Evaluation of dolutegravir safety for the treatment of HIV-1

Bibliography

• HIV/AIDS. Fact sheet 360, Geneva, Switzerland; 2013. Available from: http://www.who.int/mediacentre/factsheets/fs360/en/ [Accessed 4 April 2014]
   Google Scholar
• May M, Gompels M, Sabin C. Life expectancy of HIV-1-positive individuals approaches normal conditional on response to antiretroviral therapy: UK Collaborative HIV Cohort Study. J Int AIDS Soc 2012. Available from: http://www.jiasociety.org/index.php/jias/article/view/18078 [Accessed 3 April 2014]
   Google Scholar
• Samji H, Cescon A, Hogg RS, et al. Closing the Gap: increases in life expectancy among treated HIV-positive individuals in the United States and Canada. PLoS One 2013;8(12):e81355
   PubMed Web of Science ®Google Scholar
• Juday T, Gupta S, Grimm K, et al. Factors associated with complete adherence to HIV combination antiretroviral therapy. HIV Clin Trials 2011;12(2):71-8
   PubMed Web of Science ®Google Scholar
• Ammassari A, Trotta MP, Shalev N, et al. Beyond virological suppression: the role of adherence in the late HAART era. Antivir Ther 2012;17(5):785-92
   PubMed Web of Science ®Google Scholar
• Raffi F, Rachlis A, Stellbrink HJ, et al. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet 2013;381:735-43
   PubMed Web of Science ®Google Scholar
• Kobayashi M, Yoshinaga T, Seki T, et al. In vitro antiretroviral properties of S/GSK1349572, a next-generation HIV integrase inhibitor. Antimicrob Agents Chemother 2011;55:813-21
   PubMed Web of Science ®Google Scholar
• Min S, Sloan L, DeJesus E, et al. Antiviral activity, safety, and pharmacokinetics/pharmacodynamics of dolutegravir as 10-day monotherapy in HIV-1-infected adults. AIDS 2011;25:1737-45
   PubMed Web of Science ®Google Scholar
• Underwood MR, Johns BA, Sato A, et al. The activity of the integrase inhibitor dolutegravir against HIV-1 variants isolated from raltegravir-treated adults. J Acquir Immune Defic Syndr 2012;61:297-301
   PubMed Web of Science ®Google Scholar
• Nichols G, Mills A, Grossberg R, et al. Antiviral activity of dolutegravir in subjects with failure on an integrase inhibitor–based regimen: week 24 phase 3 results from VIKING-3 [abstract O232]. 11th International Congress on Drug Therapy in HIV Infection; 11–15 November 2012; Glasgow, UK
   Google Scholar
• Johns BA, Kawasuji T, Weatherhead JG, et al. Carbamoyl pyridine HIV-1 integrase inhibitors 3: a diastereomeric approach to chiral nonracemic tricyclic ring systems and the discovery of dolutegravir (S/GSK1349572) and (S/GSK1265744). J Med Chem 2013;56:5901-16
   PubMed Web of Science ®Google Scholar
• Fantauzzi A, Turriziani O, Mezzaroma I. Potential benefit of dolutegravir once daily: efficacy and safety. HIV AIDS (Auckl) 2013;5:29-40
   Google Scholar
• Pommier Y, Johnson AA, Marchand C. Integrase inhibitors to treat HIV/AIDS. Nat Rev Drug Discov 2005;4:236-48
   PubMed Web of Science ®Google Scholar
• Hare S, Smith SJ, Metifiot M, et al. Structural and functional analysis of the second-generation integrase strand transfer inhibitor dolutegravir (S/GSK1349572). Mol Pharmacol 2011;80:565-72
   PubMed Web of Science ®Google Scholar
• Hightower KE, Wang R, DeAnda F, et al. Dolutegravir (S/GSK1349572) exhibits significantly slower dissociation than raltegravir and elvitegravir from wild-type and integrase inhibitor-resistant HIV-1 integrase-DNA complexes. Antimicrob Agents Chemother 2011;55:4552-9
   PubMed Web of Science ®Google Scholar
• Cooper DA, Steigbigel RT, Gatell JM, et al. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N Engl J Med 2008;359:355-65
   PubMed Web of Science ®Google Scholar
• Castagna A, Maggiolo F, Penco G, et al. Dolutegravir in antiretroviral-experienced patients with raltegravir-and/or elvitegravir-resistant HIV-1: 24-week results of the phase III VIKING-3 study. J Infect Dis 2014;210(3):354-62
   PubMed Web of Science ®Google Scholar
• Quashie PK, Mesplede T, Han Y-S, et al. Characterization of the R263K mutation in HIV-1 integrase that confers low-level resistance to the second-generation integrase strand transfer inhibitor dolutegravir. J Virol 2012;86(5):2696-705
   PubMed Web of Science ®Google Scholar
• Reese MJ, Savina PM, Generaux GT, et al. In vitro investigations into the roles of drug transporters and metabolizing enzymes in the disposition and drug interactions of dolutegravir, an HIV integrase inhibitor. Drug Metab Dispos 2013;41:353-61
   PubMed Web of Science ®Google Scholar
• Kusuhara H, Ito S, Kumagai Y, et al. Effects of a MATE protein inhibitor, pyrimethamine, on the renalelimination of metformin at oral microdose and at therapeutic dose in healthy subjects. Clin Pharmacol Ther 2011;89:837-44
   PubMed Web of Science ®Google Scholar
• Koteff J, Borland J, Chen S, et al. A phase I study to evaluate the effect od dolutegravir on renal function via measurement of iohexol and para-aminohippurate clearance in healthy subjects. Br J Clin Pharmacol 2013;75:990-6
   PubMed Web of Science ®Google Scholar
• Song I, Borland J, Chen S, et al. Effect of food on the pharmacokinetics of the integrase inhibitor dolutegravir. Antimicrob Agents Chemother 2012;56:1627-9
   PubMed Web of Science ®Google Scholar
• Cottrell ML, Hadzic T, Kashuba ADM. Clinical pharmacokinetic, pharmacodynamic and drug-interaction profile of the integrase inhibitor dolutegravir. Clin Pharmacokinet 2013;52:981-94
   PubMed Web of Science ®Google Scholar
• Castellino S, Moss L, Wagner D, et al. Metabolism, excretion, and mass balance of the HIV-1 integrase inhibitor dolutegravir in humans. Antimicrob Agents Chemother 2013;57:3536-46
   PubMed Web of Science ®Google Scholar
• Song I, Min SS, Borland J, et al. The effect of lopinavir/ritonavir and darunavir/ritonavir on the HIV integrase inhibitor S/GSK1349572 in healthy participants. J Clin Pharmacol 2011;51:237-42
   PubMed Web of Science ®Google Scholar
• Ford SL, Gould E, Chen S, et al. Lack of pharmacokinetic interaction between rilpivirine and integrase inhibitors dolutegravir and GSK1265744. Antimicrob Agents Chemother 2013;57:5472-7
   PubMed Web of Science ®Google Scholar
• Song I, Min SS, Borland J, et al. Lack of interaction between the HIV integrase inhibitor S/GSK1349572 and tenofovir in healthy subjects. J Acquir Immune Defic Syndr 2010;55:365-7
   PubMed Web of Science ®Google Scholar
• Song I, Borland J, Lou Y, et al. Effects of the enzyme inducers, tipranavir and efavirenz, on the pharmacokinetics of the integrase inhibitor, dolutegravir (S/GSK1349572) [abstract O-02]. 12th International Workshop on Clinical Pharmacology of HIV Therapy; 13–15 April 2011; Miami, FL
   Google Scholar
• Song I, Borland J, Min S, et al. Effects of etravirine alone and with ritonavir-boosted protease inhibitors on the pharmacokinetics of dolutegravir. Antimicrob Agents Chemother 2011;55:3517-21
   PubMed Web of Science ®Google Scholar
• Dooley K, Sayre P, Borland J, et al. Safety, tolerability, and pharmacokinetics of HIV integrase inhibitor dolutegravir given twice daily with rifampin or once daily with rifabutin: results of a phase 1 study among healthy subjects. JAIDS 2013;62:21-7
   Google Scholar
• Song I, Mark S, Chen S, et al. Dolutegravir does not affect methadone pharmacokinetics in opioid-dependent, HIV-seronegative subjects. Drug Alcohol Depend 2013;133:781-4
   PubMed Web of Science ®Google Scholar
• Buttgereit F. A fresh look at glucocorticoids: how to use an old ally more effectively. Bull NYU Hosp Jt Dis 2012;70(Suppl 1):S26-9
   PubMedGoogle Scholar
• Zoorob RJ, Cender D. A different look at corticosteroids. Am Fam Physician 1998;58:443-50
   PubMed Web of Science ®Google Scholar
• Meintjes G, Wilkinson RJ, Morroni C, et al. Randomized placebo-controlled trial of prednisone for paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome. AIDS 2010;24:2381-90
   PubMed Web of Science ®Google Scholar
• Kaplan LD. HIV-associated lymphoma. Best Pract Res Clin Haematol 2012;25:101-17
   PubMed Web of Science ®Google Scholar
• Wilkin A, Feinberg J. Pneumocystis carinii pneumonia: a clinical review. Am Fam Physician 1999;60:1699-708
   PubMed Web of Science ®Google Scholar
• Song I, Borland J, Chen S, et al. Effect of prednisone on the pharmacokinetics of the integrase inhibitor dolutegravir. Antimicrob Agents Chemother 2013;57:4394-7
   PubMed Web of Science ®Google Scholar
• Patel P, Song I, Borland J, et al. Pharmacokinetics of the HIV integrase inhibitor S/GSK1349572 co-administered with acid-reducing agents and multivitamins in health volunteers. J Antimicrob Chemother 2011;66:1567-72
   PubMed Web of Science ®Google Scholar
• Raffi F, Jaeger H, Quiros-Roldan E, et al. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral naïve adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, noninferiority trial. Lancet Infect Dis 2013;13(11):927-35
   PubMed Web of Science ®Google Scholar
• Walmsley SL, Antela A, Clumeck N, et al. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Eng J Med 2013;369:1807-18
   PubMed Web of Science ®Google Scholar
• Cahn P, Pozniak A, Mingrone H, et al. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naïve adults with HIV: week 48 results from the randomised, double blind, non-inferiority SAILING study. Lancet 2013;382:700-8
   PubMed Web of Science ®Google Scholar
• Quashie PK, Mesplede T, Han Y-S, et al. Characterization of the R263K mutation in HIV-1 integrase that confers low-level resistance to the second-generation integrase strand transfer inhibitor dolutegravir. J Virol 2012;86(5):2696-705
   PubMed Web of Science ®Google Scholar
• Underwood M, Dudas K, Horton J, et al. Analysis and characterization of treatment-emergent resistance in ART-experienced, integrase inhibitor-naïve subjects with dolutegravir (DTG) versus raltegravir (RAL) in SAILING (ING111762). International Workshop on HIV and Hepatitis Virus Drug Resistance and Curative Strategies. Toronto, Canada; 2013
   Google Scholar
• Blanco JL, Varghese V, Rhee SY, et al. HIV-1 integrase inhibitor resistance and its clinical implications. J Infect Dis 2011;203:1204-14
   PubMed Web of Science ®Google Scholar
• Tivicay [package insert]. NC:ViiV Healthcare; Research Triangle Park: 2013
   Google Scholar
• Smith KY, Patel P, Fine D, et al. Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment. AIDS 2009;23(12):1547
   PubMed Web of Science ®Google Scholar
• Bansi L, Sabin C, Gilson R, et al. Virological response to initial antiretroviral regimens containing abacavir or tenofovir. J Infect Dis 2009;200(5):710
   PubMed Web of Science ®Google Scholar
• Tan DH, Chan K, Raboud J, et al. Comparison of abacavir/lamivudine and tenofovir/emtricitabine among treatment-naive HIV-infected patients initiating therapy. J Acquir Immune Defic Syndr 2011;58:38-46
   PubMed Web of Science ®Google Scholar
• Clotet B, Feinberg J, van Lunzen J, et al. Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study. Lancet 2014;383(9936):2222-31
   PubMed Web of Science ®Google Scholar