Gilead Sciences Inc. has announced a new licensing deal to provide its twice-yearly experimental HIV prevention drug, lenacapavir, to six generic drug manufacturers to produce affordable versions of the drug for 120 low- and middle-income countries, including Nigeria, once regulatory approval is secured.
The company has been criticized for prioritizing profit over patient access, highlighting the urgent need for affordable treatment options for those at risk of HIV.
By partnering with these manufacturers, Gilead hopes to expand access to lenacapavir and address the ongoing challenges of HIV prevention and treatment.
Lenacapavir has shown promise as a powerful new HIV prevention option, with impressive results in clinical trials. In one trial involving men and transgender people, only two out of more than 2,000 participants who received the drug contracted HIV. In another trial involving women and adolescent girls in Africa, the drug prevented 100% of HIV cases.
Although the drug has yet to be approved for prevention, research indicates that a generic version could be produced for as little as $40 per year. The drugs current list price in the US is $42,250 for the first year and $39,000 a year after that. The encouraging trial results have increased pressure on Gilead to expedite access to the drug in countries with high HIV rates that may struggle to afford brand-name versions.
“Gilead teams have been working with urgency to bring on high-volume generic manufacturers now,” said Gilead CEO Daniel O’Day, as they work towards scaling production once approval is granted.
Gilead aims to apply for regulatory approvals in some countries by the end of this year. The drug is already approved under the brand name Sunlenca as an HIV treatment for people who have not responded to other therapies. Through the voluntary licensing agreements, low-cost versions will also be available for people with hard-to-treat HIV.
However, Gilead noted that it will take time for the generic companies to ramp up production. The company plans to prioritize getting approval in 18 countries with high HIV rates, including South Africa, Kenya, Nigeria, Thailand, and Vietnam.
About Lenacapavir
Lenacapavir is a significant advancement in HIV treatment and prevention, offering a long-acting solution that improves adherence by reducing dosing frequency.
It’s different from daily pills because it only needs to be injected once every six months, making it easier for people to stick to their treatment. Lenacapavir works by targeting the virus’s protective shell, stopping it from multiplying and spreading in the body.
Studies have shown that it effectively lowers the amount of HIV in people already infected and helps prevent the virus in those at high risk.
Rising HIV crisis among children
The federal government has raised concerns about the alarming number of children infected with HIV in Nigeria, with an estimated 140,000 currently living with the virus. Despite ongoing efforts, pediatric treatment coverage remains at just 35%, far below the global standard of 95%.
This leaves a significant number of children vulnerable, as the country records over 22,000 new HIV infections annually, with around 300 children dying each year due to complications from the virus.
Globally, the situation is equally dire. According to UNICEF, of the estimated 40 million people living with HIV worldwide in 2023, 2.38 million were children aged 0-19. Each day, approximately 685 children become infected with HIV, and around 250 children die from AIDS-related causes, primarily due to inadequate access to HIV prevention, care, and treatment services. As of 2023, about 14.1 million children under the age of 18 have lost one or both parents to AIDS-related causes. Millions more are impacted by the epidemic, facing heightened risks of poverty, homelessness, school dropout, discrimination, and loss of opportunities, exacerbated by COVID-19. In total, of the estimated 630,000 people who died from AIDS-related illnesses in 2023, about 90,000 (or roughly 14%) were children under 20 years old.
