The US authorities on Wednesday approved an injection vaccine for preventing Human Immunodificiency Virus and Aquired ImmunoDificiency Syndrome disease.
The Drug
The US Food and Drug Administration approved Gilead Sciences’ new drug, lenacapavir—a twice-yearly injection, for preventing HIV infection in adults and adolescents.
The drug, developed by Gilead Sciences, will be marketed under the brand name ‘Yeztugo’.
Lenacapavir belongs to a new class of antiretrovirals known as capsid inhibitors.
Excellent Effectiveness
In large-scale clinical trials conducted last year, the drug demonstrated nearly 100 per cent effectiveness in preventing HIV transmission, raising hopes for a breakthrough in curbing the virus’s spread.
The drug will become available in the U.S. following the approval, though it’s unclear who will initially have access to the drug.
Gilead Sciences CEO Daniel O’Day said in a statement the approval could help make the goal of ending HIV “a reality,” saying the injectable “offers a very real opportunity to help end the HIV epidemic.”
The drug (which has the generic name lenacapavir) will become available in the U.S. following the approval, though it’s unclear who will initially have access to the drug.
Cost
According to CNBC, Yeztugo has an annual list price of $28,218 before insurance, a figure similar to prices of other branded medications approved for the same use.
Why Lenacapavir Was Approved
Two clinical Yeztugo trials showed that the Lenacapavir drug could nearly prevent all HIV infections, with zero infections among 2,134 participants in one trial and two infections among 2,179 participants in another trial.
Yeztugo is Gilead’s latest pre-exposure treatment for HIV prevention, as the pharma company has also produced daily oral pills (Truvada and Descovy) to reduce the risk of HIV infection.
Devastating Spread of HIV
1.2 million people in the U.S. were estimated to have HIV in 2022, with around 31,800 people contracting the virus that year, according to the Centers for Disease Control and Prevention.
Kenya, which ranks seventh globally in HIV burden with an estimated 1.4 million people living with the virus, is expected to be among the key beneficiaries if access to the drug is expanded to low- and middle-income countries.
The approval comes at a critical time as Kenya works to maintain its momentum in HIV response, having already surpassed the UNAIDS 95-95-95 treatment targets and achieved a 28 per cent reduction in new infections over the past decade.
Gilead was initially under pressure from activists and advocates to license its experimental outcomes to six generic drug manufacturers.
However, it later bowed to the pressure. Kenya, alongside other countries such as South Africa and Nigeria, is among the 18 nations Gilead has prioritised for early access to lenacapavir.
For those who have failed other treatments, this new option could provide a much-needed lifeline.
WHO estimates that nearly 40 million people globally are living with HIV, making access to affordable treatments and prevention methods more crucial than ever.
Meanwhile, Kenya has been among the countries that have suffered a shortage of HIV life-saving drugs precipitated by a decision by US President Donald Trump to pause US foreign aid in January.
Since the start of the pandemic in the 1980s, 40.4 million people have died from AIDS-related illnesses, according to USAID.
