Dataset Information

A multicenter study of initiation of antiretroviral therapy and transmitted drug resistance in antiretroviral-naive adolescents and young adults with HIV in New York City.

ABSTRACT:

Background

In December 2009, the Department of Health and Human Services guidelines for initiation of antiretroviral therapy (ART) changed to include patients with CD4 counts between 350 and 500 cells/µL. The aims of this study were to assess uptake of this recommendation in ART-naive youth with human immunodeficiency virus (HIV) and to describe the epidemiology of transmitted genotypic drug resistance mutations (DRMs) in this population.

Methods

A multicenter, retrospective cohort study of ART initiation in ART-naive youth was performed. Eligible subjects were 13-25 years of age, were diagnosed with HIV within 1 year of presentation to care at the study sites, and presented to care from January 2007 to June 2011.

Results

Of 685 potential subjects identified, 331 (49%) fulfilled inclusion criteria. Mean CD4 count at presentation to care was 452 cells/µL. Overall, 191 (58%) subjects started ART. The mean CD4 count at ART initiation was 261 cells/µL before and 363 cells/µL after the 2009 guideline change (P < .0001). Of 212 (64%) subjects with resistance testing available prior to ART initiation, 38 (18%) subjects had a major DRM and an increased proportion of resistance was seen in later study years.

Conclusions

Our study demonstrated an uptake in recently changed guideline recommendations to treat HIV-infected individuals at higher CD4 counts and reinforces the importance of performing resistance testing at entry into care, as 18% of our population had major DRMs prior to initiation of ART.

SUBMITTER: Gagliardo C

PROVIDER: S-EPMC3988426 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Publications

A multicenter study of initiation of antiretroviral therapy and transmitted drug resistance in antiretroviral-naive adolescents and young adults with HIV in New York City.

Gagliardo Christina C Brozovich Ava A Birnbaum Jeffrey J Radix Anita A Radix Anita A Foca Marc M Nelson John J Saiman Lisa L Yin Michael M Carras-Terzian Elektra E West Emily E Neu Natalie N

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20140114 6

<h4>Background</h4>In December 2009, the Department of Health and Human Services guidelines for initiation of antiretroviral therapy (ART) changed to include patients with CD4 counts between 350 and 500 cells/µL. The aims of this study were to assess uptake of this recommendation in ART-naive youth with human immunodeficiency virus (HIV) and to describe the epidemiology of transmitted genotypic drug resistance mutations (DRMs) in this population.<h4>Methods</h4>A multicenter, retrospective cohor ...[more]

PMID: 24429431

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Project description:BackgroundImmediate initiation of antiretroviral treatment (iART) is a proven intervention that significantly decreases time to viral suppression and increases patient retention. iART involves starting medication as early as possible, often after a reactive rapid HIV test or re-engagement in care, although it does not have a universal definition. We aimed to understand iART from an implementation science perspective in a wide range of New York City (NYC) clinics providing HIV primary care, including staff knowledge, attitudes, and practices, as well as clinic barriers and facilitators to iART.MethodsWe used a mixed-methods, convergent study design, with a quantitative survey and in-depth interview (IDI), to understand individual-level knowledge, attitudes, and practices, as well as clinic-level barriers and facilitators to iART. We recruited at least one medical and non-medical staff member from a diverse purposive sample of 30 NYC clinics. In quantitative analyses, we used separate binomial logistic regression models to estimate odds ratios (OR) and 95% confidence intervals (95% CI). In qualitative analyses, we used codebooks created by thematic analyses structured using a Framework Model to develop descriptive analytic memos.ResultsRecruited staff completed 46 surveys and 17 IDIs. We found high levels of awareness of the viral suppression and retention in care benefits of iART. Survey respondents more commonly reported medication starts within three to four days of a reactive rapid HIV test rather than same-day initiation. Among survey respondents, compared to medical staff, non-medical staff were more likely to agree that medication should only be initiated after receiving confirmatory HIV test results (OR: 0.2, 95% CI: 0.06-0.8). Additionally, survey respondents from clinics serving a majority people of color were less likely to report iART on the same day as a reactive rapid HIV test (OR: 0.2, 95% CI: 0.02-1.0, p-value < 0.5). IDI results elucidated barriers to implementation, including perceived patient readiness, which potentially leads to added disparities in iART access.ConclusioniART has proven benefits and support for its implementation among HIV clinic staff. Our findings indicate that barriers to expanding iART access may be overcome if implementation resources are allocated strategically, which can further progress towards health equity.

Project description:BackgroundThe early initiation of antiretroviral therapy (ART) in HIV-1-infected infants reduces mortality and prevents early CD4 T-cell loss. However, the impact of early ART on the immune system has not been thoroughly investigated in children over five years of age or adolescents. Here, we describe the levels of naive CD4 and CD8 T lymphocytes (CD4/CD8TN), reflecting the quality of immune reconstitution, as a function of the timing of ART initiation (early (<6 months) versus late (≥24 months of age)).MethodsThe ANRS-EP59-CLEAC study enrolled 27 children (5-12 years of age) and nine adolescents (13-17 years of age) in the early-treatment group, and 19 children (L-Ch) and 21 adolescents (L-Ado) in the late-treatment group. T lymphocytes were analyzed by flow cytometry and plasma markers were analyzed by ELISA. Linear regression analysis was performed with univariate and multivariate models.ResultsAt the time of evaluation, all patients were on ART and had a good immunovirological status: 83% had HIV RNA loads below 50 copies/mL and the median CD4 T-cell count was 856 cells/µL (interquartile range: 685-1236 cells/µL). In children, early ART was associated with higher CD8TN percentages (medians: 48.7% vs. 31.0%, P = 0.001), and a marginally higher CD4TN (61.2% vs. 53.1%, P = 0.33). In adolescents, early ART was associated with low CD4TN percentages and less differentiated memory CD8 T cells. CD4TN and CD8TN levels were inversely related to cellular activation and gut permeability.ConclusionIn children and adolescents, the benefits of early ART for CD8TN were clear after long-term ART. The impact of early ART on CD4TN appears to be modest, because pediatric patients treated late respond to HIV-driven CD4 T-lymphocyte loss by the de novo production of TN cells in the thymus. Our data also suggest that current immune activation and/or gut permeability has a negative impact on TN levels.Clinical trial registrationClinicalTrials.gov, identifier NCT02674867.

Dataset Information

A multicenter study of initiation of antiretroviral therapy and transmitted drug resistance in antiretroviral-naive adolescents and young adults with HIV in New York City.

Background

Methods

Results

Conclusions

Publications

A multicenter study of initiation of antiretroviral therapy and transmitted drug resistance in antiretroviral-naive adolescents and young adults with HIV in New York City.

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