title: Cost-efficacy comparison among three antiretroviral regimens in HIV-1 infected, treatment-experienced patients.
abstract: OBJECTIVE
  In the face of increasing antiretroviral (ARV) treatment options and costs, payers are progressively challenged with prioritising resources. The cost effectiveness of the ARV agent enfuvirtide has been shown to be comparable to that of other available HIV treatment strategies, based on Markov modeling. However, an evaluation of enfuvirtide treatment costs that considers the impact of virological and immunological responses to therapy may provide a more clinically meaningful perspective for primary HIV healthcare providers. The aim of this study was to assess the cost per unit change in efficacy (HIV RNA decreases and CD4 count increases) of three different ARV regimens for triple class-experienced HIV-1 infected patients using actual drug costs and data from randomised, controlled clinical trials.
  
  
  METHODS
  The analysis included three steps. First, re-analysis of 48-week clinical trial data (T-20 vs Optimized Regimen Only [TORO]) to allow for a more direct comparison of enfuvirtide versus other commonly used ARV agents. All patients included in the re-analysis received a common optimised background (COB) regimen of three drugs: two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and a ritonavir-boosted protease inhibitor (PI), lopinavir. HIV RNA levels and CD4 count changes were determined for three patient groups according to the treatment received - group 1: COB + enfuvirtide; group 2: COB + PI; group 3: COB + NRTI + PI. The second step of the analysis involved calculating the annualised regimen costs ($US wholesaler acquisition cost) for each patient group. In the third step, cost-efficacy ratios were calculated and compared between groups: (a) the annualised regimen cost ($US)/change in viral load from baseline, and (b) the annualised regimen cost ($US)/change in CD4+ cell count from baseline.
  
  
  RESULTS
  One hundred and fifty-seven patients were included in this previously unplanned secondary analysis (group 1: 79 patients; group 2: 42 patients; group 3: 36 patients). HIV RNA and CD4 count changes from baseline to week 48 were -1.80, -0.89 and -0.61 log(10) copies/mL (p < 0.001 for enfuvirtide vs each non-enfuvirtide group) and +102, +57 and +52 cells/mm(3) (p < 0.05 for enfuvirtide versus each non-enfuvirtide subgroup) for groups 1, 2 and 3, respectively. The annualised costs of the combination therapies were $US 35,624, $US 27,549 and $US 30,624; and the costs per 0.50 log(10) copies/mL HIV RNA decrease were $US 9,872, $US 15,542 and $US 24,907 (p < 0.05 for enfuvirtide vs each non-enfuvirtide subgroup) for groups 1, 2 and 3, respectively. The costs per 25 cells/mm(3) CD4 count increase were $US 8,722, $US 12,127 and $US 14,636 for subgroups 1, 2 and 3, respectively. Similar patterns in regimen cost per unit change were achieved after adjusting for baseline prognostic variables. The incremental cost-efficacy ratios for group 1 versus the combination of groups 2 and 3 were $US 3,124 for HIV RNA reduction and $US 3,239 for CD4 count increase.
  
  
  CONCLUSIONS
  Enfuvirtide-containing regimens are associated with higher cost as well as improved virological and immunological outcomes when compared with alternative four- and five-drug regimens. When costs and outcomes are considered jointly, an enfuvirtide-based regimen is more cost efficacious than alternative regimens in this patient population.
authors.affiliation: Roche Pharmaceuticals, Nutley, NJ 07110 USA. joerg.ruof@roche.com
authors.forename: Jörg
authors.initials: J
authors.lastname: Ruof
authors.forename: Alexander
authors.initials: A
authors.lastname: Dusek
authors.forename: Michael
authors.initials: M
authors.lastname: DeSpirito
authors.forename: Ralph A
authors.initials: RA
authors.lastname: Demasi
mesh_terms: D000465:Algorithms; D019380:Anti-HIV Agents / Q000191:economics / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active / Q000191:economics*; D003362:Cost-Benefit Analysis; D004338:Drug Combinations; D000077560:Enfuvirtide; D015700:HIV Envelope Protein gp41 / Q000191:economics / Q000627:therapeutic use; D015658:HIV Infections / Q000188:drug therapy* / Q000191:economics* / Q000821:virology; D015497:HIV-1; D006801:Humans; D010446:Peptide Fragments / Q000191:economics / Q000627:therapeutic use; D012367:RNA, Viral / Q000097:blood
chemical_list: D019380:Anti-HIV Agents; D004338:Drug Combinations; D015700:HIV Envelope Protein gp41; D010446:Peptide Fragments; D012367:RNA, Viral; D000077560:Enfuvirtide