title: Abacavir/Lamivudine plus Rilpivirine Is an Effective and Safe Strategy for HIV-1 Suppressed Patients: 48 Week Results of the SIMRIKI Retrospective Study.
abstract: OBJECTIVE
  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.
authors.affiliation: Hospital Universitario Infanta Leonor, Madrid, Spain.
authors.forename: Jesús
authors.initials: J
authors.lastname: Troya
authors.affiliation: Hospital Universitario Infanta Leonor, Madrid, Spain.
authors.forename: Pablo
authors.initials: P
authors.lastname: Ryan
authors.affiliation: Hospital Universitario Vall d'Hebrón, Barcelona, Spain.
authors.forename: Esteban
authors.initials: E
authors.lastname: Ribera
authors.affiliation: Hospital Universitario de Bellvitge, Barcelona, Spain.
authors.forename: Daniel
authors.initials: D
authors.lastname: Podzamczer
authors.affiliation: Hospital Universitario La Paz/IdiPAZ, Madrid, Spain.
authors.forename: Victor
authors.initials: V
authors.lastname: Hontañón
authors.affiliation: Hospital Jerez de la Frontera, Jerez de la Frontera, Spain.
authors.forename: Jose Alberto
authors.initials: JA
authors.lastname: Terrón
authors.affiliation: Hospital General Universitario de Alicante, Alicante, Spain.
authors.forename: Vicente
authors.initials: V
authors.lastname: Boix
authors.affiliation: Hospital Universitario Ramón y Cajal, Madrid, Spain.
authors.forename: Santiago
authors.initials: S
authors.lastname: Moreno
authors.affiliation: Hospital de Mataró, Mataró, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Barrufet
authors.affiliation: Hospital Regional Universitario de Málaga, Málaga, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Castaño
authors.affiliation: Hospital Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Carrero
authors.affiliation: Hospital Clínico de Valencia, Valencia, Spain.
authors.forename: María José
authors.initials: MJ
authors.lastname: Galindo
authors.affiliation: Hospital Universitario Infanta Elena, Huelva, Spain.
authors.forename: Ignacio
authors.initials: I
authors.lastname: Suárez-Lozano
authors.affiliation: Hospital del Mar, Barcelona, Spain.
authors.forename: Hernando
authors.initials: H
authors.lastname: Knobel
authors.affiliation: Hospital Universitario Infanta Elena, Huelva, Spain.
authors.forename: Miguel
authors.initials: M
authors.lastname: Raffo
authors.affiliation: Hospital Universitario Infanta Leonor, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Solís
authors.affiliation: Fundación SEIMC-GESIDA, Madrid, Spain.
authors.forename: María
authors.initials: M
authors.lastname: Yllescas
authors.affiliation: Fundación SEIMC-GESIDA, Madrid, Spain.
authors.forename: Herminia
authors.initials: H
authors.lastname: Esteban
authors.affiliation: Hospital Universitario La Paz/IdiPAZ, Madrid, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: González-García
authors.affiliation: Hospital Regional Universitario de Málaga, Málaga, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: Berenguer
authors.affiliation: Hospital Universitario de Bellvitge, Barcelona, Spain.
authors.forename: Arkaitz
authors.initials: A
authors.lastname: Imaz
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D003863:Depression / Q000209:etiology; D015224:Dideoxynucleosides / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D005919:Glomerular Filtration Rate; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D007668:Kidney / Q000378:metabolism; D019259:Lamivudine / Q000009:adverse effects / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D008099:Liver / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood; D012189:Retrospective Studies; D000068696:Rilpivirine / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D000099227:Abacavir
chemical_list: D019380:Anti-HIV Agents; D015224:Dideoxynucleosides; D004338:Drug Combinations; D019259:Lamivudine; D008055:Lipids; D012367:RNA, Viral; D000068696:Rilpivirine; C492871:abacavir, lamivudine drug combination; D000099227:Abacavir