Short-term cost analysis of raltegravir versus atazanavir + ritonavir or darunavir + ritonavir for treatment-naive adults with HIV-1 infection in the United States

The head-to-head AIDS Clinical Trial Group (ACTG) 5257 clinical trial found raltegravir (RAL) to be superior to atazanavir + ritonavir (ATV/r) and darunavir + ritonavir (DRV/r), when used in combination with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) by treatment-naive adults with HIV-1 infection, in a 96-week composite endpoint combining virologic efficacy and tolerability. The objective of this study was to estimate the total HIV treatment costs associated with these three regimens in the United States. METHODS: Ninety-six–week costs for antiretroviral drugs, adverse event management, and HIV care for individuals initiating RAL, ATV/r, or DRV/r as first-line therapy for HIV-1 infection were estimated using an economic model. Efficacy and safety data (mean CD4 cell count changes, discontinuation rates, grade 3/4 adverse event incidence) for each regimen through 96 weeks of treatment were taken from the ACTG 5257 clinical trial. Antiretroviral drug costs for each initial regimen and for each substitution regimen, as used by individuals who discontinued their initial regimen, were based on wholesale acquisition costs. Adverse event management costs and HIV care costs, stratified by CD4 cell count range, were taken from published sources and inflated to 2016 dollars. Scenario and sensitivity analyses were conducted to assess the robustness of the results. Cost outcomes were discounted at an annual rate of 3.0%. RESULTS: Total 96-week costs were $81,231 for RAL, $88,064 for ATV/r, and $87,680 for DRV/r, where differences were primarily due to lower antiretroviral drug costs for RAL than for ATV/r or DRV/r. These results were found to be robust in scenario and sensitivity analyses. CONCLUSIONS: Relative to the DRV/r and ATV/r regimens, the RAL regimen had the lowest cost for treatment-naive adults with HIV-1 infection in the United States.