US - FDA approves Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents for pre-exposure HIV prophylaxis

In Trial 2, 3,224 cisgender women received either Apretude or Truvada. The trial measured the rate of HIV infections in participants who took oral cabotegravir and injections of Apretude compared to those who took Truvada orally. The trial showed participants who took Apretude had 90% less risk of getting infected with HIV when compared to participants who took Truvada.

Side effects occurring more frequently in participants who received Apretude compared to participants who received Truvada in either trial include injection site reactions, headache, pyrexia (fever), fatigue, back pain, myalgia and rash.

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.

Apretude was granted a Priority Review and Breakthrough Therapy designation.

Apretude has been approved by FDA (US market).