Switch to Rilpivirine/Emtricitabine/Tenofovir Single-Tablet Regimen of Human Immunodeficiency Virus-1 RNA-Suppressed Patients, Agence Nationale de Recherches sur le SIDA et les Hépatites Virales CO3 Aquitaine Cohort, 2012–2014

Introduction of combined antiretroviral therapy (cART) has been accompanied by a significant and rapid decline in human immunodeficiency virus (HIV)-related and acquired immune deficiency syndrome-related morbidity and mortality. To date, suppression of HIV type 1 (HIV-1) is the rule for the vast majority of patients with a variety of cART regimens. Rilpivirine (RPV), a second-generation nonnucleoside reverse-transcriptase inhibitor (NNRTI) (Edurant, Janssen Therapeutics and Janssen-Cilag), is active against wild-type viruses and remains efficient against some NNRTI- resistant HIV-1 strains [1–3]. The efficacy of oral RPV in antiretroviral-naive HIV-1 patients was first evaluated in a phase 2, randomized, dose-ranging study [4, 5], in phase 3 double-blinded studies (ECHO and THRIVE) [6, 7], and in a phase 3 open-label study (STaR) [8]. Pill count, dosing frequency, dietary requirements, and tolerability can impact adherence, virologic efficacy, and quality of life [9–11]. Rilpivirine and its coformulation with emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as a single-tablet regimen ([STR] RPV/FTC/TDF) is now approved by the European Medicines Agency and the US Food and Drug Administration as a once-daily oral treatment for adults infected with HIV-1 without mutations associated with resistance to TDF, FTC, or the NNRTI class, and harboring a viral load (VL) ≤100 000 HIV-1 RNA copies/mL. Current antiretroviral treatment guidelines recommend switching therapy in virologically suppressed patients to improve adherence or tolerability or to allow for treatment simplification [12–14]. In the SPIRIT study, a phase 3b randomized, open-label, multicenter, 48-week switch study (immediate switch or delayed switch at week 24), significant fasting serum lipid profile improvements were observed in virologically suppressed HIV-1-infected patients switching to RPV/FTC/TDF from a ritonavir-boosted protease inhibitor (PI/r)-based regimen, compared with those who continued treatment with a PI/r regimen. Moreover, the authors showed a maintained virologic suppression with a low risk of virologic failure (VF) [15]. Thus, switching from efavirenz (EFV)/FTC/TDF to RPV/FTC/TDF was considered a safe, efficacious option for virologically suppressed HIV-infected patients with EFV intolerance [16]. Strategies of treatment simplification have been mostly explored in treatment-experienced patients [15]. In September 2012, the RPV/FTC/TDF coformulation was approved as a STR in France in treatment-naive HIV-infected patients with VL ≤100 000 copies/mL. However, in clinical practice, in accordance with French guidelines, the RPV/FTC/TDF STR is frequently used as a switch drug combination for virologically suppressed treatment-experienced patients with various baseline cART regimens. The aim of this study was to describe, in a real-world setting, the efficacy of this STR strategy in 304 HIV-1 infected, virologically suppressed patients switching to RPV/FTC/TDF, independently of their previous antiretroviral regimen, compared with baseline characteristics. We also focused on clinical and metabolic tolerability.