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Professor of Medicine
Division of HIV, Infectious Diseases, and Global Medicine
University of California, San Francisco
Ward 86 HIV Clinic
San Francisco General Hospital
San Francisco, California
Monica Gandhi, MD, MPH, has no relevant conflicts of interest to report.
Rapid ART Initiation at Ward 86
We at Ward 86―the HIV/AIDS treatment program at the University of California, San Francisco―have taken the rapid antiretroviral therapy (ART) start model to heart. We developed a unique test-and-treat rapid ART program in 2012 that includes anyone newly diagnosed with HIV from the entire city of San Francisco. We offer transportation—even by rideshare or cab—to Ward 86 and start patients on ART that very day. We have been able to show that rapid ART is extremely successful, especially in a very vulnerable population with numerous concomitant challenges, with a documented virologic suppression rate of 96% out to 2 years and a high acceptability rate among our patients.
The medications that we prescribe for rapid ART have been evolving, but there is a consensus that the initial regimen should have a high genetic barrier to resistance, because we don’t know anything about the patient’s virus on the day they start ART. We don’t even know HIV-1 RNA or CD4+ count or any of their other laboratory measurements. The regimen is started with laboratory follow-up later.
There have been several trials on which antiretroviral regimen to start. For instance, the DIAMOND study looked at darunavir (DRV)/cobicistat/tenofovir alafenamide (TAF)/emtricitabine (FTC). Lately, we’ve been looking at the efficacy and safety of using bictegravir (BIC)/FTC/TAF.
BIC/FTC/TAF for Rapid ART Initiation
The new IMEA 055 FAST study was presented at the 18th European AIDS Conference (EACS 2021). This study enrolled anyone who came in with a new HIV diagnosis from 15 sites in France from November 2019 to September 2020. All patients started ART with BIC/FTC/TAF. This 1-pill coformulation is a very common first-line regimen, is well tolerated, and has a high genetic barrier to resistance. It has been shown to be effective even in the presence of transmitted M184V. The IMEA 055 FAST study analyzed data from 112 patients in France for up to 24 weeks and looked at adherence to the regimen and virologic outcomes.
At 24 weeks, patients did well virologically by either intention-to-treat or per-protocol analysis, both of which demonstrated >80% of patients with virologic suppression. This means the patients actually took the ART regimen faithfully. The per-protocol analysis (which includes the people who stayed on the regimen) was particularly encouraging, with 87.4% achieving HIV-1 RNA <50 copies/mL at 24 weeks. In this analysis, we saw a nice, persistent suppression out to 24 weeks whether the person started with high HIV-1 RNA (>500,000 copies/mL) or lower HIV-1 RNA (<100,000 copies/mL). As we might expect, however, outcomes were better among those who started in the lower HIV-1 RNA stratum (HIV-1 RNA <100,000 copies/mL).
Of importance, there were no emergent resistance mutations, although it would be nice to see if there were any proviral DNA resistance results at baseline in a future study analysis. By 24 weeks, there was no emergence of virological resistance to any drugs in the regimen among those adherent to the BIC/FTC/TAF. As we have seen in other clinical trials and in real-world experience, the regimen was well tolerated. Therefore, the conclusion of this study is that is that BIC/FTC/TAF is safe and effective for same-day ART initiation in a test-and-treat setting.
The Ward 86 Experience With ART Regimens for Rapid Start
We have 3 regimens on our formulary for rapid start, and this includes BIC/FTC/TAF. The other regimens we use are DRV/cobicistat/FTC/TAF and dolutegravir (DTG) + FTC/TAF or DTG + FTC/TDF. We purchase the medications and give starter packs to patients for about 5 days while we’re working with their insurance or arranging insurance coverage, so for us, it is a matter of what we can access. This study provides important confirmatory data for one of our commonly used regimens in this setting.
What is your experience with test-and-treat ART initiation in your clinic? Answer the polling question and/or join the discussion by posting a comment. For more from EACS 2021, download capsule summaries of these and other key studies and watch on-demand webcasts featuring expert insights on the clinical implications of the latest data.