Antiretroviral Therapy During Pregnancy and the Risk of an Adverse Outcome

Tuomala, Ruth; Shapiro, David E.; Mofenson, Lynne M.; Bryson, Yvonne J.; Culnane, Mary; Hughes, Michael D.; O'Sullivan, M. J.; Scott, Gwendolyn B.; Stek, Alice; Wara, Diane W.; Bulterys, Marc

doi:10.1097/00006254-200211000-00002

Cited by 88 publications

(128 citation statements)

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“…This finding is consistent to what has been reported in a large American cohort of HIV-1 infected women (Tuomala et al 2002) that demonstrated a significant increase in HAART use with and without protease inhibitor from the early 90s to 1998. In the WITS study, HIV-1 vertical transmission rate was 20% for women not receiving prenatal ART 10.4% for those receiving ZDV monotherapy, 3.8% for multi-ART, and 1.2% for HAART (Cooper et al 2002).…”

Section: Discussionsupporting

confidence: 91%

Determinants and trends in perinatal human immunodeficiency virus type 1 (HIV-1) transmission in the metropolitan area of Belo Horizonte, Brazil: 1998 - 2005

Kakehasi

Pinto

Romanelli

et al. 2008

Mem. Inst. Oswaldo Cruz

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Section: Discussionsupporting

confidence: 91%

Determinants and trends in perinatal human immunodeficiency virus type 1 (HIV-1) transmission in the metropolitan area of Belo Horizonte, Brazil: 1998 - 2005

Kakehasi

Pinto

Romanelli

et al. 2008

Mem. Inst. Oswaldo Cruz

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“…7 Our study supports ECS data with respect to preterm labour. We did not confirm a difference neither in preterm delivery rate nor in incidence of pre-eclampsia between women using a PI-containing or a PI-free HAART regime.…”

Section: Commentsupporting

confidence: 88%

“…6 US studies found no association between HAART treatment and preterm delivery, but an increased very low birthweight rate. 7 To explore the relationship between the use and timing of HAART and pregnancy-related disorders, controlling for population characteristics, we compared preterm delivery rate, low birthweight rate and their risk factors, incidence of pre-eclampsia and other obstetric complications in HIVpositive women and HIV-negative matched controls. Further, we explored the safety of vaginal delivery with respect to MTCT under effective HAART treatment.…”

Section: Introductionmentioning

confidence: 99%

The AmRo study: pregnancy outcome in HIV‐1‐infected women under effective highly active antiretroviral therapy and a policy of vaginal delivery

Boer¹,

Nellen

Patel

et al. 2007

BJOG

118

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Objective To explore pregnancy outcome in HIV-1-positive and HIV-negative women, and mother-to-child transmission (MTCT) according to mode of delivery under effective highly active antiretroviral therapy (HAART).Design Cohort of 143 pregnant HIV-1-infected women including a matched case-control study in a 2:1 ratio of controls to cases (n = 98).Setting Academic Medical Center in Amsterdam and Erasmus Medical Center in Rotterdam, the Netherlands.Population Consecutive referred HIV-1 infected pregnant women treated with HAART and matched control not infected pregnant women.Main outcome measures MTCT, preterm delivery, low birthweight, pre-eclampsia.Results MTCT was 0% (95% CI 0-2.1%). Seventy-eight percent of HIV-1-infected women commenced and 62% completed vaginal delivery. The calculated number of caesarean sections needed to prevent a single MTCT was 131 or more. Preterm delivery rates were 18% (95% CI 11-27) in women infected with HIV-1 and 9% (95% CI 5-13) in controls (P = 0.03). HAART used at <13 weeks of gestation was associated with a 44% preterm delivery rate compared with 21% when HAART was started at or after 13 weeks and 14% in controls. (Very) low birthweight and incidence of pre-eclampsia were not different between HIV-1 and controls.Conclusions We have not demonstrated any MTCT after vaginal delivery in women effectively treated by HAART. The HAARTassociated increase in preterm delivery rate is mainly seen after first trimester HAART use.

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“…Congenital malformation rates are reported at ∼3% to 6% in HIV-exposed infant cohorts 18,19 but longer periods of observation tend to uncover higher rates of conditions unidentified at birth. 20 One advantage of prospectively managing HIV-exposed infants is the opportunity for multiple diagnostic evaluations, which enable detection of clinical conditions, something that cannot be ascertained through antiretroviral pregnancy registries, as these do not include follow-up for infants. There were a number of SAEs reported in this study that would require additional follow-up time for evaluation of clinical significance and/or potential resolution as there is a paucity of data on long-term pediatric outcomes.…”

Section: Discussionmentioning

confidence: 99%

Infant Outcomes After Maternal Antiretroviral Exposure in Resource-Limited Settings

et al. 2012

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WHAT'S KNOWN ON THIS SUBJECT: Information on infant safety after exposure to maternal antiretroviral regimens during pregnancy in international clinical trials is lacking. As antiretroviral drugs are released to populations in resource-limited settings through clinical trials, it becomes critical to collect pediatric outcome data. WHAT THIS STUDY ADDS:The study demonstrates the feasibility of reporting infant outcomes following adult antiretroviral trials in developing countries, provides HIV-free infant survival and prospective growth data in association with maternal parameters, and details morbidity, mortality, and genetic defects following maternal antiretroviral exposure. abstract BACKGROUND AND OBJECTIVE: The impact of maternal antiretrovirals (ARVs) during pregnancy, labor, and postpartum on infant outcomes is unclear.METHODS: Infants born to HIV-infected mothers in ARV studies were followed for 18 months. RESULTS:Between June 2006 and December 2008, 236 infants enrolled from Africa (n = 36), India (n = 47), Thailand (n = 152), and Brazil (n = 1). Exposure to ARVs in pregnancy included $3 ARVs (10%), zidovudine/ intrapartum ARV (81%), and intrapartum ARV (9%). There were 4 infant infections (1 in utero, 3 late postpartum) and 4 deaths with 1.8% mortality (95% confidence interval [CI], 0.1%-3.5%) and 96.4% HIV-1-free survival (95% CI, 94.0%-98.9%). Birth weight was $2.5 kg in 86%. In the first 6 months, Indian infants (nonbreastfed) had lowest median weights and lengths and smallest increases in growth. After 6 months, African infants had the lowest median weight and weight-for-age z scores. Infants exposed to highest maternal viral load had the lowest height and height-for-age z scores. Serious adverse events occurred in 38% of infants, did not differ by country, and correlated with less maternal ARV exposure. Clinical diagnoses were seen in 84% of Thai, 31% of African, and 9% of Indian infants. Congenital defects/ inborn errors of metabolism were seen in 18 (7.6%) infants, of which 17 were Thai (11%: 95% CI, 6.7%-17.0%); none had first trimester ARV exposure.

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Antiretroviral Therapy During Pregnancy and the Risk of an Adverse Outcome

Cited by 88 publications

References 0 publications

Determinants and trends in perinatal human immunodeficiency virus type 1 (HIV-1) transmission in the metropolitan area of Belo Horizonte, Brazil: 1998 - 2005

Determinants and trends in perinatal human immunodeficiency virus type 1 (HIV-1) transmission in the metropolitan area of Belo Horizonte, Brazil: 1998 - 2005

The AmRo study: pregnancy outcome in HIV‐1‐infected women under effective highly active antiretroviral therapy and a policy of vaginal delivery

Infant Outcomes After Maternal Antiretroviral Exposure in Resource-Limited Settings

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