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Department of Microbiology
Universidad de Guanajuato
Hospital Regional de Alta Especialidad del Bajio
Leon, Guanajuato, Mexico
Juan Luis Mosqueda Gomez MD, MSc, has disclosed that he has received consulting fees from MSD and ViiV Healthcare and fees for non-CME services from Gilead Sciences, Janssen, and MSD.
Implementation of test-and-treat approaches for rapid initiation of antiretroviral therapy (ART) is a promising strategy for ending the HIV epidemic, as it may improve rates of treatment uptake and retention in care and hence reduce onward transmission. In this context, I want to share my thoughts on the IMEA 055 FAST study presented at the 2021 European AIDS Conference (EACS 2021).
The IMEA 055 FAST study was a prospective, single-arm study at 15 sites in France to assess the safety and efficacy of bictegravir (BIC)/emtricitabine (FTC)/tenofovir alafenamide (TAF) in a rapid-start protocol in ART-naive people with HIV (PWH) at their first medical appointment following a positive HIV test. The study included a significant percentage of patients with advanced disease at baseline, defined as an HIV-1 RNA level >500,000 copies/mL (19%) or a CD4+ cell count <200 cells/mm³ (17%). Bachelard and colleagues reported that 110/112 (98%) patients initiated therapy on the same day as enrolling in the trial, with the other 2 initiating therapy after 1 day.
Results of the Week 24 FDA snapshot analysis showed that >80% of patients were virally suppressed. Among the 19% of patients with high baseline HIV-1 RNA, approximately 62% had viral suppression. Of importance, there were no cases of treatment-emergent resistance among the patients who were not virally suppressed.
These data are consistent with the results of the STAT rapid-start pilot study presented by Rolle and colleagues at IDWeek 2021 evaluating the safety and efficacy of fixed-dose dolutegravir (DTG)/lamivudine (3TC) in 131 treatment-naive adults with HIV within 14 days of HIV diagnosis. In the Week 48 FDA snapshot analysis in the intention-to-treat population, approximately 76% were virally suppressed on DTG/3TC. Among the 11 patients with the most advanced disease,10 were virally suppressed at Week 48. The study design also incorporated an ART switch from DTG/FTC to an appropriate 3-drug regimen in the 7/131 patients found to have baseline hepatitis B virus (HBV) coinfection; none with available genotyping developed treatment-emergent HBV resistance.
Implications for PWH in Latin America
Strategies for rapid initiation of ART are recommended by US Department of Health and Human Services, International Antiviral Society-USA, European AIDS Clinical Society, and WHO guidelines. Despite this, test-and-treat strategies are not widely used in my home country of Mexico. However, these new data supporting the use of BIC/FTC/TAF for same-day ART initiation are timely because BIC/FTC/TAF is commonly offered as first-line ART in Mexico, with a majority of our ART-naive PWH initiating ART with this single-tablet regimen. Furthermore, initiating ART with BIC/FTC/TAF eliminates the need to switch to a regimen that includes 2 drugs with activity against HBV, which can be important in patients subsequently found to have HBV coinfection.
In Mexico, as in other countries in Latin America, late diagnosis remains an important problem, and a high percentage of our PWH have advanced disease at diagnosis. For example, during the first 3 months of 2021, 44.5% of recently diagnosed PWH had CD4+ cell counts <200 cells/mm3. In this context, the IMEA 055 FAST data showing >60% efficacy in PWH with high HIV-1 RNA and low CD4+ cell counts are encouraging.
The Joint United Nations Programme on HIV/AIDS (UNAIDS) has previously set 2020 treatment targets known as “90-90-90” to help end the HIV epidemic: 90% of people living with HIV know their status, 90% of people diagnosed with HIV receive sustained ART, and 90% of PWH receiving ART have viral suppression. In Latin America, much progress has been made along the continuum of HIV care in the past 2 decades. The UNAIDS 2019 report suggested that the biggest remaining gap in Mexico is to reach the first target (approximately 32,900 PWH remained unaware of their diagnosis as of December 2018). Coupled with measures to expand testing, test-and-treat strategies that have been demonstrated to be safe and effective will help us progress toward achieving all 3 of the 90-90-90 targets by improving the linkage to care, retention in care, and the percentage of patients who are virologically suppressed.
Will the results of these studies influence your use of rapid-start ART in your practice? For more details on this and other key HIV issues from EACS 2021, review more CCO Conference Coverage, including Capsule Summary slidesets, video recaps with expert faculty, and other ClinicalThought commentaries highlighting US and global perspectives.