Same-day antiretroviral therapy initiation improves HIV care engagement

Initiating antiretroviral therapy (ART) with the fixed-dose combination of bictegravir, emtricitabine, and tenofovir alafenamide (BIC/FTC/TAF) on the same day of HIV diagnosis appears to promote a high level of engagement in care in Taiwan.

In the 48-week, multicentre, single-arm trial wherein an accelerated HIV diagnostic algorithm was integrated with initiation of BIC/FTC/TAF within 24 h of confirmed diagnosis, retention rate was high at 96 percent. All participants received BIC/FTC/TAF within 24 h, with 85.8 percent taking the ART regimen on the same clinic visit. [Int J Infect Dis 2026;doi:10.1016/j.ijid.2025.108284]

Virologic suppression (plasma HIV RNA load <50 copies/mL) rate at week 48 was 76 percent, with 5.8 percent of patients achieving viral suppression after only 1 week of treatment.

The percentage of patients with plasma HIV RNA load below 200 copies/mL was 12 percent at week 1, 65.8 percent at week 4, and 89.8 percent at week 48.

In multivariable analysis, a high plasma HIV RNA load and low CD4 count at baseline was associated with lower odds of achieving viral suppression at week 48 (adjusted odds ratio [OR], 0.70, 95 percent confidence interval [CI], 0.58–0.83; p<0.001). Meanwhile, the odds were more than twofold higher among participants with a body weight of ≥60 vs <60 kg (adjusted OR, 2.34, 95 percent CI, 1.08–5.06; p=0.030), with a lower body weight a potential indicator of HIV-associated wasting, according to the investigators.

Safety

“The regimen showed excellent tolerability, with only 0.9-percent discontinuation due to drug-related skin rash,” they said.

There were 18 serious adverse events (AEs) reported at week 4 and 49 at week 48, none of which were related to BIC/FTC/TAF. Most serious AEs were associated with opportunistic infections, such as pneumocystis pneumonia and cytomegalovirus disease.

BIC/FTC/TAF-related AEs occurred in 42 participants (18.7 percent), with more than half of them having grade 1 or 2 gastrointestinal events such as nausea, vomiting, and bloating. Two participants who discontinued treatment reported severe skin rash (grade 3) and urticaria (grade 3), and one participant reported severe insomnia (grade 3). None of these drug-related AEs resulted in hospitalization or prolonged disability.

Structural enablers

These findings suggest that same-day initiation of BIC/FTC/TAF is feasible and may further improve the HIV care continuum and support the prevention of onward transmission, in line with the “undetectable equals untransmittable” principle, according to the investigators.

Taiwan’s success with same-day HIV treatment was the result of a deliberate, nationwide “readiness” strategy, they noted. Anonymous voluntary counselling and testing services have been widely promoted within key-population communities. Rapid HIV diagnosis is incentivized through a national pay-for-performance case management programme. Finally, immunochromatographic testing has been adopted as confirmatory tests in national guidelines, significantly shortening laboratory turnaround times.

The investigators argued that for the same-day ART initiation approach to work elsewhere, specific “structural enablers” may first be implemented. “Consequently, our findings provide a practical model for health systems seeking to plan or operationalize the ‘test-and-treat’ principle efficiently.”

Study details

The study included 225 adults aged ≥20 years (mean age 34.1 years, 96.8 assigned male at birth) who had no prior ART exposure, underwent screening tests by clinical care providers or at voluntary counselling and testing services, and started BIC/FTC/TAF within 24 h of confirmed HIV diagnosis.

At diagnosis, 34.9 percent of the participants had a CD4 count below 200 cells/µL, and the median plasma HIV RNA load was 5.3 log₁₀ copies/mL. Roughly a quarter of the participants (23.1 percent) presented with acute HIV infections, 13.7 percent presented with AIDS-defining illnesses, and around 5 percent tested positive for hepatitis B surface antigen (3.2 percent) or cryptococcal antigen (2 percent).

The investigators acknowledged that the virologic suppression rates at weeks 24 and 48 (68.9 percent and 76 percent, respectively) were lower than those observed in other same-day or rapid initiation cohorts treated with integrase strand-transfer inhibitor (INSTI)-based regimens (80–88 percent at week 24 and 84–96 percent at week 48) in studies such as the STAT, FAST, BICNOW, and RAINBOW. [J Antimicrob Chemother 2023;78:769-778; Open Forum Infect Dis 2023;10:ofad101; Int J Antimicrob Agents 2024;63: 107164; Int J Antimicrob Agents 2024;63:107049; Clin Infect Dis 2024;79:169-176]

The suboptimal virologic suppression rate may be potentially explained by the high proportion of participants with very high-level viremia at baseline (32 percent had a plasma HIV RNA load of >500,000 copies/mL), as well as adherence-related factors, they said.