Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial

The Lancet - Tập 370 - Trang 49-58 - 2007
José Valdez Madruga1, Daniel Berger2, Marilyn McMurchie3, Fredy Suter4, Denes Banhegyi5, Kiat Ruxrungtham6, Dorece Norris7, Eric Lefebvre8, Marie-Pierre de Béthune9, Frank Tomaka10, Martine De Pauw9, Tony Vangeneugden9, Sabrina Spinosa-Guzman9
1Centro de Referência e Treinamento DST/AIDS, Mariana-São Paulo, Brazil
2Northstar Medical Center, Chicago, IL, USA
3University of Sydney, Sydney, Australia
4Ospedali Riuniti di Bergamo, Bergamo, Italy
5Szent Lásló Hospital, Budapest, Hungary
6HIVNAT, Thai Red Cross AIDS Research Centre and Chulalongkorn University, Bangkok, Thailand
7Comprehensive Research Institute, Tampa, FL, USA
8Janssen-Cilag, Tilburg, Netherlands
9Tibotec, Mechelen, Belgium
10Tibotec, Yardley, PA, USA

Tài liệu tham khảo

Clotet, 2007, Efficacy and safety of darunavir-ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: a pooled subgroup analysis of data from two randomised trials, Lancet, 369, 1169, 10.1016/S0140-6736(07)60497-8 El-Sadr W, for the SMART Study Group. Inferior clinical outcomes with episodic CD4-guided antiretroviral therapy aimed at drug conservation (DC) in SMART study: consistency of finding in all patient subgroups. Toronto: 16th International AIDS Congress, 2006 (abstr WEAB0204). DeJesus E, LaMarca A, Sension M, Beltran C, Yeni P. The CONTEXT study: efficacy and safety of GW433908/r in PI-experienced subjects with virological failure (24 week results). Boston: 10th Conference on Retroviruses and Opportunistic Infections, 2003 (abstr 178). Johnson, 2005, Atazanavir plus ritonavir or saquinavir, and lopinavir/ritonavir in patients experiencing multiple virological failures, AIDS, 19, 685, 10.1097/01.aids.0000166091.39317.99 Pollard RB, Thompson MA, Hicks CB, et al. Phase 3 comparison of lopinavir/ritonavir vs investigator-selected protease inhibitors in single PI-experienced, NNRTI-naive patients: 48-week results of study M98-888. Glasgow: Proceedings of the 7th International Congress on Drug Therapy in HIV Infection, 2004 (abstr PL3.2). Benson, 2002, Safety and antiviral activity at 48 weeks of lopinavir/ritonavir plus nevirapine and 2 nucleoside reverse transcriptase inhibitors in human immunodeficiency virus type 1-infected protease inhibitor-experienced patients, J Infect Dis, 185, 599, 10.1086/339014 Hammer, 2006, Treatment for adult HIV infection: 2006 recommendations of the International AIDS Society-USA panel, JAMA, 296, 827, 10.1001/jama.296.7.827 Gazzard, 2006, British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy (2006), HIV Med, 7, 487, 10.1111/j.1468-1293.2006.00424.x De Meyer S, Vangeneugden T, Lefebvre E, et al. Phenotypic and genotypic determinants of resistance to TMC114: pooled analysis of POWER 1, 2 and 3. Sitges: 15th International HIV Drug Resistance Workshop, 2006 (abstr 73). Johnson, 2006, Update of the drug resistance mutations in HIV-1: fall 2006, Top HIV Med, 14, 125 De Meyer S, De Paepe E, Vangeneugden T, et al. Effect of baseline and on-treatment mutations on the antiretroviral activity of darunavir/ritonavir (DRV/r) and lopinavir (LPV/r): results of a randomised, controlled, phase III study (TITAN). Sydney: 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention, 2007 (abstr WEPEB038). Katlama, 2007, Efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients: 24-week results of POWER 1, AIDS, 21, 395, 10.1097/QAD.0b013e328013d9d7 Haubrich, 2007, Week 24 efficacy and safety of TMC114/ritonavir in treatment-experienced HIV patients, AIDS, 21, F11, 10.1097/QAD.0b013e3280b07b47 Lalezari, 2003, Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America, N Engl J Med, 348, 2175, 10.1056/NEJMoa035026 Nieto-Cisneros, 2003, Antiviral efficacy, metabolic changes and safety of atazanavir (ATV) versus lopinavir/ritonavir (LPV/r) in combination with 2 NRTIs in patients who have experienced virologic failure with prior PI-containing regimen(s): 24-week results from BMS A1424-043, Antivir Ther, 8, S212 Cozzi Lepri, 1998, The relative prognostic value of plasma HIV RNA levels and CD4 lymphocyte counts in advanced HIV infection, AIDS, 12, 1639, 10.1097/00002030-199813000-00011