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New phase III data support the sustained, long-acting efficacy of lenacapavir

Read time: 3 mins
Published:19th Jul 2021
Gilead Sciences, Inc. announced new results from the ongoing Phase II/III CAPELLA trial evaluating lenacapavir, the company’s investigational, long-acting HIV-1 capsid inhibitor, in heavily treatment-experienced people living with multi-drug resistant HIV.

The findings demonstrate that lenacapavir, administered subcutaneously every six months in combination with other antiretrovirals, achieved high rates of virologic suppression at Week 26 in people living with HIV whose virus was no longer effectively responding to therapy. In this patient population of high unmet medical need, 81% (n=29/36) of participants receiving lenacapavir in addition to an optimized background regimen achieved an undetectable viral load (<50 copies ml) at week 26. the data were presented at the 11th international aids society (ias) conference on hiv science. these data support the ongoing evaluation of lenacapavir for the treatment of hiv-1 infection and form the basis of the new drug application (nda) that the company recently submitted seeking fda approval for the treatment of hiv-1 infection in heavily treatment-experienced people with multi-drug resistant hiv-1 infection in combination with other antiretrovirals. if approved, lenacapavir would be the first capsid inhibitor and the only hiv-1 treatment option administered every six months.></50>

Lenacapavir is being developed in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg with multi-drug resistant HIV-1 infection who are currently on a failing antiretroviral treatment regimen due to resistance, intolerance or safety considerations. Lenacapavir is a potentially first-in-class capsid inhibitor without overlapping resistance with any currently approved antiretroviral therapy (ART). Lenacapavir is designed to inhibit HIV replication by interfering with multiple, essential steps of the viral lifecycle, including capsid-mediated uptake of HIV-1 proviral DNA, virus assembly and release, and capsid core formation. In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs.

In addition to 81% of CAPELLA participants achieving an undetectable viral load at Week 26, participants achieved a mean increase in CD4 count of 81 cells/µL. In the data presented at the virtual 28th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2021), the CAPELLA trial achieved its primary endpoint by demonstrating that a significantly higher proportion of participants randomly allocated to receive lenacapavir (n=24) achieved a clinically meaningful viral load reduction of at least 0.5 log10 copies/mL from baseline compared with those randomly allocated to receive placebo (n=12) during the 14-day functional monotherapy period (88% vs. 17%, p<0.0001). those who received lenacapavir achieved a statistically significantly greater mean decrease in viral load than those who received placebo during the functional monotherapy period (-1.93 log10 copies ml vs. -0.29 log10 copies ml, p><0.0001).></0.0001).></0.0001).>

Lenacapavir was generally well tolerated, with no adverse events (AEs) leading to study drug discontinuation and no serious adverse events related to lenacapavir . The most common adverse events observed to date in the CAPELLA study were injection site reactions, which were mostly mild in severity. The most common injection site reactions were injection site swelling (26%) and erythema (24%). Four participants experienced treatment-emergent lenacapavir resistance and three of these four participants later re-suppressed while continuing lenacapavir in addition to their optimized background regimen. One participant did not re-suppress.

Gilead presented additional lenacapavir clinical development program data at the conference. Phase II data from CALIBRATE , an ongoing, open-label, active-controlled trial in treatment-naïve people with HIV-1 infection showed lenacapavir, given subcutaneously or orally, in combination with oral daily emtricitabine/tenofovir alafenamide (F/TAF) led to high rates of viral suppression by Week 28 (94%; n=147/157). Specifically, in the pooled subcutaneous lenacapavir + F/TAF arms, 93% (n=98/105) achieved an undetectable viral load (<50 copies ml). in the oral lenacapavir + f taf arm, 94% (n="49/52)" achieved an undetectable viral load (><50 copies ml). these results support the ongoing evaluation and further development of lenacapavir in combination with other long-acting partner agents for the treatment of hiv-1 infection and will support gilead’s long-acting oral and injectable development program.></50></50>

Lenacapavir was generally well tolerated. The most common AEs observed to date in the CALIBRATE study among those who received subcutaneous lenacapavir were injection site reactions, which were generally mild in severity. The most common injection site reactions were injection site swelling (18%) and erythema (17%). Importantly, there were no serious AEs related to study drug. Two participants discontinued due to AEs (both due to mild injection site induration). One participant had treatment-emergent resistance to study drugs.

Condition: HIV/AIDS
Type: drug

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