Background A once-daily single-tablet regimen (STR) containing rilpivirine/emtricitabine/tenofovir (RPV/FTC/TDF) has been recently approved by the European Medicines Agency (EMA) for the treatment of treatment-naïve HIV patients with a baseline viral load below 100,000 copies/mL. Additionally, it’s prescribed when switching treatment.

Purpose To describe the characteristics of patients starting RPV/FTC/TDF during the first six months of its inclusion in our hospital.

To define reasons to be on RPV/FTC/TDF other than initiating antiretroviral treatment (ART) in treatment-naïve patients.

Materials and methods Retrospective descriptive study including all patients starting or switching to RPV/FTC/TDF between April–September 2013 in a tertiary university hospital. Data collected: demographics (sex, age), starting or switching reasons, previous ART, CD4⁺ count and HIV viral load at baseline. Data are expressed as median (Q1-Q3).

Results 78 patients initiated RPV/FTC/TDF: 18 (23%) treatment-naïve patients and 60 (77%) pre-treated patients.

Treatment-naïve patients. Men: 16 (88.9%); age: 34.6 (33.8–42.9) years; CD4⁺ count: 358.0 (304.3–464.5) cell/mcL; HIV-RNA: 44513 (21130–71551) copies/mL. Reasons to start treatment: CD4⁺ count <500 cell/mcL: 13 (72.2%); patient’s request: 4 (22.2%) and ART restart: 1 (5.6%).

Pre-treated patients. Men: 54 (90.0%); age: 44.9 (38.0–51.2) years; CD4⁺ count 645.0 (405.8–807.5) cell/mcL; HIV-RNA <50 copies/mL: 48 (89%) patients. Reasons for switching to RPV/FTC/TDF: side effects 48 (80%) patients; drug interactions 3 (5.0%); simplifying to STR 6 (10.0%) and patient’s request 3 (5.0%). Type of side effects: CNS effects 34 (70.8%) patients; gastrointestinal tract dysfunctions 11 (22.9%) and lipid profile abnormalities 3 (6.25%). Previous treatment: non-nucleoside reverse-transcriptase inhibitors (NNRTI) 39 (65.0%) patients and protease inhibitors 21 (35.0%).

Conclusions Only 23% patients starting RPV/FTC/TDF were treatment-naïve, following EMA approval conditions.

Naïve patients were younger, had a lower CD4⁺ count and higher viral load than pre-treated patients.

Main reason for initiating ART with RPV/FTC/TDF was immunological progression.

Main reasons for switching to RPV/FTC/TDF were side effects such as CNS and gastrointestinal tract dysfunctions.

The most common previous treatment was NNRTI-based ART.

No conflict of interest.