Researchers from the collaborative effort between Mulago-based Makerere University and Johns Hopkins University (MU-JHU) have disclosed that the soon-to-be-approved long-acting Cabotegravir injection, designed to prevent HIV, is deemed safe for adolescents.
The administration of this HIV-preventing drug involves initial injections four weeks apart, followed by subsequent injections every eight weeks. The drug is intended for use by HIV-negative individuals at high risk, such as sex workers, discordant couples, or those with multiple partners.
On Tuesday, MU-JHU researchers informed URN that their study confirmed the safety of the medicine for sexually active adolescents, a demographic with a significant number of new HIV infections.
Dr. Sheila Bamweyana, one of the researchers, explained that participants as young as 16 were recruited for the study, and the medicine was both effective in preventing infection and safe for use, with no serious adverse reactions recorded.
Citing the efficacy of the injection in preventing HIV, Dr. Bamweyana noted that participants in the study did experience cases of gonorrhea and chlamydia, highlighting the high risk of HIV infection among adolescents.
Dr. Brenda Gati, another researcher, emphasized that the injection could play a crucial role in reducing HIV infections among girls. She advocated for NDA approval covering both adults and adolescents, citing research confirming its safety.
The World Health Organization has already given its approval and issued guidelines for countries adopting Cabotegravir as part of a comprehensive HIV prevention strategy.
The injection has shown safety and high efficacy in studies involving cisgender women, cisgender men who have sex with men, and transgender women who have sex with men, as evidenced by randomized controlled trials HPTN 083 and HPTN 084.
These studies revealed a 79% relative reduction in HIV risk compared to oral PrEP.
While the National Drug Authority previously hinted at issuing approval this month, Abiaz Rwamwiri, the authority’s spokesperson, did not confirm this when contacted by URN.