Dataset Information

The impact of short term Antiretroviral Therapy (ART) interruptions on longer term maternal health outcomes-A randomized clinical trial.

ABSTRACT: BACKGROUND:Given well documented challenges faced by pregnant women living with HIV taking lifetime ART, it is critical to understand the impact of short-term ART exposure followed by treatment interruption on maternal health outcomes. METHODS:HIV+ breastfeeding (BF) and Formula Feeding (FF) women with CD4 counts > 350 cells/mm3, enrolled in the 1077BF/1077FF PROMISE trial were followed to assess the effect of ART during pregnancy and breastfeeding respectively. The first analysis compared ART use limited to the antepartum period (AP-only) relative to women randomized to Zidovudine. The second analysis included women with no pregnancy combination ART exposure; and compared women randomized to either ART or no ART during postpartum (PP-only). Both analyses included follow-up time beyond breastfeeding period. The primary outcome was progression to AIDS and/or death. Secondary outcomes included adverse events and HIV-related events. RESULTS:3490 and 1137 HIV+ women were enrolled from 14 sites in Africa and India from April 2011 through September 2014 in cohort AP-only and PP-only, respectively. Most were Black African (96%); median age was 27 years; 97% were WHO Clinical Stage I; and most had a screening CD4 count ?500 cells/mm3 (78%). The rate of progression to AIDS and/or death was similar and low across all comparison arms (AP comparison, HR = 1.14, 95%CI (0.44, 2.96), p-value = 0.79). In the PP-only cohort, the rate of WHO stage 2-3 events was lower for women randomized to ART(HR = 0.65, 95% CI 0.42, 1.01, p-value = 0.05). CONCLUSION:The incidence of AIDS and/or death was low in pregnant/postpartum HIV+ women with highCD4 cell counts for all comparison arms. This provides some reassurance that there were limited consequences for short term ART interruption in this group of asymptomatic HIV+ women during up to 4 years of follow up; and underscores that even short term ART exposure postpartum may reduce the risk of WHO grade 2-3 disease progression.

SUBMITTER: Atuhaire P

PROVIDER: S-EPMC6992010 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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The impact of short term Antiretroviral Therapy (ART) interruptions on longer term maternal health outcomes-A randomized clinical trial.

Atuhaire Patience P S Brummel Sean S Mmbaga Blandina Theophil BT Angelidou Konstantia K Fairlie Lee L Violari Avy A Theron Gerhard G Mukuzunga Cornelius C Mawlana Sajeeda S Mubiana-Mbewe Mwangelwa M Naidoo Megeshinee M Makanani Bonus B Mandima Patricia P Nematadzira Teacler T Suryavanshi Nishi N Mbengeranwa Tapiwa T Loftis Amy A Basar Michael M McCarthy Katie K Currier Judith S JS Fowler Mary Glenn MG

PloS one 20200130 1

<h4>Background</h4>Given well documented challenges faced by pregnant women living with HIV taking lifetime ART, it is critical to understand the impact of short-term ART exposure followed by treatment interruption on maternal health outcomes.<h4>Methods</h4>HIV+ breastfeeding (BF) and Formula Feeding (FF) women with CD4 counts > 350 cells/mm3, enrolled in the 1077BF/1077FF PROMISE trial were followed to assess the effect of ART during pregnancy and breastfeeding respectively. The first analysis ...[more]

PMID: 31999753

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Project description:IntroductionSuccessful management of pediatric and adult human immunodeficiency virus (HIV) disease includes lifelong administration of antiretroviral therapy (ART). The need for the continuous use of antiretroviral drugs throughout the life course poses a challenge to children, adolescents, and adults living with HIV and their caregivers. Historically, treatment interruptions have been viewed as a negative therapeutic strategy. Recently, however, treatment interruptions or treatment reduction strategies have become a focus of investigations as innovative approaches to the long-term management of HIV disease. Current challenges with treatment interruptions include identifying an appropriate timeframe for length of interruptions and identifying HIV patient populations in whom the treatment interruption can be successful.ObjectiveIn this review, we aimed at summarizing recent studies of planned and unplanned treatment interruptions in children and adults living with HIV.Materials and methodsWe searched two databases (PubMed and Cochrane Controlled Trials Register) using keywords (HIV OR AIDS OR acquired immunodeficiency syndrome OR HIV-1 OR antiretroviral) AND (treatment interruption OR planned interruption OR therapeutic interruption OR unplanned interruption), for published randomized and nonrandomized clinical trials and observational cohort studies in children and adults (from birth to 99 years of age) in global settings covering a period from 2012 to 2018. In this review, only the studies that contained pediatric and adolescent populations with baseline immunological, virological, and clinical characteristics and outcomes after treatment interruption were included.ResultsA total of 174 eligible citations from the two databases were identified. We identified 10 prospective treatment interruption studies on children (five studies) and adults (five studies) during 2012-2018 with a total of 863 pediatric and 273 adult subjects. Collectively, recent studies on children and adults with HIV infection suggest that treatment interruptions with proper monitoring can be successful by instituting well-defined immunological and virological parameters or thresholds such as CD4 count, CD4%, and HIV RNA viral load that identify low-risk populations with treatment failure. In addition to standard virological and immunological outcome measurements, selected biomarkers that help detect early immune activation may also be useful in the monitoring of treatment interruption.ConclusionTreatment interruptions in adult and especially pediatric patients with well-controlled HIV disease may provide an alternative opportunity to optimize long-term HIV management by minimizing drug-associated toxicity and improving long-term adherence and quality of life.

Project description:BackgroundMaternal obesity complicates a high number of pregnancies. The degree to which neonatal outcomes are adversely affected is unclear.ObjectiveThis study aimed to evaluate neonatal outcomes of pregnancies complicated by maternal obesity.Study designThis study was a secondary analysis of a cohort of deliveries occurring on randomly selected days at 25 hospitals from 2008 to 2011. Data were collected by certified abstractors. This analysis included singleton deliveries between 24 and 42 weeks of gestation. Body mass index was calculated on the basis of maternal height and most recent weight before delivery. Normal and overweight (reference group; body mass index, 18.5-29.9 kg/m2), obese (body mass index, 30.0-39.9 kg/m2), morbidly obese (body mass index, 40.0-49.9 kg/m2), and super morbidly obese (body mass index, ≥50 kg/m2) patients were compared. Patients in the reference group were matched in a 1:1 ratio with those in all other groups with obesity using the baseline characteristics of age, race and ethnicity, previous cesarean delivery, preexisting diabetes mellitus, chronic hypertension, parity, cigarette use, and insurance status. The primary outcome was composite neonatal morbidity, including fetal or neonatal death, hypoxic-ischemic encephalopathy, respiratory distress syndrome, intraventricular hemorrhage grade 3 or 4, necrotizing enterocolitis, sepsis, birth injury, seizures, or ventilator use. We used a modified Poisson regression to examine the associations between body mass index and composite neonatal outcome. Preterm delivery at <37 weeks of gestation and the presence of maternal preeclampsia or eclampsia were included in the final model because of their known associations with neonatal outcomes.ResultsOverall, 52,162 patients and their neonates were included after propensity score matching. Of these, 21,704 (41.6%) were obese, 3787 (7.3%) were morbidly obese, and 590 (1.1%) were super morbidly obese. A total of 2103 neonates (4.0%) had the composite outcome. Neonates born to pregnant people with morbid obesity had a 33% increased risk of composite neonatal morbidity compared with those in the reference group (adjusted odds ratio, 1.33; 95% confidence interval, 1.17-1.52), but no significant association was observed for persons with obesity (adjusted odds ratio, 1.05; 95% confidence interval, 0.97-1.14) or with super morbid obesity (adjusted odds ratio, 1.18; 95% confidence interval, 0.86-1.64).ConclusionCompared with the reference group, gravidas with morbid obesity were at higher risk of composite neonatal morbidity.

Project description:IntroductionThe antiretroviral therapy (ART) adherence club (AC) model has supported clinically stable HIV patients' retention with group ART refills and psychosocial support. Reducing visit frequency by increasing ART refills to six months could further benefit patients and unburden health systems. We conducted a pragmatic non-inferiority cluster randomized trial comparing standard of care (SoC) ACs and six-month refill intervention ACs in a primary care facility in Khayelitsha, South Africa.MethodsExisting community-based and facility-based ACs were randomized to either SoC or intervention ACs. SoC ACs met five times annually, receiving two-month refills with a four-month refill over year-end. Blood was drawn at one AC visit with a clinical assessment at the next. Intervention ACs met twice annually receiving six-month refills, with an individual blood collection visit before the annual clinical assessment AC visit. The first study visits were in October and November 2017 and participants followed for 27 months. We report retention in care, viral load completion and viral suppression (<400 copies/mL) 24 months after enrolment and calculated intention-to-treat risk differences for the primary outcomes using generalized estimating equations specifying for clustering by AC.ResultsOf 2150 participants included in the trial, 977 were assigned to the intervention arm (40 ACs) and 1173 to the SoC (48 ACs). Patient characteristics at enrolment were similar across groups. Retention in care at 24 months was similarly high in both arms: 93.6% (1098/1173) in SoC and 92.6% (905/977) in the intervention arm, with a risk difference of -1.0% (95% CI: -3.2 to 1.3). The intervention arm had higher viral load completion (90.8% (999/1173) versus 85.1% (887/977)) and suppression (87.3% (969 /1173) versus 82.6% (853/977)) at 24 months, with a risk difference for completion of 5.5% (95% CI: 1.5 to 9.5) and suppression of 4.6% (95% CI: 0.2 to 9.0).ConclusionsIntervention AC patients receiving six-month ART refills showed non-inferior retention in care, viral load completion and viral load suppression to those in SoC ACs, adding to a growing literature showing good outcomes with extended ART dispensing intervals.

Project description:Rationale & objectiveAssessing the optimal therapy for older patients (aged ≥65 years) with end-stage kidney disease requires knowledge of longevity and health-related quality of life (HRQoL) outcomes. Kidney transplantation prolongs survival but its long-term impact on HRQoL in older recipients is not well defined. We aimed to prospectively evaluate HRQoL changes from enlisting until 3 years posttransplantation and examine pretransplantation predictors of posttransplantation outcomes.Study designProspective cohort study.Setting & participantsPatients 65 years and older enlisted at the Norwegian National Transplant Center between January 2013 and November 2016.PredictorsKidney transplantation, dialysis vintage, and pretransplantation comorbidity assessed using the Liu Comorbidity Index.OutcomesHRQoL, assessed using the Kidney Disease Quality of Life Short Form, version 1.3.Analytical approachHRQoL scores obtained at 3 years posttransplantation were compared with those obtained pretransplantation and after 1 year using a paired-sample t test. Multivariable linear mixed-effect models were used to identify possible predictors of HRQoL changes over time.ResultsAmong 289 patients included, 220 (mean age, 71.5 years) had undergone transplantation and 136 had completed the 3-year HRQoL follow-up by October 2020. Posttransplant HRQoL, both generic and kidney specific, substantially improved and the benefit persisted for 3 years. For wait-listed candidates remaining on dialysis, HRQoL gradually deteriorated, and recipients who died within 3 years posttransplantation experienced no improvement during the first year. Moderately elevated pretransplantation comorbidity scores and prolonged dialysis vintage independently predicted poor HRQoL outcomes posttransplantation. Recipients receiving dialysis for 1 year or longer with pretransplantation comorbidity scores ≥ 7 experienced a marked and sustained physical deterioration after transplantation.LimitationsHomogenous and highly selected population.ConclusionsTransplantation is associated with a sustained HRQoL improvement and should be the preferred treatment for selected older patients. The value of a pretransplant comorbidity score to predict posttransplantation outcomes warrants further evaluation and may improve the selection process.

Dataset Information

The impact of short term Antiretroviral Therapy (ART) interruptions on longer term maternal health outcomes-A randomized clinical trial.

Publications

The impact of short term Antiretroviral Therapy (ART) interruptions on longer term maternal health outcomes-A randomized clinical trial.

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