RESUMO
BACKGROUND: Pregnancy outcomes of perinatally human immunodeficiency virus-infected women (PHIV) are poorly defined. METHODS: We compared preterm delivery and birth weight (BW) outcomes (low BW [LBW], <2500 g), small-for-gestational-age [SGA], and BW z scores [BWZ]) in HIV-exposed uninfected infants of PHIV vs nonperinatally HIV-infected (NPHIV) pregnant women in the Pediatric HIV/AIDS Cohort Study Surveillance Monitoring of ART Toxicities or International Maternal Pediatric Adolescent AIDS Clinical Trials P1025 studies. Mixed effects models and log binomial models were used to assess the association of maternal PHIV status with infant outcomes. Age-stratified analyses were performed. RESULTS: From 1998 to 2013, 2270 HIV-infected pregnant women delivered 2692 newborns (270 born to PHIV and 2422 to NPHIV women). PHIV women were younger, (mean age 21 vs 25 years, P < .01) and more likely to have a pregnancy CD4 count <200 cells/mm3 (19% vs 11%, P = .01). No associations between maternal PHIV status and preterm delivery, SGA, or LBW were observed. After adjustment, BWZ was 0.12 lower in infants of PHIV vs NPHIV women (adjusted mean, -0.45 vs -0.33; P = .04). Among women aged 23-30 years (n = 1770), maternal PHIV was associated with LBW (aRR = 1.74; 95% confidence interval, 1.18, 2.58; P < .01). CONCLUSION: The overall lack of association between maternal PHIV status and preterm delivery or infant BW outcomes is reassuring. The higher rates of LBW observed in PHIV women aged 23-30 years warrants further mechanism-based investigations as this is a rapidly growing and aging population worldwide. CLINICAL TRIALS REGISTRATION: PHACS SMARTT study, NCT01310023. CLINICAL TRIALS REGISTRATION: IMPAACT 1025, NCT00028145.
Assuntos
Peso ao Nascer , Infecções por HIV/epidemiologia , Infecções por HIV/transmissão , Transmissão Vertical de Doenças Infecciosas , Complicações Infecciosas na Gravidez/epidemiologia , Nascimento Prematuro/epidemiologia , Adulto , Contagem de Linfócito CD4 , Feminino , Infecções por HIV/sangue , Humanos , Recém-Nascido de Baixo Peso , Recém-Nascido Pequeno para a Idade Gestacional , Masculino , Gravidez , Estudos Prospectivos , Estados Unidos/epidemiologia , Adulto JovemRESUMO
BACKGROUND: Conflicting results have been reported among studies of protease inhibitor (PI) use during pregnancy and preterm birth. Uncontrolled confounding by indication may explain some of the differences among studies. METHODS: In total, 777 human immunodeficiency virus (HIV)-infected pregnant women in a prospective cohort who were not receiving antiretroviral (ARV) treatment at conception were studied. Births <37 weeks gestation were reviewed, and deliveries due to spontaneous labor and/or rupture of membranes were identified. Risk of preterm birth and low birth weight (<2500 g) were evaluated by using multivariable logistic regression. RESULTS: Of the study population, 558 (72%) received combination ARV with PI during pregnancy, and a total of 130 preterm births were observed. In adjusted analyses, combination ARV with PI was not significantly associated with spontaneous preterm birth, compared to ARV without PI (odds ratio [OR], 1.22; 95% confidence interval [CI], 0.70-2.12). Sensitivity analyses that included women who received ARV prior to pregnancy also did not identify a significant association (OR, 1.34; 95% CI, 0.84-2.16). Low birth weight results were similar. CONCLUSIONS: No evidence of an association between use of combination ARV with PI during pregnancy and preterm birth was found. Our study supports current guidelines that promote consideration of combination ARV for all HIV-infected pregnant women.
Assuntos
Antirretrovirais/efeitos adversos , Infecções por HIV/tratamento farmacológico , Inibidores da Protease de HIV/efeitos adversos , Complicações Infecciosas na Gravidez/tratamento farmacológico , Complicações Infecciosas na Gravidez/virologia , Nascimento Prematuro/etiologia , Adolescente , Adulto , Antirretrovirais/uso terapêutico , Distribuição de Qui-Quadrado , Estudos de Coortes , Feminino , Inibidores da Protease de HIV/uso terapêutico , Humanos , Modelos Logísticos , Gravidez , Nascimento Prematuro/induzido quimicamente , Nascimento Prematuro/virologia , Cuidado Pré-Natal/métodos , Estudos Prospectivos , Medição de Risco , Sensibilidade e EspecificidadeRESUMO
OBJECTIVE: The objective of the study was to review pregnancy and neonatal outcomes among perinatally infected pregnant patients at our institution. STUDY DESIGN: A retrospective review of maternal and neonatal records for all 10 perinatally infected adolescents between 1997 and 2007 was performed. Demographics, CD4 and viral load, antiretroviral treatment, medical comorbidities, pregnancy outcomes, and neonatal human immunodeficiency virus (HIV) status were abstracted. RESULTS: The median age at first pregnancy was 18.5 years and 70% were African American. The most common comorbidities were hematologic abnormalities (70%) and cervical dysplasia/sexually transmitted infections (STIs) (80%). Initial median CD4 and viral load were 317 cells/mm(3) and 8780 copies/mL, respectively. The median gestational age at delivery was 38 weeks. The most common obstetrical complications were preeclampsia (23%) and premature rupture of membranes/preterm delivery (31%). The cesarean delivery (CD) rate was 62%, with HIV as the indication in 75%. All infants were born alive; 1 was HIV infected. CONCLUSION: Despite high rates of STIs, CD, preterm delivery, and hypertensive disorders, perinatal outcomes were favorable.
Assuntos
Infecções por HIV/transmissão , HIV-1 , Transmissão Vertical de Doenças Infecciosas , Complicações Infecciosas na Gravidez/virologia , Adolescente , Feminino , Infecções por HIV/virologia , Humanos , Gravidez , Resultado da Gravidez , Estudos RetrospectivosRESUMO
OBJECTIVE: To evaluate the effect of protease inhibitors on lipid and lactate levels and gastrointestinal symptoms in pregnancy. METHODS: Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group (ACTG) A5084 was an observational cohort study of human immunodeficiency virus (HIV)-infected pregnant women. Women recruited between 20 and 34 weeks of gestation were required to be on a stable, highly active antiretroviral therapy (HAART) regimen, stratified by protease inhibitor compared with no protease inhibitor regimens. Interval history was assessed, and lipid and lactate levels were drawn every 8 weeks during pregnancy and 12 weeks postpartum, with levels closest to delivery and postpartum used for analysis. Statistical comparisons used Kruskal-Wallis and Fisher exact tests. RESULTS: One-hundred fifty-eight women were evaluated. Total cholesterol levels (median 230 mg/dL, interquartile range [197, 259], compared with 212 [179, 246] mg/dL, P=.042) and triglycerides (median 224 mg/dL, interquartile range [187, 288], compared with 185 [142, 230] mg/dL, P<.001] were elevated in the protease inhibitor group during pregnancy and remained higher in this group after delivery (total cholesterol 185 [163, 224] mg/dl compared with 171 [140, 190] mg/dL, P<.004; triglycerides 122 [87, 175] mg/dL compared with 89 [66, 150] mg/dL, P=.02). No difference was seen in lactate levels or rates of gastrointestinal symptoms between groups. Obstetric outcomes were similar between the two groups. A higher number of low birth weight infants were born to women in the highest twentieth percentile of triglycerides compared with the lowest across medication groups. CONCLUSION: Cholesterol and triglycerides were higher in protease inhibitor-treated women in pregnancy. Lactate and gastrointestinal symptoms were not different. A higher number of low birth weight infants were noted in women with high triglycerides, but other elevated lipid levels did not affect pregnancy outcomes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00017797 LEVEL OF EVIDENCE: II.
Assuntos
Terapia Antirretroviral de Alta Atividade/efeitos adversos , Infecções por HIV/tratamento farmacológico , Complicações Infecciosas na Gravidez/sangue , Complicações Infecciosas na Gravidez/tratamento farmacológico , Inibidores de Proteases/farmacologia , Adolescente , Adulto , HDL-Colesterol/sangue , HDL-Colesterol/efeitos dos fármacos , Estudos de Coortes , Feminino , Humanos , Recém-Nascido de Baixo Peso , Recém-Nascido , Ácido Láctico/sangue , Gravidez , Complicações Infecciosas na Gravidez/virologia , Resultado da Gravidez , Triglicerídeos/sangueRESUMO
Adherence to antiretroviral therapy (ART) in pregnancy is crucial to optimize its efficacy and minimize mother-to-child transmission. Our objective was to examine adherence patterns to ART and health behaviors during and after pregnancy among HIV-positive women enrolled in A5084, a prospective, observational, multisite study. Between 2002-2005, HIV-infected women between 20 and 34 weeks'gestation completed at least 1 self-reported adherence questionnaire antepartum (AP), and were followed through 12 weeks' postpartum (PP). Questionnaires also addressed tobacco, alcohol, and illicit drugs use. Adherence was defined as reporting not having missed any doses for more than 3 months. Exact McNemar's tests were used for paired binary data and exact logistic regression was used for predictors of nonadherence. We report on 149 women (55% black, 26% Hispanic, 32% less than 25 years, 9% with AIDS, 100% on ART). PP, 31 (21%) women stopped ART and 18 (12%) withdrew from the study. AP, 57% reported adherence to ART and PP, 45% (p = 0.03, n = 87). AP, 11% reported ongoing alcohol use and 23% tobacco use compared to 37% and 30% PP (p < 0.0001, n = 103; p = 0.07, n = 99, respectively). Although 39% ever used marijuana (n = 116) and 25% used illicit drugs (n = 107), few participants reported use during the study. In multivariate analyses, those who had ever used illicit drugs had 5.95 times higher odds (p = 0.002) and those who missed prenatal vitamins had 4.84 times higher odds (p = 0.001) of ART nonadherence. Women reporting a history of illicit drug use and/or having missed prenatal vitamins should be targeted for programs to enhance adherence to ART during pregnancy.
Assuntos
Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/tratamento farmacológico , Drogas Ilícitas , Cooperação do Paciente , Complicações Infecciosas na Gravidez/tratamento farmacológico , Cuidado Pré-Natal , Transtornos Relacionados ao Uso de Substâncias/complicações , Vitaminas/administração & dosagem , Adolescente , Adulto , Feminino , Infecções por HIV/virologia , HIV-1/fisiologia , Humanos , Masculino , Período Pós-Parto , Valor Preditivo dos Testes , Gravidez , Complicações Infecciosas na Gravidez/virologia , RNA Viral/sangue , Assunção de Riscos , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Antiretrovirals (ARVs) are recommended for maternal health and to reduce HIV-1 mother-to-child transmission, but suboptimal adherence can counteract its benefits. OBJECTIVES: To describe antepartum and postpartum adherence to ARV regimens and factors associated with adherence. METHODS: We assessed adherence rates among subjects enrolled in Pediatric AIDS Clinical Trials Group Protocol 1,025 from August 2002 to July 2005 on tablet formulations with at least one self-report adherence assessment. Perfectly adherent subjects reported no missed doses 4 days before their study visit. Generalized estimating equations were used to compare antepartum with postpartum adherence rates and to identify factors associated with perfect adherence. RESULTS: Of 519 eligible subjects, 334/445 (75%) reported perfect adherence during pregnancy. This rate significantly decreased 6, 24, and 48 weeks postpartum [185/284 (65%), 76/118 (64%), and 42/64 (66%), respectively (P < 0.01)]. Pregnant subjects with perfect adherence had lower viral loads. The odds of perfect adherence were significantly higher for women who initiated ARVs during pregnancy (P < 0.01), did not have AIDS (P = 0.02), never missed prenatal vitamins (P < 0.01), never used marijuana (P = 0.05), or felt happy all or most of the time (P < 0.01). CONCLUSIONS: Perfect adherence to ARVs was better antepartum, but overall rates were low. Interventions to improve adherence during pregnancy are needed.
Assuntos
Fármacos Anti-HIV/administração & dosagem , Infecções por HIV/prevenção & controle , HIV-1 , Complicações Infecciosas na Gravidez/prevenção & controle , Cuidado Pré-Natal , Adulto , Contagem de Linfócito CD4 , Estudos de Coortes , Feminino , Infecções por HIV/imunologia , Infecções por HIV/virologia , Humanos , Lactente , Cooperação do Paciente , Período Pós-Parto , Gravidez , Complicações Infecciosas na Gravidez/imunologia , Complicações Infecciosas na Gravidez/virologia , Estudos Prospectivos , Inquéritos e Questionários , Comprimidos/administração & dosagem , Estados Unidos , Carga ViralRESUMO
Human immunodeficiency virus type 1 (HIV-1) infection decreases the production of interleukin-2 (IL-2) from CD4+ and CD8+ T cells. Recombinant IL-2 (rIl-2) has been given to HIV-infected individuals to generate significant increases in CD4+ T-cell counts. There are limited data regarding the effects of pregnancy and HIV infection on IL-2 production in humans. To investigate the effects of human pregnancy, HIV infection, and HIV therapy on IL-2 production, we evaluated 61 women. Intracellular IL-2 production by CD4+ T cells from nonpregnant HIV-infected women was significantly lower than in that in uninfected women (45% +/- 8% versus 52% +/- 8%, P = 0.04). In contrast, there was no difference in levels of intracellular IL-2 production between HIV-infected and uninfected pregnant women. These observations suggest that pregnancy may down-regulate IL-2 production regardless of HIV infection status. Future studies should evaluate IL-2 production patterns in larger cohorts of women so that the physiological significance of IL-2 down-regulation in pregnancy can be further evaluated. This information is essential to assess the possible use of IL-2 supplementation therapy as a means of enhancing immune responses among HIV-infected pregnant women.
Assuntos
Infecções por HIV/imunologia , Interleucina-2/metabolismo , Líquido Intracelular/química , Gravidez/imunologia , Adulto , Fatores Etários , Animais , Terapia Antirretroviral de Alta Atividade , Contagem de Linfócito CD4 , Linfócitos T CD4-Positivos/imunologia , Linfócitos T CD8-Positivos/imunologia , Feminino , Citometria de Fluxo , Humanos , Interleucina-2/imunologia , Líquido Intracelular/imunologiaRESUMO
Zidovudine prophylaxis is recommended to reduce perinatal HIV-1 transmission, but there are limited data on long-term effects on women's health. Pediatrics AIDS Clinical Trials Group (PACTG) 288 was a prospective observational study among US women randomized to zidovudine or placebo in PACTG 076 that was designed to evaluate and compare postpartum clinical, immune, and viral parameters between randomized treatment arms. Forty-eight percent (226/474) of eligible women enrolled in the study (mean follow-up of 4.1 years). Progression and time to AIDS or death were similar in both groups, observed in 21 (19%) zidovudine group women and 29 (25%) placebo group women (RR = 0.73, 90% CI: 0.46-1.17). No significant differences in CD4 lymphocyte count or HIV RNA levels were detected. Genotypic zidovudine resistance was detected in 10% of 156 women (9% of zidovudine group women and 11% of placebo group women). Based on our data, ZDV monotherapy could be considered as chemoprophylaxis to reduce perinatal HIV transmission for minimally symptomatic HIV-infected pregnant women with a low viral load and normal CD4 cell count who do not want to receive highly active antiretroviral therapy because of concern about potential side effects or who wish to reduce fetal exposure to multiple drugs during pregnancy.