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Gazzard B, Girard PM, Di Perri G, et al. 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. J Int AIDS Soc. 2014;17(4):19767doi: 10.7448/IAS.17.4.19767.
Gazzard, B., Girard, P. M., Di Perri, G., Gallant, J., Towner, W., Rogatto, F., Demorin, J., McColl, D., Liu, H., Rhee, M., Szwarcberg, J., & Piontkowsky, D. (2014). 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. Journal of the International AIDS Society, 17(4), 19767. https://doi.org/10.7448/IAS.17.4.19767
Gazzard, Brian, et al. "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." Journal of the International AIDS Society vol. 17,4 (2014): 19767. doi: https://doi.org/10.7448/IAS.17.4.19767
Gazzard B, Girard PM, Di Perri G, Gallant J, Towner W, Rogatto F, Demorin J, McColl D, Liu H, Rhee M, Szwarcberg J, Piontkowsky D. 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. J Int AIDS Soc. 2014 Nov 02;17(4):19767. doi: 10.7448/IAS.17.4.19767. eCollection 2014. PMID: 25397511; PMCID: PMC4225383.
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J Int AIDS Soc. 2014 Nov 02;17(4):19767. doi: 10.7448/IAS.17.4.19767. eCollection 2014.

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.

Journal of the International AIDS Society

Brian Gazzard, Pierre Marie Girard, Giovanni Di Perri, Joel Gallant, William Towner, Felipe Rogatto, Jennifer Demorin, Damian McColl, Hui Liu, Martin Rhee, Javier Szwarcberg, David Piontkowsky

Affiliations

  1. Infectious Disease, Chelsea and Westminster Hospital, London, UK.
  2. Infectious Diseases, Center Hospital at University St Antoine, Paris, France.
  3. Internal Medicine, School of Medicine, University of Turin, Torino, Italy.
  4. Infectious Diseases, Southwest CARE Center, Santa Fe, NM, USA.
  5. Internal Medicine, Kaiser Permanente, Los Angeles, CA, USA.
  6. Medical Affairs, Gilead Sciences Europe, Stockley Park, UK.
  7. HIV Medical Affairs, Gilead Sciences, Foster City, CA, USA.
  8. Biostats, Gilead Sciences, Foster City, CA, USA.
  9. Clinical Research, Gilead Sciences, Foster City, CA, USA.

PMID: 25397511 PMCID: PMC4225383 DOI: 10.7448/IAS.17.4.19767

Abstract

INTRODUCTION: 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.

MATERIALS AND 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

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