The world of HIV Prevention scored a major victory to end the year and it’s hard not to suspect that Santa Claus may have had a role in delivering this gift; well, maybe not Santa but the Food and Drug Administration (FDA) should get credit. Injectable Cabotegravir, a product named Apretude was approved for HIV prevention (Pre-Exposure Prophylaxis or PrEP) on December 20th. This makes it the third medication approved for HIV prevention in the US and it is likely to provide the best protection so far.
Two drugs were previously approved for PrEP in the US: Truvada is a combination pill containing Tenofovir and Emtricitabine (FTC). It is available even in low-income countries. It is highly effective at preventing HIV transmission when taken as prescribed, which is usually every day. In some circumstances, it may be dosed around the time of a sex act (on-demand PrEP).
Descovy is a combination product similar to Truvada, but it has a form of Tenofovir (Tenofovir alafenamide) that reaches higher levels in the tissues than tenofovir. It may be slightly more effective than Truvada. It is currently only approved for use in men. Truvada can be used in anyone.
Again, both Truvada and Descovy must be taken as prescribed to be effective. This is where injectable Cabotegravir for PrEP may offer advantages. Considering that medication adherence is the biggest challenge in controlling HIV disease, with Truvada and Descovy, we are asking people to take medicine every day who don’t have any disease. They are taking medicines to prevent HIV infection. Injectable cabotegravir requires an injection in the buttocks every two months.
Cabotegravir is a drug in the integrase inhibitor class, the most potent HIV drugs in use. Injectable cabotegravir was approved for HIV treatment earlier this year, in combination with injectable rilpivirine, a product called Cabanuva (see “The future is now! The first long-acting treatment for HIV has been approved” April 4, 2021 in the HIV/AIDS section).
In an article posted on November 20, 2020, I reported on the results of a large clinical trial that compared the effects of Truvada and injectable cabotegravir in preventing HIV infection in young African women, a group at high risk for HIV infection (”Breaking News: Long-acting drug prevents women from HIV-infection”).
While the Truvada reduced the risk of HIV infection by an impressive degree, the cabotegravir reduced risk even more, and demonstrated high levels of safety and acceptability.
Using a product that was injected every two months significantly reduced the stigma around taking HIV medicines for protection from HIV.
Study participants didn’t have to worry about missing a dose now and then (however, they do have to receive their injections on time). The treatment was demonstrated to be effective in protecting men before the success in women was shown.
People in the US now have a powerful tool for protecting themselves from HIV infection through sex or intravenous drug use (sharing needles). It is hoped that this product will also be available to help in the fight against AIDS in developing countries with limited resources.
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