The Food and Drug Administration recently approved a monthly injectable medication for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The medication is designed to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. According to STAT, the newly approved medicine, Cabenuva, represents a significant advance in treating HIV.
Based on a 2019 estimate by UNAIDS, over 4 million people currently live with HIV/AIDS in West and Central Africa.
“This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” said John Farley, the head of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, in a statement. “Having this treatment available for some patients provides an alternative for managing this chronic condition.”
“We see Cabenuva as the beginning of long-acting treatment for HIV,” Kimberly Smith, the head of global research and medical strategy at ViiV, who expects to seek FDA approval for this version of the shot in coming weeks, says. “We’re opening the door with Cabenuva and will only create more hunger for other long-acting therapies. It really becomes a sort of anchor.”
According to STAT, the wholesale price is $3,960 a month, or more than $47,500 a year. The list price for the one-time initiation dose is $5,490. However, a ViiV spokeswoman explained that a 30-day oral “lead-in,” which is required as part of the approval, will be made available at no charge to patients. She also maintained the list price for the monthly shot is “within the range” of HIV treatment pills on the market today, STAT reports.
