Long-term efficacy and safety of E/C/F/TDF vs EFV/FTC/TDF and ATV+RTV+FTC/TDF in HIV-1-infected treatment-naïve subjects ≥50 years.
BACKGROUND
In high-income countries, ≥30% of HIV-infected patients are ≥50 years (yrs) old (UNAIDS 2013). In two phases, three clinical trials (Studies 102 and 103) elvitegravir/cobicistat/emtricitabine/tenofovir DF (E/C/F/TDF; STB) had non-inferior efficacy and favourable safety vs efavirenz/emtricitabine/tenofovir DF (EFV/FTC/TDF; ATR) or ritonavir-boosted atazanavir (ATV+RTV)+FTC/TDF (TVD) in HIV-infected, treatment-naïve subjects at Week 144. The efficacy and safety of STB in subjects < or ≥50 yrs is described.


METHODS
Post hoc analysis of efficacy, tolerability and safety in subjects < or ≥50 yrs at Week 144.


RESULTS
Subjects ≥50 yrs in Study 102: STB: 14% (49/348), ATR: 16% (56/352); in Study 103: STB: 14% (48/353), ATV+RTV+TVD: 14% (48/355). Efficacy, safety and tolerability by age and study endpoint are shown in Table 1. Regardless of age, STB had robust efficacy at Week 144 with similar virologic outcomes vs ATR or ATV+RTV+TVD. Discontinuations (DC) due to AE on STB were similar to the comparators, most occurred by Week 48. Median changes in eGFR on STB were similar by age; DC with renal PRT was rare [STB: 4 (0.6%); ATV: 3 (0.8%); ATR: 0], 2 and 1 in ≥50 yrs old strata, respectively.


CONCLUSIONS
STB compared to ATR or ATV+RTV+TVD, is an efficacious, well-tolerated and safe regimen for HIV-1-infected, treatment-naïve subjects<or≥50 yrs of age.
Infectious Disease, Chelsea and Westminster Hospital, London, UK.
Brian
B
Gazzard
Infectious Diseases, Center Hospital at University St Antoine, Paris, France.
Pierre Marie
PM
Girard
Internal Medicine, School of Medicine, University of Turin, Torino, Italy.
Giovanni
G
Di Perri
Infectious Diseases, Southwest CARE Center, Santa Fe, NM, USA.
Joel
J
Gallant
Internal Medicine, Kaiser Permanente, Los Angeles, CA, USA.
William
W
Towner
Medical Affairs, Gilead Sciences Europe, Stockley Park, UK.
Felipe
F
Rogatto
HIV Medical Affairs, Gilead Sciences, Foster City, CA, USA.
Jennifer
J
Demorin
HIV Medical Affairs, Gilead Sciences, Foster City, CA, USA.
Damian
D
McColl
Biostats, Gilead Sciences, Foster City, CA, USA.
Hui
H
Liu
Clinical Research, Gilead Sciences, Foster City, CA, USA.
Martin
M
Rhee
Clinical Research, Gilead Sciences, Foster City, CA, USA.
Javier
J
Szwarcberg
HIV Medical Affairs, Gilead Sciences, Foster City, CA, USA.
David
D
Piontkowsky