HIV: Lenacapavir for injection, in combination with other antiretrovirals, available in Italy and in
reimbursement scheme with the NHS for the treatment of adult patients with HIV-1 infection
multidrug-resistant for which it is not possible to establish an alternative suppressive antiviral regimen
Milan, 11 October 2023 – Gilead Sciences announces the availability in Italy of lenacapavir, a new option
therapeutic product which has obtained reimbursement approval from the Italian Medicines Agency
(AIFA), for the treatment of adults with multi-resistant HIV infection for whom it is not possible to establish
an alternative suppressive antiviral regimen. Lenacapavir is a long-acting molecule, the progenitor of
a new class of antiretroviral drugs: its multistage action inhibits the HIV capsid at multiple points of the
life cycle of the virus, thus preventing its replication.
Although advances in ARV therapy have been significant over the decades, populations of
people with HIV who have limited treatment options available. It’s about those who are not in
unable to maintain virological suppression due to resistance or difficulties in maintaining
adherence to a complex therapeutic regimen. Lenacapavir, used with other antiretrovirals, therefore represents
a new treatment opportunity thanks to an innovative mechanism of action and long duration of action.
The start of treatment with lenacapavir includes an initial loading phase which involves taking
oral tablets followed by subcutaneous administration, through six-monthly injections. The
The regimen is therefore administered only twice a year and provides comprehensive HIV treatment
when used in combination with other antiretrovirals.
Lenacapavir was authorized by the European Commission on 17 August 2022 and, starting from 9 October
2023, is commercially available in Italy (300 mg tablet and 463.5 mg/1.5 ml injection).
Lenacapavir
Lenacapavir is an approved, first-in-class, long-acting HIV capsid inhibitor.
combination with other antiretrovirals, in the United States, the United Kingdom, Canada and the European Union for
treatment of HIV infection in people with multidrug-resistant HIV. Lenacapavir tablets are approved for
oral load before administration of the extended-release injectable formulation.
The multistage mechanism of action of lenacapavir distinguishes itself from other classes of antiviral agents currently
approved, and is designed to pave a new path to the development of long-lasting therapeutic options
of action for people with multidrug-resistant HIV whose virus no longer responds effectively to therapy. While
Most antivirals act on only one stage of viral replication, lenacapavir was developed
to inhibit HIV at multiple stages of its life cycle, and has no known cross-resistance with other drug classes
existing. Lenacapavir is also the only biannual HIV treatment option.
About Gilead Sciences
Gilead Sciences is a Californian biopharmaceutical company that has been researching and developing drugs for over 35 years
innovative to contribute to the health of the world. The company is committed to progress in medicine for
the prevention and treatment of diseases such as HIV/AIDS, liver disease, COVID-19, pathologies
haematological and oncological. Millions of people living with HIV around the world are receiving treatment today
antiretroviral supplied by Gilead or the company’s partner manufacturers. Gilead has been headquartered in Milan since 2000
collaborates with institutional, scientific, academic, industrial partners and local communities to research,
develop and make therapies available also for Italian patients.
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