HIV prevention: United States endorses semi-annual injections
In a significant breakthrough for HIV prevention, the US Food and Drug Administration (FDA) has approved Gilead's Yeztugo (lenacapavir), a long-acting injectable medication given twice yearly. This new drug, shown to have very high efficacy of ≥99.9% in preventing HIV sexual transmission in key clinical trials, offers a significant advantage over daily oral PrEP like Truvada by eliminating the need for daily adherence, a major compliance challenge with traditional pills.
The efficacy of Yeztugo was demonstrated in the PURPOSE 1 and PURPOSE 2 trials, where it showed 100% and 99.9% efficacy, respectively, compared to real-world estimates for daily oral PrEP such as Truvada. Safety data, including for pregnant and breastfeeding people, show maintained drug levels similar to non-pregnant participants, with no new safety concerns identified, expanding its suitability across populations.
The subcutaneous injection given every six months greatly simplifies HIV prevention, likely improving adherence compared to daily tablets like Truvada or bimonthly injections. This could enhance protection rates especially in populations where stigma or access to daily medications is problematic.
While detailed broad population data are still accumulating, the safety profile in trials appears favorable. The injection avoids gastrointestinal and renal side effects common with some oral PrEP medications, but injection site reactions may occur as with other injectable drugs.
Yeztugo represents a promising development for both developed and low-income settings. In low-income countries, longer-acting injectables like Yeztugo could be transformative by reducing clinic visits and adherence barriers, although equitable access and healthcare infrastructure remain critical challenges to widespread rollout.
In comparison to daily oral PrEP like Truvada, Yeztugo offers superior efficacy and patient compliance benefits. The drug will initially be more expensive than other PrEP combinations in low- and middle-income countries.
Daniel O'Day, Gilead's chief executive, described Yeztugo as offering "a very real opportunity to help end the HIV epidemic." Dennis Liotta at Emory University in Atlanta, US, notes that lenacapavir performs significantly better than daily tablets of Gilead's older preventive drug combination Truvada (emtricitabine and tenofovir disoproxil) in trials in sub-Saharan Africa.
However, Liotta warns that lenacapavir is not a panacea and has serious side effects such as joint pain after injections in some people. He and his team are working to develop their own antiviral and PrEP drugs.
It's worth mentioning that Science magazine named lenacapavir as its 2024 breakthrough of the year. Lenacapavir works by interfering with HIV's ability to form its outer protein shell (capsid) and hits the virus at multiple points in its replication. The drug hinders viral DNA entry into host cells, virus assembly, and capsid formation.
As the phase 3 trials for the mRNA vaccine for HIV begin, the approval of Yeztugo marks a significant step forward in the fight against HIV. However, ensuring equitable access and managing the challenges of rollout will be crucial to realising the full potential of this revolutionary drug.
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