Cabotegravir plus rilpivirine, once a day, after induction with cabotegravir plus nucleoside reverse transcriptase inhibitors in antiretroviral-naive adults with HIV-1 infection (LATTE): a randomised, phase 2b, dose-ranging trial

The Lancet Infectious Diseases - Tập 15 - Trang 1145-1155 - 2015
David A Margolis1, Cynthia C Brinson2, Graham H R Smith3, Jerome de Vente4, Debbie P Hagins5, Joseph J Eron6, Sandy K Griffith1, Marty H St Clair1, Marita C Stevens7, Peter E Williams7, Susan L Ford1, Britt S Stancil1, Melinda M Bomar1, Krischan J Hudson1, Kimberly Y Smith8, William R Spreen1
1GlaxoSmithKline, Infectious Diseases, Research Triangle Park, NC, USA
2Central Texas Clinical Research, Austin, TX, USA
3Maple Leaf Medical Clinic, Toronto, ON, Canada.
4Living Hope Foundation, Long Beach, CA, USA
5Chatham County Health Department, Savannah, GA, USA
6University of North Carolina, Chapel Hill, NC, USA
7Janssen Infectious Diseases, Beerse, Belgium
8ViiV Healthcare, Research Triangle Park, NC, USA

Tài liệu tham khảo

Lee, 2014, Efficacy of initial antiretroviral therapy for HIV-1 infection in adults: a systematic review and meta-analysis of 114 studies with up to 144 weeks follow-up, PLoS One, 9, e97482, 10.1371/journal.pone.0097482 Eron, 2013, Efficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies: final results of two randomised, placebo-controlled trials, Lancet Infect Dis, 13, 587, 10.1016/S1473-3099(13)70093-8 Elion, 2013, A randomized phase 3 study comparing once-daily elvitegravir to twice-daily raltegravir in treatment-experienced subjects with HIV-1 infection: 96-week results, J Acquir Immune Defic Syndr, 63, 494, 10.1097/QAI.0b013e318298469c Zolopa, 2010, Activity of elvitegravir, a once-daily integrase inhibitor, against resistant HIV type 1: results of a phase 2, randomized, controlled, dose-ranging clinical trial, J Infect Dis, 201, 814, 10.1086/650698 Schrijvers, 2012, Quad's in it for antiretroviral therapy?, Lancet, 379, 2403, 10.1016/S0140-6736(12)61029-0 Cahn, 2013, Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study, Lancet, 382, 700, 10.1016/S0140-6736(13)61221-0 Capetti, 2014, Four years data of raltegravir-based salvage therapy in HIV-1-infected, treatment-experienced patients: the SALIR-E study, Int J Antimicrob Agents, 43, 189, 10.1016/j.ijantimicag.2013.10.013 Elion, 2013, A randomized phase 3 study comparing once-daily elvitegravir with twice-daily raltegravir in treatment-experienced subjects with HIV-1 infection: 96-week results, J Acquir Immune Defic Syndr, 63, 494, 10.1097/QAI.0b013e318298469c Eron, 2013, Efficacy and safety of raltegravir for treatment of HIV for 5 years in the BENCHMRK studies: final results of two randomised, placebo-controlled trials, Lancet Infect Dis, 13, 587, 10.1016/S1473-3099(13)70093-8 Molina, 2012, Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 receiving a ritonavir-boosted protease inhibitor: randomised, double-blind, phase 3, non-inferiority study, Lancet Infect Dis, 12, 27, 10.1016/S1473-3099(11)70249-3 Kulkarni, 2014, Week 144 resistance analysis of elvitegravir/cobicistat/emtricitabine/tenofovir DF versus atazanavir+ritonavir+emtricitabine/tenofovir DF in antiretroviral-naïve patients, HIV Clin Trials, 15, 218, 10.1310/hct1504-218 Lennox, 2009, Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial, Lancet, 374, 796, 10.1016/S0140-6736(09)60918-1 Raffi, 2013, Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial, Lancet Infect Dis, 13, 927, 10.1016/S1473-3099(13)70257-3 Ford, 2013, Lack of pharmacokinetic interaction between rilpivirine and integrase inhibitors dolutegravir and GSK1265744, Antimicrob Agents Chemother, 57, 5472, 10.1128/AAC.01235-13 Spreen, 2013, Pharmacokinetics, safety, and monotherapy antiviral activity of GSK1265744, an HIV integrase strand transfer inhibitor, HIV Clin Trials, 14, 192, 10.1310/hct1405-192 Nelson, 2013, Rilpivirine versus efavirenz in HIV-1-infected subjects receiving emtricitabine/tenofovir DF: pooled 96-week data from ECHO and THRIVE Studies, HIV Clin Trials, 14, 81, 10.1310/hct1403-81 Spreen, 2013, Long-acting injectable antiretrovirals for HIV treatment and prevention, Curr Opin HIV AIDS, 8, 565, 10.1097/COH.0000000000000002 Spreen, 2014, GSK1265744 pharmacokinetics in plasma and tissue after single-dose long-acting injectable administration in healthy subjects, J Acquir Immune Defic Syndr, 67, 481, 10.1097/QAI.0000000000000301 Jackson, 2014, A compartmental pharmacokinetic evaluation of long-acting rilpivirine in HIV-negative volunteers for pre-exposure prophylaxis, Clin Pharmacol Ther, 96, 314, 10.1038/clpt.2014.118 Johnson, 2013, Update of the drug resistant mutations in HIV-1: March 2013, Top Antivir Med, 21, 6 Stellbrink, 2013, Dolutegravir in antiretroviral-naive adults with HIV-1: 96-week results from a randomized dose-ranging study, AIDS, 27, 1771, 10.1097/QAD.0b013e3283612419 Walmsley, 2013, Dolutegravir plus abacavir–lamivudine for the treatment of HIV-1 infection, N Engl J Med, 369, 1807, 10.1056/NEJMoa1215541 Dudas, 2015, Resistance mutations observed in a study subject on oral two-drug maintenance therapy with 10 mg cabotegravir + 25 mg rilpivirine, Glob Antivir J, 11 Gallego, 2004, Analyzing sleep abnormalities in HIV-infected patients treated with efavirenz, Clin Infect Dis, 38, 430, 10.1086/380791