U.S. Waits on Approval of Long-Acting HIV Treatment as European Union Gives the Green Light

From the TheBodyPro

The era of once-a-month HIV treatment has begun in the European Union—and it may soon commence in the U.S. as well. Long-acting pre-exposure prophylaxis (PrEP) is also on the horizon.

On Dec. 21, the European Commission authorized use of the long-acting injectable HIV treatment regimen of cabotegravir and rilpivirine (LA-CAB+RPV) for combination antiretroviral therapy in the European Union. These two drugs are the first long-acting injectable HIV treatments to enter clinical use. The authorization comes after the European Medicines Agency recommended authorization on Oct. 16.

Cabotegravir is an integrase strand transfer inhibitor (INSTI), and rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). The combination regimen is administered by intramuscular injection monthly or every two months. It is indicated for maintenance treatment of adults with HIV who meet the following criteria:

  • Undetectable viral load (HIV RNA less than 50 copies/mL) on current antiretroviral regimen.
  • Virus that has not exhibited NNRTI or INSTI resistance.
  • No history of virologic failure while on an NNRTI- or INSTI-containing regimen.

“I continue to be surprised by the level of enthusiasm by many of our patients for getting their medicines by monthly injection, or injections every two months,” said Susan Swindells, M.B.B.S., the lead investigator of the Antiretroviral Therapy as Long-Acting Suppression (ATLAS) study, which was pivotal in the drug regimen’s eventual approval in Europe. “Taking one pill once a day does not seem that difficult in theory, but for many patients it is a challenge—and, importantly, a daily reminder of the fact that they have HIV. Having this alternative to offer is a great benefit for interested patients.”

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