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HomeHIV/AIDSFDA approves monthly injectable Cabenuva to treat HIV

FDA approves monthly injectable Cabenuva to treat HIV

In a move that could transform HIV treatment, the US Food and Drug Administration has approved a monthly injectable medication, a regimen designed to rival pills that must be taken daily. Stat News reports that the newly approved medicine, Cabenuva, represents a significant advance in treating what continues to be a highly infectious disease. In 2018, for instance, there were approximately 36,400 newly infected patients living with HIV in the US, according to the US Centres for Disease Control and Prevention. About 1.7m people worldwide became newly infected in 2019, according to UNAIDS.

The report says although several medicines exist for treating HIV, ViiV Healthcare is banking on the improved convenience of getting a monthly shot, even if it must be administered by a health care provider. The company gathered data showing nine of 10 patients in pivotal studies claimed to prefer the shot over taking pills each day.

“This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” said John Farley, who heads the Office of Infectious Diseases in the FDA’s Centre for Drug Evaluation and Research. “Having this treatment available for some patients provides an alternative for managing this chronic condition.”

Two clinical studies of more than 1,100 patients from 16 countries found that Cabenuva was as effective in suppressing the virus as the daily, oral, three-drug regimens that were taken by patients throughout the 48-week study period. However, patients must first take an oral version of the injectable medicine and another pill for the first month before pivoting to monthly shots, according to the FDA.

The cost, however, is steep – the list, or wholesale, price is $3,960 a month, or more than $47,500 a year. The list price for the one-time initiation dose is $5,490. However, a ViiV spokesperson explained that a 30-day oral “lead-in,” which is required as part of the approval, will be made available at no charge to patients. She also maintained the list price for the monthly shot is “within the range” of HIV treatment pills on the market today.

“We see Cabenuva as the beginning of long-acting treatment for HIV,” said Kimberly Smith, who heads global research and medical strategy at ViiV. “We’re opening the door with Cabenuva and will only create more hunger for other long-acting therapies. It really becomes a sort of anchor.”

 

[link url="https://www.statnews.com/pharmalot/2021/01/21/fda-hiv-aids-injectable/"]Full State News report[/link]

 

[link url="https://www.fda.gov/news-events/press-announcements/fda-approves-first-extended-release-injectable-drug-regimen-adults-living-hiv"]FDA statement[/link]

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