US authorizes the first injectable medication to prevent HIV infection
After the US Food and Drug Administration authorized its use in adults and adolescents, people at risk of contracting HIV will now have an injectable alternative for pre-exposure prophylaxis (Prep).
The injectable medicine cabotegravir, marketed with the trade name Apretude, is the first injectable HIV Prep option, with at-risk individuals taking it every two months.
The Food and Drug Administration has set a proviso for its usage, which is that the person must be HIV negative and weigh at least 35 kilograms.
Prior to its approval, alternative forms of PrEP used by HIV-negative at-risk adults were daily tablets, with only two varieties licensed for use—Truvada and Descovy.
“Today’s approval adds an important tool to the effort to end the HIV epidemic by providing the first HIV prevention option that does not involve taking a daily pill,” said Debra Birnkrant, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, in a press release.
Dr Marianne Mureithi, an HIV/AIDS researcher with the Kenya Aids Vaccine Initiative (Kavi), explained on Wednesday, December 22, that the injection is a timely discovery.
She said that scientific studies have indicated that using the long-acting injectable Apretude (cabotegravir) as a PrEP is more successful at preventing HIV on a population level since it is simpler to adhere to.
“This is a much-needed and welcome boost for HIV prevention.” This very effective type of PrEP, with as little as six doses per year, may help bend the curve of the HIV pandemic,” she added.
“It’s a terrific choice for many people searching for an alternative to daily medicines for HIV prophylaxis, especially those who have a high risk of infection.”
Dr. Mureithi, on the other hand, is requesting a more effective method of disseminating the medicine.
This follows disparity in the delivery of the Covid-19 vaccine to Africa’s most vulnerable communities.
“What we urgently want today is an equitable rollout for the individuals who require this prevention the most, notably those from Sub-Saharan Africa.” “How long before this is accessible in low- and middle-income countries?” she inquired.
Injectable PrEP is now accessible in the United States, and the Aids vaccine advocacy coalition (Avac) said immediately after its approval that Avac and its allies will strive to promote the evaluation by health regulatory authorities in other areas of the globe.
“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 medicine being licensed for use by the US FDA, the nation’s drug regulatory body, the Pharmacy and Poisons Board, must also approve it before it is rolled out in the country.
Clinical research conducted last year revealed that injectable PrEP outperformed oral tablets in terms of efficacy.
The World Health Organization issued a report in November last year based on a survey of HIV-infected women in the south and eastern Africa, including Kenya, that revealed a bias for injectables.
“While oral PrEP is very successful in preventing HIV in women when used as directed, some women find it difficult to take a daily dose, and inconsistent usage of oral PrEP lowers the preventative impact.” “A long-acting injectable formulation has the potential to boost prevention impact without depending on adherence to a daily oral PrEP regimen, as well as to broaden preventive options and acceptance among women,” according to WHO.
“These findings do not contradict evidence that consistent use of oral PrEP is very effective, as proven in multiple studies.” However, it is critical to stick to the regular dose regimen. Even brief interruptions in using oral PrEP may diminish HIV protection.”
Two trials cited by the FDA demonstrated that, as compared to oral tablets, injectable PrEP provided effective protection.
In one of the trials, individuals who took the novel injectable Apretude had a 69% lower chance of contracting HIV than those who used the study’s Truvada PrEP tablet.
The second research found that taking the injection reduced the chance of contracting HIV by 90%.
