US approves Gilead’s twice-yearly shot for HIV prevention
Lenacapavir was nearly 100 per cent effective in preventing HIV in clinical trials
The US Food and Drug Administration on Wednesday approved Gilead Sciences’ twice-yearly injection to prevent HIV - a move the company hailed as a major breakthrough in the fight against the sexually transmitted virus.
Drugs to prevent HIV transmission, known as pre-exposure prophylaxis or PrEP, have existed for more than a decade. But because they typically require taking a daily pill, they have yet to make a significant dent in global infections.
“This is a historic day in the decades-long fight against HIV,” Gilead chairman and chief executive Daniel O’Day said in a statement.
Lenacapavir, marketed under the brand name Yeztugo, has been shown to reduce the risk of HIV transmission by more than 99.9 per cent in adults and adolescents - making it functionally akin to a powerful vaccine.
The company conducted two large clinical trials. The first, involving more than 2,000 women in sub-Saharan Africa, resulted in a 100 per cent reduction in infections and demonstrated superiority over the daily oral pill Truvada.