Shots:

• The approval is based on the P-IIb/III (HPTN 083/084) trial to evaluate cabotegravir (q8w) vs FTC/TDF (200/300 mg) in 7,700+ patients who were at high risk of sexually acquiring HIV including HIV-negative men who have sex with men, transgender women & cisgender women across 13 countries
• The results demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF) in reducing the risk of HIV. In (HPTN 083 & HPTN 084) trial, participants who received cabotegravir experienced a lower incidence of HIV compared to FTC/TDF (69% & 90%)
• Apretude is expected to be available in early 2022 in the US. The company has initiated the submissions to other regulatory authorities

Ref: GSK | Image: ViiV Healthcare