Latest news with #JaredBaeten
Yahoo
10 hours ago
- 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.'
CNN
11 hours ago
- 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
11 hours ago
- 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.'
Yahoo
12-03-2025
- Health
- Yahoo
Gilead to launch Phase III once-yearly HIV PrEP trial after Phase I success
Gilead is set to launch a Phase III trial of its once-yearly lenacapavir pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) following the success of a Phase I study. The Phase I trial investigated two single 5,000mg doses of the yearly injection in 40 healthy participants at low risk of acquiring HIV. One formula contained 5% ethanol, the second contained 10% ethanol. Both groups achieved and maintained plasma concentrations above the 95% efficacy threshold for 56 weeks. The data, presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025) as well as in The Lancet, showed lenacapavir plasma trough concentrations for both formulations of once-yearly lenacapavir at week 52, 57.0ng/mL and 65.6ng/mL, were higher than those from twice-yearly lenacapavir in the Purpose 1 and Purpose 2 trials (NCT04994509 and NCT04925752) after 26 weeks, an average of 23.4ng/mL. The Purpose 1 programme saw 100% prevention of HIV cases while Purpose 2 showed a 99.9% prevention in lenacapavir-treated patients. Twice-yearly lenacapavir is currently under priority review by the US Food and Drug Administration (FDA) with a decision expected by June 19. The most common adverse event (AE) for both cohorts was injection site pain, which was mostly mild in severity and resolved within one week. Medication-emergent AEs were similar between the two cohorts and mostly mild to moderate in severity. The study was designed to evaluate the safety and pharmacokinetics (PK) of the therapy. Participants had to be found to be negative for HIV prior to the trial. Data from the trial confirmed that both once-yearly formulations of lenacapavir warrant further investigation, according to Gilead, with the company set to launch Phase III trials of the therapy in the second half of 2025. Gilead Sciences's senior vice president and virology therapeutic area head Dr Jared Baeten said: 'Gilead is continuing to innovate in our work to develop additional person-centered long-acting injectable and oral options to help people find an HIV prevention choice that is right for them. Once-yearly lenacapavir, if approved, could become an important new HIV prevention option that could help address PrEP adherence and persistence challenges for individuals who need or want PrEP around the world.' Alongside its Phase III plans, Gilead also presented more data from its Purpose clinical programme at the California conference. This included data from adolescents, aged 16 and 17 who were enrolled in the Purpose 1 study, with lenacapavir plasma concentrations being comparable between adolescent and adult trial groups. The therapy was also able to show 100% no incidence of HIV infections across the adolescent group, the same as the adult group in the same study. Participants in both groups experienced the same most common AEs. Gilead now intends to submit data to agencies to support the use of twice-yearly lenacapavir in adolescents. Gilead also revealed quantitative and qualitative survey data from the Purpose 1 trial, with approximately two-thirds of survey respondents preferring twice-yearly lenacapavir compared to once-daily pills. Additionally, 61% of respondents reported they would feel more protected from HIV with twice-yearly PrEP injections compared with once-daily pills, and 61% of respondents also reported they would feel more confident about not missing a PrEP dose with twice-yearly injections. According to UNAIDS, 39.9 million people globally were living with HIV in 2023, with 1.3 million new infections in the same year. After Gilead presented the flagship Purpose trial data, UNAIDS executive director Winnie Byanyima called upon Gilead Sciences to make twice-yearly lenacapavir available to people from developing countries. Byanyima said that people in Africa could be 'freed from the stigma and fear of being attacked' that they face if they are seen swallowing tablets. Gilead responded by stating it had provided royalty-free voluntary licensing agreements with six generic manufacturers to increase access to lenacapavir for HIV prevention in high-incidence, resource-limited countries. "Gilead to launch Phase III once-yearly HIV PrEP trial after Phase I success" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
12-03-2025
- Business
- Yahoo
Gilead Presents New HIV Treatment and Cure Research Data at CROI 2025, Including an Investigational Long-Acting, Twice-Yearly Therapy Option
– Long-Term Outcomes Reinforce the High Efficacy of Biktarvy® in People with HIV and HBV Coinfection – – Investigational Long-Acting, Twice-Yearly Treatment Regimen of Lenacapavir and Broadly Neutralizing Antibodies (bNAbs) Meets Primary Endpoint in Phase 2 Study and Gains Breakthrough Therapy Designation – – Late-Breaker Oral Presentation of Phase 2 Results from the First HIV Cure Clinical Trial Conducted in South Africa – FOSTER CITY, Calif., March 12, 2025--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of late-breaking data and multiple oral presentations from its innovative HIV treatment portfolio and pipeline at the Conference on Retroviruses and Opportunistic Infections (CROI 2025). The new findings reflect a transformative portfolio and a rapidly advancing forward-looking pipeline focused on expanding choices and enhancing outcomes for those with HIV, while continuing to reach towards a cure. "Gilead is fueling the next wave of innovation in HIV to help end the epidemic globally," said Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head. "Our contributions to CROI spotlight our dedication to scientific discovery, reflect our commitment to addressing the diverse treatment needs and preferences of communities affected by HIV and underscore the vital importance of catalyzing research reaching towards a cure." Biktarvy Demonstrates High Rates of Viral Suppression in People with HIV/HBV Coinfection ALLIANCE (NCT03547908) is an ongoing Phase 3 study evaluating Biktarvy versus dolutegravir 50 mg (DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, F/TDF, DTG+F/TDF, in adults with HIV-1/HBV co-infection initiating treatment. The ALLIANCE trial is the first randomized clinical trial of TAF- vs TDF-based regimens in treatment naïve adults with HIV/HBV coinfection. Its goal is to evaluate treatment regimens that may effectively suppress both HIV and HBV. Previously reported results demonstrated the efficacy of both antiretroviral regimens. New outcomes were presented at CROI. Week 48 outcomes from the open-label extension phase following the 96-week randomized phase reported on the longer-term efficacy and safety of the investigational use of Biktarvy in adults with HIV/HBV coinfection initiating treatment. The newly presented data shows that Biktarvy maintained high rates of HIV-1 (95.4%) and HBV (86.6%) virologic suppression, defined as HIV RNA <50 copies/ mL and HBV DNA <29 IU/ mL, respectively, in participants (n=89) following a switch to Biktarvy after 96 weeks of treatment with DTG+ F/TDF. Study drug-related treatment-emergent adverse events (TEAEs) were reported in 19% of participants and most were mild to moderate, with zero discontinuations due to TEAEs. The most commonly reported study drug–related TEAEs were weight gain (9%) and low-density lipoprotein (LDL) cholesterol increased (3%). These data demonstrate the high rates of viral suppression by Biktarvy in adults with both HIV-1 and HBV switching their treatment to Biktarvy. The use of Biktarvy in individuals with HIV/HBV co-infection is investigational and the safety and efficacy of this use have not been established. Breakthrough Therapy Designation Awarded to Long-Acting, Twice-Yearly Investigational Treatment Combination Regimen of Lenacapavir and Broadly Neutralizing Antibodies (bNAbs) In January 2025, the FDA granted lenacapavir (LEN) with bNAbs (teropavimab [GS-5423, TAB] and zinlirvimab [GS-2872, ZAB]) Breakthrough Therapy Designation, which is intended to expedite the development of new drugs that may demonstrate substantial improvement over available therapy. LEN+TAB+ZAB (LTZ) harbors the potential to be the first long-acting combination treatment regimen with twice-yearly dosing. At CROI 2025, the primary results of a Phase 2 study evaluating the investigational combination of LTZ were presented during an oral session and featured in the press program; those data announced at CROI confirm previously presented Phase 1b results. The Phase 2 (NCT05729568) open-label study from Gilead's long-acting treatment pipeline evaluated the treatment response of participants receiving the investigational combination of LTZ. Efficacy and safety results were evaluated when virologically suppressed adults switched to LTZ every 6 months versus staying on stable baseline oral antiretroviral regimen. The study met its primary endpoint, which is the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26 as determined by the US FDA-defined snapshot algorithm. The Week 26 data demonstrated the high efficacy of the LTZ regimen, with 96% (n=51 of 53) of participants who received LTZ and 96% (n=26 of 27) who received SBR remained virologically suppressed. CD4 cell counts also increased from baseline to week 26 in both groups, with a mean change of +23/μL (n=143) with LTZ and +69/μL (n=203) with SBR. The most common AEs with LTZ were injection site reactions related to subcutaneous LEN administration. There were no serious adverse events (AEs) related to LTZ; there were no infusion reactions related to TAB or ZAB. One participant in the SBR arm discontinued the study due to a serious treatment-related AE. Teropavimab and zinlirvimab are investigational compounds. The use of these compounds in combination with lenacapavir are investigational. They are not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use, alone or in combination with lenacapavir. Their safety and efficacy are unknown. The use of lenacapavir in virologically suppressed people with HIV is investigational and the safety and efficacy of this use have not been established. Landmark HIV Cure Clinical Trial Conducted in South Africa Results from the first HIV cure trial to be conducted in South Africa, sponsored by Gilead, demonstrated that complex cure studies can be successfully conducted, alongside community, in resource-limited settings where great unmet need exists. As part of Gilead's efforts to find a cure for HIV, the Phase 2a GS-US-382-5445 trial (NCT05281510) enrolled 20 South African cisgender women from the FRESH (Females Rising through Education, Support, and Health) cohort who had received antiretroviral therapy (ART) soon after acquiring HIV and were virologically suppressed for at least 12 months. Participants received up to 10 oral doses of Gilead's investigational TLR7 agonist, vesatolimod, every 2 weeks starting on day 0, plus IV infusions of broadly neutralizing antibodies (bNAbs) VRC07-523LS and CAP256V2LS, provided by the National Institutes of Health (NIH), on day 7. Participants began an analytical treatment interruption (ATI) on Day 35 and remained off ART until Week 48, or until they met restart criteria. Participants who reached week 48 without meeting ART restart criteria had the option of remaining off ART through the end of study follow-up at Week 60. Results presented at CROI showed the treatment combination was generally well-tolerated with no treatment-related serious adverse events (TEAEs) reported. The most common study TEAEs were infusion-related reactions (n = 18; 16 grade 1, 2 grade 2). Seventy percent of participants (n=14) met ART restart criteria. Thirty percent (n=6) remained off ART through Week 48, of which 4 remained off ART through Week 60. While the data suggest that the trial regimen alone is not sufficient as an HIV cure regimen, the mechanistic learnings will inform the development of future cure approaches. There is currently no cure for HIV or AIDS. Vesatolimod, VRC07-523LS and CAP256V2LS are investigational compounds. They are not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use, alone or in combination. Their safety and efficacy are unknown. Please see below for U.S. Indications and Important Safety Information, including Boxed Warning, for Biktarvy. About Lenacapavir Lenacapavir is approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established. The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead's HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. Science Magazine named lenacapavir its 2024 "Breakthrough of the Year." About Biktarvy Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir with the F/TAF backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines. U.S. Indication for Biktarvy Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically-suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. U.S. Important Safety Information for Biktarvy BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted. Contraindications Coadministration : Do not use BIKTARVY with dofetilide or rifampin. Warnings and precautions Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions. Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported. New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus. Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. Adverse reactions Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%). Drug interactions Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1. Drugs affecting renal function: Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions. Dosage and administration Dosage: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes. Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min. Hepatic impairment: Not recommended in patients with severe hepatic impairment. Prior to or when initiating: Test patients for HBV infection. Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus. Pregnancy and lactation Pregnancy: BIKTARVY is recommended in pregnant individuals who are virologically suppressed on a stable ARV regimen with no known substitutions associated with resistance to any of the individual components of BIKTARVY. Lower plasma exposures of BIKTARVY were observed during pregnancy; therefore, viral load should be monitored closely during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for BIC, FTC, or TAF show no difference in the rates of birth defects compared with a US reference population. Lactation: Individuals infected with HIV-1 should be informed of the potential risks of breastfeeding. About Gilead HIV Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead has been repeatedly recognized as one of the top two leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. Forward Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Biktarvy, bictegravir, lenacapavir, teropavimab, zinlirvimab and GS-1720 (such as the ALLIANCE, ARTISTRY, BICSTaR, NCT04811040 and NCT05585307 studies); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for indications currently under evaluation, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of programs for indications that are currently under evaluation, including bictegravir, lenacapavir, teropavimab, zinlirvimab and GS-1720, and, as a result, these programs may never be successfully commercialized for such indications; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. U.S. full Prescribing Information for Biktarvy, including Boxed Warning, and U.S. full Prescribing Information for lenacapavir is available at Gilead, Biktarvy and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company's website at follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn, or contact Gilead Public Affairs at public_affairs@ 1-800-GILEAD-5 or 1-650-574-3000. View source version on Contacts Blair Baumwell, Mediapublic_affairs@ Jacquie Ross, Investorsinvestor_relations@
