Long-Acting HIV Drug Outperforms Daily Pills for Non-Adherent Patients

ViiV Healthcare, a biotech firm with majority ownership by GSK, has announced interim results from the Phase III LATITUDE trial, which show that its HIV drug Cabenuva is more effective than daily oral medication for patients who struggle with adherence to their medication schedules. The trial compared the long-acting injectable drug, which contains cabotegravir and rilpivirine, to daily oral antiretroviral therapy. Although specific data was not disclosed, the Data Safety Monitoring Board (DSMB) found that the injectable treatment demonstrated superior efficacy.

The LATITUDE study, which is sponsored by the National Institute of Allergy and Infectious Diseases, is a randomized, open-label trial involving 350 HIV-positive individuals with a history of poor adherence to treatment and evidence of viremia. Participants were initially treated with a three-drug oral regimen until their viral load was suppressed, after which they were randomly assigned to receive either Cabenuva or continue with daily oral therapy. The primary outcome of the study is to measure regimen failure, with secondary endpoints focusing on virologic and treatment-related failures.

Cabenuva, a product of GSK and ViiV, combines cabotegavir, an integrase strand transfer inhibitor, and rilpivirine, a non-nucleoside reverse transcriptase inhibitor. Cabotegavir inhibits HIV DNA replication, while rilpivirine prevents the virus from multiplying. The drug was first approved by the FDA in January 2021 and later had its dosing frequency reduced to once every two months, with an optional oral lead-in period.

In February 2023, positive 12-month data from the Phase IIIb SOLAR study were revealed, showing that Cabenuva was non-inferior to Gilead's Biktarvy in treating HIV-1 and was preferred by 90% of participants who switched from daily oral treatment.

The ongoing LATITUDE trial is taking place at 31 sites across the U.S. and is supported by the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, a global clinical trials network funded by the National Institutes of Health, as well as by ViiV and J&J’s Janssen.