A Phase II noncomparative multicenter trial

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
Baseline characteristics (n 103)
TUPDB204
In 60 of 90 patients who received an OBT GSS of
the OBT lt1
3
Proportion of patients with HIV RNA lt 50
copies/ml at 48 weeks (missing failure)
TUPDB204
Wk 24 90
Wk 48 86
Median CD4 count increase from baseline to week
48 108/mm3
4
Clinical Adverse Events and Laboratory
Abnormalities (n103)
TUPDB204

• Grade 3-4 clinical adverse events 15 (14.6)
• possibly related to investigational drugs 4 (
  3.9)
• Grade 3-4 laboratory adverse events 20 (19.4)
• Creatinine phosphokinase gt5xULN 11 (10.7)
• Gamma-GT gt5xULN 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
Conclusion
TUPDB204

• 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) Perpign
an (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 (provided
raltegravir) A. Aslan E. Dohin Tibotec, a
division of Janssen Cilag (provided
etravirine) A. Cheret MB. Hadacek
7
Back-up slide
8
Proportion of patients with HIV-RNA lt50 copies/ml
at week 48, according to OBT