FDA Allows Resumption of Gilead’s Lenacapavir AIDS Trials

Gilead Sciences, a key player in the global AIDS drug development, announced that the FDA has lifted its previously issued clinical hold, allowing the company to proceed with clinical trials of lenacapavir, an investigational new drug (IND) for treating AIDS.

In December 2021, the FDA placed a clinical hold on the injectable AIDS drug lenacapavir due to safety concerns about the incompatibility of the glass material with lenacapavir, which is contained in a borosilicate glass vial. After Gilead switched to aluminosilicate glass and provided safety data related to compatibility, the FDA decided to remove the hold, allowing resumption of all clinical studies evaluating injectable lenacapavir.

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Lenacapavir Offers Combination of Therapeutic and Pre-exposure Prophylaxis

Currently, there is no effective cure for AIDS, and patients who fail to take their medications regularly may develop HIV drug resistance, making the treatment even more difficult. In 2020, a team of researchers described a long-acting small molecule that targets the HIV capsid protein in an article published in Nature. This molecule, originally codenamed GS-6207, was then developed into lenacapavir, a long-acting HIV-1 capsid inhibitor for the treatment of HIV-1 infection and pre-exposure prophylaxis (PrEP).

Lenacapavir is a multi-stage viral proliferation inhibitor, unlike most existing anti-HIV drugs that inhibit viral replication in a single stage, lenacapavir is long-acting and does not have cross resistance issues with other types of antiviral drugs.

Gilead is currently conducting multiple clinical trials of lenacapavir in a Phase 2/3 trial evaluating its antiviral activity known as CAPELLA. The drug is administered by a subcutaneous injection every 6 months in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. The primary outcome results, published in The New England Journal of Medicine in its May 12, 2022 issue, showed that the drug remained well tolerated after 26 weeks of administration and no serious adverse reactions were observed, confirming the drug’s safety profile.

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Lenacapavir Could Be the First HIV-1 Treatment Option to Only Require 2 Injections Yearly

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. Given future approval, it will be the only HIV-1 treatment option that requires only two injections a year.

Another important recent progress for HIV long-acting drugs is the FDA’s first approval of CABENUVA in January 2021. It is a prescription regimen that requires only one injection monthly and is comprised of two separate injectable drugs: rilpivirine developed by Janssen Pharmaceuticals, and cabotegravir developed by ViiV Healthcare, a division of GSK.

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