Latest news with #Gilead
IOL News
5 hours ago
- Health
- IOL News
Why the world must aim to eliminate PEPFAR and end the HIV epidemic
Last week, the President's Emergency Plan for AIDS Relief narrowly escaped a devastating $400 million budget cut thanks to Republican Sens. Susan Collins (Maine) and Lisa Murkowski (Alaska), who voted alongside their Democratic colleagues to protect the program. That was a relief: Since its creation under President George W. Bush in 2003, the anti-HIV/AIDS program has saved an estimated 26 million lives and allowed 7.8 million babies to be born HIV-free. But preserving PEPFAR shouldn't be seen as the end goal. Instead, global health officials should be working toward the day when the world no longer needs it. That ambitious goal might sound far-fetched, given that an estimated 1.3 million people were newly infected with HIV in 2023 globally. But consider this: Last month, the Food and Drug Administration approved a drug called lenacapavir, a twice-yearly injectable treatment that clinical trials have shown is 100 percent effective at preventing HIV infection among young women and 96 percent effective among gay and bisexual men and transgender people. The drug has the potential to be a groundbreaking improvement over the current standard for HIV prevention, oral PrEP (pre-exposure prophylaxis treatment). For all its promise, oral PrEP has confronted the difficult realities of human behaviour. Adhering to a daily medication regimen is challenging under any circumstances, but especially so in communities where HIV-related stigma is pervasive. Even in wealthier countries, gay men who take the medication have been disparaged. Oral PrEP also tends to be less effective in women, though studies differ on whether this is due to lower adherence and access barriers or biological differences in how the medication is absorbed in female anatomy. Lenacapavir, manufactured by Gilead Sciences, could help address these challenges. It is discreet and can be administered privately in a clinical setting. It requires dosing only twice a year, and it is easier and less painful to administer than previous injectable drugs to prevent HIV. In the United States, lenacapavir costs more than $28,000 per person per year before insurance. But Gilead has licensed six generic manufacturers to produce the drug at cost for 120 low- and middle-income countries. Together with the Global Fund, the company has pledged to distribute 2 million doses - still a drop in the bucket compared to what's needed for population-level protection, but a meaningful start. Video Player is loading. Play Video Play Unmute Current Time 0:00 / Duration -:- Loaded : 0% Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Transparency Opaque Semi-Transparent Background Color Black White Red Green Blue Yellow Magenta Cyan Transparency Opaque Semi-Transparent Transparent Window Color Black White Red Green Blue Yellow Magenta Cyan Transparency Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Dropshadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. Advertisement Next Stay Close ✕ Ad loading Of course, the drug is no silver bullet. Unfortunately none of the licensed generic manufacturers are based in sub-Saharan Africa, the region with the greatest need, and scaling up production could take years. So far, the U.S. is the only country to approve it, and regulatory timelines elsewhere are likely to lag. Nevertheless, lenacapavir is exciting for what it represents: An innovation that can draw PEPFAR into a new era defined not by fighting HIV, but ending it. Advocates of the program should remember that it was designed as an emergency response to an uncontained pandemic; for it to become a permanent fixture of global health would constitute a failure of its mission. Moreover, the program is far from perfect. Like many HIV prevention programs, it often sacrifices preventative care for treatment when budgets tighten. Those trade-offs stand in the way of HIV elimination. The program is also, regrettably, subject to the whims of U.S. politics. In February, Secretary of State Marco Rubio restricted HIV prevention aid so that only pregnant and breastfeeding women can receive it - as if to invite more AIDS epidemics. The world has a long way to go until PEPFAR can safely be shuttered. After all, foundations and private companies cannot replace the program, which provides nearly 70 percent of global financing for HIV/AIDS response. But it's possible to imagine a future in which biomedical science and investments into a sustainable health infrastructure make the program obsolete. That's something the world should strive for. - The Washington Post
Associated Press
8 hours ago
- Health
- Associated Press
Looking Back to the Future: Gilead's Long-Standing Commitment To Help End the HIV Epidemic
In June 1981, news of a mysterious disease first began making headlines out of San Francisco, Los Angeles and New York. People who were impacted developed unusual infections and grew sick as their immune systems failed. Those early days of what we now know as the HIV epidemic were marked by great fear and loss. By the time the first medicine was introduced in the United States in 1987, more than 5,000 people had died and the number of people impacted continued to balloon. In the decades since then, Gilead has been committed to relentless innovation to treat and prevent HIV – and its scientific advances have helped reshape the course of the epidemic: The company created the first single-tablet daily HIV treatment in 2006. Prior to this innovation, the first therapies to treat HIV required people to often take more than 20 pills a day and deal with potentially numerous side effects. Six years later, in 2012, Gilead again brought another tool to fight the epidemic when its first HIV prevention medicine was approved. Still a host of social factors, including stigma and access, have continued to contribute to the human toll and economic impact that HIV has had around the world. In the U.S. alone, 100 people die from HIV-related illnesses and 700 people are newly diagnosed each week. Thus, Gilead remains steadfastly committed to helping end the epidemic. Gilead is at the forefront of pioneering innovations in HIV, providing prevention and treatment options that help meet unmet needs. The company closed out 2024 earning the Breakthrough of the Year honor by Science magazine for one of its innovations in HIV. For Gilead, this new chapter of innovation in HIV is driven by two primary themes: putting people first and long-acting prevention options. Putting people first means, in part, partnering with communities early in the clinical development process. Researchers worked with the community in the design of its groundbreaking PURPOSE HIV prevention program. For example, researchers worked with the community in the design of its groundbreaking PURPOSE HIV prevention program, which is considered to be the most comprehensive and diverse of any HIV prevention program conducted. 'To make substantial progress, we must be intentional about both the scientific and community-based factors that help shape the epidemic,' says Moupali Das, Vice President, Clinical Development, HIV Prevention & Pediatrics. 'It's critical to focus on groups who are disproportionately affected by HIV and who most need new options for prevention.' Gilead also goes beyond investing in world-class science and putting people at the center of the drug development process. It also works with community organizations and global partners to reduce barriers to care and help enable access to its medicines. 'To help stop HIV, we need to help enable access to our medicines to everyone who could benefit, no matter who or where they are,' says Janet Dorling, Senior Vice President, Intercontinental Region, and Gilead Patient Solutions (GPS). Staying true to the company's heritage of pioneering access programs, Gilead is committed to supplying its medicines where the need is greatest. Ultimately, it will take a combination of bold, scientific innovation coupled with partnerships to help end the epidemic that has taken the lives of more than 42 million people since the 80s. 'We have a responsibility to help end one of the greatest public health challenges of our time,' says Daniel O'Day, Chairman and Chief Executive Officer. 'The opportunity to end the HIV epidemic has never been greater.' Originally published by Gilead Sciences Visit 3BL Media to see more multimedia and stories from Gilead Sciences
The Star
13 hours ago
- Health
- The Star
Lenacapavir: A game changer for HIV prevention in South Africa
"This is a game changer for South Africa," said Health Minister Aaron Motsoaledi as T he Global Fund to Fight AIDS, Tuberculosis and Malaria on Wednesday secured access to breakthrough HIV prevention for low and middle income countries. "Lenacapavir offers young women, and everyone at risk, a discreet, long-acting option to stay HIV-free. " For far too long, women and girls in our country have carried the greatest burden of this epidemic. "But scientific breakthroughs must be backed by political will, community leadership, and sustained investment. We are determined to ensure no one is left behind.' The deal signed between with US pharmaceutical giant Gilead and the Global Fund will mean lower-income countries will gain access to a the HIV prevention drug at the same time as in high-income countries. There was particular urgency in countries like South Africa, where adolescent girls and young women are disproportionately affected by HIV. The Global Fund said it hoped the agreement with Gilead would make it possible to reach two million people with the drug, which was approved by the US Food and Drug Administration last month. 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.
Yahoo
6 days ago
- Health
- Yahoo
GSK's Linerixibat Poised to Address Substantial Unmet Need for the Treatment of Pruritus Associated with Primary Biliary Cholangitis, According to Spherix Global Insights
Despite new market entrants in the form of Gilead's Livdelzi and Ipsen's Iqirvo, US gastroenterologists report nearly half of PBC patients suffer from moderate to severe pruritus, underscoring an existing unmet need. EXTON, PA, July 17, 2025 (GLOBE NEWSWIRE) -- The treatment landscape for primary biliary cholangitis (PBC) has undergone a marked transformation over the past year, driven by the recent approvals of Gilead's Livdelzi (seladelpar) and Ipsen's Iqirvo (elafibranor). These additions to the therapeutic arsenal represent meaningful progress in disease management. However, new data from Spherix Global Insights' Market Dynamix™: Primary Biliary Cholangitis and Primary Sclerosing Cholangitis 2025 (US) reveal that pruritus—a persistent and often debilitating symptom—continues to pose a significant unmet need for many patients living with PBC. Among the 104 US gastroenterologists surveyed in the study, there was near-universal agreement on the importance of addressing pruritus—one of the most burdensome and distressing symptoms associated with PBC. Respondents estimated that approximately half of their PBC patients suffer from moderate to severe pruritus, a manifestation that significantly impacts quality of life and remains challenging to manage. As one specialist poignantly noted, 'Patients with cholestatic liver disease will go to the world's end to escape from pruritus and the insomnia it causes.' Most gastroenterologists surveyed also acknowledged a substantial unmet need for therapies specifically targeting PBC-associated pruritus. While Livdelzi has demonstrated a significant reduction in itch symptoms after six months of treatment, only about half of respondents reported that their patients on Livdelzi required no additional intervention for pruritus. The need for effective symptom control is even more pronounced among patients receiving Iqirvo, further highlighting the gap in adequate pruritus management and the continued demand for novel therapeutic approaches. In June, GSK announced that the FDA had accepted the New Drug Application (NDA) for its ileal bile acid transporter (IBAT) inhibitor, linerixibat, for the treatment of cholestatic pruritus in patients with PBC. The PDUFA target action date is set for March 24, 2026. Awareness of the IBAT class is already high among gastroenterologists, and most report they are likely to incorporate linerixibat into their treatment armamentarium if approved. As one specialist expressed, 'The results seem promising with a significant symptom reduction among moderate to severe pruritus. However, abdominal pain and diarrhea side effects are somewhat concerning and may limit real-world use.' Another echoed the sentiment, noting, 'It significantly improved symptoms of pruritus along with quality of life, which can be a challenging and quite debilitating symptom to treat.' If approved, linerixibat could represent a meaningful advancement for patients struggling with PBC-related pruritus—a symptom that continues to profoundly impair quality of life and remains inadequately addressed by current therapies. Spherix Global Insights will continue to closely track emerging developments across the PBC treatment landscape and pipeline through its Market Dynamix™: Primary Biliary Cholangitis and Primary Sclerosing Cholangitis service. Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a paradigm shift within the next three to five years. Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit or connect through LinkedIn. For more details on Spherix's primary market research reports and interactive dashboard offerings, visit or register here: NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and analysis addressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release. CONTACT: Jim Hickey, Gastroenterology Franchise Head Spherix Global Insights 4848794284 in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
6 days ago
- Health
- Yahoo
GSK's Linerixibat Poised to Address Substantial Unmet Need for the Treatment of Pruritus Associated with Primary Biliary Cholangitis, According to Spherix Global Insights
Despite new market entrants in the form of Gilead's Livdelzi and Ipsen's Iqirvo, US gastroenterologists report nearly half of PBC patients suffer from moderate to severe pruritus, underscoring an existing unmet need. EXTON, PA, July 17, 2025 (GLOBE NEWSWIRE) -- The treatment landscape for primary biliary cholangitis (PBC) has undergone a marked transformation over the past year, driven by the recent approvals of Gilead's Livdelzi (seladelpar) and Ipsen's Iqirvo (elafibranor). These additions to the therapeutic arsenal represent meaningful progress in disease management. However, new data from Spherix Global Insights' Market Dynamix™: Primary Biliary Cholangitis and Primary Sclerosing Cholangitis 2025 (US) reveal that pruritus—a persistent and often debilitating symptom—continues to pose a significant unmet need for many patients living with PBC. Among the 104 US gastroenterologists surveyed in the study, there was near-universal agreement on the importance of addressing pruritus—one of the most burdensome and distressing symptoms associated with PBC. Respondents estimated that approximately half of their PBC patients suffer from moderate to severe pruritus, a manifestation that significantly impacts quality of life and remains challenging to manage. As one specialist poignantly noted, 'Patients with cholestatic liver disease will go to the world's end to escape from pruritus and the insomnia it causes.' Most gastroenterologists surveyed also acknowledged a substantial unmet need for therapies specifically targeting PBC-associated pruritus. While Livdelzi has demonstrated a significant reduction in itch symptoms after six months of treatment, only about half of respondents reported that their patients on Livdelzi required no additional intervention for pruritus. The need for effective symptom control is even more pronounced among patients receiving Iqirvo, further highlighting the gap in adequate pruritus management and the continued demand for novel therapeutic approaches. In June, GSK announced that the FDA had accepted the New Drug Application (NDA) for its ileal bile acid transporter (IBAT) inhibitor, linerixibat, for the treatment of cholestatic pruritus in patients with PBC. The PDUFA target action date is set for March 24, 2026. Awareness of the IBAT class is already high among gastroenterologists, and most report they are likely to incorporate linerixibat into their treatment armamentarium if approved. As one specialist expressed, 'The results seem promising with a significant symptom reduction among moderate to severe pruritus. However, abdominal pain and diarrhea side effects are somewhat concerning and may limit real-world use.' Another echoed the sentiment, noting, 'It significantly improved symptoms of pruritus along with quality of life, which can be a challenging and quite debilitating symptom to treat.' If approved, linerixibat could represent a meaningful advancement for patients struggling with PBC-related pruritus—a symptom that continues to profoundly impair quality of life and remains inadequately addressed by current therapies. Spherix Global Insights will continue to closely track emerging developments across the PBC treatment landscape and pipeline through its Market Dynamix™: Primary Biliary Cholangitis and Primary Sclerosing Cholangitis service. Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a paradigm shift within the next three to five years. Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit or connect through LinkedIn. For more details on Spherix's primary market research reports and interactive dashboard offerings, visit or register here: NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and analysis addressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release. CONTACT: Jim Hickey, Gastroenterology Franchise Head Spherix Global Insights 4848794284 in to access your portfolio
