Latest news with #Lenacapavir


Time Magazine
2 days ago
- Health
- Time Magazine
TIME100 Most Influential Companies 2025: Gilead
It's been more than four decades since the first cases of HIV emerged, and while there are effective drug treatments to control the virus, there's still no vaccine. But it turns out that an anti-HIV drug, injected twice a year, could be just as effective as a vaccine in protecting people from getting infected, according to strong results from studies published in 2024. Leading HIV treatment developer Gilead's scientists spent 20 years developing lenacapavir, an antiviral drug that targets a specific protein on the virus' shell. Vaccines have similarly targeted other outer viral proteins, and the idea is that priming the immune system to recognize this part of HIV can help it to generate defenses against the virus if someone is later exposed. Lenacapavir was already approved to treat HIV, and in June the FDA also approved it as a preventive therapy. Widespread use of the medication could bring the world closer to ending the HIV epidemic. The company's CEO Dan O'Day says Gilead is equally committed to ensuring that those who are at highest risk of getting infected with HIV have access to the drug. He signed a voluntary licensing agreement in 2024 that allows half a dozen generic manufacturers to make lenacapavir for 120 low and middle income countries, where HIV remains a significant threat. Close to 40 million people have HIV or AIDS globally, but a disproportionate number—about two-thirds—live in subsaharan Africa. 'Not that many companies focus on virology,' he says. 'And if we are going to produce a drug, and put our blood, sweat and tears into it, then it's got to end up in everybody's hands who can use it.' Expanding on its expertise in immune-based treatments—the company's remdesivir was the first antiviral approved to treat COVID-19—O'Day says Gilead is also developing treatments for blood and solid cancers as well as autoimmune diseases. 'We are in build mode, but it is already a significant part of our company and the fastest-growing part of the company today,' he says of the cancer projects. 'I expect five years from now you will see Gilead making a bigger impact across the world, in a variety of disease states.'


India Today
2 days ago
- Health
- India Today
FDA approves first HIV prevention drug: All about it
FDA approves first HIV prevention drug: All about it Credit: Getty Images The US Food and Drug Administration (FDA) has approved lenacapavir as a long-acting injectable drug to prevent HIV. HIV is one of the most dangerous diseases that attacks the immune system. If left untreated, it can lead to AIDS, the most advanced stage of HIV. What is HIV? Lenacapavir is being sold under the brand name Yeztugo. There is currently no cure for HIV or AIDS. Credit: AFP This makes Yeztugo the first and only HIV pre-exposure prophylaxis (PrEP) option in the United States that is required just twice a year. First HIV preventive drug Data from clinical trials suggest 99.9% of people who received Yeztugo remained HIV-negative during the study period. It is being manufactured by Gilead Sciences and was first approved in 2012. It is 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. How it works It is not a complete treatment for people who already have HIV, and people must be tested for HIV before starting the injection. Several Indian pharmaceutical companies have signed a deal with Gilead to produce generic versions of lenacapavir. Credit: India Today


Economic Times
3 days ago
- Health
- Economic Times
Game-changer HIV shot approved in US may enter Canada by 2026; Just two injections a year
Agencies Canada reviews groundbreaking twice-a-year HIV prevention shot after US approval, offering hope but raising concerns over access and cost A twice-a-year injectable drug being hailed as a breakthrough in HIV prevention could be available in Canada as early as mid-2026, offering new hope in the fight against the virus. The drug, lenacapavir, developed by Gilead Sciences, was approved by the US Food and Drug Administration (FDA) last week for pre-exposure prophylaxis (PrEP). It is the first and only HIV prevention medication that requires just two doses per year. Gilead Canada submitted the drug to Health Canada in April for review, which was accepted earlier this month. Lenacapavir was approved in Canada in 2022 for treatment, but this is the first time it's under review for prevention.'This is absolutely a monumental advance in prevention,' said Peter Newman, a professor at the University of Toronto whose work focuses on HIV prevention. 'It's certainly cost-effective in the long run because you're going to prevent a lot of cases of new HIV.' Lenacapavir works by creating a slow-release 'depot' of medicine under the skin, delivering protection for six months. Clinical trials showed near-total effectiveness: among more than 2,000 high-risk women in Africa, zero new infections were recorded. In another trial among gay and bisexual men and transgender women, only two infections occurred, both in participants who were already HIV-positive before the injection. Gilead's US list price is $28,218 a year, sparking concerns about access and affordability, especially for marginalized groups. 'We could get a lot of interest, but if people can't afford it, it's dead in the water,' O'Byrne in Canada, 54 percent of PrEP prescriptions are paid for by private insurance and 43 percent by public programs, according to the Public Health Agency of Canada. Gilead says it will work with both public and private payers to 'accelerate availability and access.'If approved, the shot will only be available through healthcare providers, doctors, or nurses. But experts argue it should be expanded to include pharmacists and nurse practitioners, especially to increase access in remote or underserved areas.


Time of India
4 days ago
- Health
- Time of India
Game-changer HIV shot approved in US may enter Canada by 2026; Just two injections a year
A twice-a-year injectable drug being hailed as a breakthrough in HIV prevention could be available in Canada as early as mid-2026, offering new hope in the fight against the virus. The drug, lenacapavir , developed by Gilead Sciences , was approved by the US Food and Drug Administration (FDA) last week for pre-exposure prophylaxis (PrEP). It is the first and only HIV prevention medication that requires just two doses per year. Gilead Canada submitted the drug to Health Canada in April for review, which was accepted earlier this month. Lenacapavir was approved in Canada in 2022 for treatment, but this is the first time it's under review for prevention. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Free P2,000 GCash eGift UnionBank Credit Card Apply Now Undo 'This is absolutely a monumental advance in prevention,' said Peter Newman, a professor at the University of Toronto whose work focuses on HIV prevention. 'It's certainly cost-effective in the long run because you're going to prevent a lot of cases of new HIV.' How does it work Live Events Lenacapavir works by creating a slow-release 'depot' of medicine under the skin, delivering protection for six months. Clinical trials showed near-total effectiveness: among more than 2,000 high-risk women in Africa, zero new infections were recorded. In another trial among gay and bisexual men and transgender women, only two infections occurred, both in participants who were already HIV-positive before the injection. Very expensive Gilead's US list price is $28,218 a year, sparking concerns about access and affordability, especially for marginalized groups. 'We could get a lot of interest, but if people can't afford it, it's dead in the water,' O'Byrne said. Currently in Canada, 54 percent of PrEP prescriptions are paid for by private insurance and 43 percent by public programs, according to the Public Health Agency of Canada. Gilead says it will work with both public and private payers to 'accelerate availability and access.' If approved, the shot will only be available through healthcare providers, doctors, or nurses. But experts argue it should be expanded to include pharmacists and nurse practitioners, especially to increase access in remote or underserved areas.


Global News
4 days ago
- Health
- Global News
‘Monumental' HIV shot could be coming to Canada. What we know
A twice-a-year shot to prevent HIV being dubbed a 'wonder drug' by some could be coming to Canada as soon as next year, though the company behind it says it could still take some time before the general population could access it. Gilead Canada confirmed to Global News that it had submitted lenacapavir for pre-exposure prophylaxis (PrEP) use as a new injectable drug to Health Canada in April of this year and it had been accepted by the agency for review this month. It said it anticipates the evaluation of the drug would be complete sometime in mid-2026. Global News has inquired with Health Canada about potential approval time as well as a timeline for the approval process. Canadian health-care experts and advocates for HIV prevention say the Gilead drug is a 'monumental advance.' Story continues below advertisement 'It's absolutely a monumental advance in prevention,' said Peter Newman, a University of Toronto social work professor, whose work includes HIV prevention. 'These kinds of things could really help to get it out there quicker and it's certainly cost-effective in the long run because you're going to prevent a lot of cases of new HIV.' The drug nearly eliminated new infections in two groundbreaking studies of people at high risk, better than the daily preventative pills people can forget to take, prompting the U.S. Food and Drug Administration to approve it in that country last week. Condoms help guard against HIV infection if used properly, but what's called PrEP — regularly using preventive medicines such as the daily pills or a shot given every two months — is increasingly important. Lenacapavir's six-month protection makes it the longest-lasting type, an option that could attract people wary of more frequent doctor visits or stigma from daily pills. Lenacapavir was initially authorized by Health Canada in 2022 both as an injection and tablets for treatment of HIV, but not prevention. 2:02 Doctors, health experts call on Nova Scotia to cover birth control and HIV-prevention drug The injection is given as two doses under the skin of the abdomen, leaving a small 'depot' of medication to slowly absorb into the body. Story continues below advertisement Patrick O'Byrne, a nurse practitioner at the STI clinic in Ottawa, said unlike pills where a dose can be forgotten, injectables are less easy to forget. Get weekly health news Receive the latest medical news and health information delivered to you every Sunday. Sign up for weekly health newsletter Sign Up By providing your email address, you have read and agree to Global News' Terms and Conditions and Privacy Policy 'It's hard to mess it up. You can get your injection and it works,' O'Byrne said. 'The injectables are much more forgiving, so they actually, in the studies, have better preventative outcomes because it's less dependent on people.' People must test negative for HIV before getting their twice-a-year dose, Gilead has warned. Much like oral PrEP, the drug only prevents HIV transmission, not other sexually transmitted diseases. According to Gilead, if approved, the twice-a-year shot must be administered by a health-care practitioner — a physician or a nurse. But some advocates say it should be expanded. 'The shots are only twice a year, which cuts down on patients spending time in a waiting room,' said Sean Hosein, science and medicines editor at the Canadian AIDS Treatment Information Exchange, known as CATIE, which is funded by federal and provincial grants. 'But I also think another way to make prevention more widely available is to enable a range of health-care providers to prescribe and to at least administer it. So we have doctors, nurses, nurse practitioners and even pharmacists can maybe pulled in to do this. Story continues below advertisement 'In clinical trials lenacapavir was better, it was more effective than the daily pill taking. So it's a wonder drug.' Health Canada told Global News last week that though it is responsible for authorizing drugs and health products for safety, efficacy and quality, it is not responsible for its availability or distribution on the Canadian market, noting each province and territory has its own drug plan. Gilead said it will work with payers in both the public and private space to 'accelerate availability and access.' How much could it cost? Since the approval of the U.S. drug, there has been concerns over accessibility. The U.S. list price, meaning before insurance, is US$28,218 a year, according to Gilead, which the company called similar to some other PrEP options. Story continues below advertisement O'Byrne said cost is a key factor in helping prevent HIV because while having such a drug is helpful, if certain populations are unable to access it, little progress can be made. 'We could get a lot of interest and if a lot of people can't afford it, it's dead in the water,' he said. Tweet This Click to share quote on Twitter: "We could get a lot of interest and if a lot of people can't afford it, it's dead in the water," he said. 'I think the biggest thing that people say when we talk about PrEP, it's how much does it cost. Some of that I think people are using the cost as, 'I don't really want to talk about it,' but nonetheless it's a huge barrier to say, 'I can't afford this.'' According to the Public Health Agency of Canada, as of 2022 54 per cent of HIV-PrEP prescriptions were paid for by private insurance, while 43 per cent was paid by public coverage. —with files from The Associated Press