Latest news with #Apretude
Yahoo
4 days ago
- Health
- Yahoo
Long-lasting HIV prevention shot heads toward approval
June 6 (UPI) -- A new vaccine to prevent HIV is expected to be approved by the U.S. Food and Drug Administration later this month. If approved, the shot -- lenacapavir -- would be given twice a year and could be a big step forward in the fight against HIV. Drugmaker Gilead Sciences tested the shot in a study of women and girls. None of the participants who received the injections got HIV. That early success helped boost Gilead's stock by 73% over the past year, The Wall Street Journal reported. "We know it's challenging to take a daily pill for prevention, and we see an incredible opportunity here," said Johanna Mercier, Gilead's chief commercial officer Right now, more than 400,000 people in the United States use pills to prevent HIV, The Wall Street Journal added. These medications are referred to as PrEP, short for pre-exposure prophylaxis. Gilead expects the number of users to top 1 million by the next decade. Many people already say they'd prefer a shot over daily pills. In one survey of more than 500 PrEP users, 95% said they would switch to a long-acting injection. Sales of other long-acting options, like the shot Apretude from GSK, have risen sharply - up 63% in the past year. Even with strong results, Gilead faces several hurdles. One is reaching the people who need PrEP the most. Black Americans represent 39% of new HIV cases but only 14% of current PrEP users. Many people still face stigma or lack insurance coverage, which can limit access. Gilead says reaching underserved groups is a top goal. Most current PrEP users have commercial insurance, but Medicaid will be key for expanding access to lower-income communities. Another concern: Some experts worry the new shot may simply replace current Gilead products, like the daily pill Descovy, which now holds about 40% to 45% of the market. But Gilead says the shot should help expand the overall number of people using PrEP in both the U.S. and abroad. "We're thinking globally about the public health impact we can have," Mercier said. The company is working with governments and health groups in the United Kingdom and low-income countries to raise awareness and make these products more available. More information The National Institutes of Health has more on Pre-Exposure Prophylaxis (PrEP). Copyright © 2025 HealthDay. All rights reserved.
UPI
4 days ago
- Health
- UPI
Long-lasting HIV prevention shot heads toward approval
June 6 (UPI) -- A new vaccine to prevent HIV is expected to be approved by the U.S. Food and Drug Administration later this month. If approved, the shot -- lenacapavir -- would be given twice a year and could be a big step forward in the fight against HIV. Drugmaker Gilead Sciences tested the shot in a study of women and girls. None of the participants who received the injections got HIV. That early success helped boost Gilead's stock by 73% over the past year, The Wall Street Journal reported. "We know it's challenging to take a daily pill for prevention, and we see an incredible opportunity here," said Johanna Mercier, Gilead's chief commercial officer Right now, more than 400,000 people in the United States use pills to prevent HIV, The Wall Street Journal added. These medications are referred to as PrEP, short for pre-exposure prophylaxis. Gilead expects the number of users to top 1 million by the next decade. Many people already say they'd prefer a shot over daily pills. In one survey of more than 500 PrEP users, 95% said they would switch to a long-acting injection. Sales of other long-acting options, like the shot Apretude from GSK, have risen sharply - up 63% in the past year. Even with strong results, Gilead faces several hurdles. One is reaching the people who need PrEP the most. Black Americans represent 39% of new HIV cases but only 14% of current PrEP users. Many people still face stigma or lack insurance coverage, which can limit access. Gilead says reaching underserved groups is a top goal. Most current PrEP users have commercial insurance, but Medicaid will be key for expanding access to lower-income communities. Another concern: Some experts worry the new shot may simply replace current Gilead products, like the daily pill Descovy, which now holds about 40% to 45% of the market. But Gilead says the shot should help expand the overall number of people using PrEP in both the U.S. and abroad. "We're thinking globally about the public health impact we can have," Mercier said. The company is working with governments and health groups in the United Kingdom and low-income countries to raise awareness and make these products more available. More information The National Institutes of Health has more on Pre-Exposure Prophylaxis (PrEP). Copyright © 2025 HealthDay. All rights reserved.
Mint
5 days ago
- Business
- Mint
A new shot prevents HIV—and breathes new life into a stagnant biotech
Later this month, the Food and Drug Administration is widely expected to approve a groundbreaking twice-yearly injection to prevent HIV—a milestone in the decadeslong fight against a once-devastating disease. For Gilead Sciences, the dominant player in HIV treatment, the breakthrough is doing what years of splashy but underwhelming acquisitions failed to achieve: It has Wall Street paying attention again. Since reporting last June that just two annual shots of lenacapavir prevented all HIV infections in a study of women and girls, shares have surged 73%. Gilead still isn't very expensive: It trades at 13.3 times forward earnings—below the industry average of 14, as measured by the NYSE Arca Pharmaceutical Index, and hardly a stretch for a company on the cusp of a new product cycle. Investors might fear they have seen this movie before. A decade ago, Gilead stock soared on excitement over its hepatitis C cure, only to stall once most patients had been treated and the market dried up. The company then fell into value-trap territory, weighed down by sluggish growth and a string of underwhelming cancer deals. This time could be different—but only if Gilead can execute. Over 400,000 people in the U.S. are currently on pre-exposure prophylaxis, or PrEP—a medication that protects against HIV infection. To hit the $4 billion in annual sales that some analysts are forecasting by the end of the decade, the company will need to not only convert a big chunk of existing patients but also expand the overall market both at home and abroad. Gilead expects the number of users in the U.S. to grow to over one million in the next decade. The early signs are promising. For starters, the market is growing fast. Sales of Gilead's daily pill Descovy rose 38% last quarter from a year ago, while GSK's Apretude—a long-acting injection given every two months—jumped 63%. Secondly, many current and potential users say they would prefer a longer-acting injection. A Jefferies survey of more than 500 PrEP users found that 95% would switch to a twice-yearly injection. In an interview, Gilead's Chief Commercial Officer Johanna Mercier said the key advantage of the company's upcoming HIV prevention shot isn't just efficacy but adherence. 'We know it's challenging to take a daily pill for prevention, and we see an incredible opportunity here," she said, citing data showing that many patients struggle to stay consistent with oral PrEP. Still, hurdles remain. Stigma continues to hinder PrEP uptake, particularly outside the core demographic of white men who have sex with men. Black Americans account for 39% of new HIV diagnoses but just 14% of PrEP users. Expanding access to underserved populations will require continued insurance coverage. While most current users are covered by commercial insurance, Medicaid will be key to reaching lower-income groups—making recent GOP proposals to cut the program a potential threat to Gilead's growth strategy. Another risk, according to RBC Capital Markets analyst Brian Abrahams, is cannibalization. Gilead's daily pill Descovy currently accounts for 40% to 45% of the PrEP market, so some of the lenacapavir growth could come at the expense of its existing business. But Mercier is confident the new product will expand the market both in the U.S. and globally. Gilead is working with governments in countries such as the U.K., where PrEP awareness is low, and planning broader rollout in low-income countries through partnerships with global health organizations. 'We're thinking globally about the public health impact we can have," she said. Gilead's growth outlook means it is, for now, steering clear of the patent cliff that is about to hit much of the industry as multibillion-dollar blockbuster drugs face generic competition. Gilead's HIV blockbuster, Biktarvy—which is prescribed after infection—retains exclusivity until 2033, with several potential successors already in the pipeline. Beyond HIV, Gilead is beginning to show signs of turning the corner in cancer, a space where past acquisitions have frustrated investors. There is growing excitement around Trodelvy—an antibody-drug conjugate acquired via its $21 billion Immunomedics deal—after data showed it delayed progression in an aggressive form of breast cancer when combined with Merck's Keytruda. Meanwhile, Gilead's cell therapy program is gaining traction, with the company aiming to challenge Johnson & Johnson in the multibillion-dollar multiple myeloma market, explains Traver Davis, a healthcare strategist at Citi. 'They have been hammered for their acquisitions and execution on the oncology side of the business in the last few years," said Davis. 'The narrative on that is definitely turning." Gilead spent years trying to move beyond HIV. In the end, it might be HIV prevention that finally delivers the breakthrough investors have been waiting for. Write to David Wainer at
CBC
22-03-2025
- Health
- CBC
There are daily pills to prevent HIV — but injectable options could change what prevention looks like
Social Sharing This story is part of CBC Health's Second Opinion, a weekly analysis of health and medical science news emailed to subscribers on Saturday mornings. If you haven't subscribed yet, you can do that by clicking here. Once a day, Tim Lagman takes a pill that reduces his risk of contracting HIV, a precaution he's taken since 2017. Pre-exposure prophylaxis, or PrEP, is part of the daily routine for a growing number of Canadians at risk of exposure to HIV through sex or injection drugs. While most people take it in pill form, Lagman, a sexual health educator and podcaster in Scarborough, Ont., is hopeful about a new, longer-lasting injectable option given every two months. "The option of injectable PrEP would help people at risk of HIV to not worry about it so much," he said. "Every other month would be a lot easier for me, my peace of mind and my schedule." The long-acting injectable drug for PrEP, cabotegravir, sold under the brand name Apretude, was approved by Health Canada in 2024 to reduce the risk of sexually acquired HIV. The antiretroviral medication is administered every two months through intramuscular injections. Quebec is the first province to cover the costs of injectable Apretude under its public prescription drug insurance plan. "This is the first treatment by injection for prevention for HIV, so it is very, very special," said Dr. Réjean Thomas, co-founder of Montreal sexual health clinic L'Actuel. Thomas has been at the forefront of the fight against HIV and AIDS for decades and in that time has seen life-saving advances in treatment and prevention. Quebec's coverage of injectable PrEP is an important step, he says, and it could be a game-changer for some patients who struggle to take daily pills. The drug is among a number of recent advances in the treatment and prevention of HIV. "It is very important because I think it's the future in the fight against AIDS," said Thomas. 'A major advance' In Canada, the number of new HIV infections increased by 35 per cent between 2022 and 2023, according to the Public Health Agency of Canada. In explaining the rise, experts point to limited testing during the COVID-19 pandemic, new immigrants who may not have known their status or didn't have access to treatment in their home country, and insufficient access to screening and prevention tools. "It means that our strategies are not reaching the right population enough," said Dr. Cécile Tremblay, an infectious disease specialist at the CHUM hospital in Montreal. "We need to innovate in terms of ways to reach out to these people and make the treatment available." WATCH | HIV rates are down globally, but rising in Canada: HIV rates dropping globally, but up in Canada 4 months ago Duration 6:18 One of those ways, she says, would be to increase screening options so people can know their status and find out if they need treatment or prevention medication. The next step, most experts agree, is making treatments free. So far, Quebec is the only Canadian province to publicly reimburse for injectable Apretude for PrEP. Even with that coverage, or with private insurance, many users still have to pay part of the cost out-of-pocket. That's the case for oral PrEP, too. The costs vary depending on the drug and the coverage plan. "It is good that at least it's reimbursed," Tremblay said. "But we would still want to go further and to have all kinds of PrEP available completely free." Right now that's only the case for some people, and only in some provinces. But many advocates, like Tremblay are pushing to change this. Dr. Darrel Tan, a clinician scientist at St. Michael's Hospital in Toronto, says the more options there are for HIV prevention, the better it is for people at risk. "Not everyone has the ability for all kinds of personal, circumstantial, structural reasons to adhere to a daily pill-taking regime," said Tan. "So this is a major advance and really something that meets an existing need." More options for HIV treatment, prevention There are also injectable treatment options for people living with HIV, and promising developments in prevention drugs that last even longer. Trials for the drug lenacapavir showed injections just twice a year were highly-effective against HIV. Ken Monteith, executive director of Quebec's network of AIDS organizations (COCQ-SIDA) in Montreal, said things have evolved since the 1980s, when HIV was a fatal diagnosis with no treatment options. He said activism and advocacy helped push the science forward and that that work continues. Monteith, 64, was diagnosed HIV positive in 1997. He takes antiretroviral medication every day to keep his viral load low. It keeps him healthy and prevents him from transmitting the virus. The daily regiment works for him, but he sees how a long-acting injection could help others — for treatment or prevention. "We want to make sure that people have all the choices possible so that we are adapting their treatment to their lifestyle and not the other way around," said Monteith. Despite advances, experts still see issues in Canada, and globally, that are getting in the way of reaching the United Nation's goal to end AIDS by 2030. Access to screening, treatment and prevention — and awareness about these tools — are barriers in Canada, said Tremblay, at Montreal's CHUM hospital. But she also points to global challenges, including uncertainty around the future of U.S. foreign aid, upon which many HIV programs depend.
CBC
21-03-2025
- Health
- CBC
Quebec becomes 1st province to cover new HIV prevention drug
Quebec is now the first province in Canada to publicly cover part of the cost of a new HIV prevention drug experts call a much-needed intervention. Apretude is a long-acting injectable drug that could replace daily oral pills.
