Gilead’s recently approved drug for HIV prevention, Yeztugo (lenacapavir), has the potential to transform the pre-exposure prophylaxis (PrEP) sector in the US, according to market analysts.
The US Food and Drug Administration (FDA) approved Yeztugo last month, bringing a more convenient PrEP option for adults and adolescents at risk of HIV exposure.
GlobalData infectious disease analyst Anaelle Tannen said: “The approval of Yeztugo is a momentous step in improving PrEP options available for people vulnerable to contracting HIV.
“Currently, the majority of PrEP therapies require daily oral administration, which can be inconvenient and often leads to poor adherence, a challenge which Yeztugo could help to address.”
Yeztugo is a long-acting antiretroviral agent that provides protection against HIV infection for six months and only needs to be administered twice a year.
The drug will compete with Gilead’s own oral PrEP therapies – Truvada (emtricitabine/ tenofovir disoproxil fumarate) and Descovy (emtricitabine/ tenofovir alafenamide), as well as ViiV Healthcare’s Apretude (cabotegravir).
Apretude is the only injectable PrEP therapy available in the US. It is given once a month for the first two injections, and then every two months, meaning Yeztugo still offers more convenient dosing.
According to GlobalData epidemiologists, 437,425 people were on PrEP in the US in 2022, but this could be considerably higher, highlighting that drugs that help protect against HIV are not being maximised in the country.
Tannen commented: “Increasing awareness and access is an important element in reducing HIV through PrEP and maximising Yeztugo sales.”
The Elton John AIDS Foundation said it was “pleased to hear about the FDA approval of lenacapavir as a new and extremely effective prevention technology for HIV transmission”.
In a statement, the foundation said: “[Yeztugo] represents a breakthrough prevention method that will fundamentally bend the curve of new HIV infections with a twice-yearly injection that has been proven to reduce HIV risk by at least 96%.”
However, KOLs interviewed by GlobalData noted that the cost of the drug could be a major barrier to uptake. The list price for Yeztugo sits at $28,218 per year for each patient. For comparison, Apretude costs $22,000 per year.
GlobalData’s Pharma Intelligence Center predicts strong growth for Yeztugo despite the high costs, forecasting annual revenue of $2.7bn for the drug by 2031.
Gilead already has several approved HIV treatments and prevention options in the US. Antiviral Biktarvy is the company’s top-selling HIV drug, generating global revenue of $13.4bn in 2024, an increase of 13% compared to 2023.
June was a mixed month for Gilead in the HIV treatment space, as the FDA paused several clinical trials evaluating two drug candidates due to safety concerns.
