Lack of Interaction Between the HIV Integrase Inhibitor S/GSK1349572 and Tenofovir in Healthy Subjects
- 1 November 2010
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in JAIDS Journal of Acquired Immune Deficiency Syndromes
- Vol. 55 (3), 365-367
- https://doi.org/10.1097/qai.0b013e3181e67909
Abstract
Background: The potential for a drug interaction between S/GSK1349572 and tenofovir disoproxil fumarate (TDF) was evaluated in an open-label, repeat dose, 3-period, drug-drug interaction study in healthy subjects. Methods: S/GSK1349572 was administered at 50 mg once daily for 5 days (period 1) followed by a 6-day washout period. TDF 300 mg once daily was then administered for 7 days (period 2). The combination of S/GSK1349572 and TDF was then coadministered for 5 days (period 3). Pharmacokinetic parameters were determined and compared between periods. Results: Fifteen subjects completed all periods and follow-up. S/GSK1349572 and TDF were generally well tolerated with few adverse events reported. No clinically significant trends in post-dose laboratory abnormalities, vital signs, or electrocardiogram values were noted. Pharmacokinetic parameters of S/GSK1349572 and tenofovir during combination therapy were similar to those when given alone, demonstrating no significant drug interaction. S/GSK1349572 geometric least squares mean ratios (90% confidence interval) for AUC(0-τ), Cmax, and Cτ were 1.01 (0.908, 1.11), 0.969 (0.867, 1.08), and 0.920 (0.816, 1.04), respectively. Tenofovir geometric least squares mean ratios (90% confidence interval) for AUC(0-τ), Cmax, and Cτ were 1.12 (1.01, 1.24), 1.09 (0.974, 1.23), and 1.19 (1.04, 1.35), respectively. Conclusion: S/GSK1349572 and TDF can be coadministered without dose adjustment.Keywords
This publication has 6 references indexed in Scilit:
- Pharmacokinetics and Safety of S/GSK1349572, a Next-Generation HIV Integrase Inhibitor, in Healthy VolunteersAntimicrobial Agents and Chemotherapy, 2010
- Lack of a Significant Drug Interaction between Raltegravir and TenofovirAntimicrobial Agents and Chemotherapy, 2008
- Pharmacokinetics of Emtricitabine, Tenofovir, and GS-9137 Following Coadministration of Emtricitabine/Tenofovir Disoproxil Fumarate and Ritonavir-Boosted GS-9137JAIDS Journal of Acquired Immune Deficiency Syndromes, 2007
- Mechanism of Active Renal Tubular Efflux of TenofovirAntimicrobial Agents and Chemotherapy, 2006
- Drug‐Drug and Drug‐Food Interactions Between Tenofovir Disoproxil Fumarate and DidanosineThe Journal of Clinical Pharmacology, 2005
- Interactions between Atazanavir-Ritonavir and Tenofovir in Heavily Pretreated Human Immunodeficiency Virus-Infected PatientsAntimicrobial Agents and Chemotherapy, 2004