FDA Approves World’s First and Only Long-Acting HIV Therapy

GSK said Cabenuva “reduces processing days from 365 days to 12 days per year”. Photo: Getty

GlaxoSmithKline (GSK.L) announced that its ViiV Healthcare branch has received U.S. Food and Drug Administration (FDA) approval for Cabenuva, the first and only comprehensive long-lasting HIV-1 treatment in action to the world.

The HIV injectable treatment regimen – which is given once a month – does not require daily pills.

It consists of a co-pack of a sustained-release formulation of the integrase inhibitor cabotegravir and an injectable version of rilpivirine, a non-nucleoside reverse transcriptase inhibitor from Janssen.

The company said Cabenuva “reduces processing days from 365 days to 12 days per year.”

Cabenuva is approved for people with an undetectable viral load on their current treatment, no history of treatment failure, and no known or suspected resistance to cabotegravir or rilpivirine and who wish to switch to a long-acting regimen.

GSK shares were up 0.01% to 1.36, Pfizer was trading down 0.05% and Shionogi fell 1.43% around 9 a.m. in London.

Chart: Yahoo Finance

Chart: Yahoo Finance

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ViiV Healthcare, an HIV company majority-owned by GSK, also has pharmaceutical giants Pfizer (PFE) and Shionogi (SGIOF) as shareholders.

Lynn Baxter, North America Manager, ViiV Healthcare, said: “Today’s FDA approval of Cabenuva represents a change in the way HIV is treated, offering people living with HIV a whole new approach to HIV treatment. care.

The HIV company will begin shipping Cabenuva to specialized wholesalers and distributors in the United States in February.

FTSE 100 (^ FTSE) said Cabenuva was preferred by nine out of 10 patients over their previous daily oral regimen in their Phase III clinical trial study.

His study recruited more than 600 HIV-positive people with a completely suppressed viral load and no history of virologic treatment failure. Participants were randomly assigned to either remain on their current oral regimen or switch to Cabenuva injections after an oral introduction.

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The results showed that the two groups were roughly equally likely to maintain viral suppression (93% and 96% respectively) after 48 weeks.

Those who wish to change their diet will take the Vocabria and Edurant pills for a month to ensure that the combination is well tolerated.

After that, they will receive two injections into the buttocks administered by a health care provider on a monthly basis. Edurant and Vocabria pills can also be used as a short-term complete regimen, for example, if someone misses their monthly Cabenuva injection.

“Within the scientific community, we recognize that the innovation behind Cabenuva is truly significant,” said Dr. David Wohl, professor of medicine at the Institute of Global Health and Infectious Diseases at the University of Carolina. North to Chapel Hill.

He added: “Not only is it the first long-acting complete regimen that dramatically reduces the frequency of administration, it was also preferred by most clinical trial participants over their oral regimens. previous dailies. The FDA approval of Cabenuva underscores the value of community-based research and I am delighted that this new option is available to people living with HIV. “

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