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Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Demonstrates Comparable Efficacy and Favorable Tolerability to
Efavirenz/Emtricitabine/Tenofovir DF and to Ritonavir-boosted Atazanavir plus Emtricitabine/Tenofovir DF in Patients ≥50 Years
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Reported by Jules Levin
52nd ICAAC Sept 9-12 2012 SF
G Richmond1, P Ruane2, W Robbins3, F Bredeek4, P Shalit5, D Hardy6, K Workowski7, M Bloch8, W Towner9,
T Lutz10, C Orkin11, J Szwarcberg12, E Quirk12, H Liu12, X Wei12, M Rhee12, D Piontkowsky12
1Fort Lauderdale, FL; 2Los Angeles, CA; 3Value Health MD, LLC, Orlando, FL; 4Metropolis Med Group, San Francisco, CA; 5Tribal Med, Seattle, WA; 6Cedars-Sinai Med Center, Los Angeles, CA; 7Emory University, Atlanta, GA; 8Holdsworth House Med Practice, Sydney, NSW, Australia; 9Kaiser Permanente, Los Angeles, CA; 10Infektio Research GmbH / Infektiologikum Frankfurt, Frankfurt, Germany; 11Barts and the London NHS Trust, London, UK; 12Gilead Sciences, Inc., Foster City, CA
CONCLUSIONS
In subjects age ≥50 years:
· EVG/COBI/FTC/TDF demonstrated high (86% in study 102 and 94% in study 103) and similar rates of virologic suppression compared to subjects age <50 years
· Resistance occurred in one subject age ≥50 years on EVG/COBI/FTC/TDF and one subject on EFV/FTC/TDF in study 102
· EVG/COBI/FTC/TDF was generally well tolerated with lower rates of neuropsychiatric and rash events in study 102 and nausea in study 103
· Modest lipid increases occurred in all treatment arms, with higher TG levels in the EVG/COBI/FTC/TDF compared to ATV + RTV + FTC/TDF arm
· Modest increase in serum creatinine occurred in the EVG/COBI/FTC/TDF arm in both studies which were statistically larger than the changes in the EFV/FTC/TDF arm,
but the same as the ATV + RTV + FTC/TDF arm
- Renal laboratory test results that led to study medication discontinuation either improved or returned to baseline after discontinuation of study medications1,2
- These findings were consistent with COBI inhibition of serum creatinine secretion3
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