Lenacapavir becomes first FDA-approved HIV preventive drug: All about it
The injectable drug is approved for use in adults and adolescents weighing at least 35 kg who are at risk of acquiring HIV through sexual contact.Clinical trial data show over 99.9% of people who received Yeztugo remained HIV-negative during the study period, highlighting its strong potential to prevent HIV infections.'This is a historic day in the decades-long fight against HIV. Yeztugo only needs to be given twice a year and has shown remarkable results. It could transform HIV prevention,' said Daniel O'Day, CEO of Gilead Sciences.GAME-CHANGER FOR HIV PREVENTIONThe first PrEP medication, also made by Gilead, was approved in 2012. But as of 2022, only about 1 in 3 people in the US who were eligible for PrEP were actually prescribed it, according to the Centers for Disease Control and Prevention (CDC).advertisementMany people, especially women, Black and Latino communities, and people in the US South, continue to face challenges such as stigma, lack of awareness, and difficulties in sticking to daily oral medications.'Yeztugo could be the transformative option we've been waiting for. A twice-yearly shot could help overcome key barriers like adherence and stigma,' said Dr. Carlos del Rio, Professor of Medicine at Emory University.HOW YEZTUGO WORKSYeztugo contains lenacapavir, a unique antiretroviral that works by blocking HIV (Human Immunodeficiency Virus) at multiple stages of its life cycle, unlike most drugs that target just one.
The injectable drug is approved for use in adults and adolescents weighing at least 35 kg who are at risk of acquiring HIV through sexual contact. ()
It is not a complete treatment for people who already have HIV, and people must be tested for HIV before starting the injection.The company has also highlighted certain safety warnings of the drug:People must be confirmed HIV-negative before starting or continuing Yeztugo. Taking it unknowingly while already infected with HIV can lead to drug-resistant strains of the virus.Common side effects include injection site reactions, headache, and nausea.Since the drug stays in the body for up to 12 months, missed doses or improper use can increase the risk of infection and drug resistance.advertisementYeztugo should not be used by individuals who are HIV-positive or whose status is unknown.HOW IT'S GIVENYeztugo is given as a subcutaneous injection every six months, but starts with a loading dose that includes two injections and oral tablets.If a patient misses a scheduled injection, temporary oral tablets may be taken weekly until injections resume.CLINICAL TRIAL SUCCESSThe FDA approval is based on two large Phase 3 trials, led by researchers from Emory University and Grady Health System.PURPOSE 1 Trial: Conducted in cisgender women in sub-Saharan Africa, this trial showed zero HIV infections among the 2,134 people who received Yeztugo, demonstrating 100% effectiveness compared to daily oral PrEP (Truvada).PURPOSE 2 Trial: Involved cisgender men and gender-diverse people across various countries. Out of 2,179 participants, only two HIV infections were recorded in those on Yeztugo, showing 99.9% effectiveness.
Yeztugo is given as a subcutaneous injection every six months, but starts with a loading dose that includestwo injections and oral tablets. ()
advertisementBoth trials found Yeztugo to be superior to daily oral PrEP and it was generally well-tolerated, with no new safety concerns.In light of this breakthrough, the peer-reviewed journal Science named lenacapavir its 2024 "Breakthrough of the Year."MAKING IT WIDELY ACCESSIBLE IN THE USTo make Yeztugo widely accessible, Gilead is working with insurers and health systems to include the drug in insurance coverage.For uninsured individuals, Gilead's assistance program will provide Yeztugo free of cost, based on eligibility.GLOBAL EXPANSION PLANSGilead has already filed for regulatory approval in Australia, Brazil, Canada, South Africa, and submitted applications to the European Medicines Agency.The company is also preparing applications in countries like Argentina, Mexico, and Peru, which rely on FDA approvals for their own processes.As of now, Yeztugo is only approved in the United States for HIV prevention. There is no cure for HIV or AIDS, but preventive tools like Yeztugo bring the world closer to controlling the epidemic.advertisementWith this FDA approval, the drug can help those who have struggled with traditional prevention methods, making the prevention more manageable.
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