Since the introduction of antiretroviral therapy in the mid-1990s, the life expectancy for patients with the human immunodeficiency virus (HIV) has soared. In 1996, a 20-year-old person with HIV could expect to live to age 39; today, the life expectancy is about 78. However, long-term treatment with some antiretroviral therapy (ART) has been associated with specific health risks. According to The Well Project, early HIV regimens were associated with heart disease due to increased trans fats; the treatment tenofovir disoproxil fumarate (TDF) has been linked to bone loss. Several early versions of ART have been associated with chronic kidney disease (CKD) and end-stage renal disease, one of the most expensive conditions for health systems.

As people with HIV live decades with the disease, drug developers have sought new therapies that reduce these long-term effects. In February 2018, the FDA approved a triple therapy combination to be sold as Biktarvy by Gilead. This single pill, given once a day, combined the unboosted integrase transfer inhibitor bictegravir with emtricitabine/tenofovir alafenamide (previously approved as Descovy). An analysis presented during Wednesday’s poster session at the Academy of Managed Care Pharmacy Nexus 2018 compared how patients with HIV-1 prescribed bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) would fare over 5 years, from both a health and cost perspective, compared with patients taking other regimens. Specifically, the analysis performed a simulation that looked at the likelihood of both treatment-naïve and previously treated adult patients with HIV developing cardiovascular disease, CKD of stage 3 or greater, and a major osteoporotic fracture (MOF), and what their medical and pharmacy costs would be.

Stage 3 CKD is characterized by moderate chronic renal insufficiency, where glomerular filtration rate indicates 40% to 59% of kidney function. Patients start to experience fluid retention, pain in the back, trouble sleeping, and fatigue.

The analysis compared B/F/TAF with 5 other regimens:

• elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF)
• elvitegravir/cobicistat/emtricitabine/TDF (E/C/FTC/TDF)
• dolutegravir + tenofovir DF / emtricitabine (DTG + FTC/TDF)
• dolutegravir + emtricitabine/tenofovir alafenamide (DTG + FTC/TAF)
• abacavir/lamivudine/dolutegravir (ABC/3TC/DTG)

Compared with the FTC/TDF–based regimens, B/F/TAF reduced the rates of Stage 3 CKD events 34.6%-34.9%. Further, B/F/TAF reduced rates of cardiovascular disease by 13.2.% compared with ABC/3TC/DTG. Patients who started the B/F/TAF regimen showed stronger treatment persistence, with an average median time to switching to another regimen or death of 6.7 months in treatment-naïve patients and 9.4 months in previously treated patients.

Average annual cost savings associated with the start of treatment with B/F/TAF in all patients with HIV-1 was $1.7 million per 1000 treated patients; this was driven by a projected reduction in treatment failure, and renal and cardiovascular events.

The B/F/TAF regimen was projected to yield medical and pharmacy savings relative to 4 of the 5 regimens on an annual basis: it saved $1.3 million compared with E/C/FTC/TDF, $3.3 million compared with DTG + FTC/TDF, $1.4 million compared with ABC/3TC/DTG, and $2.8 million compared with DTG + FTC/TAF. The E/C/F/TAF regimen, sold by Gilead as Genvoya, produced $500,000 more in annual savings.

Gilead Sciences funded the study.

Reference

DeJesus E, Folse H, Altice F. A cost-consequence analysis of bictegravir/emtricitabine/tenofovir alafenamide compared with other antiretroviral regimens in a simulated model of adult HIV patients. J Manag Care Spec Pharm. 2018;24(10-a). Abstract B6.