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Treatment Failure, Drug Resistance, and CD4 T-Cell Count Decline Among Postpartum Women on Antiretroviral Therapy in South Africa.

ABSTRACT: BACKGROUND:We assessed HIV RNA suppression, resistance, and CD4 T-cell count 12 months postpartum among pregnant women retained in care in an observational cohort study. METHODS:We prospectively followed two groups of HIV-infected pregnant women--with or without tuberculosis--recruited from prenatal clinics in South Africa. Women who received antiretroviral therapy during pregnancy and reported being on therapy 12 months postpartum were included. Serum samples from women with HIV viremia 12 months postpartum were tested for drug resistance. RESULTS:Of 103 women in the study, median age and CD4 T-cell count at enrollment were 29 years [interquartile range (IQR): 26-32] and 317 cells per cubic millimeter (IQR: 218-385), respectively; 43 (42%) had tuberculosis at baseline. During pregnancy, 87% of the women achieved an HIV RNA <400 copies per milliliter compared with 71% at 12 months postpartum (P < 0.001). Factors independently associated with an HIV RNA <400 copies per milliliter at 12 months were age ? 30 years, detectable plasma efavirenz concentration, and HIV RNA <400 copies per milliliter while pregnant; there was a trend toward both a detectable viral load and peripartum depression. HIV drug resistance results were available from 25 women, and 12 (48%) had major drug resistance mutations. CD4 T-cell count declined a median of 13 cells per cubic millimeter (IQR: -66 to 140) from delivery to 12 months in women with viremia at 12 months. CONCLUSIONS:Success with maintaining virologic control declined postpartum among HIV-infected women who remained in care and on antiretroviral therapy, and CD4 T-cell count decline and drug resistance were common.

SUBMITTER: Hoffmann CJ

PROVIDER: S-EPMC4713347 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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Treatment Failure, Drug Resistance, and CD4 T-Cell Count Decline Among Postpartum Women on Antiretroviral Therapy in South Africa.

Hoffmann Christopher J CJ Cohn Silvia S Mashabela Fildah F Hoffmann Jennifer D JD McIlleron Helen H Denti Paolo P Haas David W DW Dooley Kelly E KE Martinson Neil A NA Chaisson Richard E RE

Journal of acquired immune deficiency syndromes (1999) 20160101 1

<h4>Background</h4>We assessed HIV RNA suppression, resistance, and CD4 T-cell count 12 months postpartum among pregnant women retained in care in an observational cohort study.<h4>Methods</h4>We prospectively followed two groups of HIV-infected pregnant women--with or without tuberculosis--recruited from prenatal clinics in South Africa. Women who received antiretroviral therapy during pregnancy and reported being on therapy 12 months postpartum were included. Serum samples from women with HIV ...[more]

PMID: 26334739

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Project description:IntroductionPast endeavours to deal with the obstacle of expensive Cluster of Difference 4 (CD4+) count diagnostics in resource-limited settings have left a long trail of suggested continuous CD4+ count clinical covariates that turned out to be a potentially important integral part of the human immunodeficiency virus (HIV) treatment process during disease progression. However, an evaluation to determine the strongest candidates among these CD4+ count covariates has not been well documented.MethodsThe Centre for the AIDS Programme of Research in South Africa (CAPRISA) initially enrolled HIV-negative (phase 1) patients into different study cohorts. The patients who seroconverted (237) during follow-up care were enrolled again into a post-HIV infection cohort where they were further followed up with weekly to fortnightly visits up to 3 months (phase 2: acute infection), monthly visits from 3-12 months (phase 3: early infection) and quarterly visits thereafter (phase 4: established infection) until antiretroviral therapy (ART) initiation (phase 5). The CD4+ count and 46 covariates were repeatedly measured at each phase of the HIV disease progression. A multilevel partial least squares approach was applied as a variable reduction technique to determine the strongest CD4+ count covariates.ResultsOnly 18 of the 46 investigated clinical attributes were the strongest CD4+ count covariates and the top 8 were positively and independently associated with the CD4+ count. Besides the confirmatory lymphocytes, these were basophils, albumin, haematocrit, alkaline phosphatase (ALP), mean corpuscular volume (MCV), platelets, potassium and monocytes. Overall, electrolytes, proteins and red blood cells were the dominant categories for the strongest covariates.ConclusionOnly a few of the many previously suggested continuous CD4+ count clinical covariates showed the potential to become an important integral part of the treatment process. Prolonging the pre-treatment period of the HIV disease progression by effectively incorporating and managing the covariates for long-term influence on the CD4+ cell response has the potential to delay challenges associated with ART side effects.

Project description:Background: The numbers of women initiating lifelong antiretroviral therapy (ART) during pregnancy and postpartum is increasing rapidly, presenting a burden on health systems and an urgent need for scalable models of care for this population. In a pilot project, we referred postpartum women who initiated ART during pregnancy to a community-based model of differentiated ART services.Methods: Eligible women (on ART for at least 3 months with viral load (VL)<1000 copies/mL) were offered a choice of two ART models of care: (i) referral to an existing system of community-based 'adherence clubs', operated by lay counsellors with medication collection every 2-4 months; or (ii) referral to local primary healthcare clinics (PHC) with services provided by clinicians and medication collection every 1-2 months (local standard of care for postpartum ART). For evaluation, women were followed through 6-months postpartum with VL testing separate from either ART service.Results: Through September 2015, n = 129 women were enrolled (median age, 28 years; median time postpartum, 10 days). Overall, 65% (n = 84) chose adherence clubs and 35% (n = 45) chose PHCs; there were no demographic or clinical predictors of this choice. Location of service delivery was commonly cited as a reason for choice by women selecting either model of care; shorter waiting times, ability to receive ART from lay counsellors and less frequent appointments were motivations for choosing adherence clubs. Among women choosing adherence clubs, 15% never attended the service and another 11% attended the service but were not retained through six months postpartum. Overall, 86% of women (n = 111) remained in the evaluation through 6 months postpartum; in this group, there were no differences in VL<1000 copies/mL at six months postpartum between women choosing PHCs (88%) vs. adherence clubs (92%; p = 0.483), but women who were not retained in adherence clubs were more likely to have VL?1000 copies/mL compared to those who remained (p = 0.002).Discussion: Adherence clubs may be a valuable model for postpartum women initiating ART in pregnancy, with good short-term outcomes observed during this critical period. To support optimal implementation, further research is needed into patient preferences for models of care, with consideration of integration of maternal and child health services, while ART adherence and retention require ongoing consideration in this population.

Project description:IntroductionLinkage to care and mobility postpartum present challenges to long-term retention after initiating antiretroviral therapy (ART) in pregnancy, but there are few insights from sub-Saharan Africa. We aimed to describe postpartum linkage to care, mobility, retention and viral suppression after ART initiation in pregnancy.MethodsUsing routine electronic data we assessed HIV-specific health contacts and clinic movements among women initiating ART in an integrated antenatal care (ANC) and ART clinic in Cape Town, South Africa. The local care model includes mandatory transfer to general ART clinics postpartum. We investigated linkage to care after leaving the integrated clinic and mobility to new clinics until 30 months on ART. We used Poisson regression to explore predictors of linkage, retention (accessing care at least once at both 12 [6 to <18] and 24 [18 to <30] months on ART), and viral suppression (HIV viral load [VL] ≤50 and ≤1000 copies/mL after 12 months on ART).ResultsAmong 617 women, 23% never linked to care; 71% and 65% were retained at 12 and 24 months on ART respectively, with 59% retained in care at both times. Those who linked (n = 485) accessed HIV care at 98 different clinics and 21% attended ≥2 clinics. Women >25 years, married/cohabiting or presenting early for ANC were more likely to link. Younger and unemployed women were more likely to attend ≥2 clinics (adjusted risk ratio [aRR] 1.10 95% confidence interval [CI] 1.02 to 1.18 and aRR 1.06 95% CI 0.99 to 1.12 respectively). Age >25 years (aRR 1.17 95% CI 1.02 to 1.33) and planned pregnancy (aRR 1.20 95% CI 1.09 to 1.33) were associated with being retained. Among 338 retained women with VL available, attending ≥2 clinics reduced the likelihood of viral suppression when defined as ≤50 copies/mL (aRR 0.81 95% CI 0.69 to 0.95). Distance moved was not associated with VL.ConclusionsThese data show that a substantial proportion of women do not link to postpartum ART care in this setting and, among those that do, long-term retention remains a challenge. Women move to a variety of clinics and young women appear particularly vulnerable to attrition. Interventions promoting linkage and continued retention for women initiating ART during pregnancy warrant urgent consideration.

Project description:BackgroundWith an increasing number of countries implementing Option B+ guidelines of lifelong antiretroviral therapy (ART) for all pregnant and breastfeeding women, there is urgent need to identify effective approaches for retaining this growing and highly vulnerable population in ART care.MethodsNewly postpartum, breastfeeding women who initiated ART in pregnancy and met eligibility criteria were enrolled, and offered the choice of two options for postpartum ART care: (i) referral to existing network of community-based adherence clubs or (ii) referral to local primary health care clinic (PHC). Women were followed at study measurement visits conducted separately from either service. Primary outcome was a composite endpoint of retention in ART services and viral suppression [VS < 50 copies/mL based on viral load (VL) testing at measurement visits] at 12 months postpartum. Outcomes were compared across postpartum services using chi-square, Fisher's exact tests and Poisson regression models. The primary outcome was compared across services where women were receiving care at 12 months postpartum in exploratory analyses.ResultsBetween February and September 2015, 129 women (median age: 28.9 years; median time postpartum: 10 days) were enrolled with 65% opting to receive postpartum HIV care through an adherence club. Among 110 women retained at study measurement visits, 91 (83%) achieved the composite endpoint, with no difference between those who originally chose clubs versus those who chose PHC services. Movement from an adherence club to PHC services was common: 31% of women who originally chose clubs and were engaged in care at 12 months postpartum were attending a PHC service. Further, levels of VS differed significantly by where women were accessing ART care at 12 months postpartum, regardless of initial choice: 98% of women receiving care in an adherence club and 76% receiving care at PHC had VS < 50 copies/mL at 12 months postpartum (p = 0.001).ConclusionThis study found comparable outcomes related to retention and VS at 12 months postpartum between women choosing adherence clubs and those choosing PHC. However, movement between postpartum services among those who originally chose adherence clubs was common, with poorer VS outcomes among women leaving clubs and returning to PHC services.Trial registrationClinicalTrials.gov NCT02417675 , April 16, 2015 (retrospectively registered).

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Treatment Failure, Drug Resistance, and CD4 T-Cell Count Decline Among Postpartum Women on Antiretroviral Therapy in South Africa.

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Treatment Failure, Drug Resistance, and CD4 T-Cell Count Decline Among Postpartum Women on Antiretroviral Therapy in South Africa.

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