US Approves Gilead's Twice-yearly Injection To Prevent HIV
The US Food and Drug Administration on Wednesday 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.
Drugs to prevent HIV transmission, known as pre-exposure prophylaxis or PrEP, have existed for more than a decade. But because they typically require taking a daily pill, they have yet to make a significant dent in global infections.
"This is a historic day in the decades-long fight against HIV," Gilead chairman and chief executive Daniel O'Day said in a statement.
Lenacapavir, marketed under the brand name Yeztugo, has been shown to reduce the risk of HIV transmission by more than 99.9 percent in adults and adolescents -- making it functionally akin to a powerful vaccine.
The company conducted two large clinical trials. The first, involving more than 2,000 women in sub-Saharan Africa, resulted in a 100 percent reduction in infections and demonstrated superiority over the daily oral pill Truvada.
In the second trial, involving over 2,000 men and gender-diverse individuals, only two infections were recorded -- a 99.9 percent prevention rate, again surpassing Truvada.
Reported side effects included injection site reactions, headache, and nausea.
Results from both trials were published in The New England Journal of Medicine, and the journal Science named lenacapavir its 2024 "Breakthrough of the Year."
Despite the impressive results, optimism may be tempered by the drug's expected high cost.
An earlier long-acting HIV prevention shot -- cabotegravir, which is injected every two months and was approved by the FDA in 2021 -- costs tens of thousands of dollars per year and has yet to make a major global impact.
While Gilead hasn't disclosed a price for Yeztugo, analysts estimate the US launch cost could reach $25,000 per year. Lenacapavir's current list price for its previously approved use as a treatment for HIV is $39,000 annually, though that is expected to drop when used as a preventive.
Activists are urging Gilead to drastically cut the price to help end the HIV pandemic.
"Even high-income countries will not be able to afford widescale use of lenacapavir at prices above US $20,000 per year," said Andrew Hill of Liverpool University, who led a team of chemists and scientists that found it could be mass-produced and sold for as little as $25 per person per year.
"I congratulate Gilead and US partners for advancing this important innovation," added Winnie Byanyima, under-secretary-general of the United Nations. "Lenacapavir could be the tool we need to bring new infections under control -- but only if it is priced affordably and made available to everyone who could benefit."
In October, Gilead signed agreements with six pharmaceutical companies to produce and distribute generic versions of the drug, pending regulatory approval, in 120 low- and middle-income countries.
Because it will take time for those countries to begin production, the company also announced a separate deal in December with the Global Fund -- an international partnership established by the United Nations, alongside the US President's Emergency Plan for AIDS Relief (PEPFAR) and others -- to purchase doses for two million people.
However, cuts to the PEPFAR program under President Donald Trump's administration have cast uncertainty over the future of that agreement.
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Int'l Business Times
10 hours ago
- Int'l Business Times
US Approves Gilead's Twice-yearly Injection To Prevent HIV
The US Food and Drug Administration on Wednesday 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. Drugs to prevent HIV transmission, known as pre-exposure prophylaxis or PrEP, have existed for more than a decade. But because they typically require taking a daily pill, they have yet to make a significant dent in global infections. "This is a historic day in the decades-long fight against HIV," Gilead chairman and chief executive Daniel O'Day said in a statement. Lenacapavir, marketed under the brand name Yeztugo, has been shown to reduce the risk of HIV transmission by more than 99.9 percent in adults and adolescents -- making it functionally akin to a powerful vaccine. The company conducted two large clinical trials. The first, involving more than 2,000 women in sub-Saharan Africa, resulted in a 100 percent reduction in infections and demonstrated superiority over the daily oral pill Truvada. In the second trial, involving over 2,000 men and gender-diverse individuals, only two infections were recorded -- a 99.9 percent prevention rate, again surpassing Truvada. Reported side effects included injection site reactions, headache, and nausea. Results from both trials were published in The New England Journal of Medicine, and the journal Science named lenacapavir its 2024 "Breakthrough of the Year." Despite the impressive results, optimism may be tempered by the drug's expected high cost. An earlier long-acting HIV prevention shot -- cabotegravir, which is injected every two months and was approved by the FDA in 2021 -- costs tens of thousands of dollars per year and has yet to make a major global impact. While Gilead hasn't disclosed a price for Yeztugo, analysts estimate the US launch cost could reach $25,000 per year. Lenacapavir's current list price for its previously approved use as a treatment for HIV is $39,000 annually, though that is expected to drop when used as a preventive. Activists are urging Gilead to drastically cut the price to help end the HIV pandemic. "Even high-income countries will not be able to afford widescale use of lenacapavir at prices above US $20,000 per year," said Andrew Hill of Liverpool University, who led a team of chemists and scientists that found it could be mass-produced and sold for as little as $25 per person per year. "I congratulate Gilead and US partners for advancing this important innovation," added Winnie Byanyima, under-secretary-general of the United Nations. "Lenacapavir could be the tool we need to bring new infections under control -- but only if it is priced affordably and made available to everyone who could benefit." In October, Gilead signed agreements with six pharmaceutical companies to produce and distribute generic versions of the drug, pending regulatory approval, in 120 low- and middle-income countries. Because it will take time for those countries to begin production, the company also announced a separate deal in December with the Global Fund -- an international partnership established by the United Nations, alongside the US President's Emergency Plan for AIDS Relief (PEPFAR) and others -- to purchase doses for two million people. However, cuts to the PEPFAR program under President Donald Trump's administration have cast uncertainty over the future of that agreement.
DW
06-06-2025
- DW
Fecal transplants: Study is a 'wake-up call' for the field – DW – 06/06/2025
They are hailed as a promising method to restore gut microbiomes, but a study suggests fecal transplants may bring unintended health risks. Fecal microbial transplants (FMTs) can be traced back to the 4th Century, but it is only since their approval by the US Food and Drug Administration in past decade that the procedure has entered wide practice. They have been hailed as a treatment for Clostridium difficile or a common bacterial infection that can cause inflammation and gastrointestinal issues. The FDA first approved FMTs as a treatment for in 2013 and approved the first drug for FMT treatment in 2022. Some think FMTs may also be an option for treating Crohn's disease— a chronic autoimmune condition — ulcerative colitis and irritable bowel disorder. But researchers warned in a study published June 6, 2025, that FMTs may introduce microbes that could hijack the host environment to suit their needs and thrive, potentially introducing new health risks. The study, which was performed in mice, human tissue samples and with a small volunteer group, found "mismatches" between the donor fecal matter and destination gut environment could have unintended consequences on the recipient's immune and metabolic function. "Even a single FMT will cause a change in the host-microbe relationships in these very different regions of the bowel that may be very difficult to reverse," said Eugene Chang, the study's senior author and a professor of medicine at the University of Chicago, US, in a press statement. How does a fecal transplant work? Every human has a unique mix of microbes in their gastrointestinal tract — the gut. This includes trillions of bacteria, fungi, viruses and other microorganisms that perform biological duties within the body. Collectively, this collection of microbes is called gut flora. For some people, this ecosystem of microbes is disrupted by infections, autoimmune issues and other problems. This disrupted state is called gut dysbiosis. FMT donors need to meet a range of requirements: For instance, they must be free of blood-related infections, such as hepatitis and HIV, and they cannot have gut issues themselves. Doctors usually perform a colonoscopy to extract the donor's stool and, after further preparation, insert the donor microbes via a long tube into the recipient's gut. How does a Fecal Microbiota Transplant work? To view this video please enable JavaScript, and consider upgrading to a web browser that supports HTML5 video Colonizing the colon In the study, microbes were taken from three separate regions of the small and large intensities and implanted into mice recipients. Each batch of newly introduced gut flora appeared to take over — or, as described by the researchers, "terraform" — the entire intestinal tract of each mouse, rather than simply occupying the same region they originated from in the donor's gut. The colonizing microbes also transformed genes and proteins in the tissues of the recipient mice to make a more accommodating environment — even at a microbial level, these introduced species appeared to thrive. An assessment in seven human volunteers over a month also found high levels of microbe colonization in the small intestine. Because this caused modifications to immune and metabolic functions, the researchers say greater care should be given to designing fecal transplants that use specific, targeted microbes for the intestines. The gut is not only for digestion To view this video please enable JavaScript, and consider upgrading to a web browser that supports HTML5 video A 'wake-up call' for the FMT field The study's lead author, Orlando DeLeon, University of Chicago, said it was a "wake-up call to the field that maybe we shouldn't willy-nilly put large bowel microbes into different parts of the intestine that shouldn't be there." OMT — omni microbial transplantation — administers a batch of good gut flora as a pill or through endoscopy, targeting specific intestinal regions with "matched" microbes. DeLeon said it's a better way forward for fecal transplants. "The microbes that were supposed to be there are better suited for it," said DeLeon, "so they're more naturally going to fill it even in the presence of other microbes." DW approached the research group for further comment but did not receive a response in time for publication. Ed Kuijper, an expert at the Leiden University Medical Centre, Netherlands, who was not involved in the study, told DW via email that the research "clearly demonstrates that FMT […] affects the microbiota composition throughout the entire intestinal tract, in both humans and mice." But Kuijper said he had concerns with the conclusion that FMT leads to "microbiota mismatches" and "unintended consequences" in various regions of the intestinal tract. Just as the research team acknowledged the limitations of only investigating seven human subjects over a month, Kuijper said a more extensive assessment in patients would be important to conclusively assess the potential negative health outcomes of fecal transplants. "A more appropriate conclusion would be that FMT induces changes in both the small and large intestines in mice, with systemic effects that vary depending on the region affected. It remains unclear if these changes persist in humans." In Europe, an inter-organization group called EurFMT exchanges research and information, and maintains a continental registry for patient follow-up. Edited by: Zulfikar Abbany
DW
03-06-2025
- DW
US Aid cuts hit schools and clinics in Africa – DW – 06/03/2025
Favour Ubanyi | Sella Oneko | Dianne Hawker 06/03/2025 June 3, 2025 We asked our correspondents in Kenya, South Africa, and Nigeria about the im-pact of aid cuts. In Kenya, patients struggle to access vital medication. In South Africa, people with HIV face shortages of antiretroviral drugs. In Nigeria, over 95% of healthcare workers are out of work, and school programs have been halted. Can these countries build local, independent support systems?
