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
| Autor: | 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, Php, Groeneveld, Wfw, Bierman, Ts, van der Werf, Eh, Gisolf, C, Richter |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Male Anti-HIV Agents HIV Infections Drug Administration Schedule Belgium Clinical Protocols Humans Prospective Studies Aged Netherlands HIV Protease Inhibitors Middle Aged Viral Load Lipids Dideoxynucleosides CD4 Lymphocyte Count Drug Combinations Treatment Outcome Lamivudine Disease Progression HIV-1 RNA Viral Drug Therapy Combination Female Zidovudine |
| Zdroj: | HIV medicine. 16(2) |
| ISSN: | 1468-1293 |
| Popis: | 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).An open-label, noninferiority study was carried out. Antiretroviral therapy (ART)-naïve patients with CD4 count ≤ 350 cells/μL and HIV-1 RNA30000 copies/mL (n=207) were treated with zidovudine/lamivudine and lopinavir/ritonavir. After achieving HIV-1 RNA50 copies/mL on two consecutive occasions between weeks 12 and 24 after baseline, 120 patients (baseline: median HIV-1 RNA 5.19 log10 copies/mL; median CD4 count 180 cells/μL) were randomized to receive abacavir/lamivudine/zidovudine (ABC/3TC/ZDV) (n=61) or to continue the PI-based ART (n=59).For the proportions of patients (intention-to-treat; missing=failure) with HIV-1 RNA400 copies/mL (PI group, 66%; ABC/3TC/ZDV group, 71%) and50 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 RNA400 copies/mL (0 of 39 patients in the PI group and two of 45 patients in the NRTI group) and for HIV-1 RNA50 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.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. |
| Databáze: | OpenAIRE |
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