The Food and Drug Administration has approved a groundbreaking drug therapy that reduces the risk of reducing HIV by 96%.
Gilead’s Yeztugo, generic name Lenacapavir (LEN), was approved in September after discovering that a highly successful trial almost eliminated spreading of the virus between patients and showed a relative risk reduction of 96% against BHIV.
The drug is intended to be administered every six months as an injection by a medical professional at the clinic. It is currently priced at $14,109 per injection or $2,352 per month. NBC Newsmakes it unclear whether insurance covers it.
Mitchell Warren, executive director of AVAC, said: statement. “However, US FDA approval is just one of the necessary sequence of steps to ensure that injectable LEN helps reduce the 1.3 million new HIV infections that occur each year.”
“Len For Prep is poised to reshape the HIV response, but only if today’s approval involves a bold, strategic, effective and fair development that reaches the population that needs access,” Warren continued. “Otherwise, the world risks wasting this preparation opportunity, as there are too many other preparation options over the last 12 years.”
The trial of renacapavir, known as objective 1 and objective 2, examined the frequency with which patients infected HIV without using PREP. Objective 1 took place in June to measure the effectiveness of lenacapavir in cisgender women in sub-Saharan Africa.
Objective 2 included cisgender and trans women, and the United States engaged in sexual relations with partners who assigned men at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States. In the Renacapavil Examination Group, there were only two cases of 9 HIV in the Truvada group.
Ian L. Haddock, founder and executive director of the Normal Abnormal Initiative, took part in Objective 2 as a trial subject. He said in a statement that he was “honored to be part of this journey and is even more excited to help our community navigate what’s coming next.”
“Being part of the Objective 2 exam was more than my own health. It was to open the door for others like me,” Haddock said. “In areas where stigma and systemic health inequality are far too often restricting access to care, this injectable preparation could change the way people protect themselves and regain institutions rather than sexual health.”
This story Additional information has been updated.
Source: Advocate.com – www.advocate.com
