Latest news with #CarlosdelRio
India Today
19-06-2025
- Health
- India Today
Lenacapavir becomes first FDA-approved HIV preventive drug: All about it
In a major breakthrough in the fight against HIV, the US Food and Drug Administration (FDA) has approved lenacapavir, under the brand name Yeztugo, a long-acting injectable drug developed by Gilead Sciences, as a preventive treatment for HIV. It has been in the making for over two for HIV prevention is not approved by any regulatory authority outside the US. There is currently no cure for HIV or makes Yeztugo the first and only HIV pre-exposure prophylaxis (PrEP) option in the United States that is required just twice a year. 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 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 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 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 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 side effects include injection site reactions, headache, and the drug stays in the body for up to 12 months, missed doses or improper use can increase the risk of infection and drug should not be used by individuals who are HIV-positive or whose status is IT'S GIVENYeztugo is given as a subcutaneous injection every six months, but starts with a loading dose that includes two injections and oral a patient misses a scheduled injection, temporary oral tablets may be taken weekly until injections TRIAL SUCCESSThe FDA approval is based on two large Phase 3 trials, led by researchers from Emory University and Grady Health 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 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 uninsured individuals, Gilead's assistance program will provide Yeztugo free of cost, based on EXPANSION PLANSGilead has already filed for regulatory approval in Australia, Brazil, Canada, South Africa, and submitted applications to the European Medicines company is also preparing applications in countries like Argentina, Mexico, and Peru, which rely on FDA approvals for their own 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 this FDA approval, the drug can help those who have struggled with traditional prevention methods, making the prevention more manageable.
Yahoo
18-06-2025
- Health
- Yahoo
FDA approves twice-a-year injection for HIV prevention
A drug currently used to treat certain HIV infections has also, on Wednesday, received approval from the US Food and Drug Administration to be used to prevent HIV. Gilead Sciences, maker of the drug, announced that a twice-a-year injection of lenacapavir has been approved in the United States for HIV prevention under the brand name Yeztugo. In clinical trials, the drug was found to dramatically reduce the risk of infection and provide near-total protection against HIV, significantly more than the primary options available for pre-exposure prophylaxis or PrEP. Therapies called PrEP have been used to prevent HIV infections for years. In the United States, this may involve taking pills, such as a daily medication called Truvada, or getting shots, such as injections every two months of the medication Apretude. But a twice-yearly shot of lenacapavir has now become another option in the prevention toolbox – making it the first and only such shot for HIV prevention. 'Yeztugo could be the transformative PrEP option we've been waiting for – offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,' Dr. Carlos del Rio, a distinguished professor of medicine in the Division of Infectious Diseases at Emory University School of Medicine and co-director of the Emory Center for AIDS Research, said in a Gilead news release. 'A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face. We also know that, in research, many people who need or want PrEP preferred less frequent dosing.' With any PrEP drug, 'by having that medicine in your bloodstream or in your body, if you encounter HIV, it blocks it from taking hold. It arrests infection from taking hold,' said Dr. Jared Baeten, senior vice president of clinical development and the virology therapeutic area head at Gilead Sciences. The human immunodeficiency virus or HIV, spread primarily through unprotected sex or sharing needles, attacks the body's immune system, and without treatment, it can lead to acquired immunodeficiency syndrome or AIDS. Although rates of new HIV infections have fallen in the US, about 1.2 million people are estimated to have HIV, and about 13% of them may not know it. A study called the PURPOSE 2 trial found that just two shots a year of lenacapavir can reduce the risk of HIV infection by 96%, proving it to offer near-total protection against HIV. Another study, the PURPOSE 1 trial, found that lenacapavir demonstrated 100% efficacy for HIV prevention in women. 'Lenacapavir is a unique option for people for HIV prevention because it's an injection given just twice a year. So people can get it privately, discreetly, and then set it and forget it and not have to think about it until six months later,' Baeten said. 'For many people, that might be the empowered, private option that might make HIV prevention workable in their lives.' There continues to be a lot of stigma, fear and misinformation around HIV, said Ian Haddock, who participated in the PURPOSE 2 trial for lenacapavir. When Haddock was a teenager living in rural Texas, he recalled, he faced some of that stigma. 'The first thing that was said when my family found out that I was queer was, 'You're going to get AIDS,' ' said Haddock, who does not live with HIV. 'So that's the first thing I heard.' Now, at 37, Haddock knows that HIV does not discriminate. He works to break such misguided stereotypes about the LGBTQ+ community as the founder of a nonprofit called the Normal Anomaly Initiative, and he said he is proud to have participated in the clinical trial. 'It feels like a full-circle moment,' he said. Haddock said he started to take daily PrEP pills in 2015 to help reduce his risk of HIV, but sometimes they would give him an upset stomach or he would forget to take them. In January 2024, when he learned about the lenacapavir clinical trial, he quickly enrolled. He had no side effects during the trial other than irritation at the injection site, he said. Even though the trial has concluded, Haddock said, he plans to continue receiving lenacapavir injections twice a year, and he hopes the FDA approval will help raise awareness of HIV prevention tools. In 2012, the FDA approved Truvada, also made by Gilead Sciences, making it the first PrEP medication for HIV prevention in uninfected adults in the United States – but 'even though PrEP has been around since 2012, people don't really know what it is, and they often kind of conflate it to having HIV or being extremely promiscuous,' Haddock said. 'So this just opens up a completely new opportunity,' he said of lenacapavir. Last year, Gilead Sciences released data from the PURPOSE 2 trial that showed 99.9% of the participants who received an injection of lenacapavir twice a year for HIV prevention did not become infected. There were only two cases among 2,180 people, effectively proving 89% more effective than the PrEP pill Truvada. The trial was unblinded early because it met its key endpoints, allowing lenacapavir to be offered to all participants, and the drug was found to be well-tolerated. 'The most common side effects, as you might expect, are injection-site reactions,' Baeten said, such as rash or discomfort. The PURPOSE 2 trial included cisgender men, transgender men, transgender women and nonbinary people 16 or older who had sex with partners assigned male at birth. Some of the study participants became pregnant during the trial and continued to receive lenacapavir during pregnancy without complications, Baeten said. 'This is a milestone moment in the decades-long fight against HIV. With twice-yearly administration and remarkable efficacy, lenacapavir will help us prevent HIV on a scale never seen before,' Daniel O'Day, chairman and chief executive officer at Gilead Sciences, said in an emailed statement. 'After 17 years of research and pioneering clinical trials, Gilead scientists have delivered the next frontier in HIV innovation: a prevention medicine with remarkable efficacy that only needs to be delivered twice a year,' O'Day said. 'It's a true scientific breakthrough that could help millions of people around the world.' Now that lenacapavir has been approved for prevention, people should be able to visit their providers and ask about the drug within two days, Gilead Sciences said in an email. The company added that it could take up to two months for someone to receive their first injections, based on coverage decisions. The list price for lenacapavir, when used for HIV prevention, will be announced soon, Baeten said. The list price is expected to be different from when lenacapavir is used for the treatment of multidrug-resistant HIV, in which other HIV medications have not worked and the patient meets certain other requirements for lenacapavir treatment. One study published in November in the Journal of Antimicrobial Chemotherapy found that for treatment, lenacapavir costs up to nearly $45,000 per person per year without insurance, as an average wholesale list price – but it could be mass-produced for less than $100 per person per year. The team of researchers behind the study projected a possible minimum price based on the drug's current ingredients, production models and cost models. They demonstrated that lenacapavir could be mass-produced for up to $93 per person per year, potentially falling to about $40 per person per year 'if voluntary licences are in place and competition between generic suppliers substantially improves.' 'Voluntary licensing and multiple suppliers are required to achieve these low prices,' the researchers wrote in the study abstract. 'This mechanism is already in place for other antiretrovirals.' Lenacapavir is the latest HIV prevention shot to receive FDA approval. Apretude, made by GSK's ViiV Healthcare, was the first injectable pre-exposure prophylaxis medication to receive approval in the US in 2021. The hope is that PrEP tools could lead to a total halt to new HIV infections in future generations, Baeten said. 'Every one of us would like nothing more than to end this epidemic, and that's what really solid prevention can do for us – that coupled with testing and treatment,' he said. 'I want this next generation to think about HIV as something that they can end in their lifetime, end in their generation. And I want their next generation to be one where they've never had to think about HIV at all,' he said. 'We've got this amazing opportune moment right now as a world to think about where we can be in the future. We can be a world without HIV.' The new FDA approval comes as the Trump administration has cut back funding for HIV-related research grants, HIV prevention and surveillance programs through the US Centers for Disease Control and Prevention, and sharply curtailed global HIV efforts. The administration's 2026 budget proposal includes the elimination of funding for HIV programs, totaling more than $1.5 billion, according to the HIV+Hepatitis Policy Institute. With the approval of lenacapavir for PrEP, 'now is not the time to pull the rug out from under HIV prevention,' Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, said in an email. 'The obliteration of CDC HIV prevention and surveillance programs is an absurd proposal that will just increase HIV infections and health costs down the road,' he said. 'We urgently call on Congress to reject these cuts in order to ensure that states and community-based organizations have the resources to prevent HIV, which is still a serious infectious disease and results in about 32,000 new cases each year.'
The Hill
18-06-2025
- Health
- The Hill
FDA approves 6-month HIV prevention shot
Pharmaceutical company Gilead Sciences announced Wednesday the Food and Drug Administration (FDA) has approved its six-month, twice-yearly HIV PrEP injection, which was found in trials to be more than 99.9 percent effective among participants. Gilead's product Yeztugo, a form of lenacapavir, was approved for reducing the risk of sexually acquired HIV in adults and adolescents when injected twice a year. Lenacapavir is also marketed as Sunlenca, administered orally or through injection, as a treatment for HIV/AIDS in combination with other drugs. The drug is solely manufactured by Gilead. There are currently three available HIV PrEP options: two oral pills taken daily — Truvada and Descovy — and a long-acting injection called Apretude administered every two months. 'Yeztugo could be the transformative PrEP option we've been waiting for — offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,' Carlos del Rio, co-Director of the Emory Center for AIDS Research, said in a statement shared by Gilead. In a Phase 3, double-blind, randomized study, there were only two HIV infections among 2,179 participants who received Yeztugo subcutaneous injections twice a year. Lenacapavir is currently not approved for HIV prevention outside of the U.S., though it is approved for treating HIV in several countries. 'In the U.S., Gilead is working closely with insurers, healthcare systems and other payers with the goal of ensuring broad insurance coverage for Yeztugo,' the company said in a statement. 'Additionally, for eligible commercially insured individuals with commercial insurance, Gilead's Advancing Access® Co-Pay Savings Program will reduce out-of-pocket costs to as little as zero dollars.' Carl Schmid, Executive Director of the HIV+Hepatitis Policy Institute, called the approval a 'monumental advance in HIV prevention.' 'Long-acting PrEP is now not only effective for up to six months but also improves adherence and will reduce HIV infections—if people are aware of it and payers, including private insurers, cover it without cost-sharing as a preventive service,' said Shmid. 'Recent actions by the Trump administration to decimate HIV prevention jeopardize access to preventive measures such as PrEP,' he added. 'In fact, the president's budget zeroes out all CDC HIV prevention and surveillance funding, hampering our nation's ability to make people aware of and access new HIV prevention measures. Dismantling these programs means that there will be a weakened public health infrastructure and much less HIV testing, which is needed before a person can take PrEP.' The Hill has reached out to the White House for comment.
CNN
18-06-2025
- Health
- CNN
FDA approves twice-a-year injection for HIV prevention
A drug currently used to treat certain HIV infections has also, on Wednesday, received approval from the US Food and Drug Administration to be used to prevent HIV. Gilead Sciences, maker of the drug, announced that a twice-a-year injection of lenacapavir has been approved in the United States for HIV prevention under the brand name Yeztugo. In clinical trials, the drug was found to dramatically reduce the risk of infection and provide near-total protection against HIV, significantly more than the primary options available for pre-exposure prophylaxis or PrEP. Therapies called PrEP have been used to prevent HIV infections for years. In the United States, this may involve taking pills, such as a daily medication called Truvada, or getting shots, such as injections every two months of the medication Apretude. But a twice-yearly shot of lenacapavir has now become another option in the prevention toolbox – making it the first and only such shot for HIV prevention. 'Yeztugo could be the transformative PrEP option we've been waiting for – offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,' Dr. Carlos del Rio, a distinguished professor of medicine in the Division of Infectious Diseases at Emory University School of Medicine and co-director of the Emory Center for AIDS Research, said in a Gilead news release. 'A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face. We also know that, in research, many people who need or want PrEP preferred less frequent dosing.' With any PrEP drug, 'by having that medicine in your bloodstream or in your body, if you encounter HIV, it blocks it from taking hold. It arrests infection from taking hold,' said Dr. Jared Baeten, senior vice president of clinical development and the virology therapeutic area head at Gilead Sciences. The human immunodeficiency virus or HIV, spread primarily through unprotected sex or sharing needles, attacks the body's immune system, and without treatment, it can lead to acquired immunodeficiency syndrome or AIDS. Although rates of new HIV infections have fallen in the US, about 1.2 million people are estimated to have HIV, and about 13% of them may not know it. A study called the PURPOSE 2 trial found that just two shots a year of lenacapavir can reduce the risk of HIV infection by 96%, proving it to offer near-total protection against HIV. Another study, the PURPOSE 1 trial, found that lenacapavir demonstrated 100% efficacy for HIV prevention in women. 'Lenacapavir is a unique option for people for HIV prevention because it's an injection given just twice a year. So people can get it privately, discreetly, and then set it and forget it and not have to think about it until six months later,' Baeten said. 'For many people, that might be the empowered, private option that might make HIV prevention workable in their lives.' There continues to be a lot of stigma, fear and misinformation around HIV, said Ian Haddock, who participated in the PURPOSE 2 trial for lenacapavir. When Haddock was a teenager living in rural Texas, he recalled, he faced some of that stigma. 'The first thing that was said when my family found out that I was queer was, 'You're going to get AIDS,' ' said Haddock, who does not live with HIV. 'So that's the first thing I heard.' Now, at 37, Haddock knows that HIV does not discriminate. He works to break such misguided stereotypes about the LGBTQ+ community as the founder of a nonprofit called the Normal Anomaly Initiative, and he said he is proud to have participated in the clinical trial. 'It feels like a full-circle moment,' he said. Haddock said he started to take daily PrEP pills in 2015 to help reduce his risk of HIV, but sometimes they would give him an upset stomach or he would forget to take them. In January 2024, when he learned about the lenacapavir clinical trial, he quickly enrolled. He had no side effects during the trial other than irritation at the injection site, he said. Even though the trial has concluded, Haddock said, he plans to continue receiving lenacapavir injections twice a year, and he hopes the FDA approval will help raise awareness of HIV prevention tools. In 2012, the FDA approved Truvada, also made by Gilead Sciences, making it the first PrEP medication for HIV prevention in uninfected adults in the United States – but 'even though PrEP has been around since 2012, people don't really know what it is, and they often kind of conflate it to having HIV or being extremely promiscuous,' Haddock said. 'So this just opens up a completely new opportunity,' he said of lenacapavir. Last year, Gilead Sciences released data from the PURPOSE 2 trial that showed 99.9% of the participants who received an injection of lenacapavir twice a year for HIV prevention did not become infected. There were only two cases among 2,180 people, effectively proving 89% more effective than the PrEP pill Truvada. The trial was unblinded early because it met its key endpoints, allowing lenacapavir to be offered to all participants, and the drug was found to be well-tolerated. 'The most common side effects, as you might expect, are injection-site reactions,' Baeten said, such as rash or discomfort. The PURPOSE 2 trial included cisgender men, transgender men, transgender women and nonbinary people 16 or older who had sex with partners assigned male at birth. Some of the study participants became pregnant during the trial and continued to receive lenacapavir during pregnancy without complications, Baeten said. 'This is a milestone moment in the decades-long fight against HIV. With twice-yearly administration and remarkable efficacy, lenacapavir will help us prevent HIV on a scale never seen before,' Daniel O'Day, chairman and chief executive officer at Gilead Sciences, said in an emailed statement. 'After 17 years of research and pioneering clinical trials, Gilead scientists have delivered the next frontier in HIV innovation: a prevention medicine with remarkable efficacy that only needs to be delivered twice a year,' O'Day said. 'It's a true scientific breakthrough that could help millions of people around the world.' Now that lenacapavir has been approved for prevention, people should be able to visit their providers and ask about the drug within two days, Gilead Sciences said in an email. The company added that it could take up to two months for someone to receive their first injections, based on coverage decisions. The list price for lenacapavir, when used for HIV prevention, will be announced soon, Baeten said. The list price is expected to be different from when lenacapavir is used for the treatment of multidrug-resistant HIV, in which other HIV medications have not worked and the patient meets certain other requirements for lenacapavir treatment. One study published in November in the Journal of Antimicrobial Chemotherapy found that for treatment, lenacapavir costs up to nearly $45,000 per person per year without insurance, as an average wholesale list price – but it could be mass-produced for less than $100 per person per year. The team of researchers behind the study projected a possible minimum price based on the drug's current ingredients, production models and cost models. They demonstrated that lenacapavir could be mass-produced for up to $93 per person per year, potentially falling to about $40 per person per year 'if voluntary licences are in place and competition between generic suppliers substantially improves.' 'Voluntary licensing and multiple suppliers are required to achieve these low prices,' the researchers wrote in the study abstract. 'This mechanism is already in place for other antiretrovirals.' Lenacapavir is the latest HIV prevention shot to receive FDA approval. Apretude, made by GSK's ViiV Healthcare, was the first injectable pre-exposure prophylaxis medication to receive approval in the US in 2021. The hope is that PrEP tools could lead to a total halt to new HIV infections in future generations, Baeten said. 'Every one of us would like nothing more than to end this epidemic, and that's what really solid prevention can do for us – that coupled with testing and treatment,' he said. 'I want this next generation to think about HIV as something that they can end in their lifetime, end in their generation. And I want their next generation to be one where they've never had to think about HIV at all,' he said. 'We've got this amazing opportune moment right now as a world to think about where we can be in the future. We can be a world without HIV.' The new FDA approval comes as the Trump administration has cut back funding for HIV-related research grants, HIV prevention and surveillance programs through the US Centers for Disease Control and Prevention, and sharply curtailed global HIV efforts. The administration's 2026 budget proposal includes the elimination of funding for HIV programs, totaling more than $1.5 billion, according to the HIV+Hepatitis Policy Institute. With the approval of lenacapavir for PrEP, 'now is not the time to pull the rug out from under HIV prevention,' Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, said in an email. 'The obliteration of CDC HIV prevention and surveillance programs is an absurd proposal that will just increase HIV infections and health costs down the road,' he said. 'We urgently call on Congress to reject these cuts in order to ensure that states and community-based organizations have the resources to prevent HIV, which is still a serious infectious disease and results in about 32,000 new cases each year.'
CNN
18-06-2025
- Health
- CNN
FDA approves twice-a-year injection for HIV prevention
A drug currently used to treat certain HIV infections has also, on Wednesday, received approval from the US Food and Drug Administration to be used to prevent HIV. Gilead Sciences, maker of the drug, announced that a twice-a-year injection of lenacapavir has been approved in the United States for HIV prevention under the brand name Yeztugo. In clinical trials, the drug was found to dramatically reduce the risk of infection and provide near-total protection against HIV, significantly more than the primary options available for pre-exposure prophylaxis or PrEP. Therapies called PrEP have been used to prevent HIV infections for years. In the United States, this may involve taking pills, such as a daily medication called Truvada, or getting shots, such as injections every two months of the medication Apretude. But a twice-yearly shot of lenacapavir has now become another option in the prevention toolbox – making it the first and only such shot for HIV prevention. 'Yeztugo could be the transformative PrEP option we've been waiting for – offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,' Dr. Carlos del Rio, a distinguished professor of medicine in the Division of Infectious Diseases at Emory University School of Medicine and co-director of the Emory Center for AIDS Research, said in a Gilead news release. 'A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face. We also know that, in research, many people who need or want PrEP preferred less frequent dosing.' With any PrEP drug, 'by having that medicine in your bloodstream or in your body, if you encounter HIV, it blocks it from taking hold. It arrests infection from taking hold,' said Dr. Jared Baeten, senior vice president of clinical development and the virology therapeutic area head at Gilead Sciences. The human immunodeficiency virus or HIV, spread primarily through unprotected sex or sharing needles, attacks the body's immune system, and without treatment, it can lead to acquired immunodeficiency syndrome or AIDS. Although rates of new HIV infections have fallen in the US, about 1.2 million people are estimated to have HIV, and about 13% of them may not know it. A study called the PURPOSE 2 trial found that just two shots a year of lenacapavir can reduce the risk of HIV infection by 96%, proving it to offer near-total protection against HIV. Another study, the PURPOSE 1 trial, found that lenacapavir demonstrated 100% efficacy for HIV prevention in women. 'Lenacapavir is a unique option for people for HIV prevention because it's an injection given just twice a year. So people can get it privately, discreetly, and then set it and forget it and not have to think about it until six months later,' Baeten said. 'For many people, that might be the empowered, private option that might make HIV prevention workable in their lives.' There continues to be a lot of stigma, fear and misinformation around HIV, said Ian Haddock, who participated in the PURPOSE 2 trial for lenacapavir. When Haddock was a teenager living in rural Texas, he recalled, he faced some of that stigma. 'The first thing that was said when my family found out that I was queer was, 'You're going to get AIDS,' ' said Haddock, who does not live with HIV. 'So that's the first thing I heard.' Now, at 37, Haddock knows that HIV does not discriminate. He works to break such misguided stereotypes about the LGBTQ+ community as the founder of a nonprofit called the Normal Anomaly Initiative, and he said he is proud to have participated in the clinical trial. 'It feels like a full-circle moment,' he said. Haddock said he started to take daily PrEP pills in 2015 to help reduce his risk of HIV, but sometimes they would give him an upset stomach or he would forget to take them. In January 2024, when he learned about the lenacapavir clinical trial, he quickly enrolled. He had no side effects during the trial other than irritation at the injection site, he said. Even though the trial has concluded, Haddock said, he plans to continue receiving lenacapavir injections twice a year, and he hopes the FDA approval will help raise awareness of HIV prevention tools. In 2012, the FDA approved Truvada, also made by Gilead Sciences, making it the first PrEP medication for HIV prevention in uninfected adults in the United States – but 'even though PrEP has been around since 2012, people don't really know what it is, and they often kind of conflate it to having HIV or being extremely promiscuous,' Haddock said. 'So this just opens up a completely new opportunity,' he said of lenacapavir. Last year, Gilead Sciences released data from the PURPOSE 2 trial that showed 99.9% of the participants who received an injection of lenacapavir twice a year for HIV prevention did not become infected. There were only two cases among 2,180 people, effectively proving 89% more effective than the PrEP pill Truvada. The trial was unblinded early because it met its key endpoints, allowing lenacapavir to be offered to all participants, and the drug was found to be well-tolerated. 'The most common side effects, as you might expect, are injection-site reactions,' Baeten said, such as rash or discomfort. The PURPOSE 2 trial included cisgender men, transgender men, transgender women and nonbinary people 16 or older who had sex with partners assigned male at birth. Some of the study participants became pregnant during the trial and continued to receive lenacapavir during pregnancy without complications, Baeten said. 'This is a milestone moment in the decades-long fight against HIV. With twice-yearly administration and remarkable efficacy, lenacapavir will help us prevent HIV on a scale never seen before,' Daniel O'Day, chairman and chief executive officer at Gilead Sciences, said in an emailed statement. 'After 17 years of research and pioneering clinical trials, Gilead scientists have delivered the next frontier in HIV innovation: a prevention medicine with remarkable efficacy that only needs to be delivered twice a year,' O'Day said. 'It's a true scientific breakthrough that could help millions of people around the world.' Now that lenacapavir has been approved for prevention, people should be able to visit their providers and ask about the drug within two days, Gilead Sciences said in an email. The company added that it could take up to two months for someone to receive their first injections, based on coverage decisions. The list price for lenacapavir, when used for HIV prevention, will be announced soon, Baeten said. The list price is expected to be different from when lenacapavir is used for the treatment of multidrug-resistant HIV, in which other HIV medications have not worked and the patient meets certain other requirements for lenacapavir treatment. One study published in November in the Journal of Antimicrobial Chemotherapy found that for treatment, lenacapavir costs up to nearly $45,000 per person per year without insurance, as an average wholesale list price – but it could be mass-produced for less than $100 per person per year. The team of researchers behind the study projected a possible minimum price based on the drug's current ingredients, production models and cost models. They demonstrated that lenacapavir could be mass-produced for up to $93 per person per year, potentially falling to about $40 per person per year 'if voluntary licences are in place and competition between generic suppliers substantially improves.' 'Voluntary licensing and multiple suppliers are required to achieve these low prices,' the researchers wrote in the study abstract. 'This mechanism is already in place for other antiretrovirals.' Lenacapavir is the latest HIV prevention shot to receive FDA approval. Apretude, made by GSK's ViiV Healthcare, was the first injectable pre-exposure prophylaxis medication to receive approval in the US in 2021. The hope is that PrEP tools could lead to a total halt to new HIV infections in future generations, Baeten said. 'Every one of us would like nothing more than to end this epidemic, and that's what really solid prevention can do for us – that coupled with testing and treatment,' he said. 'I want this next generation to think about HIV as something that they can end in their lifetime, end in their generation. And I want their next generation to be one where they've never had to think about HIV at all,' he said. 'We've got this amazing opportune moment right now as a world to think about where we can be in the future. We can be a world without HIV.' The new FDA approval comes as the Trump administration has cut back funding for HIV-related research grants, HIV prevention and surveillance programs through the US Centers for Disease Control and Prevention, and sharply curtailed global HIV efforts. The administration's 2026 budget proposal includes the elimination of funding for HIV programs, totaling more than $1.5 billion, according to the HIV+Hepatitis Policy Institute. With the approval of lenacapavir for PrEP, 'now is not the time to pull the rug out from under HIV prevention,' Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, said in an email. 'The obliteration of CDC HIV prevention and surveillance programs is an absurd proposal that will just increase HIV infections and health costs down the road,' he said. 'We urgently call on Congress to reject these cuts in order to ensure that states and community-based organizations have the resources to prevent HIV, which is still a serious infectious disease and results in about 32,000 new cases each year.'
