The United States Food and Drug Administration (FDA) has approved lenacapavir, a long-acting injectable drug for HIV prevention, despite growing concerns from activists over its high cost, which could place it out of reach for many people in need.
Lenacapavir, which was also tested in Uganda, has demonstrated 100 percent effectiveness in preventing HIV infections. Unlike daily oral pre-exposure prophylaxis (PrEP), it is administered just twice a year, making it a more convenient option for those at risk.
Hailed as a major advancement in HIV prevention, the drug’s rollout faces a major hurdle—affordability. Media reports suggest that the injectable could cost as much as $28,218 (approximately Shs102 million) per person annually, a price that is unattainable for most individuals in low- and middle-income countries.
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Following the FDA’s approval, UNAIDS has appealed to the manufacturer, Gilead Sciences, to significantly reduce the drug’s cost. In a June 18 statement, UNAIDS cited a study published in The Lancet HIV indicating that generic versions of lenacapavir could be produced for $35–$46 per person per year, and potentially as low as $25 with widespread demand.
“This is a historic moment. The approval of lenacapavir reflects years of public investment, scientific innovation, and the dedication of trial participants and communities,” said Ms Winnie Byanyima, Executive Director of UNAIDS.
She commended Gilead and its U.S. partners for their efforts but stressed the need for global access: “Lenacapavir has the potential to change the course of HIV prevention – but only if it is made affordable and accessible to everyone who needs it.”
Byanyima added, “UNAIDS has seen data showing lenacapavir could be produced for $40 per person annually, and even drop to $25 with expanded demand. Gilead’s current price tag of $28,218 is indefensible.”
“If this life-saving innovation remains financially out of reach, its impact will be minimal. I call on Gilead to act responsibly: lower the price, boost production, and give the world a fair chance to end AIDS,” she emphasized.
The drug’s release comes at a critical time, as numerous recent efforts to find a cure or effective vaccine for HIV have failed. Meanwhile, global health leaders are striving to eliminate HIV/AIDS as a public health threat by 2030.
In Uganda, around 1.5 million people are currently living with HIV, with an estimated 730 new infections reported weekly, according to the Uganda AIDS Commission.
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