ViiV Healthcare today announced positive headline results from its global, Phase III FLAIR (First Long-Acting Injectable Regimen) study of a long-acting, injectable two-drug regimen for the treatment of HIV.
The study showed long-acting cabotegravir and rilpivirine, injected once a month, had similar efficacy to Triumeq at Week 48 based on the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre using the FDA Snapshot algorithm.
John C. Pottage, Jr., MD, Chief Scientific and Medical Officer of ViiV Healthcare, said: “The data provide further evidence that a long-acting, injectable 2DR of cabotegravir and rilpivirine may offer an alternative to daily, oral therapy for people who have previously achieved viral suppression. This innovative dosing regimen could transform HIV therapy by reducing the number of days a person receives treatment from 365 to 12. Work on new methods of HIV treatment, including long-acting injectable therapies, supports our goal of making HIV a smaller part of the lives of people living with HIV”.
Detailed results from the study will be presented at an upcoming scientific meeting.
Cabotegravir is an investigational integrase inhibitor (INI) and is not approved by regulatory authorities anywhere in the world. Cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV and is currently being evaluated as a long-acting formulation for intramuscular injection and also as a once-daily oral tablet for short-term use and oral bridging, to establish the tolerability of cabotegravir prior to long-acting injection.
Edurant® (rilpivirine) is a once daily non-nucleoside reverse transcriptase inhibitor (NNRTI) used for the treatment of human immunodeficiency virus (HIV-1) infection in combination with other antiretroviral agents in antiretroviral treatment-naïve adult patients with a viral load ≤ 100,000 HIV RNA copies/mL. Long-acting rilpivirine is not approved by regulatory authorities anywhere in the world.