A randomized controlled trial of single-class maintenance therapy with abacavir/lamivudine/zidovudine after standard triple antiretroviral induction therapy: final 96-week results from the FREE study

H. G. Sprenger*, N. Langebeek, P. G. H. Mulder, C. H. H. ten Napel, R. Vriesendorp, A. I. M. Hoepelman, J. C. Legrand, P. P. Koopmans, B. Bravenboer, R. W. ten Kate, P. H. P. Groeneveld, W. F. W. Bierman, T. S. van der Werf, E. H. Gisolf, C. Richter

*Corresponding author voor dit werk

OnderzoeksoutputAcademicpeer review

4 Citaten (Scopus)

Samenvatting

ObjectivesThe aim of the study was to test the antiviral efficacy of a triple nucleoside reverse transcriptase inhibitor (NRTI) regimen, with potential beneficial metabolic effects, as maintenance therapy after induction with dual NRTIs and a boosted protease inhibitor (PI).

MethodsAn open-label, noninferiority study was carried out. Antiretroviral therapy (ART)-naive patients with CD4 count 350 cells/L and HIV-1 RNA >30000 copies/mL (n=207) were treated with zidovudine/lamivudine and lopinavir/ritonavir. After achieving HIV-1 RNA

ResultsFor the proportions of patients (intention-to-treat; missing=failure) with HIV-1 RNA 400 copies/mL (0 of 39 patients in the PI group and two of 45 patients in the NRTI group) and for HIV-1 RNA >50 copies/mL (two of 39 and three of 45 patients, respectively) was +4.4 percentage points (95% CI -2.1 to +11.0 percentage points) and +1.5 percentage points (95% CI -8.6 to +11.7 percentage points), respectively, also showing noninferiority. Serum lipids significantly improved in the NRTI group, but not in the PI arm.

ConclusionsA single-class NRTI regimen after successful induction with standard ART had similar antiviral efficacy compared to continuation of a PI-based regimen at 96 weeks after baseline, with improved serum lipids.

Originele taal-2English
Pagina's (van-tot)122-131
Aantal pagina's10
TijdschriftHIV Medicine
Volume16
Nummer van het tijdschrift2
DOI's
StatusPublished - feb.-2015

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