ViiV’s long-acting HIV drug Cabenuva gets FDA approval
The FDA has approved ViiV’s Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults, for use in the US.
Cabenuva is provided as a co-pack with two injectable medicines — ViiV’s cabotegravir and Janssen’s rilpivirine — dosed once monthly, as an option to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.
The treatment’s approval is based on the pivotal Phase III ATLAS and FLAIR studies that included more than 1,100 patients from 16 countries. Before beginning treatment with Cabenuva, oral dosing of cabotegravir and rilpivirine was administered for approximately one month to assess the tolerability of each therapy. In these studies, Cabenuva was as effective in maintaining viral suppression as continuing a daily oral three-drug regimen when injected intramuscularly in the buttocks once a month throughout the 48-week study period.
Patient preference data collected from trial participants revealed that the drug was preferred by nine out of 10 patients over their previous daily oral therapy in these pivotal studies.
To support the successful delivery of the once-monthly regimen to people living with HIV (PLHIV), ViiV sponsored the CUSTOMIZE trial, the first-ever, pre-approval implementation science study to identify and evaluate approaches to integrate Cabenuva into clinical practices in the US. Interim findings presented at AIDS2020 demonstrated that at four months, the majority of clinical staff participants continued to perceive the implementation of the drug as highly acceptable, feasible and appropriate for PLHIV, and clinical staff had a substantial decrease in what they thought would be barriers to implementation of the injectable regimen.
Dr David Wohl, Professor of Medicine at the University of North Carolina Institute of Global Health and Infectious Diseases in Chapel Hill, said: “Among the scientific community, we recognise the innovation behind Cabenuva is truly meaningful. Not only is it the first, complete long-acting regimen, which allows for a dramatic reduction in the frequency of dosing, but it also was preferred by most clinical trial participants when compared to their prior daily oral regimens.
“The FDA approval of Cabenuva underscores the value of community-centric research and I am pleased this new option will be available for those living with HIV.”
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