GlaxoSmithKline (GSK.L) announced its ViiV Healthcare arm has received approval from the US Food and Drug Administration (FDA) for Cabenuva, the world’s first and only complete long-acting HIV-1 treatment.
The injectable HIV treatment regimen — which is administered once a month — does not require daily pills.
It consists of a co-pack of an extended-release formulation of the integrase inhibitor cabotegravir plus an injectable version of Janssen’s non-nucleoside reverse transcriptase inhibitor rilpivirine.
The company said that Cabenuva “reduces the treatment dosing days from 365 days to 12 days per year.”
Cabenuva is approved for people with an undetectable viral load on their current therapy, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine and who want to switch to a long-acting regimen.
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Lynn Baxter, Head of North America, ViiV Healthcare, said: “Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care.
The specialist HIV company will begin shipping Cabenuva to wholesalers and specialty distributors in the US in February.
The FTSE 100 (^FTSE) company said that Cabenuva was preferred by nine out of 10 patients over their previous daily oral therapy in their Phase III clinical trials study.
It’s study enrolled more than 600 HIV-positive people with a fully suppressed viral load and no history of virological treatment failure. The participants were randomly assigned to either stay on their current oral regimen or switch to Cabenuva injections after an oral lead-in.
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The findings showed that both groups were about equally likely to maintain viral suppression (93% and 96%, respectively), after 48 weeks.
Those who want to switch their regimen will take Vocabria and Edurant pills for a month to ensure that the combination is well tolerated.
After that, they will receive two injections in the buttocks administered by a health care provider on a monthly basis. Edurant and Vocabria pills can also be used as a complete short-term regimen, for example, if someone misses their monthly Cabenuva injection.
"Among the scientific community, we recognise the innovation behind Cabenuva is truly meaningful,” said Dr David Wohl, professor of medicine at the University of North Carolina Institute of Global Health and Infectious Diseases in Chapel Hill.
He added: “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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