Simplifying treatment regimens for people living with HIV may improve patients’ adherence and quality of life, according to three studies presented at CROI 2024, held in Denver.
“Reducing the pill burden for many of our aging HIV patients who are already on other medications for other chronic conditions is of paramount importance,” said Karam Mounzer, MD, the chief scientific officer for Philadelphia FIGHT Community Health Centers.
One study conducted in Kenya evaluated the efficacy of switching older adults from their first-line regimen to bictegravir-emtricitabine-tenofovir alafenamide (BIC/FTC/TAF; Biktarvy, Gilead) (poster 643). Older adults with HIV may have more comorbidities that make them more vulnerable to adverse events from antiretroviral therapy or affect the pharmacokinetics and pharmacodynamics of ART.
The researchers randomly selected participants on a 1:1 basis between February and May 2022 to either stay on their current regimen or switch to BIC/FTC/TAF. Patients had a median age of 64 years, and 95% were receiving dolutegravir-lamivudine plus tenofovir disoproxil fumarate (DTG/3TC+TDF).
“As part of assessing safety, we assessed the change in bone mineral density over 48 weeks,” said Loice Achieng Ombajo, MBChB, MMed, MSc, the lead author of the study, and an infectious disease specialist and senior lecturer at the University of Nairobi and Kenyatta National Hospital, in Kenya.
“The main difference between BIC/FTC/TAF and DTG/3TC+TDF being the TAF in BIC/FTC/TAF may be safer for the kidney and bone [than TDF].”
At a follow-up of 48 weeks, BIC/FTC/TAF was found to be noninferior to DTG/3TC+TDF in terms of efficacy, and was associated with an improvement in bone mineral density. Participants were followed up at 96 weeks, and Dr. Ombajo said the data are still being analyzed.
Protease Inhibitor to BIC/FTC/TAF
Another study assessed switching virally suppressed adults in Haiti from a second-line protease inhibitor (PI/r) regimen to BIC/FTC/TAF (poster 641). The primary end point was virologic outcomes 48 weeks after making the switch.
“The challenges HIV patients face in resource-limited settings are even more pronounced in Haiti due to the direct consequences of the current severe sociopolitical crisis,” said Samuel Pierre, MD, the lead author of the study and clinical research site coordinator at the Haitian Global Health Alliance. “All social and economic indicators have turned red, significantly impacting health determinants.”
The preliminary results showed that switching to BIC/FTC/TAF was noninferior to continuing the PI/r, which indicate that transitioning to newer regimens, even in resource-limited settings, is feasible. Researchers will continue to assess outcomes after week 48.
“Collaborative efforts among organizations, governments and healthcare providers are crucial to improving HIV care in resource-limited settings. Research like this contributes to evidence-based practices and informs policy decisions,” Dr. Pierre said.
ARTISTRY-1 Trial
Dr. Mounzer was the lead author of another study that described the results of ARTISTRY-1, a phase 2/3 trial comparing how the single-tablet combination regimen of BIC and lenacapavir (LEN; Sunlenca, Gilead) performed in higher and lower doses (poster 642). Patients switched to it from a multitablet regimen.
“Bictegravir is a second-generation integrase strand transfer inhibitor, with a high genetic barrier to resistance, and lenacapavir, a first-in-class capsid inhibitor, a very potent antiviral, as it blocks the life cycle of the virus at different stages,” he said.
Outcomes at a follow-up of 24 weeks showed that both regimens of BIC and LEN were highly effective in maintaining viral suppression, with similar safety profiles observed in the two treatment groups. The combination is now being evaluated in a phase 3 study.
“If the safety and efficacy of the STR [single-tablet regimen] (BIC/LEN) holds true in the phase 3 trials, it could become a game changer in treatment optimization and simplification for patients with HIV who are on complex regimens,” Dr. Mounzer said.
Dr. Mounzer reported relationships with Gilead Sciences, GSK, Janssen, Merck Sharpe & Dohme and ViiV Healthcare. Drs. Ombajo and Pierre reported no relevant financial disclosures.
This article is from the June 2024 print issue.