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.
Monitor of Adverse event and management The subjective adverse events will be inquired during
each visit and recorded with the use of questionnaire interviews. According to the national
HIV treatment guidelines in Taiwan, the liver and renal functions and muscle enzymes will be
followed during treatment as part of the standard of care. The study team will provide best
clinical care if adverse events develop and the cost of medical care required will be covered
by the insurance company. Severe adverse event and withdrawal from the study will be reported
to the primary investigator on a monthly basis. When the number of drop-out is higher than
30%, the enrollment will be stopped temporarily until the investigation ensures the safety of
the participants.
Study Endpoints
Primary endpoints 1) The rate of retention in care at Week 48 2) The proportion of viral
suppression (<50 copies/ml) at Week 48
Secondary endpoints 1) The rate of same-day initiation of ART among patients who receive
a confirmed diagnosis of HIV infection 2) The proportion of viral suppression (<200
copies/ml) at Weeks 1, 4, and 48 3) Any/severe adverse effect of B/F/TAF before Weeks 4
and 48 4) Patient's satisfaction at Weeks 1, 4, and 48
Statistical analysis
This is a feasibility study aiming to investigate the rate of engagement in same-day ART
initiation and retention in care at Week 48. No sample size calculation is needed. The
sample size of 200 participants is estimated by taking into account the case numbers of
newly diagnosed HIV-positive patients seeking HIV care and cART at each participating
hospitals during the past 1 year.
Timetable for study and enrollment:
- Total subjects expected to be enrolled: 200 2) Total subjects expected to enter treatment:
195 3) Total subjects expected to complete treatment: 191 4) Duration of enrolled period: 20
months 5) Number of subjects entering treatment per month: 10 ( 2 subjects per site)