title: Effectiveness of antiretroviral therapy in individuals who for economic reasons were switched from a once-daily single-tablet regimen to a triple-tablet regimen.
abstract: BACKGROUND
  To assess the impact on virological outcomes of a switch from branded single-tablet regimen (STR) including tenofovir, efavirenz, and emtricitabine (STR-TEE) to generic triple-tablet regimen (TTR), including tenofovir, efavirenz, and lamivudine (TTR-TEL), which was implemented on April 1, 2011 to obtain economic savings.
  
  
  RESULTS
  From the Capital Region of Denmark (covering two-thirds of the Danish HIV patients), we included combination antiretroviral therapy (cART)-naive patients who administered STR-TEE from April 1, 2010 to March 31, 2011 (n = 111) or TTR-TEL from April 1, 2011 to March 31, 2012 (n = 56) and cART-experienced HIV patients who were on STR-TEE from April 1, 2010 (n = 356) or were switched from STR-TEE to TTR-TEL after April 1, 2011 (n = 512). We estimated the fraction with detectable HIV-RNA, development of the 184V/I resistance mutations, and time to switch of cART. Approximately 96.2% of cART-experienced patients on STR-TEE were shifted to TTR-TEL after April 1, 2011. For the naive STR-TEE and TTR-TEL patients, the fractions with detectable HIV-RNA at week 48 were 7.0% and 8.3% and for the cART experienced 4.0% and 4.4%, respectively. The 184V/I resistance mutation was detected in 1 cART-experienced patient on TTR-TEL with virological failure. The risk of switch to a new cART regimen was slightly increased in the cART-experienced population (difference in 1-year risk: 1.5%; 95% confidence interval: -2.4% to 5.4%).
  
  
  CONCLUSIONS
  In settings comparable with the Danish health care system, the estimated economic savings from a switch from STR-TEE to TTR-TEL can be realized with negligible short-term risk of adverse outcomes.
authors.affiliation: *Department of Infectious Diseases, Copenhagen University Hospital, Rigshospitalet, Denmark; †Department of Microbiology Diagnostics and Virology, Statens Serum Institut, Copenhagen, Denmark; ‡Department of Infectious Diseases, Copenhagen University Hospital, Nordsjælland Hospital, Denmark; and §Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre, Denmark.
authors.forename: Frederik N
authors.initials: FN
authors.lastname: Engsig
authors.forename: Jan
authors.initials: J
authors.lastname: Gerstoft
authors.forename: Marie
authors.initials: M
authors.lastname: Helleberg
authors.forename: Lars N
authors.initials: LN
authors.lastname: Nielsen
authors.forename: Gitte
authors.initials: G
authors.lastname: Kronborg
authors.forename: Lars R
authors.initials: LR
authors.lastname: Mathiesen
authors.forename: Niels
authors.initials: N
authors.lastname: Obel
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D003718:Denmark / Q000453:epidemiology; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D004338:Drug Combinations