Efficacy and safety Rilvipirine/tenofovir/emtricitabine in HIV-infected naive patients: results from SCOLTA Project

Introduction: Rilpivirine (RPV) is a new NNRTI firstly indicated in naive patients with HIV RNA ≤100,000 copies/ml. Rilpivirin is available as single drug (RPV, 25 mg tablet) or co-formulated with tenofovir and emtricitabine (RPV/TDF/FTC 25/245/200 mg tablet). Data from clinical studies have suggested that RPV/TDF/FTC is associated with a good safety profile especially regarding lipid metabolism. However, data from observational cohorts are still lacking. Purpose of the study: we aimed to describe efficacy and safety of RPV/TDF/FTC-based HAART in clinical practice. In particular we evaluated the modification of eGFR and lipid profile in naïve patients. Methods: The SCOLTA Project is a prospective, observational, multicenter study created to assess the incidence of adverse events in patients receiving new antiretroviral drugs in clinical practice. The Project has an internet site (http://www.cisai.info) where all grade adverse events according to DAIDS table are recorded. Results: A total of 110 HIV- infected naive patients with a mean age of 37.9 ± 9.6 years were enrolled, of these 82 (74.5%) were male and 99 (90 %) were Caucasian. As regard to HIV-risk transmission 53 (48.2%) cases were heterosexuals, 48 (43.6%) homosexuals, 4 (3.6%) were previous intravenous drug-users and in 5 (4.5%) patients it was unknown. A total of 87 (79.1%) patients were in CDC stage A, mean CD4 cell count nadir was >350 cells/mm3 in 62 (56.4%) and HIV-RNA was 4.42 log10 cp/ml. Seven (6.4%) had HCV coinfection. After a median follow up of week 48, 5 (4.5%) therapy interruptions were reported. These were caused by virological failure in 1 (0.9%) and adverse events in 3 (2.7%). Among adverse eventsrelated interruptions 2 were 3 grade ≥3 reactions: 1 acute renal failure and 1 arthralgia, and 1 was grade <3 (rash). Among patients with available follow up data at week 24 and 48 we found a significant reduction in eGFR at both follow up times (-4.42 ml/min/1.73m2, p=0.017 and -9.3 ml/min/1.73m2 p=0.0002, respectively). Regarding lipid profile we observed a significant reduction in total cholesterol at week 24 (-6.69 mg/dl, p=0.036) but not at week 48 and a slight increase in HDL cholesterol. Triglycerides level showed a progressive but non significant increase over follow up. Finally, Blood glucose showed a slight and non significant increase. Conclusions:. Our data, although preliminary, confirm in clinical practice the good safety profile of RPV/TDF/FTC in naïve patients. Starting a regimen with RPV/TDF/FTC STR led to an improvement of the metabolic profile. A decrease in eGFR was observed but did not appear to be clinically relevant since only one interruption for renal AE occurred.