URN.The drug was only approved by the U.S. Food and Drug Administration (FDA) on Monday. Dr. Mitchell Warren told a meeting attended by journalists from Africa that timelines have already been set between the necessary approvals and global access.
Apretude, the first long acting HIV prevention injection drug to be approved for use in adults and adolescents at risk of HIV infection will be available for use in Africa six months from now.
The drug was only approved by the U.S. Food and Drug Administration -FDA on Monday. Dr. Mitchell Warren told a meeting attended by journalists from Africa that timelines have already been set between the necessary approvals and global access.
He notes though that they don’t know with exactness how long it will take African regulators to review the data but that they indicated they will not wait three years before approvals on the continent can start.
Warren who is the Executive Director of a global HIV prevention advocacy entity AVAC, said the new drug comes at a time when many countries are discussing simplifying oral Pre Exposure Prophylaxis (PrEP) by giving multi-months prescriptions. He says with the new drug, they are discussing for it to be aligned with contraceptives such that when a woman goes for their injectable contraceptives every three months, they can as well be able to access the injectable PrEP.
According to a press release by FDA, Apretude also called cabotegravir extended – release injectable suspension should in adolescents be used only among those that weigh 35 kilograms and above. Both among adolescents and adults, it’s given first as two initiation injections administered one month apart, and then every two months thereafter.
The safety and efficacy of Apretude to reduce the risk of acquiring HIV were evaluated in two randomized trials that compared the drug to Truvada, a once daily oral medication that’s already approved as HIV PrEP.
While the first trial involved HIV negative men and transgender women who have sex with men who have high-risk behavior for HIV infection, trial two included uninfected cisgender women at risk of acquiring HIV.
However, it should be noted that while more options for PrEP are coming up, in many countries access has been a challenge. In Uganda for instance, only about 150,000 people have enrolled for PrEP at the 260 sites designated throughout the country yet it was adopted for use way be in 2016.
In an earlier meeting, Dr. Herbert Kadama, the Coordinator of PrEP in the Ministry of Health said most of their clients are sex workers. But, they are also not consistently using their treatment.
Meanwhile, the criteria used for enrolling people into PrEP include anyone who has used Post Exposure Prophylaxis -PEP for more than three times, those with multiple sex partners and if one has been treating recurrent sexually transmitted infections in a year.