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Efficacy and Safety of Tenofovir Alafenamide in HIV-Infected Women With Renal Impairment: 96-Week Results
  Study GS-US-292-0112
Reported by Jules Levin
ASM/ICAAC 2016 June 16-20 Boston, MA
Cheryl McDonald1, Ann Khalsa2, Shubha Kerkar3, Jennifer Bartczak4, Indira Brar5, Shuping Jiang6, Lijie Zhong6, Moupali Das6, Marshall Fordyce6
1Tarrant County Infectious Disease Associates, Fort Worth, TX; 2McDowell Healthcare Center, Phoenix, AZ; 3Desert Medical Group, Palm Springs, CA; 4Rowan Tree Medical, Wilton Manors, FL; 5Henry Ford Hospital, Detroit, MI; 6Gilead Sciences, Inc., Foster City, CA


Program Abstract
Background: Women with HIV and renal disease urgently need antiretroviral regimens with high efficacy and improved tolerability. Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir (TFV) that results in 90% lower plasma TFV levels as compared to tenofovir disoproxil fumarate (TDF), and has demonstrated improved renal and bone safety. Study GS-US-292-0112 assessed the safety and efficacy of a once-daily single tablet regimen of elvitegravir, cobicistat, emtricitabine, and TAF (E/C/F/TAF) in HIV-1 infected patients with mild to moderate renal impairment.
Methods: Virologically suppressed adults (N=242) with stable renal impairment (eGFRCG 30 to 69 mL/min) switched to open-label E/C/F/TAF. We present Week 96 (W96) outcomes.
Results: At W96, 90% of women had VL <50 compared to 88% of men. 21% of participants were female. More women were non-white (black 26% vs. 16%); (Hispanic 16% vs. 12%); (Asian 18% vs. 13%); and acquired HIV heterosexually (90% vs. 28%). At baseline, women had lower bone mineral density (BMD) at hip (0.84 vs. 0.92 g/cm2) and spine (0.962 vs. 1.10 g/cm2) compared to men (p<0.001 for both); 59% of women had osteopenia or osteoporosis compared to 51% of men. At W96, women had greater percentage increases in spine BMD (3.6% vs. 1.6%; p=0.09) and similar increases in hip BMD (2.1% vs. 1.8%; p=0.96); 19% of women vs. 10% of men improved their osteopenia/osteoporosis.
Conclusions: HIV-infected women with renal impairment who switched to E/C/F/TAF had excellent virologic suppression and improvement in BMD after two years. E/C/F/TAF may fulfill an unmet need as a potent and safe regimen for women with impaired renal function.







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