Rapid Initiation of Antiretroviral Therapy Following Diagnosis of Human Immunodeficiency Virus Among Patients with Commercial Insurance Coverage.

Abstract

New guidelines for the treatment of human immunodeficiency virus (HIV) advocate for rapid initiation of antiretroviral therapy (ART) ≤ 7 days after HIV diagnosis with agents that have a high genetic barrier to resistance, good tolerability, and convenient dosing. To describe characteristics, time to ART initiation, and health care costs in commercially insured patients living with HIV in the United States who are treated ≤ 60 days after HIV diagnosis. IBM MarketScan Research Databases (January 1, 2012-December 31, 2017) were used to identify ART-naive adults with HIV-1, ≥ 6 months of continuous eligibility before first HIV diagnosis, and ART initiation ≤ 60 days of first diagnosis. ART regimen had to include a protease inhibitor (PI), an integrase strand transfer inhibitor (INSTI), or a non-nucleoside reverse transcriptase inhibitor (NNRTI) with ≥ 2 nucleoside reverse transcriptase inhibitors. Cohorts were formed based on time to ART initiation after diagnosis: ≤ 7 days or 8-60 days. Health care costs were evaluated at 6, 12, 24, and 36 months after diagnosis among patients with ≥ 36 months of continuous eligibility. Among 9,351 patients, median time to treatment was 31.0 days. Patients initiating ART > 60 days after HIV diagnosis were excluded (N = 2,608 [27.9%]), while 6,743 (72.1%) initiated ART ≤ 60 days after diagnosis and were analyzed; 18.3% and 81.7% were classified in the ≤ 7 days and 8-60 days cohorts, respectively. For all analyzed patients, mean age was 38.0 (SD = 12.0) years and 13.2% were female; 12.7%, 56.2%, and 31.1% initiated a PI, INSTI, or NNRTI-based regimen, respectively. Elvitegravir (32.9%), efavirenz (20.9%), dolutegravir (18.5%), and darunavir (8.5%) were the most commonly used antiretrovirals; most patients (74.3%) were initiated on single-tablet regimens. PI-based regimens were more common in the ≤ 7 days cohort (PI = 18.1%; darunavir = 11.4%) than in the 8-60 days cohort (PI = 11.5%; darunavir = 7.8%). INSTI-based regimens were more common in the 8-60 days cohort (INSTI = 57.7%; elvitegravir = 33.8%) than in the ≤ 7 days cohort (INSTI = 49.2%; elvitegravir = 29.1%). NNRTI-based regimens were as common in the ≤ 7 days (32.7%) and 8-60 days (30.7%) cohorts. Mean total accumulated costs were lower among patients in the ≤ 7 days cohort than in the 8-60 days cohort at all time points analyzed after diagnosis (e.g., 36 months: ≤ 7 days = $109,456; 8-60 days = $116,870). Total per-patient per-month costs decreased over time in the ≤ 7 days (i.e., 6 months = $4,359; 36 months = $3,040) and 8-60 days cohort (6 months = $4,727; 36 months = $3,246). Although 72.1% of patients initiated ART ≤ 60 days after HIV diagnosis, only 18.3% initiated ART ≤ 7 days. Many patients initiating ART ≤ 7 days used suboptimal agents with low rather than high genetic barriers to resistance (i.e., efavirenz and elvitegravir) or agents (dolutegravir) coformulated with other antiretrovirals that require testing to prevent hypersensitivity reactions. Patients in the ≤ 7 days cohort showed lower total health care costs relative to those in the 8-60 days cohort, highlighting the potential long-term benefits of rapid ART initiation. This study was supported by Janssen Scientific Affairs, which was involved in the study design, interpretation of results, manuscript preparation, and publication decisions. Emond, Lefebvre, Lafeuille, and Côté-Sergent are employees of Analysis Group, a consulting company that was contracted by Janssen Scientific Affairs to conduct this study and develop the manuscript. Benson, Tandon, Chow, and Dunn are employees of Janssen Scientific Affairs and stockholders of Johnson & Johnson. Part of the material in this study has been presented at the AMCP 2019 Annual Meeting; March 25-28, 2019; San Diego, CA.