GSK's HIV prevention drug Approved by FDA

 The US Food and Drug Administration(FDA) has approved GlaxoSmithKline’s HIV prevention injectable drug called Apretude. This is the first of its kind as before now drugs comparable to this were all oral tablets.

The Hill reports that the drug, called will be available to at-risk adults and adolescents who weigh at least 77 pounds and have tested negative for HIV immediately beforehand.

The agency’s endorsement opens up the alternative for patients to receive the injectable drug instead of daily HIV prevention oral medication, such as Truvada. Apretude instead requires two initiation injections, one month apart, and then shots every two months.

The Hill further reports that two trials conducted across 13 countries determined that Apretude was more effective at preventing HIV infection than Truvada. Among more than 4,500 cisgender men and transgender women who have sex with men, participants who took the injectable medicine after the oral drug cabotegravir were 69 percent less at risk to getting infected with HIV. 

“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” said Debra Birnkrant, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. 

According to FDA, Apretude includes a boxed warning to not use the drug unless a negative HIV test is confirmed. It must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing drug resistance. Drug-resistant HIV variants have been identified in people with undiagnosed HIV when they use Apretude for HIV PrEeP. Individuals who become infected with HIV while receiving Apretude for PrEP must transition to a complete HIV treatment regimen. The drug labeling also includes warnings and precautions regarding hypersensitivity reactions, hepatotoxicity (liver damage) and depressive disorders.

FDA concludes that drug given every two months rather than daily pill is an important tool in the effort to end the HIV epidemic. 

Apretude, a new drug approved by the FDA as significantly more effective at reducing the risk of sexually-acquired HIV.
Credit: ViiV Healthcare and NPR





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