Variables

Primary outcomes assessed treatment effectiveness through the HIV-RNA viral load (copies/mL) and CD4 cell count (cells/mm³) measured at M6, M12 and M24 following initiation of the RPV/TDF/FTC co-formulation. We defined virological suppression as HIV-RNA <50 copies/mL. Secondary outcomes assessed treatment safety and used total cholesterol (mmol/L), high-density lipoprotein (mmol/L), triglycerides (mmol/L), alanine aminotransferase (UI/L), creatinine (μmol/L), and the estimated glomerular function rate (eGFR) (ml/min/1.73 m²) calculated according to the Modification of Diet in Renal Disease equation, as well as body mass index (kg/m²). Sociodemographic and clinical data were prospectively collected as part of the SHCS 6-monthly assessments at the time of initiation of the RPV/TDF/FTC co-formulation (referred to as baseline) and at M6, M12 and M24.

Reasons for switching to RPV/TDF/FTC were collected retrospectively. From January 1, 2015, onwards, the HIV Cohorts Data Exchange Protocol (HICDEP) coding [22] was used to document treatment switches in the SHCS database. However, before this date, treating physicians did not have the possibility to code regimen changes intended to simplify treatment. To obtain these data, we conducted a survey among treating physicians of all patients included in our study. We created a standardized questionnaire with a closed list of reasons for switching, which was first evaluated to assess its reliability among 6 physicians at the HIV unit of Geneva University Hospitals. The questionnaire was then sent to all physicians participating in the SHCS who had switched their patients to the RPV/TDF/FTC co-formulation. When physicians declared the reason for the switch as “toxicity, predominantly from CNS”, they were asked to give the exact reasons from a list of CNS-specific symptoms: i) symptoms of depression; ii) sleep disturbances/insomnia; iii) abnormal dreams; iv) dizziness/vertigo; v) fatigue/tiredness; and vi) other. Physicians were also required to document CNS symptoms at M6 and M12 after the switch as “worsening”, “stable”, “improvement”, “not available” or “other”.

In addition, we assessed a cross-section of patients who had discontinued the RPV/TDF/FTC co-formulation within M24 post-treatment initiation in both the treatment-naïve and -experienced groups and the reasons for discontinuation according to the HICDEP coding registered in the SHCS database.