Troya, JesúsRyan, PabloRibera, EstebanPodzamczer, DanielHontañón, VictorTerrón, Jose AlbertoBoix, VicenteMoreno, SantiagoBarrufet, PilarCastaño, ManuelCarrero, AnaGalindo, María JoséSuárez-Lozano, IgnacioKnobel, HernandoRaffo, MiguelSolís, JavierYllescas, MaríaEsteban, HerminiaGonzález-García, JuanBerenguer, JuanImaz, Arkaitz2016-11-112016-11-112016-10-11Troya J, Ryan P, Ribera E, Podzamczer D, Hontañón V, Terrón JA, et al. Abacavir/Lamivudine plus Rilpivirine Is an Effective and Safe Strategy for HIV-1 Suppressed Patients: 48 Week Results of the SIMRIKI Retrospective Study. PLoS ONE. 2016; 11(10):e0164455http://hdl.handle.net/10668/2520JOURNAL ARTICLE;OBJECTIVES Based on data from clinical practice, we evaluated the effectiveness and safety of switching to abacavir/lamivudine plus rilpivirine (ABC/3TC+RPV) treatment in virologically suppressed HIV-1-infected patients. METHODS We performed a multicenter, non-controlled, retrospective study of HIV-1-infected patients who switched treatment to ABC/3TC+RPV. Patients had an HIV-RNA <50 copies/mL for at least 24 weeks prior to changing treatments. The primary objective was HIV-1 RNA <50 copies/mL at week 48. Effectiveness was analyzed by intention-to-treat (ITT), missing = failure and on-treatment (OT) analyses. The secondary objectives analyzed were adverse effects changes in renal, hepatic or lipid profiles, changes in CD4+ cell count and treatment discontinuations. RESULTS Of the 205 patients included, 75.6% were men and the median age was 49. At baseline, before switching to ABC/3TC+RPV, median time since HIV diagnosis was 13.1 years, median time with undetectable HIV-1 RNA was 6.2 years and median time of previous antiretroviral regimen was 3.1 years (48.3% patients were taking efavirenz and ABC/3TC was the most frequent backbone coformulation in 69.7% of patients). The main reasons for switching were drug toxicity/poor tolerability (60.5%) and simplification (20%). At week 48, the primary objective was achieved by 187 out of 205 (91.2%) patients by ITT analysis, and 187 out of 192 (97.4%) patients by OT analysis. The CD4+ lymphocyte count and CD4+ percentage increased significantly from baseline to week 48 by a median of 48 cells/μL (-50 to 189) and 1.2% (-1.3% to 4.1%), respectively, P<0.001. Thirty-eight adverse events (AE) were detected in 32 patients. Of these, 25 had no clear association with treatment. Three patients interrupted therapy due to AE. We observed a decrease in all lipid parameters, P<0.001, and a slight improvement in the glomerular filtration rate, P<0.01. Therapy was considered to have failed in 18 patients owing to virological failure (5 [2.4%]), toxicity/poor tolerability (4 [2%]), clinical decision (3 [1.5%]), loss to follow-up (3 [1.5%]), death (1 [0.5%]), and no clinical data (2 [1%]). CONCLUSIONS The results of this study confirms that ABC/3TC+RPV is an effective, safe, and cost-effective option for the treatment of patients with virologically stable HIV-1 infection.enBenzoxazinasRecuento de Linfocito CD4DidesoxinucleósidosCombinación de medicamentosEfectos colaterales y reacciones adversas relacionados con medicamentosEstudios de seguimientoTasa de filtración glomerularInfecciones por VihVIH-1HumanosAnálisis de intención de tratarLamivudineLípidosMasculinoARNEstudios retrospectivosRilpivirineMedical Subject Headings::Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 1-Ring::Oxazines::BenzoxazinesMedical Subject Headings::Phenomena and Processes::Cell Physiological Phenomena::Cell Count::Blood Cell Count::Leukocyte Count::Lymphocyte Count::CD4 Lymphocyte CountMedical Subject Headings::Chemicals and Drugs::Nucleic Acids, Nucleotides, and Nucleosides::Nucleosides::Deoxyribonucleosides::DideoxynucleosidesMedical Subject Headings::Chemicals and Drugs::Pharmaceutical Preparations::Drug CombinationsMedical Subject Headings::Diseases::Chemically-Induced Disorders::Drug-Related Side Effects and Adverse ReactionsMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies::Follow-Up StudiesMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Techniques, Urological::Kidney Function Tests::Glomerular Filtration RateMedical Subject Headings::Diseases::Immune System Diseases::Immunologic Deficiency Syndromes::HIV InfectionsMedical Subject Headings::Organisms::Viruses::RNA Viruses::Retroviridae::Lentivirus::Lentiviruses, Primate::HIV::HIV-1Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Controlled Clinical Trials as Topic::Randomized Controlled Trials as Topic::Intention to Treat AnalysisMedical Subject Headings::Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 1-Ring::Pyrimidines::Pyrimidine Nucleosides::Cytidine::Deoxycytidine::Zalcitabine::LamivudineMedical Subject Headings::Chemicals and Drugs::LipidsMedical Subject Headings::Check Tags::MaleMedical Subject Headings::Chemicals and Drugs::Nucleic Acids, Nucleotides, and Nucleosides::Nucleic Acids::RNAMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Retrospective StudiesMedical Subject Headings::Chemicals and Drugs::Organic Chemicals::Nitriles::Rilpivirineresearch article27727331open access10.1371/journal.pone.01644551932-6203PMC5058546