Abacavir/Lamivudine plus Rilpivirine Is an Effective and Safe Strategy for HIV-1 Suppressed Patients: 48 Week Results of the SIMRIKI Retrospective Study.

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  • dc.contributor.author Troya, Jesúsca
  • dc.contributor.author Knobel Freud, Hernandoca
  • dc.contributor.author Imaz, Arkaitzca
  • dc.contributor.author GESIDA-8314 Study Groupca
  • dc.date.accessioned 2016-11-23T09:51:44Z
  • dc.date.available 2016-11-23T09:51:44Z
  • dc.date.issued 2016
  • dc.description.abstract 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.ca
  • dc.description.sponsorship The study was supported by ViiV Healthcare and SEIMC-GESIDA Foundation (grant number Gesida-8314). ViiV Healthcare provided SEIMC-GESIDA funds for the coordination and operational aspects of this study (administrative costs, payment for including different hospitals, collecting patient data and data analysis) but did not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. SEIMC-GESIDA Foundation was the sponsor of the study and managed all the operational aspects, including design, data collection and data analysis
  • dc.format.mimetype application/pdfca
  • dc.identifier.citation Troya 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 Oct 11;11(10):e0164455. doi: 10.1371/journal.pone.0164455ca
  • dc.identifier.doi http://dx.doi.org/10.1371/journal.pone.0164455
  • dc.identifier.issn 1932-6203
  • dc.identifier.uri http://hdl.handle.net/10230/27577
  • dc.language.iso engca
  • dc.publisher Public Library of Science (PLoS) ca
  • dc.relation.ispartof PLoS One. 2016 Oct 11;11(10):e0164455
  • dc.rights © 2016 Troya et al/nThis is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.ca
  • dc.rights.accessRights info:eu-repo/semantics/openAccessca
  • dc.rights.uri https://creativecommons.org/licenses/by/4.0/ca
  • dc.subject.other VIH (Virus) -- Tractamentca
  • dc.title Abacavir/Lamivudine plus Rilpivirine Is an Effective and Safe Strategy for HIV-1 Suppressed Patients: 48 Week Results of the SIMRIKI Retrospective Study.ca
  • dc.type info:eu-repo/semantics/articleca
  • dc.type.version info:eu-repo/semantics/publishedVersionca

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