Gilead files with the US Food and Drug Administration for approval of its HIV drug lenacapavir

US – The American biopharmaceutical company, Gilead Sciences has filed its investigational long -acting HIV therapy, lencapavir with the US Food and Drug Administration (USFDA) for approval as therapy for patients with multi-drug resistant infection.

In its submission, Gilead has included data from the Phase II/III CAPELLA trial, which evaluated the safety and efficacy of lenacapavir administered subcutaneously (under the skin) every six months in combination with an optimized antiretroviral background regimen.

The FDA has already granted lenacapavir a breakthrough therapy designation for the treatment of HIV-1 infection in this patient population, as part of a combination regimen with other antiretroviral drugs.

Lenacapavir is a HIV-1 capsid inhibitor in development for the treatment HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1.

The drug is designed to inhibit HIV-1 replication by interfering with a number of ‘essential’ steps in the viral lifecycle, including capsid-mediated uptake of HIV-1 proviral DNA, virus assembly and release and capsid core formation.

Its use has shown significant decrease in viral load when compared to placebo.

Currently, the USFDA has approved seven classes of HIV medication and lenacapavir will become the eighth approved class of drugs under the classification capsid inhibitors.

The available existing classification are: on-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors, protease inhibitors, fusion inhibitors, CCR5 antagonists, integrase strand transfer inhibitors, and post-attachment inhibitors.

With Gilead’s progress in achieving this milestone, the drug is expected to help eradicate the HIV epidemic.

According to data from WHO, an estimated 37.6 million (30.2–45.0 million) people are living with HIV and Africa accounts for two-thirds of this data.

The report also recorded that 690 000 (480 000–1 million) people died from HIV-related causes in 2020 and so far, a total of 34.7 million (26.0–45.8 million) lives has been lost since it was discovered.

Since 2016, WHO has been recommending that all people living with HIV be provided with lifelong ART, including children, adolescents, adults and pregnant & breastfeeding women.

By June 2020, 185 countries had already adopted this recommendation, covering 99% of all people living with HIV globally.

Globally, 27.4 million (26.5–27.7 million) people living with HIV were receiving Anti-retroviral therapy (ART) in 2020 and this equates to a global ART coverage rate of 73% (57–88%).

Gilead is hopeful to have its drug hit the ART market in a bid to help reduce new infections from the already existing case and most importantly improve the lifestyle of HIV positive patients.

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