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A P hase II non-comparative multicenter trial

TUPDB204. Efficacy and safety of r altegravir plus etravirine and darunavir/ritonavir in treatment-experienced patients with multidrug-resistant virus: 48-week results from the ANRS 139 TRIO trial. A P hase II non-comparative multicenter trial

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A P hase II non-comparative multicenter trial

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  1. TUPDB204 Efficacy and safety of raltegravir plus etravirine and darunavir/ritonavir in treatment-experienced patients with multidrug-resistant virus: 48-week results from the ANRS 139 TRIO trial A Phase II non-comparative multicenter trial Fagard C.1, Descamps D.2, Dubar V.3, Colin C.1,Taburet AM.4, Roquebert B.2, Katlama C.5, Jacomet C. 6, Piketty C.7, Molina JMM.8, Chene G.1, Yazdanpanah Y 3 and the ANRS 139 TRIO Trial Group

  2. TUPDB204 Baseline characteristics (n = 103) *In 60% of 90 patients who received an OBT GSS of the OBT <1

  3. TUPDB204 Proportion of patients with HIV RNA < 50 copies/ml at 48 weeks (missing = failure) Wk 24 = 90% Wk 48 = 86% Median CD4 count increase from baseline to week 48 = 108/mm3

  4. TUPDB204 Clinical Adverse Events and Laboratory Abnormalities (n=103) • Grade 3-4 clinical adverse events 15 (14.6%) possibly related to investigationaldrugs4 ( 3.9%) • Grade 3-4 laboratory adverse events 20 (19.4%) • Creatininephosphokinase >5xULN 11 (10.7%) • Gamma-GT >5xULN 4 (3.9%) • Adverse events leading to discontinuation 1 (1.0%) = grade 4 skin rash with fever • Death 1 (1.0%) = myocardial infarction after aortobifemoral bypass surgery

  5. TUPDB204 Conclusion In patients with multi-drug resistant virus and few remaining treatment options, at 48 weeks the combination of raltegravir, etravirine and darunavir/r is well tolerated and is associated with a similar rate of virologic suppression than that expected in treatment-naïve patients.

  6. Acknowledgments The patients for their participation and their commitment during the study and the TRIO Study Group: SCIENTIFIC COMMITTEE Y. Yazdanpanah (Chair) G. Chêne D. Descamps V. DubarC. JacometC. Katlama JM. Molina C. PikettyB. Roquebert AM. Taburet ANRS JF Delfraissy MJ. Commoy S. Couffin-Cadiergues A. Bouxin-Metro A. Diallo CTU INSERM U897/ISPED G. Chêne C. Fagard C. Jean-Marie A. Beuscart I. Tschöpe C. Colin M. Bertoncello S. Martiren Grenoble (P. Leclercq) Saint-Louis, Paris (FJ. Timsit) Saint-Denis(MA. Khuong-Josse) Hôtel-Dieu, Lyon (C. Trepo) Bordeaux (JM. Ragnaud) Belfort (JP. Faller) Nice (E. Rosenthal) Toulouse (L. Cuzin) Créteil (Y. Lévy) Avicenne, Bobigny (M. Bentata) Annecy (J. Gaillat) La Roche/Yon (P. Perré) Rennes (F. Souala) Avignon (G. Pichancourt) Mulhouse (G. Beck-Wirth) Avicenne, Bobigny(S. Abgrall) Pitié-Salpêtrière, Paris (A. Simon) Bordeaux (M. Dupon) Clermont-Ferrand (C. Jacomet) Caen (R. Verdon) Dijon (L. Piroth) Hôtel-Dieu, Paris (A. Compagnucci) Perpignan (H. Aumaitre) Tours (F. Bastides) Pontoise (L. Blum) CLINICAL CENTERS Saint-Louis, Paris (JM. Molina) Pitié-Salpêtrière, Paris (C. Katlama) Tenon, Paris (G. Pialoux) Saint-Antoine, Paris (PM. Girard) Saint-Louis, Paris (D. Sereni) Tourcoing (Y. Yazdanpanah) Bichat, Paris (P. Yeni) HEGP, Paris (L. Weiss) Nantes (F. Raffi) Paul Brousse, Villejuif (D. Vittecoq) Edouard Herriot, Lyon (F. Jeanblanc) Necker, Paris (JP. Viard) Marseille (I. Poizot-Martin) Lariboisière, Paris (A. Rami) Angers (JM. Chennebault) Garches (P. De Truchis) Saint-Louis, Paris (L. Gerard) Bicêtre (C. Goujard) Nice (J. Durant) Corbeil-Essones (P. Chevojon) Besançon (C. Drobacheff) Antoine Béclère,Clamart (F. Boué) Cochin, Paris (D. Salmon-Ceron) Bordeaux (P. Morlat) DSMB D. Costagliola J. Caron F. Berdougo D. Rey O. Patey Merck Sharpe &Dohme-Chibret (providedraltegravir) A. Aslan E. Dohin Tibotec, a division of Janssen Cilag(providedetravirine) A. Cheret MB. Hadacek

  7. Back-up slide

  8. Proportion of patients with HIV-RNA <50 copies/ml at week 48, according to OBT

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