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Hair concentrations of antiretrovirals predict viral suppression in HIV-infected pregnant and breastfeeding Ugandan women.

ABSTRACT: 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.

SUBMITTER: Koss CA

PROVIDER: S-EPMC4438773 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Hair concentrations of antiretrovirals predict viral suppression in HIV-infected pregnant and breastfeeding Ugandan women.

Koss Catherine A CA Natureeba Paul P Mwesigwa Julia J Cohan Deborah D Nzarubara Bridget B Bacchetti Peter P Horng Howard H Clark Tamara D TD Plenty Albert A Ruel Theodore D TD Achan Jane J Charlebois Edwin D ED Kamya Moses R MR Havlir Diane V DV Gandhi Monica M

AIDS (London, England) 20150401 7

<h4>Objective</h4>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.<h4>Design and methods</h4>The Prevention of Malaria and HIV Disease in Tororo trial (NCT00993031) enrolled HIV-infected pregnant Ugandan women at 12-28 weeks gestatio ...[more]

PMID: 25985404

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Project description:IntroductionPrevention of mother to child transmission of HIV (PMTCT) is frequently challenged by irregular access to more effective anti-retroviral therapy. Nevirapine single dose (sdNVP), sdNVP+AZT+3TC for MTCT prophylaxis and NVP+ AZT+3TC for treatment and PMTCT were withdrawn due to low genetic resistance barrier and low efficacy. However current PMTCT lines in Mozambique include DTG+3TC+TDF, TDF+3TC+EFV, DTG +ABC+3TC, and AZT + NVP syrup prophylaxis for exposed babies. We assessed NVP hair and plasma concentrations and association with HIV-1RNA suppression among HIV+ ante-partum and post-partum women under PMTCT in Maputo, Mozambique.MethodsFrom December 2013 to November 2014, prospectively were enrolled 200 HIV+ ante-partum women on 200mg nevirapine and zidovudine 300 plus lamivudine 150mg twice daily at least with 3 months treatment and seen again at 24 weeks post-partum. Self-reported pill-taking adherence, NVP concentrations in hair, plasma, hemoglobin, CD4 cell count, HIV-1 RNA load was evaluated. NVP concentration in hair and plasma was analyzed as categorical quartile variable based on better data fit. NVP concentration was set between ≤3.77 ng/ml in plasma and ≤17,20 ng/mg in hair in quartile one to ≥5.36 ng/ml in plasma and ≥53.21 ng/mg in hair in quartile four. Logistic regression models for repeated measures were calculated. Following the World Health Organization (WHO) guidelines we set viral suppression at HIV-1RNA < 1000 c/mL. Outcome was HIV-1 RNA<1000 copies/ml. Predictor was NVP concentration in hair categorized in quartiles.ResultsIn total 369 person-visits (median of 1.85) were recorded. Self-reported adherence was 98% (IQR 97-100%) at ante-partum. In 25% person visits, NVP concentrations were within therapeutic levels (3.77 ng/ml to 5.35 ng/ml) in plasma and (17.20 ng/mg to 53.20 ng/mg) in hair. In 50% person visits NVP concentrations were above 5.36 ng/ml in plasm and 53.21 ng/mg in hair. HIV-1 RNA suppression was found in 34.7% of women with two viral loads, one at enrollment and another in post-partum. Odds of HIV-1 RNA suppression in quartile 4, was about 6 times higher than in quartile 1 (p-value = 0.006) for NVP hair concentration and 7 times for NVP plasma concentration (p-value = 0.012).ConclusionsThe study results alert for potential low efficacy of current PMTCT drug regimens in use in Mozambique. Affordable means for individual monitoring adherence, ART plasma and hair levels, drug resistant and HIV-1 RNA levels monitoring are recommended for prompt identification of inadequate drug regimens exposure patterns and adjust accordingly.

Project description:ObjectiveTo describe viral load levels among pregnant women and factors associated with failure to achieve viral suppression (viral load ?50 copies/ml) during pregnancy.DesignBetween 1 October and 15 November 2017, a cross-sectional survey was conducted among 15-49-year-old pregnant women attending antenatal care (ANC) at 1595 nationally representative public facilities.MethodsBlood specimens were taken from each pregnant woman and tested for HIV. Viral load testing was done on all HIV-positive specimens. Demographic and clinical data were extracted from medical records or self-reported. Survey logistic regression examined factors associated with failure to achieve viral suppression.ResultOf 10?052 HIV-positive participants with viral load data, 56.2% were virally suppressed. Participants initiating antiretroviral therapy (ART) prior to pregnancy had higher viral suppression (71.0%) by their third trimester compared with participants initiating ART during pregnancy (59.3%). Booking for ANC during the third trimester vs. earlier: [adjusted odds ratio (AOR) 1.8, 95% confidence interval (CI):1.4-2.3], low frequency of ANC visits (AOR for 2 ANC visits vs. ?4 ANC visits: 2.0, 95% CI:1.7-2.4), delayed initiation of ART (AOR for ART initiated at the second trimester vs. before pregnancy:2.2, 95% CI:1.8-2.7), and younger age (AOR for 15-24 vs. 35-49 years: 1.4, 95% CI:1.2-1.8) were associated with failure to achieve viral suppression during the third trimester.ConclusionFailure to achieve viral suppression was primarily associated with late ANC booking and late initiation of ART. Efforts to improve early ANC booking and early ART initiation in the general population would help improve viral suppression rates among pregnant women. In addition, the study found, despite initiating ART prior to pregnancy, more than one quarter of participants did not achieve viral suppression in their third trimester. This highlights the need to closely monitor viral load and strengthen counselling and support services for ART adherence.

Project description:INTRODUCTION:Published data on viral suppression among pregnant and breastfeeding women in routine care settings are scarce. Here, we report provincial estimates of undetectable and suppressed viral load among pregnant or breastfeeding women in HIV care in Kinshasa, Democratic Republic of Congo (DRC) and associated risk factors. METHODS:This cross-sectional study was conducted as part of a baseline assessment for the CQI-PMTCT study: an ongoing cluster randomized trial to evaluate the effect of continuous quality interventions (CQI) on long-term ART outcomes among pregnant and breastfeeding women (NCT03048669). From November 2016 to June 2018, in each of the 35 Kinshasa provincial health zones (HZ), study teams visited the three busiest maternal and child health clinics, enrolled all HIV-positive pregnant or breastfeeding women (≤1 year post-delivery) receiving ART, and performed viral load testing. Log binomial models with generalized estimating equations to account for clustering at the HZ level, were used to estimate prevalence ratios comparing participants with undetected (<40 copies/mL) or suppressed (<1000 copies/mL) viral load across levels of individual and site characteristics. RESULTS:Of the 1752 eligible women, 1623 had viral load results available, including 38% who had been on ART for <6 months and 74% were on tenofovir-lamivudine-efavirenz. Viral load was undetectable in 53% of women and suppressed in 62%. Among women who were on ART for ≥12 months, only 60% and 67% respectively, had undetectable or suppressed viral load. Viral load was undetectable in 53%, 48% and 58% of women testing during pregnancy, at delivery, and in postpartum respectively. In multivariable log binomial models, duration of ART >12 months, older age, being married, disclosure of HIV status, receiving care in an urban health zone or one supported by PEPFAR were all positively associated with viral suppression. CONCLUSIONS:The observed high level of detectable viral load suggests that high ART coverage alone without substantial efforts to improve the quality of care for pregnant and breastfeeding women, will not be enough to achieve the goal of virtual elimination of vertical HIV transmission in high-burden and limited resources settings like DRC.

Project description:Achieving the UNAIDS 95% sustained viral suppression (VS) rate requires considerable global efforts, particularly among adolescents living with HIV (ALHIV) who are often associated with high rates of virological failure (VF). In this study, we prospectively assessed the rate of VS, and the factors associated with VF in a cohort of adolescents followed up according to the WHO guidelines in Cameroon. A cross-sectional study was carried out in 2021 among adolescents (aged 10-19 years) receiving ART in the national program in Cameroon. Socio-demographic and clinical data were collected using patients' medical files and a brief interview with the participant and/or his guardian. Thereafter, a first viral load test (VL1) was performed using the ABBOTT Platform. For adolescents with VL1 > 1000 copies/ml, adherence-enhancing interventions were routinely performed each month for 3 consecutive months, after which a second viral load (VL2) was measured. Adolescents with VL2 > 1000 copies/ml were considered in VF. Overall, 280 adolescents were enrolled, of whom 89.3% (250/280) acquired HIV infection via mother-to-child transmission. The median age was 16.0 (IQR: 13.0-18.0) years and the median duration on ART was 9.8 (IQR: 5.1-12.8) years. Females and males were almost equally represented, as 52.1% (146/280) were female, while 47.9% (134/280) were males (p = 0.47). The VS rate was 88.2% (CI: 83.8-91.7%) overall; 89.0% (CI: 82.0-93.1%) and 88.7% (CI: 81.2-93.0%) in females and males, respectively. Being on second or third-line ART, self-declared suboptimal adherence, and a history of past VF were independently associated with VF. The high rate of VS we report in this study is welcome in the era of the 95/95/95 UNAIDS goals, and indicates that improving treatment outcomes in this specific and fragile population that represent adolescents in Sub-Saharan Africa is achievable. 20/10/2020 NCT04593979 ( https://clinicaltrials.gov/ct2/show/NCT04593979 ).

Project description:Prenatal hair cortisol concentration is inconsistently associated with maternal psychological distress. However, prior studies have not often measured hair cortisol and maternal psychological distress prospectively over time, examined within-person associations, nor concurrently considered the complex hormonal milieu in which cortisol operates during pregnancy. We addressed these limitations and tested associations against a similar non-pregnant comparison group. Participants included 68 women (34 pregnant and 34 non-pregnant; Mage = 29.14 and 83 % White) from the Midwestern United States. Pregnant women were assessed each trimester, at 12, 26, and 38 weeks and non-pregnant women were assessed three times on the same schedule. At each assessment, participants completed measures of psychological distress and provided hair samples. The first 3 cm (from the scalp) of hair was assayed using enzyme immune-assay kits to reflect cumulative levels within the given trimester/3-month time period of cortisol, dehydroepiandrosterone (DHEA) and testosterone. Within-person associations of hair cortisol and ratio of hair cortisol-to-DHEA and cortisol-to-testosterone with psychological distress were assessed using multilevel models. There were positive within-person associations of hair cortisol with cumulative psychological distress (γ = 0.01, s.e. = 0.003, p = .049), anxiety (γ = 0.09, s.e. = 0.04, p = .046), and pregnancy-related anxiety symptoms (γ = 0.10, s.e. = 0.05, p = .041) in the pregnant sample such that on occasions when hair cortisol was higher than average so were psychological distress symptoms. No within-person associations of hair cortisol were supported in non-pregnant women although there was a negative within-person association, such that on occasions of having lower testosterone level than typical, depression symptoms were higher. There were no within-person associations of psychological distress and cortisol-to-DHEA ratio or cortisol-to-testosterone ratio in either the pregnant or non-pregnant sample. At the between person-level for pregnant women, lower cortisol levels were associated with higher perceived stress (γ = -0.28, s.e. = 0.09, p = .003) and depression symptoms (γ = -0.11, s.e. = 0.06, p = .039), whereas higher cortisol levels were associated with higher psychological distress (γ = 0.03, s.e. = 0.01, p = .010), state anxiety (γ = 0.33, s.e. = 0.13, p = .010), and depression symptoms (γ = 0.23, s.e. = 0.09, p = .017) in non-pregnant women. Modeling hair cortisol at the within-person and between-person level revealed differential findings in pregnant and non-pregnant women. Hair cortisol concentration, psychological distress, pregnancy, hormone coupling, within-person associations.

Dataset Information

Hair concentrations of antiretrovirals predict viral suppression in HIV-infected pregnant and breastfeeding Ugandan women.

Publications

Hair concentrations of antiretrovirals predict viral suppression in HIV-infected pregnant and breastfeeding Ugandan women.

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