Cost-Consequences and Health Outcomes of Emtricitabine and Tenofovir Alafenamide (FTC/TAF): A Novel Two-Drug, Fixed-Dose Combination for Human Immunodeficiency Virus (HIV) Patients

Abstract

Background. Effective, well-tolerated antiretroviral (ARV) therapies have transformed the treatment of HIV. Patients are living longer, but conditions such as chronic kidney disease (CKD) and cardiovascular disease (CVD) are increasing as patients age. This has increased the need for ARV with reduced impact on these conditions. FTC/TAF adds an option with high virologic efficacy-equivalent to FTC/TDF-based regimens-with the renal and bone safety benefits of TAF and without increased CVD risk that has been associated with abacavir. FTC/TAF can be paired with various third agents to allow for individualized treatment choices. Methods. A cost-consequence analysis (CCA) was developed using an event simulation framework which considers patients' underlying risk factors and conditions that impact CKD and CVD events. Inputs were drawn from published trials, peer-reviewed literature, and real-world database analyses. Model structure and inputs were validated by a panel of experts in HIV, nephrology, CVD, and endocrinology. Analyses compared FTC/TAF paired with protease inhibitors (PIs) or with dolutegravir (DTG) and FTC/TDF paired with the same third agents (CKD outcomes), and with abacavir, lamivudine, and DTG (ABC/3TC/DTG) single tablet regimen (CVD outcomes). Time horizons of 1-5 years were assessed for simulated cohorts of 1000 US insured treatment naive (TN) and treatment experienced (TE) patients. Results. Tables 1 and 2 summarize 5-year outcomes for TN and TE patients, respectively. Compared to FTC/TDF-based regimens, FTC/TAF reduced the number of patients progressing to CKD-III 31-39%. Patients treated with FTC/TAF also experienced 25-37% fewer CVD events compared to those treated with ABC/3TC/DTG. As a result, first-line persistence was increased for patients treated with FTC/TAF compared to regimens containing FTC/TDF or ABC. When examining the annualized 5-year costs per patient, savings of 1-2.9% in the total and pharmacy costs were seen. Results were similar between TN and TE patients. Conclusion. According to this analysis, FTC/TAF reduces CKD and CVD events, reduces ARV therapy switching, improves patient health outcomes, and provides sig- nificant cost offsets. (Table Presented) .