US Approves First Injectable Drug To Prevent HIV Infection

By Mukidi Hannington

After the US Food and Drug Administration approved its use in adults and adolescents, people at risk of contracting HIV will now have an injectable option for pre-exposure prophylaxis (Prep).

The injectable drug cabotegravir, marketed under the brand name Apretude, is the first injectable HIV Prep option, with at-risk individuals taking it every two months.

The Food and Drug Administration has imposed a caveat for its use, which is that the user must be HIV negative and weigh at least 35 kilograms.

Prior to this approval, other forms of PrEP used by HIV-negative at-risk individuals were daily pills, with only two types approved for use—Truvada and Descovy.

In a press statement, Debra Birnkrant, director of the FDA’s Center for Drug Evaluation and Research’s Division of Antivirals, said, “Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill.”

Dr Marianne Mureithi, an HIV/AIDS researcher with the Kenya Aids Vaccine Initiative (Kavi), told The East African yesterday, December 22, that the injectable is a timely breakthrough.

She also added that Clinical trials have shown that the long-acting injectable Apretude (cabotegravir) as a PrEP is more effective at preventing HIV in the general population because it is easier to adhere to.

“This is a much-needed and welcome boost for HIV prevention.” This highly effective form of PrEP, with as few as six shots per year, can help bend the curve of the HIV epidemic,” she said. “It’s a fantastic option for many people looking for an alternative to daily pills for HIV prevention, especially those who have a high risk of infection.”
“What we urgently require now is an equitable rollout for the people who require this prevention the most, particularly those from Sub-Saharan Africa.” “How long until this is available in low- and middle-income countries?” she inquired.

Injectable PrEP is now available in the United States, and the Aids vaccine advocacy coalition (Avac) stated shortly after its approval that Avac and partners would work to support the review by health regulatory authorities in other parts of the world.

“With as few as six shots per year, this highly effective form of injectable PrEP can help bend the curve of the HIV epidemic – but only if its approval is accompanied by a strategic, effective, and equitable rollout that transforms the growing list of HIV prevention options into real and accessible choices for the people who need prevention the most,” Avac executive director Mitchell Warren said.

According to Kenya’s Health Ministry’s PrEP Programme Manager Mary Mugambi, despite the drug being approved for use by the US FDA, the country’s drug regulatory authority, the Pharmacy and Poisons Board, must also approve it before it is rolled out in the country.
The World Health Organization published a report in November last year based on a study of HIV-infected women in south and eastern Africa, including Kenya, that revealed a bias toward injectables.

“While oral PrEP is extremely effective in preventing HIV in women when used as directed, some women find it difficult to take a daily tablet, and inconsistent use of oral PrEP reduces the prevention effect.”

“A long-acting injectable formulation has the potential to improve prevention effect without relying on adherence to a daily oral PrEP regimen, as well as to increase prevention options and acceptability among women,” according to WHO.

“These findings do not contradict evidence that consistent use of oral PrEP is highly effective, as demonstrated in several trials.” However, it is critical to stick to the daily dosing schedule. Even brief interruptions in taking oral PrEP can reduce HIV protection.” Two studies cited by the FDA demonstrated that, when compared to oral pills, injectable PrEP provided effective protection.

In one of the studies, participants who used the novel injectable Apretude had a 69 percent lower risk of contracting HIV than those who took the Truvada PrEP tablet. The second study found that taking the injection reduced the chance of contracting HIV by 90%.