The USA's FDA (Food and Drug Administration) has approved the first long-acting HIV preventative medication. ViiV Healthcare developed the drug, which is long-acting cabotegravir injected once every two months. The FDA has approved the medication for adults and adolescents weighing at least 35 kilos who are at risk of contracting HIV sexually.
The development is a massive milestone in advancing biomedical HIV prevention treatments available to people in America. It would be an enormous contribution to HIV Drugs Market as it would provide patients with an alternative way of combating the disease than other medications available before.
The approval was primarily based on data accumulated from two clinical trials supported by NIH, namely HPTN 084 and HPTN 083. The trials aimed to analyse the effectiveness and safety of a PrEP regimen. It consisted of a regimen of daily oral PrEP and long-acting injectable cabotegravir.
The trial (HPTN 083) undertook the participation of around 4,500 cisgender men with a sexual preference towards men. Further, it also included transgender women with a history of sexual intercourse with men originating from South Africa, Argentina, the United States, Brazil, Thailand, Peru and Vietnam.
The other trial ( HPTN 084) enrolled around 3,200 cisgender women. They were found from all over, including Malawi, Botswana, Eswatini, Uganda, South Africa, and Zimbabwe. The trials helped the team discover that HIV prevention methods were highly effective and secure. However, injectable cabotegravir was more effective than regular oral PrEP at preventing HIV acquisition.
NIAID sponsored both trials. They were conducted by the NIH-funded HPTN (HIV Prevention Trials Network). The research and subsequent approval are highly relevant for the United States and the world. It will help lay foundational ground in studying immune-mediated and infectious diseases cases. Moreover, it would allow the development of better ways, catering towards prevention, diagnosis and treatment of numerous illnesses.