A new type of PrEP injection, requiring only three injections a year, could be on the way.
The FDA approved injections of cabotegravir in 2021 as a form of PrEP, to minimize the risk of acquiring HIV. Health providers give it every two months as an intramuscular injection in the buttocks.
Now, the drug’s makers, ViiV Healthcare, have posted the results of a trial into a strengthened form of the drug. If it passes further trials the company believes it would be suitable for injections every four months.
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The new form of the drug is called “cabotegravir ultra long-acting” (CAB-ULA).
ViiV presented its findings last week at the Conference on Retroviruses and Opportunistic Infections (CROI 2024) in Denver, Colorado.
The trial included 70 participants. Researchers tested injecting the new formulation of the drug. They tried three different strengths and tested it both as an intramuscular (muscle) injection and a subcutaneous injection.
Intramuscular injections are usually deeper and need to be administered by a health professional. Subcutaneous injections are into the fat just beneath the skin and can sometimes be self-administered at home.
Some of those in the trial received the regular cabotegravir plus another drug known as a rHuPH20. The latter allows for a bigger amount of cabotegravir to be injected at once.
However, although it proved effective protection from HIV (a desirable amount of the drug was measured in the blood afterward), many of the participants suffered side effects at the sight of the injection. According to aidsmap, eight had “severe reactions”, with one needing wound treatment.
However, the new CAB-ULA formulation was tolerated far better. Although most of those who received it had some redness at the sight of injection, the side effects were mild. The drug was absorbed more slowly and lasted far longer inside the body. Hence the four months between injections.
“Revolutionise how HIV is treated and prevented”
Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said in a statement, “The HIV community has told us of their desire for longer-acting medicines that can help alleviate the burden of daily treatment.
“ViiV Healthcare is a pioneer and leader in the development of long-acting HIV medicine, having already brought innovations through injectable therapies to the HIV community. This new formulation of cabotegravir (CAB-ULA) with a higher concentration and at least double the half-life puts us on the path toward delivering dosing at every four months for HIV treatment and PrEP.”
Besides PrEP, cabotegravir is also used for the treatment of HIV, in combination with the drug rilpivirine. At the moment, this can be administered as a once-a-month injection.
The new “ultra” cabotegravir will go forward to a larger clinical trial.
“We look forward to the further clinical development of this promising medicine,” said Dr Kelong Han, the study’s lead investigator. “As we look to the future, further advancements in longer acting medicines have the potential to revolutionise how HIV is treated and prevented.”
