Title:Outcomes in Older Versus Younger Patients Over 96 Weeks in HIV-1– Infected Patients Treated with Rilpivirine or Efavirenz in ECHO and THRIVE
VOLUME: 11 ISSUE: 7
Author(s):Robert Ryan, Yaswant K. Dayaram, Deborah Schaible, Bruce Coate and David Anderson
Affiliation:Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA.
Keywords:Aging, ECHO, efavirenz, rilpivirine, THRIVE, treatment-naive.
Abstract:Objectives: Increasing life expectancy of HIV-1–infected patients raises interest in how trial results apply to
older patients. This post-hoc analysis evaluated potential differences in efficacy and safety in older (≥50 years) versus
younger (<50 years) patients in the ECHO and THRIVE trials over 96 weeks.
Methods: HIV-infected, treatment-naïve adults were randomized to receive rilpivirine (RPV) or efavirenz (EFV), plus a
background regimen. Virologic response rates (FDA snapshot analysis; HIV-1 RNA <50 copies/mL) were assessed at
Week 96. Total-body bone mineral density was evaluated at baseline and Week 96 by dual-energy X-ray absorptiometry
scans. Serum concentrations of 25-hydroxy vitamin D (ECHO trial only) were also measured at baseline, Week 24 and
Week 48.
Results: 1368 patients were treated. At Week 96, virologic response rates were similar between older (77%) and younger
(76%) RPV-treated patients and numerically higher in older (84%) versus younger (76%) EFV-treated patients. No
clinically relevant age-related differences were observed in immunologic responses. Small differences were noted in older
versus younger patients in adverse events (higher rates of depression, insomnia, and rash in older EFV-treated patients),
laboratory abnormalities (increased low-density lipoprotein cholesterol and hyperglycemia in older EFV-treated patients
and increased amylase in older patients across treatments), bone mineral density (larger decreases in older patients across
treatments), and progression to severe vitamin D deficiency (greater in older versus younger EFV-treated patients).
Conclusion: Efficacy and safety outcomes were generally similar in older versus younger patients in the ECHO and
THRIVE trials.
