Yeztugo holds potential to address key unmet needs for PrEP usage including adherence issues: GlobalData
Twice-yearly injectable therapy may improve adherence and expand access to HIV prevention, but affordability and insurance coverage remain key concerns, says GlobalData
The FDA has recently approved Gilead Sciences’ Yeztugo (lenacapavir) for the prevention of HIV infection. This is the first and only FDA approved HIV pre-exposure prophylaxis (PrEP) option offering six months of protection. The approval was based on the Phase III PURPOSE 1 and PURPOSE 2 trials that showed that more than 99 per cent of participants remained HIV negative on the twice-yearly injectable therapy. The drug has potential to address key unmet needs for PrEP usage, including adherence issues, says GlobalData.
Yetzugo is a long-acting HIV-1 capsid inhibitor that reduces the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg. 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), the only other injectable PrEP therapy available in the US. However, Apretude, which is typically administered once every two months, requires more frequent dosing than Yetzugo.
Anaelle Tannen, Infectious Disease Analyst at GlobalData, comments, “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.”
PrEP usage has not been maximised across the US. According to GlobalData epidemiologists, 437,425 people were on PrEP in the US in 2022, but this could be much higher. In the same year, only 1 in 3 (36 per cent) people in the US who met the CDC’s eligibility criteria for PrEP were prescribed a form of PrEP. CDC data shows that vulnerable populations in the US are not yet using PrEP at rates that could end transmission of the virus at the population level, with particular gaps among women, Black/African American and Hispanic/Latino people.
Tannen adds, “Increasing awareness and access is an important element in reducing HIV through PrEP and maximising Yetzugo sales.”
Key Opinion Leaders (KOL), previously interviewed by GlobalData, expressed that there is often a psychosocial burden when taking daily PrEP due to stigma, concerns about others discovering their medication, and adherence challenges. Therefore, Yeztugo could address these key issues. However, KOLs noted that the cost of the drug could be a major barrier to uptake. Gilead has announced the US price of Yeztugo for PrEP at $28,218 per year for each patient.
KOLs also expressed doubts about whether insurance companies will cover the cost of the drug, considering that generic versions of oral PrEP medications are widely available and much less expensive, and this situation may be exacerbated by the Trump administration’s proposed HIV funding cuts.
Tannen concludes, “Yeztugo is likely to be approved in other countries shortly, as Gilead has filed for regulatory approvals in several markets, including the European Medical Agency (EMA), where it is under accelerated review.”