Optimizing the virological success of tenofovir DF/FTC/rilpivirine in HIV-infected naive and virologically suppressed patients through strict clinical and virological selection*

Abstract

Background: Tenofovir DF/FTC/rilpivirine (TDF/FTC/RPV) is a single tablet regimen considered as safe and efficacious in HIV population as long as food requirements, concomitant PPI administration, and compromised antiviral activity have been carefully reviewed. We evaluated TDF/FTC/RPV in a real-life setting with focus on clinical and virological outcomes.

Methods: OCEAN II is a prospective, two-centre observational study. From September 2012 to December 2013, antiretroviral-naive patients with HIV RNA <100,000 copies/mL or wishing to switch for simplification were considered for TDF/FTC/RPV. A systematic review of potential obstacles to TDF/FTC/RPV administration was undertaken during a multidisciplinary meeting, including DNA genotyping to detect archived RPV and/or NRTI-associated resistance mutations if historical RNA resistance testing was lacking.

Results: TDF/FTC/RPV was considered for 480 patients, however was not offered to 194 patients (40%), mainly because of risk of insufficient virological efficacy, issues on adherence, patient refusal, meal constraint, or PPI therapy. A total of 286 patients (269 in maintenance; 17 ART-naive) received TDF/FTC/RPV. After a median follow-up of 30 months, virological failure occurred in five patients (1.7%) without the emergence of resistance mutations. Discontinuation of TDF/FTC/RPV occurred in 98 patients, due to adverse events in 43 patients (44%) and non-safety reasons in 55 patients (56%). No grade three-fourth adverse events occurred.

Conclusion: In this real-life experience, cohort consisting primarily of virologically suppressed patients, TDF/FTC/RPV usually maintained virologic suppression. Discontinuation of therapy because of intolerability was due to mild adverse events. Strict clinical and virological screening probably explained the low rate of virological failure.

Keywords:

• HIV
• NNRTI
• rilpivirine
• STR
• switch
• tolerability
• virological response

Acknowledgements

The authors gratefully thank all the patients who participated in the study and the members of OCEAN-II group: F. Raffi, C. Allavena, E. Billaud, C. Biron, B. Bonnet, S. Bouchez, D. Boutoille, L. Khatchatourian C. Brunet, T. Jovelin, N. Hall, C. Bernaud, P. Morineau, V. Reliquet, O. Aubry, P. Point, M. Besnier, H. Hüe, S. Pineau, E. André-Garnier, A. Rodallec, V. Ferré, F. Vivrel, M. Lefebvre, O. Grossi (Nantes); P. Perré, T. Guimard, S. Léautez, J.L. Esnault, O. Bollengier-Stragier, L. Lainé, H. Durand, C. Garnier, M. Morrier (La Roche sur Yon)

Disclosure statement

This study was sponsored in part by a grant from Gilead Sciences, Inc., who had no role in data collection and data analysis. All other authors declare no conflict of interest.

Funding information

Camille Bernaud received travel grants from MSD, Janssen and Gilead Sciences, Philippe Perre received travel grants or honoraria from Bristol-Myers Squibb, Gilead Sciences, Janssen, MSD, Abbvie and ViiV Healthcare, Elisabeth André-Garnier received travel grants or hononaria from Bristol-Myers Squibb, Gilead Sciences, Janssen, MSD, and ViiV Healthcare, Nolwenn Hall received travel grants from Janssen and Gilead, Clotilde Allavena received travel grants or hononaria from Mylan, Bristol-Myers Squibb, Gilead Sciences, Janssen, MSD, and ViiV Healthcare, François Raffi received research funding or honoraria from or consulted for Abbvie, Bristol-Myers Squibb, Gilead Sciences, Janssen-Cilag, Merck-Sharp and Dohme, and ViiV Healthcare.