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A study recently published in The New England Journal of Medicine has demonstrated the superior efficacy (99.9%) of investigational drug lenacapavir in HIV infection prevention. This was among a broad and geographically diverse range of cisgender men and gender-diverse people.

This will serve as good news globally in the fight against the virus.

Global HIV burden

According to UNAIDS, a total of 88.4 million people have become infected with HIV since the beginning of the epidemic, claiming a total of 42.3 million lives in the process.

With 1.3 million people becoming newly infected in 2023, the virus shows no signs of slowing down, and it’s therefore crucial to implement new innovative strategies to mitigate this situation.

In steps lenacapavir

Lenacapavir is a first-in-class capsid inhibitor that works in two ways: one, by interrupting viral replication through preventing HIV from reaching the nucleus of an infected cell, which then blocks reproduction, and two, by interfering with the production of viral progeny, making them "defective" so that they are not able to infect other cells.

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The drug is currently approved by the US Food and Drug Administration (FDA) in combination with other antiretrovirals for the management of HIV in heavily treatment-experienced adults with multidrug-resistant HIV.

Lenacapavir's usage to prevent HIV is still in the experimental stage, has not been proven to be safe or effective, and is not approved anywhere in the world for this type of use.

More about the study

According to the phase III study coded PURPOSE 2, twice-yearly lenacapavir for pre-exposure prophylaxis (PrEP) reduced HIV infection by 96% compared to background HIV incidence.

With only two incident cases out of 2,179 participants, 99.9% of participants in the lenacapavir group did not contract HIV.

In addition to being better than once-daily emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg fixed dose combination for PrEP, twice-yearly lenacapavir was also generally well-tolerated, with no noteworthy or novel safety issues found.

The PURPOSE 1 trial, which showed zero infections and 100% efficacy for the exploratory use of lenacapavir for PrEP in cisgender women in sub-Saharan Africa, is in line with lenacapavir's strong efficacy and safety.

Conclusion

Despite the promising data, access to lenacapavir, which currently costs $25,395 - $44,819 per person per year, still remains a challenge for many, especially in the low- and middle-income countries.

It is therefore critical to implement strategies that would make the injection not only available but also affordable to all.

Source:  New England Journal of Medicine

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