1. Efficacy and safety of dolutegravir/rilpivirine in real‐world clinical practice. GeSIDA study 1119.
- Author
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Palacios, R., Gómez‐Ayerbe, C., Casado, J. L., Tejerina, F., Montes, M. L., Castaño, M., Ocampo, A., Rial, D., Ribera, E., Galindo, M. J., Hidalgo, C., Fariñas, C., Montero, M., Payeras, T., Fanjul, F., de la Torre, J., and Santos, J.
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DRUG efficacy , *HIV infections , *GLOMERULAR filtration rate , *TRIGLYCERIDES , *KIDNEYS , *CLINICAL trials , *CONFIDENCE intervals , *FUNCTIONAL status , *RILPIVIRINE , *ANTIRETROVIRAL agents , *LDL cholesterol , *DESCRIPTIVE statistics , *RESEARCH funding , *MEDICAL practice , *ADVERSE health care events , *PATIENT safety , *CREATININE , *PHARMACODYNAMICS - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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