Zero Cases of HIV Acquisition Seen for Apretude, Cabenuva Treatment
Additional data shows that an investigational drug, given every 4 months with Apretude, kept viral levels suppressed for patients who were already on stable treatment.
There were zero cases of HIV acquisition for cabotegravir long-acting (CAB LA; Apretude) as pre-exposure prophylaxis (PrEP), according to data presented at the Conference on Retroviruses and Opportunistic Infection (CROI) in San Francisco, California. Further, ViiV Healthcare also presented real-world data on cabotegravir plus rilpivirine long-acting (CAB+RPV LA; Cabenuva).1
Additional data shows that an investigational drug, given every 4 months with Apretude, kept viral levels suppressed for patients who were already on stable treatment. Image Credit: artegorov3@gmail | stock.adobe.com
“Our ongoing, real-world and implementation studies for Apretude show effectiveness of HIV prevention of more than 99% in nearly 4,000 people, and we have real-world experience in more than 15,000 people receiving Cabenuva for HIV treatment showing continued high effectiveness up to 2 years,” Harmony P. Garges, MD, MPH, chief medical officer at ViiV Healthcare, said in the news release.1 “Our data at CROI 2025 reinforce that, across a broad range of settings and populations, our long-acting injectables provide a highly effective option for both HIV treatment and prevention, that remove the need for daily pills.”
For CAB LA, the 12-month data (NCT05374525) show no cases were observed through 1 year, and persistence was high for 85% of individuals at 6 months and 72% at 12 months. Adverse events (AEs) were uncommon, according to the data, with the most frequently reported being injection site pain at 3%. Five of 201 individuals discontinued treatment due to AEs, mainly injection site pain. Additionally, in another study, CAB LA improved PrEP coverage and HIV prevention, with 0 cases of HIV reported over 798.4 person-years. There were 8 HIV acquisition over 408.52 person years in the oral PrEP comparison group, according to the data.1
For CAB + RPV LA, the first OPERA analysis showed that for patients switching to the drug, 95% maintained virological suppression at a median follow-up time of 11 and 1% experienced confirmed virological failure after 7 months. In the second analysis, at a median of 12 months, 94% of patients maintained suppression and confirmed virological failure was 1.3% or less. As for the Trio Health cohort, approximately 91% of individuals on CAB + RPV LA had viral suppression, and 1.6% had confirmed virological failure at a median follow-up of 12 months.1
In addition to the established regimens from the company, additional data from the EMBRACE phase 2b study were presented at the conference. These data showed that N6LS (VH3810109 or VH109), given every 4 months with CAB LA, kept viral levels suppressed for patients with HIV who were already on stable treatment.2
“The EMBRACE study demonstrated that VH109, a CD4-binding broadly neutralizing antibody, administered every four months with cabotegravir, achieved high efficacy and was well tolerated through 6 months,” Kimberly Smith, MD, MPH, head of research and development at ViiV Healthcare, said in a news release.2 We’re looking forward to continuing the development of VH109 as a component of our future ultra long-acting regimens.”
At 6 months, 96% of patients receiving the investigational intravenous drug and 88% receiving the subcutaneous drug maintained HIV RNA levels below 50 copies/mL compared with 96% in the standard of care group. From each investigational group, 2 participants had confirmed virological failure.2 Approximately 4% in the intravenous group and 6% in the subcutaneous group had RNA levels above 50 copies/mL compared to none in the standard of care group.2
The company will continue to study the intravenous formulation at 6 months in the second part of the EMBRACE study.2
