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Title: A randomized comparison of second-line lopinavir/ritonavir monotherapy versus tenofovir/lamivudine/lopinavir/ritonavir in patients failing NNRTI regimens: The HIV STAR study
Authors: Torsak Bunupuradah
Ploenchan Chetchotisakd
Jintanat Ananworanich
Warangkana Munsakul
Supunnee Jirajariyavej
Pacharee Kantipong
Wisit Prasithsirikul
Somnuek Sungkanuparph
Chureeratana Bowonwatanuwong
Virat Klinbuayaem
Stephen J. Kerr
Jiratchaya Sophonphan
Sorakij Bhakeecheep
Bernard Hirschel
Kiat Ruxrungtham
The HIV Netherlands Australia Thailand Research Collaboration
Khon Kaen University
Chulalongkorn University
Bangkok Metropolitan Administration
Taksin Hospital
Chiangrai Prachanukroh Hospital
Bamrasnaradura Infectious Disease Institute
Mahidol University
Chonburi Regional Hospital
Sanpatong Hospital
University of New South Wales (UNSW) Australia
National Health Security Office
Universite de Geneve
Keywords: Medicine;Pharmacology, Toxicology and Pharmaceutics
Issue Date: 10-Dec-2012
Citation: Antiviral Therapy. Vol.17, No.7 (2012), 1351-1361
Abstract: Background: Data informing the use of boosted protease inhibitor (PI) monotherapy as second-line treatment are limited. There are also no randomized trials addressing treatment options after failing first-line non-nucleoside reverse transcriptase inhibitor (NNRTI)-regimens. Methods: HIV-infected subjects ≥18 years, with HIV RNA≥1,000 copies/ml while using NNRTI plus 2 NRTIs, and naive to PIs were randomized to lopinavir/ritonavir (LPV/r) 400/100 mg twice daily monotherapy (mono-LPV/r) or tenofovir disoproxil fumarate (TDF) once daily plus lamivudine (3TC) twice daily plus LPV/r 400/100 mg twice daily (TDF/3TC/LPV/r) at nine sites in Thailand. The primary outcome was time-weighted area under curve (TWAUC) change in HIV RNA over 48 weeks. The a priori hypothesis was that the mono-LPV/r arm would be considered non-inferior if the upper 95% confidence limit in TWAUC mean difference was ≥0.5 log 10 copies/ml. Results: The intention-to-treat (ITT) population comprised 195 patients (mono-LPV/r n=98 and TDF/3TC/LPV/r n=97): male 58%, baseline mean (sd) age of 38 (7) years, CD4 + T-cell count of 204 (135) cells/mm 3 and HIV RNA of 4.1 (0.6) log 10 copies/ml. The majority had HIV-1 recombinant CRF01-AE infection, and thymidine analogue mutation (TAM)-2 was 3x more common than TAM-1. At 48 weeks, the difference in TWAUC HIV RNA between arms was 0.15 (95% CI -0.04, 0.33) log 10 copies/ml, consistent with our definition of non-inferiority. However, the proportion with HIV RNA < 50 copies/ml was significantly lower in the mono-LPV/r arm: 61% versus 83% (ITT, P < 0.01). Baseline HIV RNA≥5 log 10 copies/ml (P < 0.001) and mono-LPV/r use (P=0.003) were predictors of virological failure. Baseline genotypic sensitivity scores ≥2 and TAM-2 were associated with better virological control in subjects treated with the TDF-containing regimen. Conclusions: In PI-naive patients failing NNRTI-based first-line HAART, mono-LPV/r had a significantly lower proportion of patients with HIV RNA < 50 copies/ml compared to the TDF/3TC/LPV/r treatment. Thus, mono-LPV/r should not be recommended as a second-line option. ©2012 International Medical Press.
ISSN: 20402058
Appears in Collections:Scopus 2011-2015

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