FDA Approves Revolutionary HIV Prevention Drug, Kenya Among Priority Beneficiaries

In a major global health milestone, the US Food and Drug Administration (FDA) has approved a groundbreaking HIV prevention drug developed by Gilead Sciences, offering renewed hope in the fight against the virus.

The injectable drug, known as lenacapavir and marketed under the brand name Yeztugo, is a twice-yearly injection designed to prevent HIV infection in both adults and adolescents. Unlike traditional daily oral antiretrovirals, Yeztugo presents a more convenient and discreet alternative for those at risk.

Lenacapavir is part of a new class of antiretrovirals called capsid inhibitors. The drug demonstrated nearly 100% effectiveness in large-scale clinical trials conducted last year, making it one of the most promising tools yet in curbing the transmission of HIV.

Kenya, currently ranked seventh globally in terms of HIV burden, with an estimated 1.4 million people living with the virus, stands to benefit significantly. The country is among 18 low- and middle-income nations prioritised for early access to Yeztugo by Gilead, alongside South Africa and Nigeria.

The FDA’s approval is timely for Kenya, which has made strides in its HIV response, recently surpassing the UNAIDS 95-95-95 treatment targets and achieving a 28% drop in new infections over the last decade. However, access to consistent treatment remains a challenge, particularly following recent shortages of life-saving HIV drugs linked to a foreign aid freeze initiated by former US President Donald Trump in 2020.

Activists and health advocates had initially pressured Gilead to license lenacapavir to generic manufacturers to increase access and affordability. The company later agreed to collaborate with six generic producers, potentially accelerating access in resource-limited settings.

Globally, the World Health Organization estimates that around 40 million people are living with HIV. With over 40.4 million deaths recorded since the epidemic began in the 1980s, the approval of lenacapavir is being hailed as a potential game-changer.

For individuals who have not responded to existing treatments or struggle with adherence to daily pills, Yeztugo could offer a safer, more practical alternative in the ongoing fight against HIV/AIDS.

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FDA Approves Revolutionary HIV Prevention Drug, Kenya Among Priority Beneficiaries