The European Commission gave the green light in August to the marketing of an HIV treatment in solution for injection twice a year for the treatment of HIV infection, in combination with one or more other antiretrovirals, in infected adults- es by a multidrug-resistant strain of HIV-1 for which it would otherwise be impossible to establish a suppressive antiretroviral therapy regimen. This will be the lenacapavir molecule marketed by Gilead under the name Sunlenca. This molecule is a new capsid inhibitor, a new target of the HIV viral cycle. It has a long half-life and strong antiviral potency. Lenacapavir has no known cross-resistance with other classes of antiretrovirals available and therefore offers a new treatment option, to be administered every six months, to people living with HIV whose virus is no longer effectively controlled by their treatment. It is administered by subcutaneous injection and is currently being tested in several studies in HIV treatment and in Prep. An international team, coordinated by Pr Jean-Michel Molina from the infectious diseases department of Saint-Louis and Lariboisière AP-HP hospitals and Paris Cité University, studied the efficacy and tolerance of lenacapavir in people living with multi-resistant HIV. The results of the Capella study, which demonstrate the very clear efficacy of this treatment in these people, were published in the New England Journal of Medecine May 11, 2022. “Lenacapavir helps meet a critical need for patients with complex treatment histories, and provides physicians with a long-awaited, twice-per-year option for patients who are at greater risk of progress to AIDS,” said Professor Molina. In a press release (August 22), Gilead welcomes this decision: “After more than thirty years of advances in the prevention and treatment of HIV infection, Gilead researchers have made it possible to propose an innovative new option for a long-acting treatment,” said Daniel O’Day of Gilead Sciences. And the laboratory adds: “Lenacapavir is a powerful and unique drug, with the potential for flexible administration. With the approval of the European MA, it is now the first treatment in two administrations per year authorized for people who are fighting once morest multidrug-resistant HIV. Our goal is to offer several long-acting options in the future, in the belief that this will help make a fundamental difference in the journey to end the HIV epidemic”. The Marketing Authorization (MA) applies to the 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein. Rarely, this European marketing authorization is issued before an American authorization. In July 2022, the US Food & Drug Administration (FDA) accepted for review the New Drug Application (NDA) resubmitted to it for investigational lenacapavir.
