9 countries(Botswana, Brazil, India, South Africa,Tanzania, Thailand, Uganda, US,Zimbabwe)Antepartum weight dataavailable 643 (100%)Antepartum weight and pregnancy outcome dataavailable 632 (98.3%)

Maternal Baseline CharacteristicsDTG FTC/TAF(N 217)DTG FTC/TDF(N 215)EFV/FTC/TDF(N 211)Total(N 643)26.826.026.626.6187 (86%)189 (88%)188 (89%)564 (88%)Gestational age (median weeks)22.121.322.121.9CD4 count (median cells/mm3)467481439466HIV-1 RNA (median copies/mL)781715135790367.7 (15.1)66.3 (16.8)64.5 (13.3)66.2 (15.2)Age (median years)Enrolled in AfricaEnrollment weight, mean kg(SD)Median duration of antepartum follow-up: 17.4 weeks

8Results: Average Weekly Maternal WeightGain by ArmAverage weekly weight gain (kg)0.5Recommended IOMweight gain 2nd/3rd trimesters(0.42 kg/week)0.4p 0.001p 0.19p 0.0110.3780.30.3190.2910.20.10DTG FTC/TAFDTG FTC/TDFDTG FTC/TAFEFV/FTC/TDF

9Low, Normal, and High Antepartum WeightGain by Arm80%154 (72.3%)141 (66.5%)132 (63.8%)70%60%50%40%30%20%62 (30.0%)50 (23.6%)32 (15.0%)27 (12.7%)10%21 (9.9%)13 (6.3%)0%Low Weight GainDTG FTC/TAFNormal Weight GainDTG FTC/TDFHigh Weight GainEFV/FTC/TDF

Low Antepartum Weight Gain and Adverse10 Pregnancy OutcomesComposite outcome definition: stillbirth ( 20 wks),preterm delivery ( 37 wks), and small forgestational age ( 10th percentile)Adjusted for gestational age stratum at baseline

High Antepartum Weight Gain and Adverse11 Pregnancy OutcomesOver all treatment arms, significant associationbetween higher average weekly weight gain and alower risk of any adverse pregnancy outcome:HR 0.50 (95%CI 0.25-0.97, p 0.04).Composite outcome definition: stillbirth ( 20 wks),preterm delivery ( 37 wks), and small forgestational age ( 10th percentile)Adjusted for gestational age stratum at baseline

12Weight Gain and Composite Adverse Pregnancy Outcome*by ArmLow vsNormalWeightGainHigh vsNormalWeightGainAdjusted forgestationalage stratumat baseline*Compositeoutcomedefinition:stillbirth ( 20wks), pretermdelivery ( 37wks), and smallfor gestationalage ( 10thpercentile)

13Future Analyses and Limitations Further planned analyses Weight gain and severe outcomes (very preterm 32 weeks;very small for gestational age ( 3rd percentile), stillbirth, andneonatal death Weight gain and macrosomia Weight gain and C-section Detailed analysis of postpartum weight through 50 weeks Limitations: lack of pre-pregnancy weight/BMI; predominantly anAfrican population, all women initiated ART in pregnancy

14Conclusions Low weight gain during pregnancy was most common in womenstarting EFV/FTC/TDF and least common with DTG FTC/TAF Low but not high weight gain associated with adverse pregnancyoutcomes Weight gain on DTG FTC/TAF approached average weight gainrecommended in the 2nd/3rd trimester based on IOM standards The lower rate of adverse pregnancy outcomes observed in theDTG FTC/TAF arm could be related to higher antepartum weightgain

AcknowledgementsThe IMPAACT 2010/VESTED Protocol Team gratefully acknowledges the dedication andcommitment of the 643 mother-infant pairs, their communities, and CAB representatives,without whom this study would not have been possible.Sponsors:US National Institutes of Health (Patrick Jean-Philippe,Renee Browning, Lynette Purdue, Nahida Chakhtoura)Gilead Sciences, Mylan, ViiV Healthcare LtdProtocol Co-Chairs: Shahin Lockman and Lameck ChinulaOperations Center: Anne Coletti and Katie McCarthyStatistical and Data Management Center: Sean Brummel,Lauren Ziemba, Benjamin Johnson, Chelsea Krotje, Kevin Knowles,Kyle WhitsonLaboratory Center: Frances Whalen, William Murtaugh,Sikhulile MoyoProtocol Team Investigators: Rivet Amico, Judith Currier, LeeFairlie, Lisa Frenkel, Risa Hoffman, Lew Holmes, GaerolweMasheto, Mark Mirochnick, Jeremiah Momper, Chelsea Morroni,Paul Sax, Roger Shapiro, Lynda Stranix-Chibanda, Jeffrey StringerCommunity: Nagawa Jaliaah, Cheryl BlanchetteSite Investigators of Record:Botswana: Gaborone and Molepolole: Gaerolwe MashetoBrazil: Inst de Puericultura e Pediatria Martagao Gesteira:Elizabeth Machado; Hosp Fed dos Servidores do Estado:Esaú João; SOM Fed Univ Minas Gerais: Jorge Pinto; HospGeral de Nova Iguacu: Jose PilottoIndia: BJMC: Pradeep SambareySouth Africa: Umlazi: Sherika Hanley; FAMCRU: GerhardTheron; Soweto: Haseena Cassim; Wits RHI Shandukani: LeeFairlieTanzania: KCMC: James NgochoThailand: Siriraj: Kulkanya Chokephaibulkit; Chiang Rai:Jullapong Achalapong; Chiang Mai Univ: Linda AurpibulUganda: MUJHU: Deo Wabwire; Baylor-Uganda: Violet KorutaroUnited States: Univ Miami: Gwendolyn Scott; Univ FlJacksonville: Mobeen RathoreZimbabwe: St. Mary’s: Patricia Mandima; Seke North: LyndaStranix-Chibanda; Harare Family Care: Tichaona Vhembo

AcknowledgementsIMPAACT 2010/VESTED is funded by the US National Institutes of Health(NIH).Overall support for the International Maternal Pediatric Adolescent AIDS ClinicalTrials Network (IMPAACT) was provided by the National Institute of Allergy andInfectious Diseases (NIAID) with co-funding from the Eunice Kennedy ShriverNational Institute of Child Health and Human Development (NICHD) and theNational Institute of Mental Health (NIMH), all components of the NationalInstitutes of Health (NIH), under Award Numbers UM1AI068632 (IMPAACTLOC), UM1AI068616 (IMPAACT SDMC) and UM1AI106716 (IMPAACT LC),and by NICHD contract number HHSN275201800001I.The content is solely the responsibility of the authors and does not necessarilyrepresent the official views of the NIH.The study products were provided by ViiV Healthcare Ltd, Gilead Sciences,Mylan.

Weight gain and severe outcomes (very preterm 32 weeks; very small for gestational age ( 3rdpercentile), stillbirth, and neonatal death Weight gain and macrosomia Weight gain and C-section Detailed analysis of postpartum weight through 50 weeks Limitations: lack of pre-pregnancy weight/BMI; predominantly an

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