IA move that could change the treatment of HIV, the Food and Drug Administration has approved a monthly injectable medication, a regimen designed to compete against pills, which must be taken daily.
The newly approved medicine, called Cabenuva, represents a major advance in the treatment of an extremely contagious disease. In 2018, for example, there were approximately 36,400 HIV-positive patients living in the U.S., according to the Centers for Disease Control and Prevention. About 1.7 million people worldwide have just become infected in 2019, according to UNAIDS.
Although there are different medicines available for the treatment of HIV, ViiV Healthcare speaks of the improved convenience of getting a monthly chance, even if it has to be administered by a healthcare provider. The company, which is largely controlled by GlaxoSmithKline (GSK), has collected data showing that nine out of ten patients in core studies claim to prefer the shot over taking pills every day.
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“With this approval, some patients can receive injections once a month instead of a daily treatment for oral treatment,” said John Farley, who heads the Office of Infectious Diseases at the FDA’s Center for Drug Evaluation and research, said in a statement. “The treatment available to some patients is an alternative to dealing with this chronic condition.”
Two clinical studies of more than 1,100 patients from 1,600 countries found that Cabenuva was just as effective in suppressing the virus as the daily, oral three-drug regimen taken by patients during 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 turning to monthly shots, according to the FDA.
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However, the cost is steep – the price, or wholesale price, is $ 3,960 per month, or more than $ 47,500 per year. The list price for the single initiation dose is $ 5,490, although a ViiV spokesperson explained that it will be made available to patients free of charge. She also maintained that the list price for the monthly survey is ‘within the range’ of HIV treatment pills currently on the market.
There is also great competition from Gilead Sciences (GILD), which markets several HIV medicines. In 2019, the HIV treatment franchise generated $ 17.2 billion in revenue, an increase of 12.5% year-on-year, and gripped more than 80% of the market for patients starting HIV therapy, according to Cowen analyst Phil Nadeau. He expects sales of HIV drugs to reach $ 24.4 billion by 2025, but points to the prevention of HIV pills as their biggest drivers.
ViiV, meanwhile, develops injections every two months in the hope of gaining a larger market share. Last year in November, an interim analysis found that Cabenuva was 89% more effective in preventing infection among women than Truvada, a Gilead pill that should be taken daily and is the current standard of care. And a separate analysis released in July showed that shots fired 66% more uninfected people every other month compared to Truvada in men at risk and transgender women having sex with men.
“We see Cabenuva as the start of long-term HIV treatment,” said Kimberly Smith, who heads the global research and medical strategy at ViiV, which expects FDA approval in the coming weeks for this version of to get the survey. ‘We are opening the door with Cabenuva and will only create more hunger for other long-acting therapies. It really becomes a kind of anchor. ”