Monthly injections offer similar efficacy to daily pills in HIV phase 3 trials
pharmafile | March 8, 2019 | News story | Medical Communications | ATLAS, GSK, HIV, ViiV, flair, injectable
A long acting, injectable two drug regimen developed by Pfizer and GSK joint venture ViiV Healthcare and J&J subsidiary Jannsen, has similar efficacy to daily, three drug antiretroviral in adults living with HIV, according to data from two Phase 3 trials.
The two drug regimen – made up of Janssen’s rilpivirine and ViiV Healthcare’s experimental treatment cabotegravir – is injected every four weeks. The combo was found to be non-inferior to a standard of care three drug combo in the 48 week long FLAIR and ATLAS trials involving 566 men and women, and 616 men and women living with HIV.
Dr John C. Pottage, Jr., Chief Scientific and Medical Officer of ViiV Healthcare, said: “With FLAIR and ATLAS, we now have positive results from two pivotal phase III studies demonstrating that this long-acting, once-monthly injectable regimen has similar efficacy, safety and tolerability to a daily oral three-drug regimen for the treatment of HIV.”
“We are also encouraged by patient preference data showing that nearly all participants who switched to the long-acting injectable regimen preferred it over their prior oral therapy. If approved, this two-drug regimen would give people living with HIV one month between each dose of antiretroviral therapy, changing HIV treatment from 365 dosing days per year, to just 12. We look forward to submitting applications to regulatory authorities later this year.”
The results comes just a week after it was announced that a man who received a bone marrow transplant has become the second person in the world to be ‘cured‘ of HIV.
Dr Chloe Orkin, Consultant Physician and Clinical Professor at Queen Mary University of London and FLAIR principal investigator, said: “The robust results of the FLAIR study lend further evidence to the potential of cabotegravir and rilpivirine as an alternative option for people currently on daily, oral therapy. This long-acting, injectable two-drug regimen may provide an opportunity to change the paradigm for people living with HIV by breaking the cycle of a daily pill, which has been a defining characteristic of HIV therapy for several decades.”
Louis Goss
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