Key Highlights :
EU medicines regulator endorses Gilead’s lenacapavir for all other HIV protection.
Injectable is 99.9% effective and two doses a year are all that are required.
Gilead to supply doses at zero cost to 2 million people in a Global Fund partnership.
Key Background :
Gilead’s lenacapavir is a new frontier in HIV prevention. In contrast to currently available daily oral PrEP regimens, the injectable takes only two doses per year, a great option for those who struggle with daily dosing due to stigma, lifestyle, or access to health care.
The drug gets a new mechanism of action—a capsid inhibitor that disintegrates the protein coat of the HIV virus, closing down replication. In more than 5,000 clinical trial participants, lenacapavir obtained unheard-of success: zero infections in cis women and just two in men and trans people. That’s a 99.9% success rate, the highest ever obtained by an HIV prevention method.
In its fulfillment of the pledge of global access, the World Health Organization has recently welcomed lenacapavir as a fundamental HIV prevention intervention. It has been welcomed by global health leaders as the next best available option after an HIV vaccine, and it is most useful among priority populations such as young people, sex workers, transgender individuals, and injecting drug users.
To enable access, Gilead pursued the EMA’s central marketing authorization and the EU-M4all process to streamline regulatory submissions in middle- and lower-income countries. These processes are especially helpful for scaling up strategies in high-prevalence areas of HIV with suboptimal infrastructures.
Gilead has also completed a no-profit supply agreement with the Global Fund to provide access for two million individuals in high-risk groups within three years. The agreement provides bridging protection as generics are produced under voluntary licenses provided to manufacturers in more than 120 nations.
When taken up by the European Commission as a recommendation from the EMA, lenacapavir will be approved in all 27 member states of the EU and receive a further year of market exclusivity. The reduced dosing regimen for this drug may make it possible to make HIV prevention affordable where, until now, it has been challenging to remain compliant with once-a-day regimens.
As global health systems struggle with how to achieve a 90% decrease in new HIV infections by 2030, lenacapavir is an available component that can join the battle, offering individuals and public health programs a viable, effective, and cost-saving option.
