Benefits and Risks of Antiretroviral Therapy for Perinatal HIV Prevention

Fowler, Mary Glenn; Qin, Min; Fiscus, Susan A.; Currier, Judith S.; Flynn, Patricia M.; Chipato, Tsungai; McIntyre, James; Gnanashanmugam, Devasena; Siberry, George K.; Coletti, Anne; Taha, Taha E.; Klingman, Karin L.; Martinson, Francis; Owor, Maxensia; Violari, Avy; Moodley, Dhayendre; Theron, Gerhard; Bhosale, Ramesh; Bobat, Raziya; Benjamin, H.; Strehlau, Renate; Mlay, Pendo; Loftis, Amy James; Browning, Renee; Fenton, Terence; Purdue, Lynette; Basar, Michael; Shapiro, David E.; Mofenson, Lynne

doi:10.1097/ogx.0000000000000427

Cited by 37 publications

(62 citation statements)

References 12 publications

(14 reference statements)

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“…This wide range of regimen comparisons may also contribute to the different conclusions reached by studies, particularly since there is uncertainty about whether any observed associations are drug specific, with some but not all reports suggesting that the relationship may be driven in part by PI-based regimens (24,75). Randomized data from Mma Bana study (38) was similar to observational studies that associated PI-based regimens with PTD (36, 60), these results were however different from results from the PROMOTE study which found no association between PIbased regimens and PTD (48). The PROMISE study results also showed differences by regimens, although it was the NRTI backbone (TDF+FTC) that was of concern with considerably more severe adverse birth outcomes (VPTD and VLBW) with the TDF+FTC backbone compared to the ZDV+3TC backbone (30).…”

Section: Different Art Regimenssupporting

confidence: 40%

“…However, studies have shown that even among women receiving ART solely for PMTCT (10,60), suggesting that ART itself could be the problem. rates of PTD and that PI regimen was the most significant risk factor for PTD (OR 2.03, 95% CI 1.26 -3.27) (38). These results could help to clarify findings from previous observational studies in high income countries that had conflicting results (12,13,59) or were underpowered to detect differences (63).…”

Section: Adverse Birth Outcomes -Art Era Datacontrasting

confidence: 36%

“…This is demonstrated in the studies conducted in Botswana, the two retrospective cohort studies were able to evaluate outcomes in approximately 10 000 HIV-infected women (32,37) compared to the RCT which only evaluated outcomes 560 HIV-infected women (38).…”

Section: Different Study Designsmentioning

confidence: 92%

“…The majority of studies estimated GA based on the obstetric records, which was primarily based on LMP and SFH (29, 30, 32, 37, 39, 41, 43, 44, 47); while the prospective studies measured GA at enrolment using a combination of estimation methods (34,38,40,48). Problems of availability mean ultrasonography is not routinely used for GA estimation in LMIC, consequently few of the study populations had US-based GA.…”

Section: Outcome Assessmentmentioning

confidence: 99%

“…Eighteen out of the 20 studies reported PTD as an outcome, with eight of the studies also reporting a PTD sub-category (30,32,34,36,38,40,47,48 The WHO definition of PTD was used in all 18 studies that reported PTD as an outcome;…”

Section: Preterm Deliverymentioning

confidence: 99%

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Antiretroviral therapy use during pregnancy and adverse birth outcomes in South African women

Malaba

Phillips

Roux

et al. 2017

International Journal of Epidemiology

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Section: Different Art Regimenssupporting

confidence: 40%

Section: Adverse Birth Outcomes -Art Era Datacontrasting

confidence: 36%

Section: Different Study Designsmentioning

confidence: 92%

Section: Outcome Assessmentmentioning

confidence: 99%

Section: Preterm Deliverymentioning

confidence: 99%

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Antiretroviral therapy use during pregnancy and adverse birth outcomes in South African women

Malaba

Phillips

Roux

et al. 2017

International Journal of Epidemiology

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Resumption of postpartum sexual activity and menses among HIV‐infected women on lifelong antiretroviral treatment compared to HIV‐uninfected women in Africa

Dadabhai

Makanani

Hua

et al. 2020

Intl J Gynecology & Obste

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Objective:To determine time from delivery to resumption of sexual activity and menses among HIV-infected women on antiretroviral treatment (ART) and HIV-uninfected women. Methods:HIV-infected women on ART and HIV-uninfected women were recruited from five health facilities at delivery and followed prospectively for a maximum of 1 year in Blantyre, Malawi from January 2016 to September 2017. Sociodemographic, clinical, and laboratory data were collected at delivery and 1.5, 3, 6, 9, and 12 months. Descriptive, time to event Kaplan-Meier, and multivariable Cox proportional hazards analyses were conducted. Results: Data on 878 women (460 [52.4%] HIV-uninfected and 418 [47.6%] HIVinfected, P=0.156) who attended at least one follow-up visit were analyzed. AmongHIV-uninfected compared to HIV-infected women, respectively, the median number of days to resumption of sexual activity was 180 vs 181; to irregular menses was 82 vs 71; and to regular menses was 245 vs 366. In multivariable models, being married was associated with early resumption of sexual activity (hazard ratio [HR] 1.91, P<0.001), and being HIV-infected and use of an effective method of family planning were associated with later start of regular menses (HR<1.0, P<0.050). Conclusion: Counseling of women on reproductive intentions should start early irrespective of HIV infection or use of ART. K E Y W O R D S Africa; Antiretroviral treatment; Effective contraceptive methods; HIV; Malawi; Menses; Reproductive intentions; Resumption of sexual activity SUPPORTING INFORMATION Additional supporting information may be found online in the Supporting Information section at the end of the article. File S1. Enrollment Form. File S2. Mother Follow-up Form.

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Perinatal outcomes following maternal pre‐exposure prophylaxis (PrEP) use during pregnancy: results from a large PrEP implementation program in Kenya

et al. 2019

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Introduction The World Health Organization, while recommending pre‐exposure prophylaxis (PrEP) for HIV‐negative pregnant and postpartum women in HIV high‐burden settings, advocates for continued safety evaluation of PrEP in this population. Methods The PrEP Implementation in Young Women and Adolescents (PrIYA) program delivered PrEP to pregnant and postpartum women integrated within routine maternal and child health clinics (MCH) at 16 sites in Western Kenya. PrEP exposure and perinatal outcome data were collected among women obtaining postnatal services during programme evaluation. PrEP use was self‐reported and confirmed with clinical records. Perinatal outcomes including gestational age at birth, birthweight, congenital malformations and infant growth outcomes were abstracted from clinical records for mother‐infant pairs attending the six week visit. Associations between infant outcomes and maternal prenatal PrEP use were assessed using univariate and multivariate logistic and linear regression. Results The PrIYA evaluation identified 1530 postpartum mother‐infant pairs with data on prenatal PrEP exposure: 206 with prenatal PrEP use, 1324 without. Median maternal age was 24 years in both groups. PrEP users (any reported PrEP use) were significantly more likely to report HIV risk factors such as: intimate partner violence, sexually transmitted infections and having a partner with positive or unknown HIV status. Most mothers initiated PrEP during the second trimester (n = 116, 57%) and used PrEP for more than one month (n = 110, 58%). The mean birthweight was 3.3 kg and gestational age at birth was 38.5 weeks in both groups. There were no major differences between PrEP exposed and unexposed infants in rates of preterm birth and low birthweight. There were no congenital malformations identified in the PrEP‐exposed group and five reported in the PrEP unexposed group. At six weeks postpartum, infants in both groups had similar growth. No differences in infant outcomes were found by duration PrEP exposure, trimester of PrEP initiation, a subset analysis of women 15 to 24 years old or in multivariate analyses. This analysis demonstrates that monitoring of infant outcomes is feasible within large‐scale programmatic implementation of PrEP among pregnant and postpartum populations. Conclusions Pregnancy outcomes and early infant growth did not differ by PrEP exposure.

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Benefits and Risks of Antiretroviral Therapy for Perinatal HIV Prevention

Abstract: BACKGROUND-Randomized-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.

Cited by 37 publications

References 12 publications

Antiretroviral therapy use during pregnancy and adverse birth outcomes in South African women

Antiretroviral therapy use during pregnancy and adverse birth outcomes in South African women

Resumption of postpartum sexual activity and menses among HIV‐infected women on lifelong antiretroviral treatment compared to HIV‐uninfected women in Africa

Perinatal outcomes following maternal pre‐exposure prophylaxis (PrEP) use during pregnancy: results from a large PrEP implementation program in Kenya

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