title: The Cost-effectiveness and Budget Impact of 2-Drug Dolutegravir-Lamivudine Regimens for the Treatment of HIV Infection in the United States.
abstract: BACKGROUND
  Recommended human immunodeficiency virus (HIV) treatment regimens in the United States contain 3 antiretroviral agents, costing >$30 000/person/year. Pilot studies are evaluating the efficacy of dual therapy with dolutegravir (DTG) and lamivudine (3TC). We examined the potential cost-effectiveness and budget impact of DTG + 3TC regimens in the United States.
  
  
  METHODS
  Using a mathematical model, we projected the clinical and economic outcomes of antiretroviral therapy (ART)-naive patients under 4 strategies: (1) no ART (for modeling comparison); (2) 2-drug: initial regimen of DTG + 3TC; (3) induction-maintenance: 48-week induction regimen of 3 drugs (DTG/abacavir [ABC]/3TC), followed by DTG + 3TC maintenance if virologically suppressed; and (4) standard of care: 3-drug regimen of DTG/ABC/3TC. Strategy-dependent model inputs, varied widely in sensitivity analyses, included 48-week virologic suppression (88%-93%), subsequent virologic failure (0.1%-0.6%/month), and Medicaid-discounted ART costs ($15 200-$39 600/year). A strategy was considered cost-effective if its incremental cost-effectiveness ratio (ICER) was <$100 000/quality-adjusted life-year (QALY).
  
  
  RESULTS
  The 3 ART strategies had the same 5-year survival rates (90%). The ICER was $22 500/QALY for induction-maintenance and >$500 000/QALY for standard of care. Two-drug was the preferred strategy only when DTG + 3TC 48-week virologic suppression rate exceeded 90%. With 50% uptake of either induction-maintenance or 2-drug for ART-naive patients, cost savings totaled $550 million and $800 million, respectively, within 5 years; savings reached >$3 billion if 25% of currently suppressed patients were switched to DTG + 3TC maintenance.
  
  
  CONCLUSIONS
  Should DTG + 3TC demonstrate high rates of virologic suppression, this regimen will be cost-effective and would save >$500 million in ART costs in the United States over 5 years.
authors.affiliation: Medical Practice Evaluation Center Division of General Internal Medicine, Massachusetts General Hospital.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Girouard
authors.affiliation: Division of Infectious Diseases, Brigham and Women's Hospital Harvard Medical School.
authors.forename: Paul E
authors.initials: PE
authors.lastname: Sax
authors.affiliation: Medical Practice Evaluation Center Harvard Medical School Biostatistics Center, Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Parker
authors.affiliation: Division of Infectious Diseases, Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Babafemi
authors.initials: B
authors.lastname: Taiwo
authors.affiliation: Medical Practice Evaluation Center Division of General Internal Medicine, Massachusetts General Hospital Harvard Medical School Division of Infectious Diseases, Massachusetts General Hospital Department of Epidemiology, Boston University School of Public Health Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Freedberg
authors.affiliation: Division of Infectious Diseases, Weill Medical College of Cornell University, New York, New York.
authors.forename: Roy M
authors.initials: RM
authors.lastname: Gulick
authors.affiliation: Department of Health Policy and Management, Harvard T. H. Chan School of Public Health, Boston, Massachusetts Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.
authors.forename: Milton C
authors.initials: MC
authors.lastname: Weinstein
authors.affiliation: Yale School of Public Health, New Haven, Connecticut.
authors.forename: A David
authors.initials: AD
authors.lastname: Paltiel
authors.affiliation: Medical Practice Evaluation Center Division of General Internal Medicine, Massachusetts General Hospital Division of Infectious Diseases, Brigham and Women's Hospital Harvard Medical School Division of Infectious Diseases, Massachusetts General Hospital.
authors.forename: Rochelle P
authors.initials: RP
authors.lastname: Walensky
mesh_terms: D019380:Anti-HIV Agents / Q000191:economics* / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active / Q000191:economics; D018791:CD4 Lymphocyte Count; D003362:Cost-Benefit Analysis; D015658:HIV Infections / Q000188:drug therapy* / Q000191:economics* / Q000453:epidemiology / Q000821:virology; D019428:HIV Integrase Inhibitors / Q000191:economics* / Q000627:therapeutic use; D015497:HIV-1 / Q000187:drug effects; D006575:Heterocyclic Compounds, 3-Ring / Q000191:economics* / Q000627:therapeutic use; D006801:Humans; D019259:Lamivudine / Q000191:economics* / Q000627:therapeutic use; D015233:Models, Statistical; D010078:Oxazines; D010879:Piperazines; D011728:Pyridones; D014481:United States / Q000453:epidemiology; D000099226:Dolutegravir
chemical_list: D019380:Anti-HIV Agents; D019428:HIV Integrase Inhibitors; D006575:Heterocyclic Compounds, 3-Ring; D019259:Lamivudine; D010078:Oxazines; D010879:Piperazines; D011728:Pyridones; D000099226:Dolutegravir
keywords: ART; HIV; cost-effectiveness; dolutegravir; lamivudine