FDA Approves First-In-Class HIV Treatment Option

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Gilead Sciences announced this week that Sunlenca® (lenacapavir), in combination with other antiretrovirals (ARV), has been granted approval by the US Food and Drug Administration (FDA) for the treatment of HIV-1 infection in adults with severe treatment experience (HTE) with drug-resistant HIV-1 infection (MDR). ). Sunlenca has a multistage mechanism of action that is distinguishable from other currently approved classes of antiviral agents and no known cross-resistance has been shown. in the laboratory for other existing drug classes. Sunlenca offers a new treatment option twice a year for adults with HIV that is not adequately controlled by the current treatment regimen.

Photo/National Institutes of Health

“An effective antiretroviral regimen can be put in place for most people living with HIV; however, some people living with HIV no longer have permanent viral suppression due to resistance to multiple classes of antiretroviral therapies,” said Sorana Segal Maurer, director of the Division of Infectious Diseases. New York-based Dr. James J. Queens Presbyterian, clinical professor of medicine at Weill Cornell Medicine and on-site principal investigator for the Capella trial.”The availability of new classes of antiretroviral drugs is critical for people with significant experience in treating people with multidrug-resistant HIV . Following today’s decision from the Food and Drug Administration, lenacapavir helps fill a critical unmet need for people with a prior complicated treatment history and offers physicians a long-awaited bi-annual option for those patients with limited treatment options.

Despite significant advances in antiretroviral therapy, there are still many critical and urgent unmet needs for people living with HIV. This is especially true for individuals with significant experience of treatment – which accounts for an estimated 2% of adults living with HIV who are on treatment globally – and unable to maintain viral suppression due to resistance, intolerance or considerations of safety. This kind of complexity increases the chance of treatment failure, which underscores the need for new treatment options that are effective against virus-resistant variants with a novel mechanism of action.

Lenacapavir is a breakthrough innovation with the potential to be a preferred, versatile long-acting primary agent due to its therapeutic potential and range of dosing frequencies and routes of administration. Lenacapavir is being developed as a basis for future Gilead HIV therapies with the goal of offering several long-acting options that help address individual needs and preferences that may help improve outcomes and reduce the burden of care. Lenacapavir is being studied in several early- and late-stage continuing development programs and has the potential to offer a variety of person-centred options for treatment and prevention that can uniquely fit the lives of people living with HIV and people who may benefit from pre-exposure prophylaxis (PEP) PREP). The use of lenacapavir to prevent HIV is under investigation and the safety and efficacy of lenacapvir for this use have not been established.

“This news is a significant milestone in the work to help end the HIV epidemic, as Sunlenca is now the only treatment approved twice a year by the FDA for people people with multidrug-resistant HIV. Gilead Sciences. Gilead scientists have developed a unique and effective antiretroviral drug at Sonlinka with the possibility of flexible dosing options. Our goal is to offer multiple long-acting treatment and prevention options that are tailored to the needs of people living with HIV and people who could benefit from PrEP medications.”

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