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Gilead shares results from HIV trial for lenacapavir

The results were presented at the 29th Conference on Retroviruses and Opportunistic Infections – virtual CROI 2022


Gilead Sciences has announced new one-year results from its ongoing phase 2/3 CAPELLA trial, assessing lenacapavir – its investigational, long-acting HIV-1 capsid inhibitor  – for people living with multi-drug resistant HIV. The results from the trial were presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022).

With approval, lenacapavir would be the only existing HIV-1 treatment option available being administered twice a year. For patients living with the condition, there is no cure for HIV or AIDS.

Lenacapavir is Gilead’s potential first-in-class, long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection. As an investigational compound, lenacapavir is not approved for any use by any regulatory authorities and its safety and effectiveness have not yet been established.

The treatment could provide a new channel of treatment options for people living with or at risk with the virus as, while most antiretroviral drugs act on only one stage of viral replication, lenacapavir inhibits HIV-1 at various stages of the virus lifecycle, with no known cross-resistance to other existing treatment classes.

The trial findings showed that lenacapavir – when given to the patient subcutaneously every six months combined with other antiretrovirals – demonstrated high rates of viral suppression alongside significant increases in CD4 cell counts in those whose HIV virus was no longer reacting to their current treatment.
Of those involved in the trial, 83% who received lenacapavir in combination with an optimised background course of treatment achieved an undetectable viral load at week 52.

In addition to the CAPELLA trial, Gilead also presented lenacapavir data from its phase 2 CALIBRATE trial – an ongoing, active-controlled, open-label trial for treatment-naïve patients with HIV-1 infection.

Jared Baeten, vice president, HIV Clinical Development at Gilead Sciences, said: “Continued scientific innovation is essential to helping end the global HIV epidemic. Gilead is committed to driving advances in HIV treatment with the goal of offering long-acting options that address the differentiated needs and preferences of a diverse range of individuals and communities impacted by this disease.

“These latest results provide further evidence of the potential for lenacapavir, as a breakthrough innovation, to fulfill the needs of heavily treatment-experienced people living with multi-drug resistant HIV, irrespective of their prior treatment history.”

Article by
Fleur Jeffries

17th February 2022

From: Research



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