ViiV Healthcare has reported positive data from two Phase III clinical trials studying cabotegravir and rilpivirine in adults living with human immunodeficiency virus type-1 (HIV-1).
Both FLAIR and ATLAS trials met the primary endpoint of non-inferiority in maintaining viral suppression, compared to a standard of care, daily, oral three-drug regimen.
The comprehensive 48-week data offers hope for an alternative to the daily tablets intake.
Cabotegravir is an investigational integrase inhibitor (INI) being developed by ViiV Healthcare, while rilpivirine is Janssen’s once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI).
The combination of these medicines is being investigated for its long-acting effect.
ViiV Healthcare chief scientific and medical officer John Pottage said: “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 open-label, active-controlled, multi-centre, parallel-group ATLAS trial is being conducted to evaluate the antiviral activity and safety of the two-drug regimen in 616 patients with HIV.
It is being conducted at sites in 13 countries, including Australia, Canada, Mexico, South Korea, and the US.
Every four-week dosing regimen of cabotegravir plus rilpivirine was compared to a continuation of current oral anti-retroviral therapy (ART) of three drugs among virally suppressed individuals.
FLAIR is a randomised, open-label, multi-centre, parallel-group study with 566 participants in 11 countries, including Japan, Russia, South Africa, the Netherlands, and the UK.
This trial is assessing the two-drug regimen in virologically suppressed patients after 20 weeks of induction therapy with Triumeq.
Treatment with cabotegravir and rilpivirine was observed to be generally well-tolerated in both trials, with low rates of withdrawals due to serious adverse events (SAEs) and adverse events (AE).
Data from the trials has been presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, Washington, US.