A Multicenter Clinical Trial to Evaluate the Feasibility and Outcome of Same-day Antiretroviral Therapy With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) Among Patients Testing Positive by HIV Confirmatory Tests

Background In 2015, WHO recommended that all patients be treated with combination antiretroviral therapy (cART) once the diagnosis of HIV infection was made. On the population level, starting cART soon after HIV diagnosis can prevent onward HIV transmission. Although WHO has recommended "treat-all" policy since 2015, there were still 1.8 million people becoming newly infected with HIV in 20179. The substantial loss of patients during the HIV care continuum among the most vulnerable populations have been major concerns in the cART scale-up. Therefore, the concept of rapid ART initiation, defined as starting ART within 7 days or even on the same day after HIV diagnosis was confirmed, was introduced to improve HIV care continuum. In several clinical trials, loss to follow-up was observed despite the clinical trial settings. From our prior study18, among 786 individuals who were screened positive for HIV, 2.4% never returned to the clinic for the confirmatory tests. Despite ART scale-up and the policy of rapid initiation, 30% the of patients who were diagnosed with HIV infection during 2017-2018 did not initiate cART within 7 days after HIV diagnosis was made. Prior studies revealed that point-of-care diagnostic methods for detection of HIV RNA can accelerate linkage to care and reduce anxiety. However, the cost of and the barriers to accessing the point-of-care HIV RNA testing remain high. By shortening the interval between infectious disease physician referral, time-lag between screening and confirmatory tests, with the use of newly developed point-of-care immunochromatographic confirmatory test, initiating a safe and potent antiretroviral therapy on the same day of HIV confirmation will be feasible to improve linkage to care and to shorten the interval between HIV diagnosis and viral suppression.

Study aim This study objective is to investigate the feasibility and outcomes of same-day initiation with Biktarvy (Bic/F/TAF) among patients who receive a diagnosis of HIV infection by confirmatory test.

Study Interventions This is a multi-center, single-arm, prospective cohort study. All individuals who fulfill the inclusion/exclusion criteria will be enrolled in our study and followed for 48 weeks. During the first visit at ID clinic, baseline clinical data will be collected by history taking, physical examination, and blood testing. The confirmatory test and baseline evaluations will be performed at the Visit 1. The test results will also be reported on the same day. Patients, who are HIV(+) by confirmatory test ,will receive a 7-day Biktarvy treatment and the first dose will be administered from Visit 1 (Day 1). The results of other evaluation including viral load, CD4 count, and coinfection will be available at visit 2.

At Visit 2, the clinical symptoms and the tolerability will be recorded. If participants continue to receive Biktarvy® at the discretion of the HIV treating physicians, Biktarvy will be continued according to the national HIV treatment guidelines, which will be reimbursed by the National Health Insurance, and the patients will be followed in our study for 48 weeks. If the patients are switched to other cART regimens than Bictarvy according to physician's clinical judgements, the participants will continue their follow-up in the study.

During the follow-up period, clinical information on symptoms, tolerability, and adverse effects with the use of face-to-face questionnaire interviews, and follow-up laboratory test results will be collected. to evaluate the efficacy and adverse effect according to the national HIV treatment guidelines and routine clinical practices.