FDA approves breakthrough monthly injections to treat HIV

The U.S. Food and Drug Administration on Thursday approved a breakthrough drug combination expected to allow certain people living with HIV to receive two monthly injections – rather than three pills per day – to treat the virus that causes AIDS.

Nine in 10 people in a trial of the treatment, called Cabenuva, said they preferred the monthly injections to taking daily pills, The New York Times reported.

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“You get your shot and forget about it till the next month. That’s great and will help people who don’t want the reminder of stigma or taking pills every day,” Dr. Tom Giordano, chief of infectious diseases at Baylor College of Medicine in Houston, told the Times.

Giordano was not involved with the drug trial.

Specifically, the FDA approved Cabenuva for use in adults who have had their disease well controlled by conventional HIV medicines and who have not shown signs of viral resistance to the two drugs in Cabenuva, The Associated Press reported.

Meanwhile, a version of the drug combination has shown effectiveness at preventing HIV infections when taken as a daily pill, but Thursday’s approval applies only to Cabenuva’s use as monthly injections, the Times reported.

According to the AP, Cabenuva combines rilpivirine, sold as Edurant by Johnson & Johnson’s Janssen unit, and a new drug — cabotegravir, from ViiV Healthcare. The drugs are packaged together but administered in separate shots once per month.

Officials with ViiV stated that the shot combo would cost $5,940 for an initial, higher dose and $3,960 per month afterward, noting those projections are “within the range” of what one-a-day pill combos cost now, the AP reported.

The FDA also approved use of the drug Vocabria to be taken in combination with the oral rilpivirine for one month prior to starting treatment with Cabenuva to “ensure the medications are well-tolerated before switching to the extended-release injectable formulation,” the agency stated in a news release.

Read more here and here.

- The Associated Press contributed to this report.

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