title: An Indirect Comparison of Efficacy and Safety of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate and Abacavir/Lamivudine + Dolutegravir in Initial Therapy.
abstract: The objective of this analysis is to perform an indirect comparison of elvitegravir, cobicistat, emtricitabine and tenofovir DF (E/C/F/TDF) to abacavir/lamivudine and dolutegravir (ABC/3TC + DTG) by using 2 trials evaluating each of these regimens in comparison to efavirenz, emtricitabine and tenofovir DF (EFV/FTC/TDF).
  
  
  
  An indirect comparison was performed by using a generalization of Bucher's methodology to calculate risk differences. Two phase III clinical trials (GS-US-236-0102 and SINGLE-described above) were used.
  
  
  
  Results of the indirect comparison showed no statistically significant risk difference of the efficacy endpoint of achieving HIV RNA < 50 copies/mL between E/C/F/TDF and ABC/3TC + DTG for the ITT population at weeks 48, 96 and 144: respectively -3.7% (CI95% = [-10.8%; 3.4%]), -5.2% (CI95% = [-13.2%; 2.8%]) and -3.1% (CI95% = [-12.0%; 5.7%]). There was no statistically significant differences in the risk difference for serious adverse events (5.7% (CI95% = [-2.2%; 12.3%])), drug related adverse event (2.7% (CI95% = [-7.0%;12.4%])), drug related serious adverse event (0.8% (CI95% = [-1.6%;3.2%])) and death (0.5% (CI95% = [-0.8%;1.8%])), respectively, between E/C/F/TDF and ABC/3TC + DTG. A significant difference was found for discontinuation due to adverse events with a higher rate for E/C/F/TDF (difference = 8.6% (CI95% = [3.3%; 13.9%])). There was also no statistically significant risk difference of the viral resistance of 1.2% (CI95% = [-1.2; 3.7]) between E/C/F/TDF and ABC/3TC + DTG at week 48, 1.7% at week 96 (CI95% = [-1.1; 4.5]) and 2.2% (CI95% = [-1.0; 5.4]) at week 144.
authors.affiliation: University Hospital Germans Trias, Barcelona, Spain.
authors.forename: Josep
authors.initials: J
authors.lastname: M Llibre
authors.affiliation: CMIT, Paris, France.
authors.forename: François
authors.initials: F
authors.lastname: Raffi
authors.affiliation: Chelsea and Westminster Hospital, London, United Kingdom.
authors.forename: Graeme
authors.initials: G
authors.lastname: Moyle
authors.affiliation: Hannover Medical School, Hannover, Germany.
authors.forename: Georg
authors.initials: G
authors.lastname: Behrens
authors.affiliation: CEMKA-EVAL, Bourg-La-Reine, France.
authors.forename: Stephane
authors.initials: S
authors.lastname: Bouee
authors.affiliation: Gilead Sciences, Stockley Park, United Kingdom.
authors.forename: Geraldine
authors.initials: G
authors.lastname: Reilly
authors.affiliation: Gilead Sciences, Stockley Park, United Kingdom.
authors.forename: Peter
authors.initials: P
authors.lastname: Borg
authors.affiliation: Gilead Sciences, Foster City, United States of America.
authors.forename: David
authors.initials: D
authors.lastname: Piontkowsky
authors.affiliation: Gilead Sciences, Stockley Park, United Kingdom.
authors.forename: Felipe
authors.initials: F
authors.lastname: Rogatto
mesh_terms: D000328:Adult; D000465:Algorithms; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D000069547:Cobicistat / Q000008:administration & dosage*; D015224:Dideoxynucleosides / Q000008:administration & dosage*; D004338:Drug Combinations; D000068679:Emtricitabine / Q000008:administration & dosage*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1; D006575:Heterocyclic Compounds, 3-Ring / Q000008:administration & dosage*; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage*; D008297:Male; D010078:Oxazines; D061214:Patient Safety; D010879:Piperazines; D011728:Pyridones; D015363:Quinolones / Q000008:administration & dosage*; D012306:Risk; D000068698:Tenofovir / Q000008:administration & dosage*; D000099226:Dolutegravir; D000099227:Abacavir
chemical_list: D019380:Anti-HIV Agents; D000069547:Cobicistat; D015224:Dideoxynucleosides; D004338:Drug Combinations; D000068679:Emtricitabine; D006575:Heterocyclic Compounds, 3-Ring; D019259:Lamivudine; D010078:Oxazines; D010879:Piperazines; D011728:Pyridones; D015363:Quinolones; D000068698:Tenofovir; D000099226:Dolutegravir; C492871:abacavir, lamivudine drug combination; D000099227:Abacavir; C509700:elvitegravir