Long-term efficacy and safety of etravirine-containing regimens in a real-life cohort of treatment-experienced HIV-1-infected patients

Abstract

Objectives Etravirine (ETR) was approved in France in September 2008 and is used in combination with a boosted protease inhibitor (bPI) and other anti-retrovirals (ART) in HIV-infected pre-treated patients. This study aimed to report in a real-life setting the efficacy and tolerability of ETR-based regimens and factors associated with virological response. Methods The study population included all treatment-experienced patients who initiated an ETR-based regimen between September 2008 and July 2013 from the French Dat’AIDS cohort. Analyses were performed in ART-experienced patients starting ETR after virological failure (VF) or as a maintenance therapy (MT), with or without bPI. Results A total of 2006 patients (VF, n = 1014 (51%); MT, n = 992 (49%)) were included. At M12, the proportion of patients with HIV RNA < 50 copies/ml was 71.7% (72.0% and 71.1% with or without bPI) in the VF group and 90.5% (85.0% and 92.3% with or without bPI) in the MT group, without significant differences regarding the use of bPI. ETR was discontinued in 8.8% of patients for adverse events in 23.9% of cases (21.5% in VF, 29.5% in MT), treatment failure in 15.2% (16.2% in VF, 7.4% in MT) or simplification in 5.4% (4.6% in VF, 7.4% in MT). In the VF group, factors associated with virological response were a longer duration of HIV infection (OR = 2.7; p < 0.001) and baseline HIV RNA < 5 log₁₀ copies/mL (OR = 2.1; p = 0.002). Conclusion This study shows that in ART-experienced patients ETR is well tolerated with a high efficacy when combined with other active drugs, even when the regimen does not include a bPI.

Keywords:

• HIV
• etravirine
• tolerability
• virological efficacy
• NNRTI

Acknowledgements

This work was presented in part at the 10th international congress on HIV drug therapy, Glasgow, UK, 2–6 November 2014 (Abstract P248).

The authors gratefully thank Pierre Pradat and Victor Virlogeux (www.alpha005.com) for editorial assistance in the preparation of the manuscript and the members of the Dat’AIDS group: F. Raffi, C. Allavena, E. Billaud, C. Biron, B. Bonnet, S. Bouchez, D. Boutoille, C. Brunet, T. Jovelin, N. Hall, C. Bernaud, P. Morineau, V. Reliquet, O. Aubry, P. Point, M. Besnier, L. Larmet, H. Hüe, S. Pineau, E. André-Garnier, A. Rodallec, V. Ferré, F. Vivrel, M. Lefebvre, O. Grossi (Nantes); S. Brégigeon, O. Faucher, V. Obry-Roguet, M. Orticoni, M. J. Soavi, I. Luquet-Besson, E. Ressiot, I. Pinot, M. J. Ducassou, H. Bertone, S. Gallie, A. Galinier, P. Martinet, S. Trijau, A. S. Ritleng, A. Ivanova, M. Guignard, C. Blanco-Betancourt, I. Poizot-Martin (Marseille); B. Marchou, P. Massip, E. Bonnet, M. Obadia, M. Alvarez, L. Porte, L. Cuzin, P. Delobel, M. Chauveau, D. Garipuy, I. Lepain, M. Marcel, E. Puntis, K. Sauné (Toulouse); P. Pugliese, C. Ceppi, E. Cua, J. Cottalorda, P. Dellamonica, E. Demonchy, B. Dunais, J. Durant, C. Etienne, S. Ferrando, J. G. Fuzibet, R. Garraffo, K. Risso, V. Mondain, A. Naqvi, N. Oran, I. Perbost, S. Pillet, B. Prouvost-Keller, C. Pradier, S. Wehrlen-Pugliese, E. Rosenthal, S. Sausse, P. M. Roger (Nice); Ph. Choisy, S. Vandame, Th. Huleux, F. Ajana, I. Alcaraz, V. Baclet, TH. Huleux, H. Melliez, N. Viget, M. Valette, E. Aissi, Ch. Allienne, A. Meybeck, B. Riff (Tourcoing); R. Agher, C. Katlama, M. A. Valantin, C. Duvivier, P. H. Consigny, G. Cessot, F. Lanternier, C. Charlier, P. Bossi, F. Touam, K. Benhadj Brahimi, O. Lortholary (Paris); L. Cotte, D. Peyramond, C. Chidiac, T. Ferry, F. Ader, F. Biron, A. Boibieux, P. Miailhes, T. Perpoint, I. Schlienger, F. Dahoud, J. Lippmann, E. Braun, J. Koffi, C. Longuet, V. Guéripel, C. Augustin-Normand, S. Degroodt (Lyon) S. Abel, A. Cabié, J. Jean-Marie, S. Pierre-François, B. Rozé (Martinique).

Disclosure statement

CA received travel grants or hononaria from Mylan, Bristol-Myers Squibb, Gilead Sciences, Janssen, MSD, and ViiV Healthcare, CK, LC has received research grants from ViiV healthcare and MSD, personal fees from Mylan and non-financial support from BMS, Gilead Science, Janssen Cilag, MSD and ViiV healthcare, PD received travel grants from Janssen, PMG, AnC and IPM have no conflict of interest, FR received research funding or honoraria from or consulted for Abbvie, Bristol-Myers Squibb, Gilead Sciences, Janssen-Cilag, Merck-Sharp and Dohme and ViiV Healthcare. CD has received travel grants, honoraria or study grants from Abbvie, Bristol-Myers-Squibb, Gilead Sciences, Janssen, Merck and ViiV Healthcare, BH, AC received travel grants from Gilead, Janssen, BMS and ViiV Healthcare, RL and ArC are employees of Janssen, PP received honoraria from BMS and Gilead.

Funding information

This study received financial support from Janssen.