Production Approved of Generic Injectable HIV-Prevention Drug for Sub-Saharan Africa

Global health agencies say a voluntary licensing agreement has been reached to allow for the generic production of the first and only long-acting injectable HIV-prevention drug. 


Until recently, Cabotegravir, the HIV-prevention medication, was available only in pill form and had to be taken daily, or in some cases before and after sex.  The injectable form can provide two months of continuous protection against HIV infection through a single intramuscular injection.   


Herve Verhoosel is spokesman for UNITAID, the global health initiative that spearheaded the agreement.  He says the price of the injectable drug is prohibitive, noting a year’s supply in the United States costs $20,000.


“That is a lot of money.  That is why the product cannot be used today in low-and-middle-income countries," Verhoosel said. "This license will, in fact, give the option to three different generic manufacturers to develop the product on a generic base … Of course, that will help to win the price of the generic version down.”  


Data from UNAIDS, the United Nations program on HIV/AIDS, finds 1.5 million people were newly infected with HIV last year, including some 650,000 deaths.


Verhoosel says cabotegravir will be available to people at high risk in the least developed, low-income, lower-middle income, and sub-Saharan African countries.  He says people with high rates of infection will benefit most from this medication.  They include men who have sex with men, sex workers, transgender women, adolescent girls, and young women.


“And I would like to insist on the importance of protecting adolescent girls and young women," Verhoosel said. "In sub-Saharan Africa, the epicenter of the epidemic, the HIV infection rate of adolescent girls aged 15 to 19 is six times that of their male peers. It is six times greater.”   


Verhoosel says the agreement will give selected manufacturers the opportunity to develop and supply generic versions of cabotegravir in 90 countries, where more than 70 percent of all new HIV infections have occurred.


He notes it might take two or more years to develop the generic product.  He says the price, which is not yet known, will likely be determined then.