Publication: Lipid changes in HIV-patients switching to the coformulated single tablet FTC/RPV/TDF (Eviplera®). Efficacy and safety analysis. GeSida Study 8114.
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Identifiers
Date
2014-11-02
Authors
Pérez-Hernández, Isabel A
Palacios, Rosario
Mayorga, Marisa
González-Doménech, Carmen M
Castaño, Manuel
Rivero, Antonio
Arco, Alfonso del
Lozano, Fernando
Santos, Jesús
Advisors
Journal Title
Journal ISSN
Volume Title
Publisher
BioMed Central
Abstract
INTRODUCTION
Rilpivirine (RPV) has a better lipid profile than efavirenz (EFV) in naïve patients (1). Switching to RPV may be convenient for many patients, while maintaining a good immunovirological control (2). The aim of this study was to analyze lipid changes in HIV-patients at 24 weeks after switching to Eviplera® (emtricitabine/RPV/tenofovir disoproxil fumarate [FTC/RPV/TDF]).
MATERIALS AND METHODS
Retrospective, multicentre study of a cohort of asymptomatic HIV-patients who switched from a regimen based on 2 nucleoside reverse transcriptase inhibitors (NRTI)+protease inhibitor (PI)/non nucleoside reverse transcriptase inhibitor (NNRTI) or ritonavir boosted PI monotherapy to Eviplera® during February-December, 2013; all had undetectable HIV viral load for ≥3 months prior to switching. Patients with previous failures on antiretroviral therapy (ART) including TDF and/or FTC/3TC, with genotype tests showing resistance to components of Eviplera®, or who had changed the third drug of the ART during the study period were excluded. Changes in lipid profile and cardiovascular risk (CVR), and efficacy and safety at 24 weeks were analyzed.
RESULTS
Among 305 patients included in the study, 298 were analyzed (7 cases were excluded due to lack of data). Men 81.2%, mean age 44.5 years, 75.8% of HIV sexually transmitted. 233 (78.2%) patients switched from a regimen based on 2 NRTI+NNRTI (90.5% EFV/FTC/TDF). The most frequent reasons for switching were central nervous system (CNS) adverse events (31.0%), convenience (27.6%) and metabolic disorders (23.2%). At this time, 293 patients have reached 24 weeks: 281 (95.9%) have continued Eviplera®, 6 stopped it (3 adverse events, 2 virologic failures, 1 discontinuation) and 6 have been lost to follow up. Lipid profiles of 283 cases were available at 24 weeks and mean (mg/dL) baseline vs 24 weeks are: total cholesterol (193 vs 169; p=0.0001), HDL-c (49 vs 45; p=0.0001), LDL-c (114 vs 103; p=0.001), tryglycerides (158 vs 115; p=0.0001), total cholesterol to HDL-c ratio (4.2 vs 4.1; p=0.3). CVR decreased (8.7 vs 7.5%; p= 0.0001). CD4 counts were similar to baseline (653 vs 674 cells/µL; p=0.08), and 274 (96.8%) patients maintained viral suppression.
CONCLUSIONS
At 24 weeks after switching to Eviplera®, lipid profile and CVR improved while maintaining a good immunovirological control. Most subjects switched to Eviplera® from a regimen based on NNRTI, mainly EFV/FTC/TDF. CNS adverse events, convenience and metabolic disorders were the most frequent reasons for switching.
Description
Meeting abstract. Abstracts of the HIV Drug Therapy Glasgow Congress 2014
MeSH Terms
Medical Subject Headings::Diseases::Virus Diseases::RNA Virus Infections::Retroviridae Infections::Lentivirus Infections::HIV Infections
Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents::Anti-Retroviral Agents::Anti-HIV Agents
Medical Subject Headings::Chemicals and Drugs::Pharmaceutical Preparations::Drug Combinations
Medical Subject Headings::Chemicals and Drugs::Lipids
Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Nucleic Acid Synthesis Inhibitors::Reverse Transcriptase Inhibitors
Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Nucleic Acid Synthesis Inhibitors
Medical Subject Headings::Chemicals and Drugs::Biological Factors::Antigens::Antigens, Surface::Antigens, Differentiation::Antigens, CD::Antigens, CD4
Medical Subject Headings::Chemicals and Drugs::Lipids::Lipoproteins::Lipoproteins, HDL
Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Organophosphorus Compounds
Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Protease Inhibitors
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Diseases::Cardiovascular Diseases
Medical Subject Headings::Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Statistics as Topic::Probability::Risk::Risk Factors
Medical Subject Headings::Check Tags::Male
Medical Subject Headings::Phenomena and Processes::Genetic Phenomena::Genotype
Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents::Anti-Retroviral Agents::Anti-HIV Agents
Medical Subject Headings::Chemicals and Drugs::Pharmaceutical Preparations::Drug Combinations
Medical Subject Headings::Chemicals and Drugs::Lipids
Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Nucleic Acid Synthesis Inhibitors::Reverse Transcriptase Inhibitors
Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Nucleic Acid Synthesis Inhibitors
Medical Subject Headings::Chemicals and Drugs::Biological Factors::Antigens::Antigens, Surface::Antigens, Differentiation::Antigens, CD::Antigens, CD4
Medical Subject Headings::Chemicals and Drugs::Lipids::Lipoproteins::Lipoproteins, HDL
Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Organophosphorus Compounds
Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Protease Inhibitors
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Diseases::Cardiovascular Diseases
Medical Subject Headings::Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Statistics as Topic::Probability::Risk::Risk Factors
Medical Subject Headings::Check Tags::Male
Medical Subject Headings::Phenomena and Processes::Genetic Phenomena::Genotype
DeCS Terms
CIE Terms
Keywords
Infecciones por VIH, Fármacos anti-VIH, Combinación de medicamentos, Lípidos, Inhibidores de transcriptasa inversa, Inhibidores de la Sintesis del ácido nucleico, Antígenos CD4, Lipoproteínas HDL, Compuestos organofosforados, Inhibidores de proteasas, Enfermedades cardiovasculares, Factores de riesgo, Genotipo
Citation
Pérez-Hernández IA, Palacios R, Mayorga M, González-Doménech CM, Castaño M, Rivero A, et al. Lipid changes in HIV-patients switching to the coformulated single tablet FTC/RPV/TDF (Eviplera®). Efficacy and safety analysis. GeSida Study 8114. J Int AIDS Soc. 2014; 17(4 Suppl 3):19795