Efficacy and safety of dolutegravir/rilpivirine in real‐world clinical practice. GeSIDA study 1119

Abstract

Introduction Dolutegravir/rilpivirine (DTG/RPV) is an effective antiretroviral (ART) regimen endorsed by clinical trials as a switch therapy. The aim of our study was to analyse the efficacy and safety of DTG/RPV in real‐world clinical practice. Methods Observational, multicentre study of patients who started DTG/RPV. Efficacy, adverse events and metabolic changes at 48 weeks were analysed. Results A total of 348 patients were included; median time of HIV infection was 21.1 years, 33.7% were AIDS cases; median nadir CD4 was 160 cells/μL; 90.5% had received ≥3 lines of ART and 179 (53.8%) had prior virological failure. Convenience (43.5%), toxicity/intolerance (28.4%) and interactions (17.0%) were the main reasons for starting DTG/RPV. Previous regimens were protease inhibitors (PI) (31.6%), non‐nucleoside reverse transcriptase inhibitors (NNRTI) (20.4%) and integrase strand transfer inhibitors (INSTI) (14.9%). Efficacy (HIV‐RNA <50 copies/mL) at 48 weeks was 89.7% (95% CI 86.1–92.6) by intention‐to‐treat (ITT) and 94.2% (95% CI 91.3–96.4) by on treatment (OT); 10 patients (3.1%) were not suppressed (3 had abandoned ART). There was a mean decrease in triglycerides, total cholesterol, low‐density lipoprotein‐cholesterol, glutamic–pyruvic transaminase (GPT), gamma‐glutamyl transferase (GGT) and alkaline phosphatase; creatinine increased with a decrease in glomerular filtration rate. Conclusions This study confirms the effectiveness, tolerability and safety of DTG/RPV in real‐world clinical practice in a different population from clinical trials, with many years of infection, low CD4 nadir, several previous treatment lines, more than half with virological failures, and one‐third diagnosed with AIDS. The switch to DTG/RPV was safe with few discontinuations due to adverse effects. Modifications of the lipid and liver profiles were favourable. There were no relevant changes in kidney function.

Sex differences in the effectiveness and tolerability of dolutegravir plus rilpivirine as a switch strategy in people living with HIV

“…suppression (94.2% in an on-treatment analysis) in a cohort more similar to ours [17]. Other studies based on clinical practice have reported similar results [18][19][20]; however, most of these studies do not separate results regarding sex.…”

“…Resistanceassociated mutation (RAM) selection is uncommon in DTG + RPV failure, but RAMs in non-nucleoside reverse transcriptase inhibitor (E138K/A, K101E, L100I) and integrase strand transfer inhibitor (N155H) genes have been described in both clinical trials and real-worldpopulations [19,22]. In conclusion, our data and those of others [12,14,17,19,23] confirm that DTG + RPV as a switch strategy provides security in terms of virological failure and RAM selection.…”

“…Regarding metabolics, recent real-world cohorts have shown a beneficial effect on lipid profiles, with decreases in total cholesterol and triglycerides [17,23]. Additionally, a weight increase of approximately 2 kg at 48 weeks of treatment has been described [32,33].…”