The Cost-effectiveness and Budget Impact of 2-Drug Dolutegravir-Lamivudine Regimens for the Treatment of HIV Infection in the United States

Clin Infect Dis. 2016 Mar 15;62(6):784-91. doi: 10.1093/cid/civ981. Epub 2015 Dec 9.

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.

Keywords: ART; HIV; cost-effectiveness; dolutegravir; lamivudine.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anti-HIV Agents / economics*
  • Anti-HIV Agents / therapeutic use
  • Antiretroviral Therapy, Highly Active / economics
  • CD4 Lymphocyte Count
  • Cost-Benefit Analysis
  • HIV Infections / drug therapy*
  • HIV Infections / economics*
  • HIV Infections / epidemiology
  • HIV Infections / virology
  • HIV Integrase Inhibitors / economics*
  • HIV Integrase Inhibitors / therapeutic use
  • HIV-1 / drug effects
  • Heterocyclic Compounds, 3-Ring / economics*
  • Heterocyclic Compounds, 3-Ring / therapeutic use
  • Humans
  • Lamivudine / economics*
  • Lamivudine / therapeutic use
  • Models, Statistical
  • Oxazines
  • Piperazines
  • Pyridones
  • United States / epidemiology

Substances

  • Anti-HIV Agents
  • HIV Integrase Inhibitors
  • Heterocyclic Compounds, 3-Ring
  • Oxazines
  • Piperazines
  • Pyridones
  • Lamivudine
  • dolutegravir