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Title: Low-dose versus standard-dose ritonavir-boosted atazanavir in virologically suppressed Thai adults with HIV (LASA): a randomised, open-label, non-inferiority trial
Authors: Torsak Bunupuradah
Sasisopin Kiertiburanakul
Anchalee Avihingsanon
Ploenchan Chetchotisakd
Malee Techapornroong
Niramon Leerattanapetch
Pacharee Kantipong
Chureeratana Bowonwatanuwong
Sukit Banchongkit
Virat Klinbuayaem
Sripetcharat Mekviwattanawong
Sireethorn Nimitvilai
Supunnee Jirajariyavej
Wisit Prasithsirikul
Warangkana Munsakul
Sorakij Bhakeecheep
Suchada Chaivooth
Praphan Phanuphak
David A. Cooper
Tanakorn Apornpong
Stephen J. Kerr
Sean Emery
Kiat Ruxrungtham
The HIV Netherlands Australia Thailand Research Collaboration
Mahidol University
Khon Kaen University
Prapokklao Hospital
Khon Kaen Regional Hospital
Chiangrai Prachanukroh Hospital
Chonburi Regional Hospital
Rayong Hospital
Sanpatong Hospital
Pranangklao Hospital
Nakhon Phatom Hospital
Taksin Hospital
Bamrasnaradura Infectious Disease Institute
Bangkok Metropolitan Administration
National Health Security Office
University of New South Wales (UNSW) Australia
Academic Medical Centre, University of Amsterdam
Chulalongkorn University
Keywords: Immunology and Microbiology;Medicine
Issue Date: 1-Aug-2016
Citation: The Lancet HIV. Vol.3, No.8 (2016), e343-e350
Abstract: © 2016 Elsevier Ltd Background Thai patients with HIV have higher exposure to HIV protease inhibitors than do white people and dose reduction might be possible. We compared the efficacy of low-dose with standard-dose ritonavir-boosted atazanavir in virologically suppressed Thai patients with HIV. Methods In this randomised, open-label, non-inferiority trial, we recruited patients aged 18 years or older who were receiving ritonavir-boosted protease-inhibitor-based antiretroviral therapy (ART) with HIV plasma viral loads of less than 50 copies per mL, an alanine aminotransferase concentration of less than 200 IU/L, and a creatinine clearance of at least 60 mL/min from 14 hospitals in Thailand. We excluded patients who had active AIDS-defining disease or opportunistic infections, had a history of an HIV viral load of 1000 copies per mL or more after 24 weeks of any ritonavir-boosted protease-inhibitor-based ART, used concomitant medications that could interact with the study drugs, were pregnant or lactating, had illnesses that might change the effect of the study drugs, or had a history of sensitivity to the study drugs. A biostatistician at the study coordinating centre randomly allocated patients (1:1) to switch the protease inhibitor for oral atazanavir 200 mg and ritonavir 100 mg or for atazanavir 300 mg and ritonavir 100 mg once daily, both with two nucleoside or nucleotide reverse transcriptase inhibitors at recommended doses. Randomisation was done with a minimisation schedule, stratified by recruiting centre, use of tenofovir, and use of indinavir as a component of the preswitch regimen. The primary endpoint was the proportion of patients with viral loads of less than 200 copies per mL at week 48, and we followed up patients every 12 weeks. Treatments were open label, the non-inferiority margin was −10%, and all patients who received at least one dose of study medication were analysed. This trial is registered with, number NCT01159223. Findings Between July 6, 2011, and Dec 23, 2013, we randomly assigned 559 patients: 279 to receive atazanavir 200 mg and ritonavir 100 mg (low dose) and 280 to atazanavir 300 mg and ritonavir 100 mg (standard dose). At week 48, 265 (97·1%) of 273 in the low-dose group and 267 (96·4%) of 277 in the standard-dose group had viral loads of less than 200 copies per mL (difference 0·68; 95% CI −2·29 to 3·65). Seven (3%) of 273 in the low-dose group and 21 (8%) of 277 in the standard-dose group discontinued their assigned treatment (p=0·01). 46 (17%) of 273 participants in the low-dose group and 97 (35%) of 277 in the standard-dose group had total bilirubin grade 3 or higher toxicity (≥3·12 mg/dL; p<0·0001). Interpretation A switch to low-dose atazanavir should be recommended for Thai patients with well controlled HIV viraemia while on regimens based on boosted protease inhibitors. Funding The National Health Security Office and Kirby Institute for Infection and Immunity in Society.
ISSN: 23523018
Appears in Collections:Scopus 2016-2017

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