The world's only twice-a-year shot to prevent HIV could stop transmission — if people can get it
WASHINGTON (AP) — The U.S. has approved the world's only twice-a-year shot to prevent HIV, the first step in an anticipated global rollout that could protect millions – although it's unclear how many in the U.S. and abroad will get access to the powerful new option.
While a vaccine to prevent HIV still is needed, some experts say the shot made by Gilead Sciences — a drug called lenacapavir — could be the next best thing. It nearly eliminated new infections in two groundbreaking studies of people at high risk, better than daily preventive pills they can forget to take.
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Toronto Sun
2 hours ago
- Toronto Sun
U.S. approves world's only twice-a-year shot to prevent HIV transmission
Published Jun 18, 2025 • 4 minute read The Gilead Sciences sign is seen outside their headquarters in Foster City, Calif., on April 30, 2020. The U.S. Food and Drug Administration on June 18, 2025, approved Gilead Sciences' twice-yearly injection to prevent HIV -- a move the company hailed as a major breakthrough in the fight against the sexually transmitted virus. Photo by JOSH EDELSON / AFP via Getty Images WASHINGTON — The U.S. has approved the world's only twice-a-year shot to prevent HIV, the first step in an anticipated global rollout that could protect millions — although it's unclear how many in the U.S. and abroad will get access to the powerful new option. This advertisement has not loaded yet, but your article continues below. THIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLY Subscribe now to read the latest news in your city and across Canada. Unlimited online access to articles from across Canada with one account. Get exclusive access to the Toronto Sun ePaper, an electronic replica of the print edition that you can share, download and comment on. Enjoy insights and behind-the-scenes analysis from our award-winning journalists. Support local journalists and the next generation of journalists. Daily puzzles including the New York Times Crossword. SUBSCRIBE TO UNLOCK MORE ARTICLES Subscribe now to read the latest news in your city and across Canada. Unlimited online access to articles from across Canada with one account. Get exclusive access to the Toronto Sun ePaper, an electronic replica of the print edition that you can share, download and comment on. Enjoy insights and behind-the-scenes analysis from our award-winning journalists. Support local journalists and the next generation of journalists. Daily puzzles including the New York Times Crossword. REGISTER / SIGN IN TO UNLOCK MORE ARTICLES Create an account or sign in to continue with your reading experience. Access articles from across Canada with one account. Share your thoughts and join the conversation in the comments. Enjoy additional articles per month. Get email updates from your favourite authors. THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK. Create an account or sign in to continue with your reading experience. Access articles from across Canada with one account Share your thoughts and join the conversation in the comments Enjoy additional articles per month Get email updates from your favourite authors Don't have an account? Create Account While a vaccine to prevent HIV still is needed, some experts say the shot made by Gilead Sciences — a drug called lenacapavir — could be the next best thing. It nearly eliminated new infections in two groundbreaking studies of people at high risk, better than daily preventive pills they can forget to take. 'This really has the possibility of ending HIV transmission,' said Greg Millett, public policy director at amfAR, The Foundation for AIDS Research. 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 different 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. Your noon-hour look at what's happening in Toronto and beyond. By signing up you consent to receive the above newsletter from Postmedia Network Inc. Please try again This advertisement has not loaded yet, but your article continues below. But upheaval in U.S. health care — including cuts to public health agencies and Medicaid — and slashing of American foreign aid to fight HIV are clouding the prospects. Millett said 'gaping holes in the system' in the U.S. and globally 'are going to make it difficult for us to make sure we not only get lenacapavir into people's bodies but make sure they come back' twice a year to keep up their protection. Read More Gilead's drug already is sold to treat HIV under the brand name Sunlenca. The prevention dose will be sold under a different name, Yeztugo. It's given as two injections under the skin of the abdomen, leaving a small 'depot' of medication to slowly absorb into the body. People must test negative for HIV before getting their twice-a-year dose, Gilead warned. It only prevents HIV transmission — it doesn't block other sexually transmitted diseases. Some researchers who helped test the shot advise cold packs to counter injection-site pain. This advertisement has not loaded yet, but your article continues below. Global efforts at ending the HIV pandemic by 2030 have stalled. There still are more than 30,000 new infections in the U.S. each year and about 1.3 million worldwide. Only about 400,000 Americans already use some form of PrEP, a fraction of those estimated to benefit. A recent study found states with high use of PrEP saw a decrease in HIV infections, while rates continued rising elsewhere. About half of new infections are in women, who often need protection they can use without a partner's knowledge or consent. One rigorous study in South Africa and Uganda compared more than 5,300 sexually active young women and teen girls given twice-yearly lenacapavir or the daily pills. There were no HIV infections in those receiving the shot while about 2% in the comparison group caught HIV from infected sex partners. This advertisement has not loaded yet, but your article continues below. A second study found the twice-yearly shot nearly as effective in gay men and gender-nonconforming people in the U.S. and in several other countries hard-hit by HIV. Ian Haddock of Houston had tried PrEP off and on since 2015 but he jumped at the chance to participate in the lenacapavir study and continues with the twice-yearly shots as part of the research follow-up. 'Now I forget that I'm on PrEP because I don't have to carry around a pill bottle,' said Haddock, who leads the Normal Anomaly Initiative, a nonprofit serving Black LGBTQ+ communities. 'Men, women, gay, straight — it really just kinds of expands the opportunity for prevention,' he added. Just remembering a clinic visit every six months 'is a powerful tool versus constantly having to talk about, like, condoms, constantly making sure you're taking your pill every day.' This advertisement has not loaded yet, but your article continues below. Gilead said the U.S. list price, meaning before insurance, is $28,218 a year, which it called similar to some other PrEP options. The company said it anticipated insurance coverage but also has some financial assistance programs. Most private insurers are supposed to cover PrEP options without a co-pay although the Supreme Court is considering a case that could overturn that requirement. Congress also is considering huge cuts to Medicaid. And while community health centres still are an option, the Trump administration has largely dismantled HIV prevention work at the Centers for Disease Control and Prevention that would normally get the message to vulnerable populations who'd qualify for the shot, said Carl Schmid of the nonprofit HIV+Hepatitis Policy Institute. This advertisement has not loaded yet, but your article continues below. Schmid worries the shot won't meet its potential because 'we're basically pulling the rug out of HIV prevention and testing and outreach programs.' Gilead also has applications pending for the twice-yearly shot in other countries. Last fall, the company signed agreements with six generic drug makers to produce low-cost versions of the shot for 120 poor countries mostly in Africa, Southeast Asia and the Caribbean. Gilead plans to make enough shots to supply 2 million people in those countries, at no profit, until the generics are available, said company senior vice-president Dr. Jared Baeten. Winnie Byanyima, executive director of UNAIDS, said in a statement the price is still too high. If it's unaffordable, she said, 'it will change nothing.' And HIV experts worry the arrangements Gilead has made to reduce costs in some countries leave out middle-income countries like some in Latin America. 'Everyone in every country who's at risk of HIV needs access to PrEP,' said Dr. Gordon Crofoot of Houston, who helped lead the study in men. 'We need to get easier access to PrEP that's highly effective like this is.' NHL Soccer Columnists Editorial Cartoons Canada
Toronto Star
5 hours ago
- Toronto Star
Scientists warn that greenhouse gas accumulation is accelerating and more extreme weather will come
WASHINGTON (AP) — Humans are on track to release so much greenhouse gas in less than three years that a key threshold for limiting global warming will be nearly unavoidable, according to a study to be released Thursday. The report predicts that society will have emitted enough carbon dioxide by early 2028 that crossing an important long-term temperature boundary will be more likely than not. The scientists calculate that by that point there will be enough of the heat-trapping gas in the atmosphere to create a 50-50 chance or greater that the world will be locked in to 1.5 degrees Celsius (2.7 degrees Fahrenheit) of long-term warming since preindustrial times. That level of gas accumulation, which comes from the burning of fuels like gasoline, oil and coal, is sooner than the same group of 60 international scientists calculated in a study last year.
National Observer
5 hours ago
- National Observer
More extreme weather on the way, as greenhouse gas accumulation accelerates, scientists say
WASHINGTON (AP) — Humans are on track to release so much greenhouse gas in less than three years that a key threshold for limiting global warming will be nearly unavoidable, according to a study to be released Thursday. The report predicts that society will have emitted enough carbon dioxide by early 2028 that crossing an important long-term temperature boundary will be more likely than not. The scientists calculate that by that point there will be enough of the heat-trapping gas in the atmosphere to create a 50-50 chance or greater that the world will be locked in to 1.5 degrees Celsius (2.7 degrees Fahrenheit) of long-term warming since preindustrial times. That level of gas accumulation, which comes from the burning of fuels like gasoline, oil and coal, is sooner than the same group of 60 international scientists calculated in a study last year. 'Things aren't just getting worse. They're getting worse faster,' said study co-author Zeke Hausfather of the tech firm Stripe and the climate monitoring group Berkeley Earth. 'We're actively moving in the wrong direction in a critical period of time that we would need to meet our most ambitious climate goals. Some reports, there's a silver lining. I don't think there really is one in this one.' That 1.5 goal, first set in the 2015 Paris agreement, has been a cornerstone of international efforts to curb worsening climate change. Scientists say crossing that limit would mean worse heat waves and droughts, bigger storms and sea-level rise that could imperil small island nations. Over the last 150 years, scientists have established a direct correlation between the release of certain levels of carbon dioxide, along with other greenhouse gases like methane, and specific increases in global temperatures. In Thursday's Indicators of Global Climate Change report, researchers calculated that society can spew only 143 billion more tons (130 billion metric tons) of carbon dioxide before the 1.5 limit becomes technically inevitable. The world is producing 46 billion tons (42 billion metric tons) a year, so that inevitability should hit around February 2028 because the report is measured from the start of this year, the scientists wrote. The world now stands at about 1.24 degrees Celsius (2.23 degrees Fahrenheit) of long-term warming since preindustrial times, the report said. Earth's energy imbalance The report, which was published in the journal Earth System Science Data, shows that the rate of human-caused warming per decade has increased to nearly half a degree (0.27 degrees Celsius) per decade, Hausfather said. And the imbalance between the heat Earth absorbs from the sun and the amount it radiates out to space, a key climate change signal, is accelerating, the report said. 'It's quite a depressing picture unfortunately, where if you look across the indicators, we find that records are really being broken everywhere,' said lead author Piers Forster, director of the Priestley Centre for Climate Futures at the University of Leeds in England. 'I can't conceive of a situation where we can really avoid passing 1.5 degrees of very long-term temperature change.' The increase in emissions from fossil-fuel burning is the main driver. But reduced particle pollution, which includes soot and smog, is another factor because those particles had a cooling effect that masked even more warming from appearing, scientists said. Changes in clouds also factor in. That all shows up in Earth's energy imbalance, which is now 25% higher than it was just a decade or so ago, Forster said. Earth's energy imbalance 'is the most important measure of the amount of heat being trapped in the system,' Hausfather said. Earth keeps absorbing more and more heat than it releases. 'It is very clearly accelerating. It's worrisome,' he said. Crossing the temperature limit The planet temporarily passed the key 1.5 limit last year. The world hit 1.52 degrees Celsius (2.74 degrees Fahrenheit) of warming since preindustrial times for an entire year in 2024, but the Paris threshold is meant to be measured over a longer period, usually considered 20 years. Still, the globe could reach that long-term threshold in the next few years even if individual years haven't consistently hit that mark, because of how the Earth's carbon cycle works. That 1.5 is 'a clear limit, a political limit for which countries have decided that beyond which the impact of climate change would be unacceptable to their societies,' said study co-author Joeri Rogelj, a climate scientist at Imperial College London. The mark is so important because once it is crossed, many small island nations could eventually disappear because of sea level rise, and scientific evidence shows that the impacts become particularly extreme beyond that level, especially hurting poor and vulnerable populations, he said. He added that efforts to curb emissions and the impacts of climate change must continue even if the 1.5 degree threshold is exceeded. Crossing the threshold "means increasingly more frequent and severe climate extremes of the type we are now seeing all too often in the U.S. and around the world — unprecedented heat waves, extreme hot drought, extreme rainfall events, and bigger storms,' said University of Michigan environment school dean Jonathan Overpeck, who wasn't part of the study. Andrew Dessler, a Texas A&M University climate scientist who wasn't part of the study, said the 1.5 goal was aspirational and not realistic, so people shouldn't focus on that particular threshold. 'Missing it does not mean the end of the world,' Dessler said in an email, though he agreed that 'each tenth of a degree of warming will bring increasingly worse impacts.' ___
