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Risk factors for antiretroviral therapy (ART) discontinuation in a large multinational trial of early ART initiators

Bansi-Matharu, Loveleena; Rodriguez Loria, Gabrielab; Cole, Stephen R.c; Mugerwa, Henryd; Vecino, Isabele; Lundgren, Jensf; Pulik, Piotrg; Smith, Colettea; Phillips, Andrew N.a for the INSIGHT START Study Group

doi: 10.1097/QAD.0000000000002210

Objective: We aimed to investigate potential causes of higher risk of treatment interruptions within the multicountry Strategic Timing of AntiRetroviral Treatment (START) trial in 2015.

Methods: We defined baseline as the date of starting antiretroviral therapy (ART) and a treatment interruption as discontinuing ART for at least 2 weeks. Participants were stratified by randomization arm and followed from baseline to earliest end date of the initial phase of START, death, date of consent withdrawn or date of first treatment interruption. Cox regression was used to calculate hazard ratios and 95% confidence intervals for factors that may predict treatment interruptions in each arm.

Results: Of the 3438 participants who started ART, 2286 were in the immediate arm and 1152 in the deferred arm. 12.9% of people in the immediate arm and 10.5% of people in the deferred arm experienced at least one treatment interruption by 3 years after starting ART. In adjusted analyses, age [hazard ratio for 35–50 years: 0.75 (95% confidence interval: 0.59–0.97) and >50 years: 0.53 (0.33–0.80) vs. <35 years], education status [hazard ratio for postgraduate education vs. less than high-school education (0.23 (0.10–0.50))] and region [hazard ratio for United States vs. Europe/Israel (3.16 (2.09–4.77))] were significantly associated with treatment interruptions in the immediate arm. In the deferred arm, age and education status were significantly associated with treatment interruptions.

Conclusion: Within START, we identified younger age and lower educational attainment as potential causes of ART interruption. There is a need to strengthen adherence advice and wider social support in younger people and those of lower education status.

aInstitute for Global Health, UCL, London, UK

bFundacion IBIS, Research, Buenos Aires, Argentina

cJohann Wolfgang Goethe University Hospital, Frankfurt, Germany

dJoint Clinical Research Centre, Kampala, Uganda

eUniversity of North Texas HSC, Fort Worth, Texas, USA

fCHIP, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark

gHospital for Infectious Diseases, HIV Out-Patient Clinic, Warsaw, Poland.

Correspondence to Loveleen Bansi-Matharu, University College London, Institute for Global Health, London, UK. E-mail:

Received 23 January, 2019

Revised 12 February, 2019

Accepted 14 February, 2019

Copyright © 2019 Wolters Kluwer Health, Inc.