Highly Active Antiretroviral Therapy and Adverse Birth Outcomes Among HIV-Infected Women in Botswana.
ABSTRACT Background. It is unknown whether adverse birth outcomes are associated with maternal highly active antiretroviral therapy (HAART) in pregnancy, particularly in resource-limited settings.Methods. We abstracted obstetrical records at 6 sites in Botswana for 24 months. Outcomes included stillbirths (SBs), preterm delivery (PTD), small for gestational age (SGA), and neonatal death (NND). Among human immunodeficiency virus (HIV)-infected women, comparisons were limited to HAART exposure status at conception, and those with similar opportunities for outcomes. Comparisons were adjusted for CD4(+) lymphocyte cell count.Results. Of 33 148 women, 32 113 (97%) were tested for HIV, of whom 9504 (30%) were HIV infected. Maternal HIV was significantly associated with SB, PTD, SGA, and NND. Compared with all other HIV-infected women, those continuing HAART from before pregnancy had higher odds of PTD (adjusted odds ratio [AOR], 1.2; 95% confidence interval [CI], 1.1, 1.4), SGA (AOR, 1.8; 95% CI, 1.6, 2.1) and SB (AOR, 1.5; 95% CI, 1.2, 1.8). Among women initiating antiretroviral therapy in pregnancy, HAART use (vs zidovudine) was associated with higher odds of PTD (AOR, 1.4; 95% CI, 1.2, 1.8), SGA (AOR, 1.5; 95% CI, 1.2, 1.9), and SB (AOR, 2.5; 95% CI, 1.6, 3.9). Low CD4(+) was independently associated with SB and SGA, and maternal hypertension during pregnancy with PTD, SGA, and SB.Conclusions. HAART receipt during pregnancy was associated with increased PTD, SGA, and SB.
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ABSTRACT: In 2011, Malawi implemented Option B+ (B+), lifelong antiretroviral therapy (ART) for pregnant and breast-feeding women. We aimed to describe changes in service uptake and outcomes along the antenatal PMTCT cascade post B+ implementation. Pre/post study using routinely collected program data from two large Lilongwe-based health centers. We compared testing of HIV-infected pregnant women at antenatal care, enrollment into PMTCT services, receipt of ART and six-month ART outcomes pre- (Oct 2009-Mar 2011) and post- (Oct 2011-Mar 2013) B+. A total of 13,926 (pre) and 14,532 (post) women presented to antenatal care. Post-B+ a smaller proportion were HIV tested (99.3% vs. 87.7% post-; p<0.0001). There were 1654 (pre) and 1535 (post) HIV-infected women identified, with a larger proportion already known to be HIV-infected (18.1% vs. 41.2% post-; p<0.001) and on ART post-B+ (18.7% vs. 30.2% post-; p<0.001). A significantly greater proportion enrolled into the PMTCT program (68.3% vs. 92.6% post-; p<0.001) and was retained through delivery post-B+ (51.1% vs. 65% post-; p<0.0001). Amongst those not on ART at enrollment there was no change in the proportion newly initiating ART/ARVs (79% vs. 81.9% post-; p=0.11); although median days to initiation of ART decreased (48d [19,130] vs. 0d [0,15.5] post-; p<0.001). Amongst those newly initiating ART, a smaller proportion was alive on ART six-months post-initiation (89.3% vs. 78.8% post-; p=0.0004). While several improvements in PMTCT program performance were noted with implementation of B+, challenges remain at several critical steps along the cascade requiring innovative solutions to ensure an AIDS-free generation.JAIDS Journal of Acquired Immune Deficiency Syndromes 01/2015; DOI:10.1097/QAI.0000000000000517 · 4.39 Impact Factor
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ABSTRACT: Combination antiretroviral therapy (ART) is now the global standard for HIV-infected pregnant and breastfeeding women at all CD4 cell counts. We compared the efficacy and safety of an efavirenz versus lopinavir/ritonavir regimen for HIV-infected pregnant women initiating ART in rural Uganda. Randomized clinical trial. We performed a planned secondary analysis comparing viral load suppression (HIV-1 RNA ≤400 copies/ml), safety, and HIV transmission to infants in a trial designed to test the hypothesis that lopinavir/ritonavir versus efavirenz-based ART would reduces placental malaria (PROMOTE, ClinicalTrials.gov, NCT00993031). HIV-infected, ART-naïve pregnant women at 12-28 weeks gestation and any CD4 cell count were randomized. ART was provided and participants were counseled to breastfeed for 1 year postpartum. The median age of the 389 study participants was 29 years; median CD4 cell count was 370 cells/μl. At delivery, virologic suppression was 97.6% in the efavirenz arm and 86.0% in the lopinavir/ritonavir arm (P < 0.001). At 48 weeks postpartum, 91.0% of women on efavirenz and 88.4% on lopinavir/ritonavir had viral suppression (P = 0.49). Grade 1 or 2 gastrointestinal adverse events were higher among women on lopinavir/ritonavir versus efavirenz. Only two infants acquired HIV (both in the lopinavir/ritonavir arm), and HIV-free infant survival was similar between study arms: 92.9% (lopinavir/ritonavir) versus 97.2% (efavirenz) (P = 0.10). Virologic suppression at delivery was higher with an efavirenz versus lopinavir/ritonavir-based regimen. However, women in both arms achieved high levels of virologic suppression through 1 year postpartum and the risk of transmission to infants was low.AIDS (London, England) 11/2014; 29(2). DOI:10.1097/QAD.0000000000000531 · 6.56 Impact Factor
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ABSTRACT: Protease inhibitor-based antiretroviral therapy (ART) has been associated with preterm birth in some studies. We examined risk factors for preterm birth among women randomized to lopinavir/ritonavir- or efavirenz-based ART.JAIDS Journal of Acquired Immune Deficiency Syndromes 07/2014; DOI:10.1097/QAI.0000000000000281 · 4.39 Impact Factor