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Incomplete ART adherence is associated with higher inflammation in individuals who achieved virologic suppression in the START study.

ABSTRACT: INTRODUCTION:Suboptimal ART adherence, despite HIV viral suppression, has been associated with chronic residual inflammation. Whether this association extends to individuals who initiate ART during early HIV infection remains unknown, which was the objective of this study. METHODS:Plasma levels of interleukin-6 (IL-6), high-sensitivity C-reactive protein, serum amyloid A protein (SAA), IL-27, soluble intercellular adhesion molecule-1, soluble vascular adhesion molecule-1, D-dimer and the CD4+/CD8+ T-cell ratio, were analysed at baseline and eight months after ART initiation in treatment-naïve participants with HIV and CD4+ T-cells >500 cells/mm3 enrolled in the immediate arm of START. Adherence was assessed by seven-day self-report. Multivariable linear regression was utilized to analyse the association between ART adherence and each biomarker at the eight-month visit in participants who achieved virologic suppression (<50 copies/mL). RESULTS:We evaluated 1627 participants (422 female) who achieved virologic suppression at the eight-month visit in the period between 2009 and 2013. Median (IQR) CD4+ T-cell count before ART was 651 (585, 769) cells/mm3 . Incomplete adherence was reported in 109 (7%) participants at the eight month visit. After adjusting for covariates, plasma IL-6 was 1.12 (95% CI, 1.00 to 1.26; p = 0.047) fold higher in participants reporting incomplete versus 100% adherence. A similar association for SAA was observed in an exploratory analysis (1.29 (95% CI 1.04 to 1.60); p = 0.02). No significant differences in other biomarkers were observed. CONCLUSIONS:Incomplete ART adherence was associated with higher IL-6 levels in individuals who achieved virologic suppression early after ART initiation in START. A potential similar association for SAA requires confirmation. These findings suggest a role for identifying strategies to maximize ART adherence even during virologic suppression. ClinicalTrials.gov number: NCT00867048.

SUBMITTER: Castillo-Mancilla JR

PROVIDER: S-EPMC6597899 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Incomplete ART adherence is associated with higher inflammation in individuals who achieved virologic suppression in the START study.

Castillo-Mancilla Jose R JR Phillips Andrew N AN Neaton James D JD Neuhaus Jacqueline J Sharma Shweta S Baker Jason V JV Collins Simon S Mannheimer Sharon S Pett Sarah S Touzeau-Römer Veronique V Polizzotto Mark N MN Lundgren Jens D JD Gardner Edward M EM

Journal of the International AIDS Society 20190601 6

<h4>Introduction</h4>Suboptimal ART adherence, despite HIV viral suppression, has been associated with chronic residual inflammation. Whether this association extends to individuals who initiate ART during early HIV infection remains unknown, which was the objective of this study.<h4>Methods</h4>Plasma levels of interleukin-6 (IL-6), high-sensitivity C-reactive protein, serum amyloid A protein (SAA), IL-27, soluble intercellular adhesion molecule-1, soluble vascular adhesion molecule-1, D-dimer ...[more]

PMID: 31250552

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Project description:BACKGROUND:An undetectable serum HIV-1 load is key to effectiveness of antiretroviral (ARV) therapy, which depends on adherence to treatment. We evaluated factors possibly associated with ARV adherence and virologic response in HIV-infected heterosexual individuals. METHODS:A cross-sectional study was conducted in 200 HIV-1 serodiscordant couples and 100 unpartnered individuals receiving ARV treatment at a tertiary hospital in southern Brazil. All subjects provided written informed consent, answered demographic/behavioral questionnaires through audio computer-assisted self-interviews (ACASI), and collected blood and vaginal samples for biological markers and assessment of sexually transmitted infections (STIs). HIV-negative partners were counseled and tested for HIV-1. RESULTS:The study population mean age was 39.9 years, 53.6% were female, 62.5% were Caucasian, 52.6% had incomplete or complete elementary education, 63.1% resided in Porto Alegre. Demographic, behavioral and biological marker characteristics were similar between couples and single individuals. There was an association between adherence reported on ACASI and an undetectable serum viral load (P<0.0001). Logistic regression analysis demonstrated that single-tablet ARV-regimens were independently associated with adherence (OR = 2.3; 95CI%: 1.2-4.4; P = 0.011) after controlling for age, gender, education, marital status, personal income, ARV regimen, and median time of ARV use. A positive correlation between genital secretion PCR results and serum viral load was significant in the presence of STIs (r = 0.359; P = 0.017). Although HIV PCR detection in vaginal secretions was more frequent in women with detectable viremia (9/51, 17.6%), it was also present in 7 of 157 women with undetectable serum viral loads (4.5%), p = 0.005. CONCLUSIONS:ARV single tablet regimens are associated with adherence. Detectable HIV-1 may be present in the genital secretions of women with undetectable viremia which means there is potential for HIV transmission in adherent individuals with serologic suppression.

Project description:BackgroundDespite advances in HIV diagnosis and treatment, adolescents and young adults 12-25 years old have high HIV incidence, poor engagement and retention in treatment, and low rates of adherence and virologic suppression when compared to their older counterparts. HIV has emerged as a chronic disease for which antiretroviral therapy (ART) adherence is critical for virologic suppression and long-term survival. Virologic suppression has been elusive for many youth with HIV (YHIV). Novel strategies designed to facilitate health care systems' support for YHIV between medical visits are essential for improving ART adherence, virologic suppression, and long-term survival.ObjectiveThe aim of this study is to compare the effectiveness of a technology-enhanced community health nursing intervention (TECH2CHECK) to a standard of care (SOC) control group for improving ART adherence and subsequent viral suppression using a randomized trial design. The objectives are to assess the feasibility, acceptability, and cost-effectiveness of TECH2CHECK as compared to SOC for management of HIV in the outpatient setting and to examine the sustainability of self-care behavior, adherence, and virologic suppression among youth following the intervention period.MethodsWe will recruit 120 adherence-challenged YHIV being followed at clinics specializing in HIV care in the Baltimore-Washington metropolitan area and in Jacksonville. Eligible participants complete an audio, computer-assisted self-interview and are randomized to either TECH2CHECK intervention or the SOC (60 participants in each arm). The primary outcome of interest is virologic suppression (viral load <20 copies/mL) and improved treatment adherence. Participants in the intervention arm receive community health nursing visits at 2 weeks, 6 weeks, 10 weeks, 14 weeks, and 26 weeks. The intervention arm also receives SMS messaging comprising daily adherence and appointment reminders and positive reinforcement for medication adherence daily for 2 weeks, on alternate days for 2 weeks, thrice weekly for 1 month, weekly for 3 months, and every 2 weeks for the rest of the study duration. The control group receives appointment reminders and SOC per clinic protocol. Exploratory analysis will be conducted to determine differences in medication adherence and virologic suppression in the 2 arms and to assess cost-effectiveness and study feasibility and acceptability.ResultsIn the first 23 months of the study (July 2018-April 2020), 56 (55%) of 102 eligible patients were enrolled and randomized. At present, participating youths are primarily African American (53/56, 95%), male (37/56, 66%), and ≥18 years old (53/56, 95%). Follow-up study visits, as required per the protocol, have been completed by 77% (43/56), 94% (45/48), 95% (37/39), 96% (24/25), and 100% (10/10) of participants at the 1-month, 3-month, 6-month, 12-month, and 18-month follow-ups, respectively.ConclusionsPreliminary accrual and retention data suggest that TECH2CHECK is feasible and acceptable.Trial registrationClinicalTrials.gov NCT03600103 https://clinicaltrials.gov/ct2/show/NCT03600103.International registered report identifier (irrid)DERR1-10.2196/23480.

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Incomplete ART adherence is associated with higher inflammation in individuals who achieved virologic suppression in the START study.

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Incomplete ART adherence is associated with higher inflammation in individuals who achieved virologic suppression in the START study.

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