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November 26, 2025
3 min read
Key takeaways:
- Many real-world patients added lenacapavir while already suppressed.
- More than half of patients simplified treatment over the course of the study.
ATLANTA — Adding lenacapavir to HIV treatment effectively simplified complicated regimens while lowering or maintaining virological suppression, according to a presentation at IDWeek.
In the study, presenter Karam Mounzer, MD, chief scientific officer and medical director at Philadelphia FIGHT Community Health Centers, and colleagues looked at adults from the OPERA longitudinal cohort who had HIV and were ART-experienced and received at least one set of lenacapavir (LEN; Sunlenca, Gilead Sciences) injections between Dec. 22, 2022, and Sept. 30, 2024.
“LEN, combined with ART in the real world, is an effective modality of treatment,” Mounzer told Healio. “In this study, 92% of patients remained suppressed, and out of those who were viremic, 76% suppressed their viremia”
“A good percentage of patients started their LEN-based regimen at a time point they were suppressed,” he continued. “However, we learned that the majority underwent treatment simplification at the time LEN was initiated or later on.”
The study included 116 adults (median age, 54 years; 22% women; 49% Black).
Although LEN received approval for treatment of HIV in heavily treatment-experienced adults, this approval was based on efficacy evidence from just 72 participants meeting these criteria in the CAPELLA trial. Mounzer said there is limited real-world evidence currently available.
At the start of the study and prior to starting LEN, 77% of patients were on a complex ART regimen with two or more core agents. Additionally, at baseline, 64% of patients were already suppressed.
“No question, that was a very surprising finding for us,” Mounzer said. “We did not know exactly what is the specific reason driving the clinicians and their patients to starting LEN. In other words, we didn’t know if … they were not tolerating one or more of their other pills, or there is potential of drug-drug interaction between some of their medication or new medication that the providers were going to start, or they were complaining about the pill burden.”
At first injection of LEN, Mounzer showed that 22% (n = 25) of patients saw a simplification of their regimen at initiation while 61% (n = 71) saw no change. After LEN initiation, 38% of patients saw a simplification and 52% saw no change, marking an overall simplification rate of 56% over the course of the study.
“What we know is that 56% of our patients who started LEN underwent a treatment simplification of their background regimen, which led us to believe … LEN was used for the purpose of simplifying their background regimen, make it simpler, more convenient,” Mounzer told Healio. “Simplicity, when it comes to HIV, equals adherence to a great extent.”
Of those already virologically suppressed at the start of LEN, the 12-month cumulative probability of maintaining this viral load in this study was 92% (95% CI, 80%-96%).
Among those with a viral load at 200 copies/mL or higher, 76% (95% CI, 62%-88%) had 12-month cumulative probability of achieving virologic suppression, Mounzer showed.
“It was very reassuring to see,” Mounzer told Healio.
Among the sets of maintenance injections (n = 144), the researchers reported 86% were on time between 24 and 28 weeks after the prior set; 3% were early prior to 24 weeks; and 11% were late, given after 28 weeks. Mounzer noted that 81% had no documented prescription for oral LEN dosing.
Overall, 91% of users remained on LEN through the end of this study and Mounzer said adherence to the twice-yearly injection schedule was “very good and while there were some delayed injections, most delays were relatively short … with a median delay of 11 days, the LEN concentration was likely to be above the IQ4 threshold for at least 50% of late injections.”
“There’s no question that tolerability of that underlying treatment, drug-drug interaction, and resistance to some of their meds may have played a role in the decision-making of the providers, but simplification is a very … important reason to change someone’s treatment,” Mounzer told Healio. “Anytime I see a patient at any visit, whether they’re suppressed or not, I always take a step back and ask myself, are they on the best regimen they can be on, or can I do better? Can I optimize for whatever reason? Is it to improve the safety profile of their regimen, to reduce some toxicities, to… enhance the forgiveness of the regimen, if they are struggling a little bit with adherence.
“In this case, when you give a drug, and it’s an injection, you’re securing drug delivery in their system. If they miss oral doses, there’s always that protection from that drug that you’ve injected that’s keep them under check in a way. So, you’re enhancing the forgiveness of a regimen as a whole by giving an injectable drug,” Mounzer said.
For more information:
Karam Mounzer, MD, can be reached at infectiousdisease@healio.com.
Sources/Disclosures
Source:
Mounzer K, et al. Abstract 390. Presented at: IDWeek; Oct. 19-22, 2025; Atlanta.
Disclosures:
Mounzer reports having financial relationships with Epividian, Gilead Sciences, GSK/ViiV Healthcare and Merck.
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