Effect of Efavirenz on Endogenous Progesterone Concentrations and Contraceptive Outcomes among Ugandan HIV Infected Women Coadministering Ethinylestradiol/Levonorgestrel.
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ABSTRACT:
SUBMITTER: Munkwase G
PROVIDER: S-EPMC5555015 | biostudies-other | 2017
REPOSITORIES: biostudies-other
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Project description:Hair concentrations are a noninvasive measure of cumulative antiretroviral exposure and the strongest predictor of viral suppression in large cohorts of nonpregnant patients. We examined hair concentrations of antiretrovirals in relation to virologic outcomes in pregnant and breastfeeding women for the first time.The Prevention of Malaria and HIV Disease in Tororo trial (NCT00993031) enrolled HIV-infected pregnant Ugandan women at 12-28 weeks gestation who were randomized to lopinavir or efavirenz-based antiretroviral therapy (ART). Small hair samples were collected at 30-34 weeks gestation and 10-25 weeks postpartum. Efavirenz and lopinavir hair concentrations were measured via liquid chromatography/tandem mass spectrometry. Multivariate logistic regression models examined predictors of viral suppression (HIV-1 RNA ?400?copies/ml) at delivery and 24 weeks postpartum.Among 325 women, median CD4 cell count was 366?cells/?l (interquartile range 270-488) at ART initiation. Mean self-reported 3-day adherence was greater than 97% in each arm. Viral suppression was achieved by 98.0% (efavirenz) and 87.4% (lopinavir) at delivery. At 24 weeks postpartum, 92.5% (efavirenz) and 90.6% (lopinavir) achieved viral suppression; 88% of women were breastfeeding. In multivariate models including self-reported adherence and pretreatment HIV-1 RNA, antiretroviral hair concentrations were the strongest predictor of viral suppression at delivery [efavirenz: adjusted odds ratio (aOR) 1.86 per doubling in concentration, 95% confidence interval (CI) 1.14-3.1, P?=?0.013; lopinavir: aOR 1.90, 95% CI 1.33-2.7, P?=?0.0004] and 24 weeks postpartum (efavirenz: aOR 1.81, 95% CI 1.22-2.7, P?=?0.003; lopinavir: aOR 1.53, 95% CI 1.05-2.2, P?=?0.026).Antiretroviral hair concentrations represent an innovative tool that strongly predicts viral suppression among HIV-infected childbearing women during the critical periods of delivery and breastfeeding.
| S-EPMC4438773 | biostudies-literature
Project description:BackgroundPreventing unintended pregnancy is critical for women living with HIV (WLWH) to safely achieve their reproductive goals. Family planning services should support WLWH at risk of repeat unintended pregnancies. We examined the relationship between unintended pregnancy and subsequent contraception use among WLWH in Uganda.Study designThis was a retrospective analysis of data from a longitudinal cohort of individuals initiating antiretroviral therapy (ART), restricted to women with pregnancy (confirmed via urine β-hcg testing) between 2011-2013. The exposure of interest was intended vs unintended pregnancy, and the outcome was self-report of modern contraceptive use (hormonal methods, intrauterine device, sterilization, and/or consistent condom use) at 12 (range 6-18) months post-partum. A log-binomial model was used to estimate relative risks of modern contraceptive use post-partum based on intent of the index pregnancy, adjusted for age, socioeconomic status, education, relationship and HIV status of pregnancy partner, contraceptive use prior to pregnancy, years since HIV diagnosis, ART regimen, and CD4 cell count.ResultsAmong 455 women, 110 women reported 110 incident pregnancies with report on intent. Women had a baseline median age of 29 years, baseline CD4 count 403 cells/mm3, and were living with HIV for 3.8 years. Fifty pregnancies (45%) were reported as unintended and 60 (55%) as intended. Postpartum, 64% of women with unintended and 51% with intended pregnancy reported modern contraception (p = 0.24). In adjusted models, there was no association between pregnancy intent and post-partum contraception. However, contraceptive use prior to the referent pregnancy was positively associated with post-partum contraceptive use (aRR 1.97 (95% CI 1.12-3.48, p = 0.02), while higher baseline CD4 cell count was associated with lower post-partum contraceptive use (aRR 0.95, 95% CI 0.90-0.99, p = 0.02).ConclusionsAlmost half of incident pregnancies among WLWH in this cohort were unintended. Experiencing an unintended pregnancy was not associated with post-partum contraceptive use. Creative strategies to support contraceptive uptake for birth spacing and prevention of unintended pregnancies in the post-partum period are needed.
| S-EPMC6201927 | biostudies-literature
Project description:ObjectiveMaternal nutritional status is an important predictor of birth outcomes, yet little is known about the nutritional status of HIV-infected pregnant women treated with combination antiretroviral therapy (cART). We therefore examined the relationship between maternal BMI at study enrollment, gestational weight gain (GWG), and hemoglobin concentration (Hb) among 166 women initiating cART in rural Uganda.DesignProspective cohort.MethodsHIV-infected, ART-naïve pregnant women were enrolled between 12 and 28 weeks gestation and treated with a protease inhibitor or non-nucleoside reverse transcriptase inhibitor-based combination regimen. Nutritional status was assessed monthly. Neonatal anthropometry was examined at birth. Outcomes were evaluated using multivariate analysis.ResultsMean GWG was 0.17 kg/week, 14.6% of women experienced weight loss during pregnancy, and 44.9% were anemic. Adverse fetal outcomes included low birth weight (LBW) (19.6%), preterm delivery (17.7%), fetal death (3.9%), stunting (21.1%), small-for-gestational age (15.1%), and head-sparing growth restriction (26%). No infants were HIV-infected. Gaining <0.1 kg/week was associated with LBW, preterm delivery, and a composite adverse obstetric/fetal outcome. Maternal weight at 7 months gestation predicted LBW. For each g/dL higher mean Hb, the odds of small-for-gestational age decreased by 52%.ConclusionsIn our cohort of HIV-infected women initiating cART during pregnancy, grossly inadequate GWG was common. Infants whose mothers gained <0.1 kg/week were at increased risk for LBW, preterm delivery, and composite adverse birth outcomes. cART by itself may not be sufficient for decreasing the burden of adverse birth outcomes among HIV-infected women.Trial registrationClinicaltrials.gov NCT00993031.
| S-EPMC3413694 | biostudies-literature
Project description:BACKGROUND:While extensive research has explored pharmacokinetic interactions between antiretroviral therapy and hormonal contraception, few studies have examined whether these interactions affect clinical outcomes. To address this gap, we conducted a systematic review of the literature that describes hormonal contraceptive among HIV infected women who also antiretroviral therapy, focusing on papers that address clinically important outcomes such as pregnancy or ovulation. METHODS:An electronic literature search was conducted of PUBMED and OVID to identify all articles that addressed hormonal contraception co-administered with antiretroviral therapy published in English between 01 January 1990 and 30 October 2014. In addition, manual reference checks of all articles of interest were conducted to identify articles not captured in the electronic search. Our search criteria identified 405 records. The title and abstract of data reports retrieved via the search were reviewed to identify potential articles of interest. Those with any indication of the main outcomes of interest were considered for inclusion (N=162). Abstracts were then reviewed to identify those manuscripts that would merit a review of the full text version (N=64). Eight articles that addressed the outcomes of interest were identified. The Newcastle-Ottawa Scale was used to assess the quality of these articles. RESULTS:The studies reviewed were limited in a number of ways that precluded their providing a rigorous assessment of the efficacy of contraception when co-administered with antiretroviral therapy. DISCUSSION:None of the studies were of adequate quality to provide the guidance that providers and HIV infected women need when considering contraceptive options. High quality, well-powered studies are required to address the efficacy of hormonal contraception when co-administered with antiretroviral therapy.
| S-EPMC5611808 | biostudies-literature
Project description:BackgroundWomen living with HIV (WLHIV) are at higher risk of micronutrient deficiencies and adverse health outcomes. There are limited data on the burden or sequelae of micronutrient deficiencies among pregnant WLHIV receiving antiretroviral therapy (ART).ObjectivesWe aimed to examine anemia and vitamin B-12, folate, and vitamin D deficiencies, and their associations with obstetric and infant outcomes, among pregnant WLHIV initiating combination antiretroviral therapy (cART) in rural Uganda.MethodsThis was a prospective analysis among pregnant WLHIV (12-28 weeks of gestation) in PROMOTE-Pregnant Women and Infants (PIs), a randomized trial comparing the effects of protease inhibitor (PI)-based ART with those of a non-PI-based ART on placental malaria risk. We conducted a substudy on the burden of anemia [trimester 1/3: hemoglobin (Hb) <11.0 g/dL; trimester 2: Hb <10.5 g/dL; n = 367] and micronutrient deficiencies (n = 127) in pregnant WLHIV and their associations with obstetric and infant outcomes. Hb was measured by cyanmethemoglobin, vitamin B-12 and folate were measured via electrochemiluminescence, and vitamin D was measured by ELISA. Linear and binomial regression were used to evaluate associations between micronutrient status during pregnancy and perinatal outcomes.Results26.8% women were anemic, 30.2% were vitamin B-12 insufficient (<221.0 pmol/L), 66.1% were folate insufficient (<13.5 nmol/L), and 65.4% were vitamin D insufficient (<30.0 ng/mL) at enrollment. Anemia during pregnancy was associated with a greater risk of small for gestational age (SGA) (RR: 1.88; 95% CI: 1.28, 2.77; P = 0.001); each 1-g/dL decrease in Hb was associated with greater risk of SGA (RR: 0.76; 95% CI: 0.65, 0.90; P = 0.001). Multivariate models showed that increased vitamin D concentrations predicted lower risk of infant wasting (WLZ < -2; RR: 0.94; 95% CI: 0.89, 0.99; P = 0.04). Multivariate models also indicated that maternal vitamin B-12 and folate concentrations at enrollment predicted maternal (P < 0.001) and infant (P = 0.02) concentrations postpartum.ConclusionsAnemia and micronutrient deficiencies are associated with a variety of adverse obstetric and infant outcomes and are an important public health concern in perinatal WLHIV on cART and their children.This trial was registered at clinicaltrials.gov as NCT00993031.
| S-EPMC7229869 | biostudies-literature
Project description:The aim of this review was to summarize the available evidence about the use of levonorgestrel-releasing intrauterine system (LNG-IUS) as a contraceptive method in nulliparous women. For this purpose, studies evaluating the efficacy, safety, bleeding pattern, satisfaction and discontinuation of the levonorgestrel-releasing intrauterine system in nulliparous women were analyzed. Only original research articles published in English between 1990-27th March 2020 were considered eligible. Reviews, book chapters, case studies, conference papers, opinions, editorials and letters were excluded. The systematic literature search of PubMed/MEDLINE, Scopus, Embase and Cochrane Library databases identified 816 articles, 23 of which were analyzed. The available evidence indicates that LNG-IUS is an effective and safe contraceptive method for nulliparous women that achieves high levels of satisfaction among patients. Moreover, nulliparous women seem to experience fewer expulsions than parous ones. Bleeding pattern is acceptable for the majority of patients, and bleeding disorders mainly occur in the first months after the insertion. More in-depth, long-term prospective studies are needed in this patient group to determine risk factors for the occurrence of side effects and associated discontinuations, which should not, however, delay the wider use of the method in this group, given the number of advantages.
| S-EPMC7408997 | biostudies-literature
Project description:INTRODUCTION:Contraceptive use among HIV-infected women in Togo is poorly documented. We aim at assessing the prevalence of modern contraceptive use and associated factors among HIV-infected women in Togo. DESIGN:Cross-sectional study. SETTING:The study was conducted in five HIV care centres in the Centrale and Kara regions in Togo. PARTICIPANTS:We included 461 HIV-positive women aged between 15 and 49 years and who were sexually active. MAIN OUTCOME MEASURE:The outcome variable was HIV-infected women who were using modern contraceptive methods. RESULTS:A total of 461 HIV-infected women were interviewed, with an average age of 34.3 (±7.1). Among them, 332 (73.1%) women reported using contraceptive methods, mostly condom alone (74.7%) or in combination with hormonal contraceptive (16.9%). In multivariate analysis, education level (primary: adjusted OR (aOR)=1.99, 95%?CI (1.05 to 3.76); secondary level and higher: aOR=3.95, 95%?CI (2.03 to 7.67)), WHO clinical stage (stage II: aOR=0.7, 95%?CI (0.37 to 1.33)), follow-up in private care facilities (aOR=2.54, 95%?CI (1.22 to 5.29)) and having a child (aOR=2.51, 95%?CI (1.41 to 4.5)) were associated with higher contraceptive use, while marital status (living in union: aOR=0.45, 95%?CI (0.28 to 0.74)) and WHO stages III and IV (aOR=0.47, 95%?CI (0.24 to 0.94)) were associated with lower contraceptive use. CONCLUSION:About three-quarters of sexually active HIV-infected women in Togo were using contraceptive methods, and private health facilities favoured this contraceptive use. It is important to strengthen the implementation of interventions to increase the incentives for HIV-infected women to use contraception in Togo.
| S-EPMC5922471 | biostudies-literature
Project description:Little is known about the impact of knowledge of HIV serostatus on pregnancy intention and contraceptive use in high-HIV-burden southern African settings in the era of widespread antiretroviral treatment availability.We analyzed interview data collected among 473 HIV-uninfected and 468 HIV-infected pregnant and recently postpartum women at two sites in southern Botswana. Participants were interviewed about their knowledge of their HIV status prior to pregnancy, intendedness of the pregnancy, contraceptive use, and future childbearing desires.The median age of the 941 women was 27 years, median lifetime pregnancies was 2, and 416 (44%) of pregnancies were unintended. Among women reporting unintended pregnancy, 36% were not using a contraceptive method prior to conception. Among contraception users, 81% used condoms, 13% oral contraceptives and 5% an injectable contraceptive. In univariable analysis, women with unintended pregnancy had a higher number of previous pregnancies (P = <0.0001), were less educated (P = 0.0002), and less likely to be married or living with a partner (P < 0.0001). Thirty-percent reported knowing that they were HIV-infected, 48% reported knowing they were HIV-uninfected, and 22% reported not knowing their HIV status prior to conception. In multivariable analysis, women who did not know their HIV status pre-conception were more likely to report their pregnancy as unintended compared to women who knew that they were HIV-uninfected (aOR = 1.7; 95%CI: 1.2-2.5). After controlling for other factors, unintended pregnancy was not associated with knowing one's HIV positive status prior to conception (compared with knowing one's negative HIV status prior to conception). Among women with unintended pregnancy, there was no association between knowing their HIV status and contraceptive use prior to pregnancy in adjusted analyses. Sixty-one percent of women reported not wanting any more children after this pregnancy, with HIV-infected women significantly more likely to report not wanting any more children compared to HIV-uninfected women (aOR = 3.9; 95%CI: 2.6-5.8).The high rates of reported unintended pregnancy and contraceptive failure/misuse underscore an urgent need for better access to effective contraceptive methods for HIV-uninfected and HIV -infected women in Botswana. Lower socioeconomic status and lack of pre-conception HIV testing may indicate higher risk for unintended pregnancy in this setting.
| S-EPMC4715872 | biostudies-other
Project description:BackgroundThe level of viral diversity in an HIV-infected individual can change during the course of HIV infection, reflecting mutagenesis during viral replication and selection of viral variants by immune and other selective pressures. Differences in the level of viral diversity in HIV-infected infants may reflect differences in viral dynamics, immune responses, or other factors that may also influence HIV disease progression. We used a novel high resolution melting (HRM) assay to measure HIV diversity in Ugandan infants and examined the relationship between diversity and survival through 5 years of age.MethodsPlasma samples were obtained from 31 HIV-infected infants (HIVNET 012 trial). The HRM assay was used to measure diversity in two regions in the gag gene (Gag1 and Gag2) and one region in the pol gene (Pol).ResultsHRM scores in all three regions increased with age from 6-8 weeks to 12-18 months (for Gag1: P?=?0.005; for Gag2: P?=?0.006; for Pol: P?=?0.016). Higher HRM scores at 6-8 weeks of age (scores above the 75(th) percentile) were associated with an increased risk of death by 5 years of age (for Pol: P?=?0.005; for Gag1/Gag2 (mean of two scores): P?=?0.003; for Gag1/Gag2/Pol (mean of three scores): P?=?0.002). We did not find an association between HRM scores and other clinical and laboratory variables.ConclusionsGenetic diversity in HIV gag and pol measured using the HRM assay was typically low near birth and increased over time. Higher HIV diversity in these regions at 6-8 weeks of age was associated with a significantly increased risk of death by 5 years of age.
| S-EPMC3077388 | biostudies-literature
Project description:BackgroundAn increasing number of women living with perinatally acquired HIV are reaching adulthood and becoming pregnant. Achieving viral suppression is challenging in this population frequently exposed to numerous antiretroviral regimens. This study describes the long-term outcomes of pregnant women living with perinatally acquired HIV in Spain.MethodsDescriptive, retrospective, multicenter study of the women living with perinatally acquired HIV who gave birth between January 2000 and December 2019 in Madrid. Epidemiological, clinical, and HIV-related data were collected from the first delivery to the end of the study period, including antiretroviral therapy, prevention strategies, and outcomes.ResultsSixty-three live births in 33 women were included. The mean number of pregnancies per women was 1.9 (range: 1-6). At first delivery, women's median age was 20 years (interquartile range: 18-23), 11 (33.3%) had been previously diagnosed with AIDS and 6 (18%) with mental health disorders. Forty percent became pregnant unsuppressed, whereas 81% achieved viral suppression at delivery. Treatment interruptions were common after delivery, as were losses to follow-up, with no positive effect of pregnancy on retention to care or the immune virological situation. Five women (15%) experienced a new AIDS event, and there were 2 deaths (6%) during follow-up. There was 1 case of mother-to-child transmission in a nonadherent woman in whom preventive measures could not be implemented.ConclusionsPregnancy in this unique population of women living with perinatally acquired HIV poses particular challenges. Specific strategies, including a multidisciplinary approach, are needed to minimize perinatal transmission risks and improve outcomes during the postpartum period.
| S-EPMC9592160 | biostudies-literature