By Ethan Covey
A novel combination of bictegravir (BIC; Biktarvy, Gilead) and lenacapavir (LEN, Sunlenca, Gilead) appears highly effective in maintaining viral suppression over 48 weeks among virologically suppressed people with HIV who were switched from a complex antiretroviral therapy (ART), according to findings presented during the “ART nouveau” session at AIDS 2024 (abstract OAB2602).
The study participants reported that the combination of BIC, an integrase strand transfer inhibitor, and LEN, a first-in-class capsid inhibitor, was also well tolerated.
“Once-daily, single-tablet regimens [STRs] are the global standard for HIV treatment,” said Sorana Segal-Maurer, MD, the director of The Dr. James J. Rahal Jr. Division of Infectious Diseases and the chair of the Infection Control Committee at NewYork-Presbyterian Queens, in New York City. “However, many persons with HIV take complex regimens for reasons including drug resistance, intolerance, toxicity, drug−drug interactions, or contraindications to existing STRs.”
The study aimed to determine whether an STR composed of BIC and LEN could optimize treatment in virologically suppressed people with HIV who are unable to take the available STRs.
The phase 2/3 ARTISTRY-1 study is investigating the safety and efficacy of switching to oral daily BIC 75 mg plus LEN 25 or 50 mg, compared with continuing on a complex ART regimen.
Preliminary 24-week outcome data, which were presented at CROI 2024, found that BIC plus LEN was both highly effective and safe among the study participants.
At AIDS 2024, Dr. Segal-Maurer, who is also a professor of clinical medicine at Weill Cornell College of Medicine, in New York City, presented long-term safety and efficacy data through 48 weeks of treatment.
The study included 128 adults 18 years of age and older, who were on a complex ART regimen. Of these, 51 participants were randomly assigned to receive BIC 75 mg plus LEN 25 mg, 52 received BIC 75 mg plus LEN 50 mg, and 25 continued on their existing regimen.
Rates of virologic suppression were high across all treatment groups, and changes in both CD4 cell counts and percentages were comparable. At 48 weeks, HIV-1 RNA of less than 50 copies/mL was achieved in 92.2% of participants in the BIC 75 mg plus LEN 25 mg arm, 90.4% in the BIC 75 mg plus LEN 50 mg arm, and all those continuing on their complex ART regimen.
The drug combination was also well tolerated, with few treatment-related adverse events (AEs) leading to premature treatment discontinuation. All AEs with a frequency of 5% or more were grade 1 or 2, except for one report of grade 3 diarrhea, which was unrelated to the study drug. No dose-dependent AEs were noted in the study.
“These findings support the continued evaluation of the combination of BIC and LEN to optimize treatment in virologically suppressed people with HIV who are receiving complex regimens,” Dr. Segal-Maurer said.
“This study laid the foundations for the development of the BIC−LEN single-tablet regimen,” Dr. Segal-Maurer added.
Dr. Segal-Maurer reported paid work on speakers bureaus from Gilead Sciences; participated on advisory boards and received consulting fees from Gilead Sciences, Janssen Therapeutics, Theratechnologies and ViiV Healthcare; received travel support from Gilead Sciences, Janssen Therapeutics and ViiV Healthcare; and will be employed by Gilead Sciencesin August 2024.
