RESUMEN
BACKGROUND: Integrase inhibitors have been associated with excess gestational weight gain that may lead to adverse pregnancy outcomes (APOs). This post hoc analysis of NICHD P1081 compared antepartum changes in weight and body mass index (BMI) in pregnant women initiating raltegravir- or efavirenz-based combined antiretroviral therapy (cART) and examined associations between rates of weight gain and APOs. SETTING: NICHD P1081 enrolled antiretroviral-naive pregnant women living with HIV in the second and third trimester in Brazil, Tanzania, South Africa, Thailand, Argentina, and the United States. METHODS: Two hundred eighty-one women enrolled between 20 and 31 gestational weeks were randomized to raltegravir- or efavirenz-based cART and followed for ≥4 weeks. A low rate of weight gain was defined as <0.18 kg/wk and high as >0.59 kg/wk. We compared weight gain and BMI increase between treatment arms using Kruskal-Wallis tests. Logistic regression was used to investigate the association between weight gain and APOs. RESULTS: Raltegravir-based cART was associated with significantly higher antepartum weight gain (median 0.36 kg/wk versus 0.29 kg/wk, P = 0.01) and BMI increase (median 0.14 kg/m 2 /wk versus 0.11 kg/m 2 /wk, P = 0.01) compared with efavirenz-based treatment. Women on raltegravir had less low weight gain (18% versus 36%) and more high weight gain (21% versus 12%) ( P = 0.001). Women with low weight gain were more likely than those with normal weight gain to have small for gestational age infants or a composite of APOs. CONCLUSIONS: A raltegravir-based antiretroviral regimen was associated with significantly higher antepartum rate of weight gain and BMI increase compared with efavirenz-based treatment in antiretroviral-naive pregnant women.
Asunto(s)
Infecciones por VIH , National Institute of Child Health and Human Development (U.S.) , Femenino , Embarazo , Humanos , Estados Unidos , Raltegravir Potásico/uso terapéutico , Infecciones por VIH/tratamiento farmacológico , Inhibidores de Integrasa , Aumento de PesoRESUMEN
BACKGROUND: Tenofovir alafenamide (TAF) is a key component of HIV treatment, but pharmacokinetic data supporting the use of TAF during pregnancy are limited. In this study, we report pharmacokinetic, safety, and birth outcomes for TAF 25 mg with a boosted protease inhibitor in pregnant women living with HIV. METHODS: IMPAACT P1026s was a multicenter, nonrandomized, open-label, phase IV prospective study. Pregnant women living with HIV receiving TAF 25 mg with a boosted protease inhibitor were eligible. Intensive pharmacokinetic assessments were performed during the second and third trimesters and 6-12 weeks postpartum. Maternal and cord blood samples were collected at delivery. Infant washout samples were collected through 5-9 days postbirth. Comparisons of paired pharmacokinetic data between pregnancy and postpartum were made using geometric mean ratios (GMR) [90% confidence intervals (CIs)] and Wilcoxon signed-rank tests with P < 0.10 considered significant. RESULTS: Twenty-nine women were enrolled from the United States (median age 31 years and weight 84.5 kg during the third trimester; 48% Black, 45% Hispanic/Latina). TAF AUCtau did not significantly differ in the second [GMR 0.62 (90% CI: 0.29 to 1.34); P = 0.46] or third trimester [GMR 0.94 (90% CI: 0.63 to 1.39); P = 0.50] vs. postpartum and were comparable with historical data in nonpregnant adults. TAF was only quantifiable in 2/25 maternal delivery samples and below the limit of quantification in all cord blood and infant washout samples, likely because of the short half-life of TAF. CONCLUSION: TAF AUCtau did not significantly differ between pregnancy and postpartum. These findings provide reassurance as TAF use during pregnancy continues to expand.
Asunto(s)
Fármacos Anti-VIH , Infecciones por VIH , Complicaciones Infecciosas del Embarazo , Adenina/uso terapéutico , Adulto , Alanina , Fármacos Anti-VIH/farmacocinética , Fármacos Anti-VIH/uso terapéutico , Antivirales/uso terapéutico , Femenino , Infecciones por VIH/tratamiento farmacológico , Humanos , Periodo Posparto , Embarazo , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Estudios Prospectivos , Inhibidores de Proteasas/uso terapéutico , Tenofovir/análogos & derivadosRESUMEN
BACKGROUND: Data on pediatric HIV in Peru are limited. The National Institute of Child Health (Instituto Nacional de Salud del Niño: INSN) cares for the most HIV-infected children under the age of 18 years in the country. We describe the outcomes of children seen at INSN's HIV clinic over the 10 years when antiretroviral therapy and prevention of mother-to-child transmission (PMTCT) interventions became available in 2004. METHODS: We conducted a retrospective review of INSN HIV clinic patients between 2003 and 2012. Deidentified data were collected and analyzed. RESULTS: A total of 280 children were included: 50.0% (140/280) were male; 80.0% (224/280) lived in metropolitan Lima. Perinatal transmission was the mode of HIV infection in 91.4% (256/280) of children. Only 17% (32/191) of mothers were known to be HIV-infected at delivery; of these mothers, 41% (13/32) were receiving antiretroviral therapy at delivery, 72% (23/32) delivered by Cesarean section and 47% (15/32) of their infants received antiretroviral prophylaxis. Median age at HIV diagnosis for all children was 35.7 months (interquartile range 14.5-76.8 months), and 67% (143/213) had advanced disease (clinical stage C). After HIV diagnosis, the most frequent hospitalization discharge diagnoses were bacterial pneumonia, chronic malnutrition, diarrhea, anemia and tuberculosis. Twenty-four patients (8.6%) died at a median age of 77.4 months. CONCLUSIONS: Most cases of pediatric HIV were acquired via perinatal transmission; few mothers were diagnosed before delivery; and among mothers with known HIV status, PMTCT was suboptimal even after national PMTCT policy was implemented. Most children were diagnosed with advanced disease. These findings underscore the need for improving early pediatric HIV diagnosis and treatment, as well as PMTCT strategies.