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.

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

Figure 1.

Cumulative discounted 5-year per-person costs (in 2014 US dollars [USD]) for the 2-drug, induction-maintenance, and standard-of-care strategies. Discounted costs stratified into first-line antiretroviral therapy (ART) costs (dark blue), second-line ART costs (yellow), and non-ART costs (light blue); the proportion of each cost category of total medical costs is labeled in each bar. Additionally, the proportion of 5-year ART costs comprised of second-line ART costs is shown.

Figure 2.

Multivariate sensitivity analyses varying 48-week virologic suppression and post–48-week later virologic failure for the induction-maintenance and 2-drug strategies. Analyses of induction-maintenance parameters. A–C, The y-axes vary the 48-week virologic suppression of the standard of care (SOC) and induction-maintenance strategy (dolutegravir [DTG]/abacavir [ABC]/lamivudine [3TC]); the x-axes vary the rate of post–48-week virologic failure for the induction-maintenance and 2-drug (DTG + 3TC) regimens. The open black boxes represent base case values. The decrease in undiscounted quality-adjusted life-months (QALMs) (A) and increase in proportion on second-line antiretroviral therapy (ART) at 10 years (B) of induction-maintenance compared to SOC are shown. C, The most cost-effective strategy with a threshold of <$100 000/quality-adjusted life-year (QALY) as the parameters on the axes are varied, keeping all others constant. Analyses of 2-drug parameters: D–F, The y-axes vary the 48-week virologic suppression of the 2-drug regimen (DTG + 3TC); the x-axes vary the rate of post–48-week virologic failure for the induction-maintenance and 2-drug (DTG + 3TC) regimens. The decrease in undiscounted QALMs (D) and increase in proportion on second-line ART at 10 years (E) of 2-drug compared to SOC are shown. F, The most cost-effective strategy with a threshold of <$100 000/QALY as the parameters on the axes are varied, keeping all others constant.