Outcomes in older versus younger patients over 96 weeks in HIV-1- infected patients treated with rilpivirine or efavirenz in ECHO and THRIVE.
OBJECTIVE
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).


CONCLUSIONS
Efficacy and safety outcomes were generally similar in older versus younger patients in the ECHO and THRIVE trials.
Robert
R
Ryan
Yaswant K
YK
Dayaram
Deborah
D
Schaible
Bruce
B
Coate
Janssen Scientific Affairs, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ 08560, USA. DAnder20@its.jnj.com.
David
D
Anderson
D015502:Absorptiometry, Photon; D000293:Adolescent; D000328:Adult; D000368:Aged; D000480:Alkynes; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects / Q000379:methods*; D048588:Benzoxazines / Q000009:adverse effects / Q000627:therapeutic use*; D015519:Bone Density; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000009:adverse effects / Q000627:therapeutic use*; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D000068696:Rilpivirine; D016896:Treatment Outcome; D014807:Vitamin D / Q000097:blood*; D055815:Young Adult
D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D003521:Cyclopropanes; D009570:Nitriles; D011743:Pyrimidines; D014807:Vitamin D; D000068696:Rilpivirine; C098320:efavirenz