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. Issue 2 (4th December 2014)

• Record Type: Journal Article
• Authors: Sprenger, HG; Langebeek, N; Mulder, PGH; ten Napel, CHH; Vriesendorp, R; Hoepelman, AIM; Legrand, JC; Koopmans, PP; Bravenboer, B; ten Kate, RW; Groeneveld, PHP; Bierman, WFW; van der Werf, TS; Gisolf, EH; Richter, C
• Is Part Of: HIV medicine. Volume 16:Issue 2(2015:Feb.)
• Page Start: 122
• Page End: 131
• Publication Date: 2014-12-04
• Subjects: HIV infections -- Treatment -- Periodicals; HIV-positive persons -- Periodicals; HIV infections -- Treatment -- Decision making -- Periodicals; 616.9792
• DOI: 10.1111/hiv.12186
• Languages: English
• ISSNs: 1464-2662

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="hiv12186-sec-0001" sec-type="section"> <title>Objectives</title> <p>The 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).</p> </sec> <sec id="hiv12186-sec-0002" sec-type="section"> <title>Methods</title> <p>An open‐label, noninferiority study was carried out. Antiretroviral therapy (ART)‐naïve patients with CD4 count ≤ 350 cells/μL and HIV‐1 RNA > 30 000 copies/mL (<italic>n</italic> = 207) were treated with zidovudine/lamivudine and lopinavir/ritonavir. After achieving HIV‐1 RNA < 50 copies/mL on two consecutive occasions between weeks 12 and 24 after baseline, 120 patients (baseline: median HIV‐1 RNA 5.19 log<sub>10</sub> copies/mL; median CD4 count 180 cells/μL) were randomized to receive abacavir/lamivudine/zidovudine (ABC/3TC/ZDV) (<italic>n</italic> = 61) or to continue the PI‐based ART (<italic>n</italic> = 59).</p> </sec> <sec id="hiv12186-sec-0003" sec-type="section"> <title>Results</title> <p>For the proportions of patients (intention‐to‐treat; missing = failure) with HIV‐1 RNA < 400 copies/mL (PI group, 66%; ABC/3TC/ZDV group, 71%) and < 50 copies/mL (PI group, 63%; ABC/3TC/ZDV group, 62%) at 96 weeks, switching to ABC/3TC/ZDV was noninferior compared with continuing the PI regimen; the difference in failure rate (ABC/3TC/ZDV minus PI) was −4.4 percentage points [95% confidence interval (CI) −21.0 to +12.3 percentage points] and +0.4 percentage points (95% CI −16.9 to +17.7 percentage points), respectively. In the per protocol analysis, the difference in virological failure for 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.</p> </sec> <sec id="hiv12186-sec-0004" sec-type="section"> <title>Conclusions</title> <p>A 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.</p> </sec> </abstract>