Safety and efficacy of lopinavir/ritonavir-containing antiretroviral therapy in patients aged <50 versus ≥50 years from randomized trials. (April 2014)

• Record Type: Journal Article
• Authors: Fisher, Martin; Norton, Michael; Saget, Brad; Fredrick, Linda; Wyk, Jean van
• Is Part Of: Future virology. Volume 9:Number 4(2014)
• Page Start: 351
• Page End: 362
• Publication Date: 2014-04
• Subjects: age -- antiretroviral therapy -- HIV -- meta-analysis; Virology -- Periodicals; Virus diseases -- Treatment -- Periodicals; 616.9101
• DOI: 10.2217/fvl.14.18
• Languages: English
• ISSNs: 1746-0794

Abstract

ABSTRACT: : Aim: Data describing the safety and efficacy of antiretroviral therapy (ART) in HIV-infected patients aged ≥50 years are limited. We evaluated the effect of age on safety, efficacy and tolerability in patients aged &lt;50 and ≥50 years receiving lopinavir/ritonavir (LPV/r)-containing ART.Methods: End points from AbbVie Inc. (IL, USA) or AIDS Clinical Trials Group randomized clinical trials in adults using LPV/r 800/200 mg/day as part of a three-drug regimen (follow-up ≥48 weeks) were evaluated using a random-effects meta-analysis (virologic efficacy; intent-to-treat; noncompleter = failure) or pooled data (other end points).Results: A total of 2608 patients (2294.3 patient-years of follow-up) from ten trials were included: 2248 patients (86.2%) &lt;50 years of age and 360 (13.8%) ≥50 years of age. Demographics and baseline characteristics were similar between age groups. At week 48, 64.9 and 67.8% of patients &lt;50 and ≥50 years, respectively, had plasma HIV-1 RNA &lt;50 copies/ml (random effects meta-analysis p = 0.992). Mean change from baseline in CD4 + T-cell count was +193.9 and +163.5 cells/μl (&lt;50 and ≥50 years, respectively; p &lt; 0.001). Smaller proportions of patients &lt;50 years of age discontinued due to adverse events (AEs)/HIV-related events (4.9 vs 9.4%; p = 0.001) and reported moderate-to-severe treatment-related AEs (30.5 vs 36.4%; p = 0.027) compared with patients ≥50 years of age.Conclusion: This analysis suggests LPV/r-anchored three-drug therapy in patients ≥50 years of age leads to comparable rates of virologic suppression, with a smaller increase in absolute CD4 + T cells and increased AEs, including discontinuations associated with AEs compared with patients &lt;50 years of age.