GSK’s long-acting HIV regimen Cabenuva has already shown it works as well as daily oral therapies in patients who have the virus under control. Now, the injection has beaten daily drugs in individuals who’ve faced issues adhering to their medications.
An independent data monitoring panel reached that conclusion in the middle of the phase 3 LATITUDE study, which is sponsored by the National Institute of Allergy and Infectious Diseases, ViiV said Wednesday.
The trial monitoring board considered the totality of all the study endpoints together and concluded that data accrued so far incidated that Cabenuva, given once every four weeks, is superior to daily oral drugs in these patients, according to ViiV. The study will therefore stop randomizing patients and will give all patients the option to take Cabenuva.
Adherence is key in ensuring success with HIV treatment. Patients who don’t take their antiretrovirals regularly may have difficulty maintaining undetectable viral loads, or worse, develop resistance to treatments.
But strict adherence to daily regimens can be challenging for a range of reasons, including access to care, financial instability and stigma with the act of taking pills. That’s why researchers figured long-acting formulations may benefit patients by alleviating some adherence burdens.
The LATITUDE trial has now showed that Cabenuva is better than daily pills at helping patients with adherence challenges keep their virus suppressed, which benefits their overall health, ViiV’s head of R&D, Kimberly Smith, M.D., said in a statement.
There’s one limitation with the study. Cabenuva is currently only approved for patients who are already virally suppressed. And patients enrolled in LATITUDE initially underwent “comprehensive and incentivized adherence support” to achieve viral suppression under traditional oral drugs before being randomized to get either Cabenuva or continue with their daily meds. The trial therefore doesn’t reflect a potential scenario where a patient with adherence challenges—and an unmanaged viral load—would seek to switch to Cabenuva.
Given Cabenuva is already cleared to treat all virally suppressed patients, GSK won’t need to apply for a separate indication based on LATITUTE. Nevertheless, as Smith pointed out, beating daily drugs is “a remarkable outcome.”
Meanwhile, GSK continues to make commercial progress with Cabenuva, which is also allowed to be administered once every two months. In the fourth quarter of 2023, GSK recorded 223 pounds ($282 million) in Cabenuva sales, an increase of 73% year over year. Based on Cabenuva’s strong performance, GSK in September increased its HIV sales projection to 7 billion pounds by 2026, compared with prior estimate of 6.4 billion pounds.
The British pharma is also working on formulations featuring even longer treatment durations. The company plans to select a once-every-four-month regimen to advance this year, with a long-term goal to introduce a twice-yearly regimen by 2030.
GSK's rival Gilead Sciences also aims to launch a six-month dosing regimen involving its Sunlenca, or lenacapavir, after 2025.