880. Interim Analysis of Real-World Community-Based HIV Rapid Start Antiretroviral with BFTAF Versus Conventional HIV Antiretroviral Therapy Start – The RoCHaCHa Study, A Pilot Study
Authors: Zuppelli Ashley R , Scutaru Jacob , Danforth Alexandra , Biernbaum Robert , Corales Roberto , Hilliard Shealynn , Valenti William M 
Published: December 2021

Abstract

Background
Trillium Health (TH) is a Federally Qualified Health Center look-alike and Ryan White C grantee in Rochester, NY providing primary and specialty care, including HIV prevention and treatment. Rapid Start Antiretroviral therapy (RSA) has been shown to decrease time to viral suppression while increasing linkage to and retention in care. However, data on a fixed-dose combination of BFTAF with these benefits are limited.
We aim to show RSA with BFTAF time to viral suppression, adherence to medication, and retention in care is statistically significant in comparison to older treatment models. Additionally, we aim to demonstrate the feasibility and acceptability of RSA with BFTAF.

Methods
This is an interim analysis of participants who enrolled in the study and been in care at TH for at least 3 months as of May 2021. All participants complete a baseline assessment and start BFTAF. Follow up visits are conducted through 48 weeks. Primary and secondary endpoints are included in the attached table 2 Barriers to care and patient reported outcomes were evaluated through a standardized questionnaire at the final study visit. Study results were compared with non-RSA historical control data from patients who received standard of care universal ART initiation at TH.

Results
Thirty-four participants have been enrolled in the study for at least 12 weeks, 33 (97%) of whom have reached and maintained viral suppression. Twenty-one participants have completed all 48 weeks, with 20 (95%) reaching and maintaining viral suppression. In comparison to historical controls, the RSA study participants had a statistically significant shorter time to viral suppression, both from diagnosis and from ART initiation. The RSA patients had statistically significant higher retention at 12, 24, and 48 weeks in comparison to historical controls. Adherence was higher in the RSA patients, though not statistically significant.
Enrollment Graphic for the Rochacha Study

Baseline Demographics of Study Participants and Controls

Clinical Outcomes of Study Participants compared to Controls

Conclusion
Our data show that RSA with BFTAF can be effective in a community based health center setting in participants facing barriers to care. The patients who were treated by RSA with BFTAF had a high viral suppression rate. To date, no BFTAF regimen had to be changed due to resistance or virologic failure in this study. These data support implementation of RSA with BFTAF as standard of care.

Disclosures
Ashley R. Zuppelli, PHARMD, BCACP, AAHIVP, Gilead Sciences (Research Grant or Support) Robert Biernbaum, DO, MS, FAAEM, AAHIVS, Gilead Sciences (Research Grant or Support) Roberto Corales, DO, AAHIVS, Gilead Sciences (Employee, Scientific Research Study Investigator) Shealynn Hilliard, MS, Gilead Sciences (Research Grant or Support) William M. Valenti, MD, FIDSA, Gilead Sciences (Research Grant or Support)