Timing of combination antiretroviral therapy (<scp>cART</scp>) initiation is not associated with stillbirth among <scp>HIV</scp>‐infected pregnant women in Malawi

Msukwa, Malango; Keiser, Olivia; Jahn, Andreas; Oosterhout, Joep J. van; Edmonds, Andrew; Phiri, Nozgechi; Manjomo, Ronald; Davies, Mary‐Ann; Estill, Janne

doi:10.1111/tmi.13233

Cited by 10 publications

(8 citation statements)

References 37 publications

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“…While a meta-analysis in 2017 suggested preconception ART was associated with higher rates of adverse outcomes, this report included older studies using less optimal ART regimens. 38 Other studies using ART regimens recommended over the past 5 years such as the EFV-based ART regimen used in Lesotho have, similar to our study, not found timing of ART to be associated with adverse outcome 39 – 41 …”

Section: Discussionsupporting

confidence: 76%

Adverse Pregnancy Outcomes Among HIV-positive Women in the Era of Universal Antiretroviral Therapy Remain Elevated Compared With HIV-negative Women

Tukei

Hoffman

Greenberg

et al. 2021

Pediatric Infectious Disease Journal

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Background: Without treatment, HIV infection in pregnant women is associated with adverse pregnancy outcomes. We compared adverse pregnancy outcomes among HIV-positive women on antiretroviral therapy (ART) and HIV-negative women who enrolled for antenatal care in selected health facilities in Maseru district, Lesotho. Methods: We enrolled a cohort of HIV-positive and HIV-negative women at their first antenatal visit and followed them through delivery. Study data on miscarriage, stillbirth, preterm birth, low birth weight and birth defects were collected through participant interviews and medical record abstraction. We used the Rao-Scott χ 2 test and the t test to assess differences in characteristics and outcomes between HIV-positive and HIV-negative women and generalized estimating equations for multivariable analysis. Results: A total of 614 HIV-positive and 390 HIV-negative pregnant women were enrolled in the study with delivery information on 571 (93.1%) and 352 (90.3%) respectively. In the delivery cohort, the median age at enrolment was 28 years for HIV-positive women and 23 years for HIV-negative women with median gestational ages of 20 and 21 weeks, respectively. A total of 149 singleton pregnancies had documented adverse pregnancy outcomes; 33 (9.6%) HIV-negative pregnancies and 116 (20.6%) HIV-positive pregnancies. Compared with their HIV-negative counterparts, HIV-positive women were more likely to experience an adverse pregnancy outcome, adjusted odds ratio (AOR) 2.6 [95% confidence interval (CI): 1.71–3.97]; an intrauterine death (miscarriage or stillbirth), AOR 2.64 [95% CI: 1.25–5.49]; or a low birth weight delivery, AOR 1.89 [95% CI: 1.16–3.09]. Conclusion: Adverse pregnancy outcomes remained 2–3 times higher among HIV-positive women compared with HIV-negative women despite universal ART.

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Section: Discussionsupporting

confidence: 76%

Adverse Pregnancy Outcomes Among HIV-positive Women in the Era of Universal Antiretroviral Therapy Remain Elevated Compared With HIV-negative Women

Tukei

Hoffman

Greenberg

et al. 2021

Pediatric Infectious Disease Journal

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“…This result was in consonance with findings of several other studies in sub-Saharan Africa that reported that a proportion of SB to be in a range of 2.5% - 10%. 12 , 13 Moreover, ART’s positive benefits in reducing SB has been demonstrated in clinical trials, such as the study by Stringer et al 14 in which data from 253 female participants were analyzed; the women became pregnant while participating in three clinical trials: the first study was used by researchers to compare a protease inhibitor-based regimen against a non-nucleoside reverse transcriptase inhibitor-based regimen; in the second study, researchers tested a once-a-day PI-based regimen versus an EFV-based regimen for initial treatment of HIV infection, and in the third study, researchers tested immediate versus delayed ART for prevention of sexual transmission of HIV-1 among serodiscordant couples. Stringer et al recorded 11 episodes of SB across the three trials, equivalent to 4% of the overall study population.…”

Section: Discussionmentioning

confidence: 99%

“…The low proportion of SB in this study supports the growing evidence of ART's positive effect on birth outcomes. [12][13][14] Indeed, HIV infection on its own in pregnant women is associated with a doubled risk of SB. 15 Hence, the researchers' finding may be a reflection of ART's beneficial effect.…”

Section: Proportion Of Pregnancy Outcomes In the Study Cohortmentioning

confidence: 99%

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Pregnancy and Birth Outcomes Among Women on Antiretroviral Therapy: A Long-term Retrospective Analysis of Data from a Major Tertiary Hospital in North Central Nigeria

et al. 2021

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Background and Objective: Antiretroviral therapy (ART) has transformed human immune deficiency virus (HIV) infection from a death sentence to a chronic syndrome, allowing infected individuals to lead near-normal lives, including achieving pregnancy and bearing children. Notwithstanding, concerns remain about the effects of ART in pregnancy. Previous studies suggested contradictory associations between ART and pregnancy. This study determined birth outcomes in pregnant women who accessed ART between 2004 and 2017 at a major tertiary hospital in North Central Nigeria. Methods: This was a retrospective study of 5,080 participants. Ethical clearance was obtained from the Institutional Review Board of the Harvard T. H. Chan School of Public Health Boston. A pro forma for data abstraction was designed and used to collect data. Abstracted data were sorted and managed using SPSS® version 22. The Chi-square test was used to calculate the proportions of pregnancy outcomes. One-way analysis of variance was used to test the effect of antiretroviral drug regimens on mean birth weight and gestational age at delivery. All levels of significance were set at p 0.05. Results: Pregnancy outcomes were recorded as live birth (99.8%), stillbirth (0.2%), preterm delivery (6.6%), and low birth weight (23%). There was a statistically significant association between ART in pregnancy and low birth weight {χ2[(5, n = 3439) = 11.99, p = 0.04]}. The highest mean birth weights were recorded in participants who received drug combinations with protease inhibitors or efavirenz, in contrast to participants who received Nevirapine, stavudine and Emtricitabine/Tenofovirbased regimens. However, there was no significant difference in the gestational age of babies at birth for the six ART regimens in the study. Conclusion and Global Health Implications: Findings support the benefits of ART in pregnancy, which is in line with the testing and treatment policies of the 90-90-90 targets for ending HIV by the year 2030. Copyright © 2021 Dapar et al. Published by Global Health and Education Projects, Inc. This is an open-access article distributed under the terms of the Creative Commons Attribution License CC BY 4.0.

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“…Previous studies of HIV-positive women initiating ART before or during pregnancy have focused on quantifying risk of PTD [1,4,7,38–41] , SGA [4,7,41,42] , LBW [7,38,39] , stillbirth [43] and/or neonatal death [42] ; virologic failure [44] ; MTCT [45] maternal plasma angiogenic factors [46] , and maternal virologic and immunologic responses [47] . This is the first study to investigate placenta pathology in association with timing of ART initiation.…”

Section: Discussionmentioning

confidence: 99%

Associating antiretroviral therapy initiated before or during pregnancy with placenta pathology in HIV infected women

Ikumi

Malaba

Pillay

et al. 2020

Preprint

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Antiretroviral therapy (ART) is universally recommended for all HIV-infected pregnant women to improve survival and to reduce mother-to-child HIV transmission. With widespread use of ART in areas of high HIV prevalence, there is concern that prolonged in-utero ART exposure may result in adverse birth outcomes, such as preterm delivery and low birthweight infants. Underlying drivers of these effects may be found in the placenta. We examined whole placentas from live births to seek an association between timing of ART initiation and pregnancy outcome. This was a nested sub-study in a larger cohort of HIV-infected women recruited in a large primary care antenatal clinic in Cape Town, South Africa. Whole placentas (n=130) were collected at delivery and examined for histopathology from two ART groups. The stable group (n=53) initiated ART prior to pregnancy and the initiating group (n=77) started ART at a median of 15 weeks gestation. Adverse birth outcomes were defined by preterm delivery (PTD n=9), small-for-gestational age (SGA n=12) and low birthweight (LBW n=11) in the two groups. Wilcoxon rank-sum and t-tests were used to measure differences in placental histopathology by ART group. Binomial and univariate linear regression models, chi-squared or Fishers exact test were used to quantify associations between placenta histopathology and maternal factors including ART timing and the association with pregnancy outcome. Women in the stable group were significantly older (median [IQR] 33 years [28 - 37] vs 28 [25 - 32]; p=0.003), had higher CD4 cell counts 455 cells/ml [381 - 602] vs 369.5 [251 - 534.5], p=0.04) and were less likely to be prehypertensive or hypertensive at first antenatal care visit (p=0.03) than women in the initiating group. Overall, 119 (91%), women were on a fixed dose regimen of Tenofovir (TDF) + Lamivudine (3TC) + Efavirenz (EFV) and only 3 (2%; all in the stable group) were on a protease inhibitor (PI)-based regimen with no difference between the groups. Overall, nearly a third of placentas were small, although the fetal-placenta weight ratio was in the normal range for most women. Meconium exposure and chorioamnionitis was seen in 19% and 15% of placentas, respectively. Apart from maternal vascular malperfusion (MVM) and decidual arteriopathy, histopathology observations did not differ significantly between stable and initiating groups. Placentas from the stable group showed increased MVM (39.6% vs 19.4%, p=0.01) and decidual arteriopathy (11.3% vs 1.3%, p=0.02), with a trend of decreased placental weight (392g vs 422g, p=0.09). MVM, in turn, was significantly associated with PTD and LBW (p=0.002 and p<0.0001) and association with SGA was borderline significant (p=0.09). ART initiation prior to pregnancy was associated with an increased risk of maternal vascular malperfusion and decidual arteriopathy, suggestive of placental dysfunction. The association between MVM with PTD and LBW suggests that a placenta-mediated mechanism may link the putative association between ART and adverse birth outcomes.

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Timing of combination antiretroviral therapy (cART) initiation is not associated with stillbirth among HIV‐infected pregnant women in Malawi

Cited by 10 publications

References 37 publications

Adverse Pregnancy Outcomes Among HIV-positive Women in the Era of Universal Antiretroviral Therapy Remain Elevated Compared With HIV-negative Women

Adverse Pregnancy Outcomes Among HIV-positive Women in the Era of Universal Antiretroviral Therapy Remain Elevated Compared With HIV-negative Women

Pregnancy and Birth Outcomes Among Women on Antiretroviral Therapy: A Long-term Retrospective Analysis of Data from a Major Tertiary Hospital in North Central Nigeria

Associating antiretroviral therapy initiated before or during pregnancy with placenta pathology in HIV infected women

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