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Gilead Sciences has announced that the US Food and Drug Administration (FDA) has accepted its New Drug Application submissions for lenacapavir for human immunodeficiency virus (HIV) prevention. Lenacapavir was granted breakthrough therapy designation for HIV prevention by the FDA in October 2024 and will be reviewed by the FDA under priority review, with an assigned Prescription Drug User Fee Act target action date of June 19, 2025. If approved, lenacapavir has the potential to revolutionise HIV preexposure prophylaxis (PrEP).
Gilead’s lenacapavir, an HIV-1 capsid inhibitor, is already marketed in the US, EU, and numerous other countries, under the brand name Sunlenca, for the treatment of adults with multidrug-resistant HIV. If approved by the FDA, lenacapavir will become the first and only twice-yearly injectable for HIV PrEP.
Conventional PrEP is administered orally once daily, but according to Phase III clinical trial data, lenacapavir demonstrated superiority in preventing HIV infections when compared with the once-daily oral comparator, Truvada. In the PURPOSE 1 trial, zero HIV infections were observed in the lenacapavir group, which was a 100% risk reduction compared to background HIV incidence. In the PURPOSE 2 trial, only two incident cases of HIV were reported, which was a 96% risk reduction compared to background HIV incidence. In both trials, twice-yearly injectable lenacapavir was superior at preventing HIV infections when compared with once-daily oral Truvada, in which 16 and nine incident cases of HIV, respectively, were observed. Further, lenacapavir was generally well-tolerated with no new safety concerns observed.
Key opinion leaders (KOLs) interviewed by leading data and analytics company GlobalData have expressed positive opinions on the development of lenacapavir for PrEP. KOLs were largely in agreement that the trial data was impressive, and the route of administration and frequency of administration make lenacapavir a practical and promising option, although they also expressed concerns about cost, long-term efficacy, and the potential development of resistance mechanisms.
Lenacapavir’s route of administration and frequency of administration make it an enticing option for PrEP, not only for those at risk of HIV infection in the US, but also in areas where adherence to a daily oral PrEP regimen is low, such as sub-Saharan Africa.
Gilead also recently announced the submission of marketing authorisation applications to the European Medicines Agency for lenacapavir for PrEP earlier this month. One of the applications seeks European Commission authorisation, and the other application would facilitate the availability of the PrEP regimen in low- and lower-middle-income countries.