Latest news with #JulieSteenhuysen
Time of India
19-06-2025
- Health
- Time of India
US FDA approves Gilead's twice-yearly injection for HIV prevention
By Deena Beasley and Julie Steenhuysen Los Angeles: The U.S. Food and Drug Administration on Wednesday approved Gilead Sciences lenacapavir , a twice-yearly injection, for preventing HIV infection in adults and adolescents at high risk of contracting the deadly virus. Investors and AIDS activists had been eagerly awaiting the regulatory decision for the drug seen as convenient enough to help end the 44-year-old HIV epidemic. It will be sold under the brand name Yeztugo in the U.S. at a list price of $28,218 a year. Lenacapavir, part of a class of drugs known as capsid inhibitors, proved nearly 100% effective at preventing HIV in large trials last year, raising new hope of interrupting transmission of the virus that infects 1.3 million people a year. Yeztugo "will only be as effective as it is accessible and affordable," Kevin Robert Frost, CEO of the Foundation for AIDS Research, said in a statement, calling on Gilead and the U.S. government to make sure people who want lenacapavir can get it. Gilead said it is working to secure health insurer coverage. It said it will provide co-pay assistance for eligible insured people, and the drug may be available free of charge for some under its program for the uninsured. Medications to prevent HIV, known as pre-exposure prophylaxis, or PrEP, are widely available. But most are daily pills, including low-cost generic versions of Gilead's older drug Truvada, that require strict adherence to be effective. Gilead said Yeztugo is priced in line with other branded drugs. "This is a milestone moment," said Gilead Chief Executive Daniel O'Day of the approval. "We believe that lenacapavir is the most important tool we have yet to bend the arc of the epidemic and move this epidemic into the history books," O'Day said. Availability of a twice-yearly HIV prevention tool is "a huge advance," that could help change the course of the epidemic, Dr. Raphael Landovitz, director of the UCLA Center for Clinical AIDS Research & Education, said in an email. But he said the product's high launch price "is almost certainly going to complicate payor coverage and access." Gilead has plans for a rapid launch in the United States as well as a wider rollout of the drug in collaboration with global partners. Gilead's chief commercial officer, Johanna Mercier, said the company's "end game" is to normalize PrEP usage, both in the United States and other countries, including low-income African nations where the virus is most prevalent. Citi Research analyst Geoff Meacham said he expects Yeztugo's launch to be slow and steady, reaching annual sales of $2.8 billion by 2030. Mercier said she expects around 75% of U.S. insurers, including government health plans, will cover lenacapavir for PrEP within about six months, with the number rising to 90% within 12 months of launch. The drug is currently sold as a treatment in the U.S. under the brand name Sunlenca for patients with advanced disease that has become resistant to other drugs. PEPFAR CUTS In December, the President's Emergency Plan for AIDS Relief (PEPFAR) under then-President Joe Biden signed an agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria to provide the treatment to as many as 2 million people for three years if it won U.S. regulatory approval for prevention. That would allow for unprecedented early access to a state-of-the-art treatment, as six generic drugmakers that have licensed the product from Gilead gear up for production of low-cost versions in 120 resource-limited countries. AIDS activists have viewed the drug as a way to significantly slow the epidemic, but cuts to PEPFAR by the Trump administration have raised concerns about the U.S. government's commitment to the rollout. O'Day acknowledged that the changes have been "challenging," but said the company has continued to have discussions with both the Global Fund and PEPFAR. "I believe that there will be sources of funding for this, and that these organizations will prioritize this type of prevention," he said.
Yahoo
05-06-2025
- Health
- Yahoo
US COVID vaccine recommendations sow confusion among doctors, insurers
By Julie Steenhuysen and Amina Niasse CHICAGO (Reuters) -Health Secretary Robert F. Kennedy Jr.'s intervention in COVID-19 vaccine recommendations without input from a key U.S. CDC advisory panel has sown confusion among physicians and insurers over who should get the shots and whether they will be covered, experts told Reuters. Kennedy, a long-time vaccine skeptic, in a video posted on social media last week said the government was dropping its recommendation that healthy children and pregnant women should receive COVID shots. Days later, the Centers for Disease Control and Prevention updated its recommended childhood vaccine schedule online to show the shots could be given to healthy children when parents and doctors agree they are needed. It removed its recommendation that pregnant women should receive the shot. The moves sidestepped the normal process in which a panel of outside experts to the CDC - the Advisory Committee on Immunization Practices - reviews data in a public meeting and votes on vaccine recommendations. The ACIP recommendations are sent to the CDC director for approval and incorporated in the agency's vaccine schedule, which helps determine insurance coverage under the Affordable Care Act. "The surprise announcement has created uncertainty for payers and providers about whether the video posting constitutes an official policy change," said Sarah Moselle, a principal at health consultancy Avalere. Insurers will wait to make coverage decisions until after ACIP makes a recommendation at its upcoming meeting scheduled for June 25-27, according to Robert Popovian, founder of healthcare consultancy Conquest Advisors. The Department of Health and Human Services overseen by Kennedy said the move was within its legal and regulatory authority and reflects the agency's move toward clinical-guided decision making, a department spokesperson said. HHS will continue to rely on the work of expert panels, including ACIP, he said, noting that the committee will be meeting this month. The meeting agenda will be released in accordance with prior practice. Determinations on coverage are up to insurance providers, the spokesperson said. The CDC has previously recommended the COVID shot for everyone aged 6 months and older. 'AWAITING CLARITY' "This whole thing is so murky," said an ACIP member who spoke on condition of anonymity. "It's very unclear whose decision is final." Infectious Diseases Society of America President Dr. Tina Tan said the conflicting COVID vaccine guidance could cause "significant confusion among medical professionals and the public." Dr. Matthew Zahn, an Orange County, California, public health official at OC Health Care Agency who serves as a liaison to the CDC's advisory panel, said: "We're all awaiting clarity." "It's going to be important to understand how these vaccines are insured," Zahn said. "Specifically, if ultimately there is a recommendation for high-risk populations to be vaccinated, how that is interpreted by insurance companies and thus, how providers can recommend it." Zahn expects CDC to clarify its guidance in the weeks ahead, though he could not comment on whether that will be at the ACIP meeting. On Tuesday, Reuters reported that pediatric infectious disease expert Dr. Lakshmi Panagiotakopoulos, a CDC official who helped oversee the expert panel on COVID vaccines, told colleagues she was leaving her post as she was "no longer able to help the most vulnerable members" of the U.S. population. The American College of Obstetricians and Gynecologists raised concerns on May 27 that the HHS decision not to recommend COVID vaccines during pregnancy would make it harder for pregnant women to get the shot "despite the clear and definitive evidence demonstrating its benefit." The Affordable Care Act generally requires insurers to cover vaccines that are listed on ACIP's vaccine schedule, according to the CDC's website. Narrowing coverage without knowing what ACIP recommends could put insurers at risk, Popovian said. "It's a liability," he said, adding that insurers need clarity on what they will be required to cover. A source familiar with plans for the meeting said the panel is expected to consider and vote on COVID-19 vaccines for the upcoming autumn and winter season, adding that the panel had been leaning toward narrowing its recommendations. The advisory panel has yet to receive an agenda for the upcoming meeting, the source said, and it is unclear whether Kennedy would override any deviation from his announced policy.
Yahoo
01-06-2025
- Business
- Yahoo
Blood test-guided treatment with AstraZeneca pill cuts breast cancer progression risk
By Julie Steenhuysen CHICAGO (Reuters) -Treating breast cancer patients with AstraZeneca's experimental pill camizestrant at the first sign of resistance to standard therapies cut the risk of disease progression or death by half, a finding that could be practice changing, experts said on Sunday. The results, presented at the American Society of Clinical Oncology meeting in Chicago, mark the first use of a blood test called a liquid biopsy to indicate the need for a change in treatment in women with a common form of breast cancer, even before tumor growth can be detected on imaging. The early switch approach in women with hormone receptor-positive, HER2-negative breast cancer resulted in a 56% reduction in the risk of disease progression or death, said Dr. Eleonora Teplinsky, an oncologist at Valley-Mount Sinai Comprehensive Cancer Care and an ASCO breast cancer expert. "When patients progress on scans, we're already behind," Teplinsky said at a media briefing. She said an early switch approach, before disease progression, allows doctors "to essentially stay ahead of the curve." Camizestrant is not yet FDA-approved, but Teplinsky said she believes the data will likely result in a new treatment paradigm. The trial involved 3,256 patients with advanced hormone receptor-positive, HER2-negative breast cancer, the most common type in which hormones such as estrogen fuel cancer growth. These cancers lack high levels of HER2, another cancer driver. Women in the trial had at least six months of treatment with aromatase inhibitors that block hormones fueling the cancer, as well as targeted drugs called CDK4/6 inhibitors such as Novartis' Kisqali, Pfizer's Ibrance or Eli Lilly's Verzenio, which block an enzyme that fuels cancer growth. About 40% of patients treated with aromatase inhibitors develop mutations in the estrogen receptor 1 gene called ESR1 mutations, a sign of early drug resistance. Camizestrant and similar drugs called selective estrogen receptor degraders, or SERDS, block estrogen receptor signaling in cancer cells. In the trial, researchers used blood tests to look for ESR1 mutations until 315 patients were identified. They were randomly assigned to either switch to camizestrant plus the CDK4/6 inhibitor or continue with standard treatment plus a placebo. The researchers found that it took 16 months for the disease to progress in women who got camizestrant, compared with 9.2 months in those who continued on standard therapy, a statistically significant difference in a measure known as progression-free survival. No new side effects were reported and few patients from either group dropped out due to side effects. "This is going to be very impactful for our patients," said Dr. Hope Rugo, head of breast medical oncology at City of Hope in Duarte, California. The question, she said, is how do doctors incorporate the testing into clinical practice. THE FUTURE OF CANCER TREATMENT AstraZeneca Chief Executive Pascal Soriot in a press briefing acknowledged that monitoring patients for drug resistance before cancer progresses would require a switch in practice, but said it represents the future of cancer treatment. "It will be complicated in the beginning," he said, "but over time, like everything else, we will manage to simplify it and it will become part of what people do." In a separate trial, adding AstraZeneca's immunotherapy Imfinzi to standard treatment before and after surgery in patients with early-stage stomach and esophageal cancers helped delay cancer progression or recurrence compared to chemotherapy alone. The global study of nearly 950 patients tested Imfinzi, known chemically as durvalumab, in combination with a chemotherapy regimen called FLOT given around the time of initial cancer surgery. The durvalumab plus FLOT combination led to a 29% reduction in disease recurrence, progression or death, referred to as event-free survival, compare with those who received the chemotherapy regimen alone. "We demonstrate that immunotherapy works in early-stage disease, which is great," lead study author Dr. Yelena Janjigian of Memorial Sloan Kettering Cancer Center in New York told reporters at the meeting. "We did not see any new safety signals, so this will change practice for our patients, which is exciting to see." Both studies were also published on Sunday in the New England Journal of Medicine.
Yahoo
01-06-2025
- Business
- Yahoo
Blood test-guided treatment with AstraZeneca pill cut risk of breast cancer progression, study finds
By Julie Steenhuysen CHICAGO (Reuters) -Treating breast cancer patients with AstraZeneca's experimental pill camizestrant at the first sign of resistance to standard treatments cut the risk of disease progression or death by half, a finding that could change the way such cancers are treated, cancer experts said on Sunday. The results, presented at the American Society of Clinical Oncology meeting in Chicago, mark the first use of a blood test called a liquid biopsy to indicate the need for a change in treatment in women with a common form of breast cancer, even before tumor growth can be detected on imaging. The early switch approach in women with hormone receptor-positive, HER2-negative breast cancer resulted in a 56% reduction in the risk of disease progression or death, said Dr. Eleonora Teplinsky, an oncologist at Valley-Mount Sinai Comprehensive Cancer Care and an ASCO breast cancer expert. "When patients progress on scans, we're already behind," Teplinsky said at a media briefing. She said an early switch approach, before disease progression, allows doctors "to essentially stay ahead of the curve." Camizestrant is not yet FDA-approved, but Teplinsky believes the data will likely result in a new treatment paradigm. The trial involved 3,256 patients with advanced hormone receptor-positive, HER2-negative breast cancer, the most common type in which hormones such as estrogen fuel cancer growth. These cancers lack high levels of HER2, another cancer driver. Women in the trial had at least six months of treatment with aromatase inhibitors that block hormones fueling the cancer, as well as targeted drugs called CDK4/6 inhibitors such as Novartis' Kisqali, Pfizer's Ibrance or Lilly's Verzenio, which block an enzyme that fuels cancer growth. About 40% of patients treated with aromatase inhibitors develop mutations in the estrogen receptor 1 gene called ESR1 mutations, a sign of early drug resistance. Camizestrant and similar drugs called Selective Estrogen Receptor Degraders (SERDS) block estrogen receptor signaling in cancer cells. In the trial, researchers used blood tests to look for ESR1 mutations until 315 patients were identified. They were randomly assigned to either switch to camizestrant plus the CDK4/6 inhibitor (157 patients) or continue with standard treatment plus a placebo (158 patients). The researchers found that it took 16 months for the disease to progress in women who got camizestrant, compared with 9.2 months in those who continued on standard therapy, a statistically significant difference in progression-free survival. No new side effects were reported and few patients from either group dropped out due to side effects. "This is going to be very impactful for our patients," said Dr. Hope Rugo, head of breast medical oncology at City of Hope in Duarte, California. The question, she said, is how do doctors incorporate the testing into clinical practice. Separately, adding AstraZeneca's immunotherapy durvalumab to standard treatment before and after surgery in patients with early-stage stomach and esophageal cancers helped extend the time patients had without cancer progression or recurrence compared to chemotherapy alone. The global study of nearly 950 patients tested durvalumab, sold under the brand Imfinzi, in combination with a chemotherapy regimen called FLOT given around the time of initial cancer surgery. Patients in the durvalumab plus FLOT arm experienced a 29% better event-free survival than those who received the chemotherapy regimen. "We demonstrate that immunotherapy works in early-stage disease, which is great," lead study author Dr. Yelena Jarnigan of Memorial Sloan Kettering Cancer Center in New York told reporters at the meeting. "We did not see any new safety signals, so this will change practice for our patients, which is exciting to see." Both studies were published on Sunday in the New England Journal of Medicine.
Yahoo
30-05-2025
- Business
- Yahoo
Gilead commits to HIV prevention rollout for low-income countries despite funding uncertainty
By Julie Steenhuysen and Deena Beasley (Reuters) -Gilead Sciences says it still plans to supply its twice-yearly injection for preventing HIV infection in low-income countries if it wins U.S. approval despite funding uncertainty over the Trump Administration's pullback in aid spending. Some AIDS experts, including activists and doctors, say the Gilead drug, lenacapavir, could help end the 44-year-old epidemic that infects 1.3 million people a year and is estimated by the World Health Organization to have killed more than 42 million. An FDA approval decision is expected by June 19 for lenacapavir, which proved to be nearly 100% effective at preventing HIV in large trials. If the Food and Drug Administration green lights the drug, and its view is seconded by the WHO, the shots could start to roll out early in 2026 to at least 2 million people in 18 low-income countries based on Gilead's agreement with the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund, a worldwide partnership targeting HIV, tuberculosis and malaria. Gilead agreed to provide lenacapavir at cost for two-to-three years while six generic drugmakers, which were granted licenses to make the medicine for low-income countries, ramp up production. Experts said a successful launch of a long-acting HIV prevention drug could help stall the epidemic. Until recently, the only pre-exposure prophylaxis (PrEP) options for people at high risk of infection were daily pills, requiring careful adherence to be effective. "You can foresee a day where there are no new HIV diagnoses. It doesn't happen if we only do this in the U.S.," Gilead Chief Commercial Officer Johanna Mercier said. "We need to make sure we have a global approach to this launch." PEPFAR being part of the effort is Gilead's intent and goal, Mercier said. "Unfortunately, if they're not part of that mix, our goal is still to meet that objective of 2 million people getting access." Wall Street has a close eye on lenacapavir, one of the highest-profile drugs to undergo FDA review since President Donald Trump named Robert F. Kennedy Jr. as health secretary and promised to upend the status quo. Most of the drug's profits are expected in the U.S., with annual sales reaching $1 billion by next year, according to analysts' estimates compiled by LSEG. 'INCREDIBLE DISMAY' Whether all of the agreed funding for low-income countries - most of which are in Africa - will come through is unclear. Countries that rely on aid are already reeling from funding cuts by the Trump Administration, including to PEPFAR, and AIDS researchers are bracing for the worst. The United Nations program on HIV/AIDS earlier this month said many HIV prevention programs supported by PEPFAR were stalled, although services for pregnant and breastfeeding women were technically exempt from the cuts. Peter Sands, executive director of the Global Fund, told Reuters the group intends to fund as much of the lenacapavir rollout as possible, but it will need to start slowly. "It's not just the uncertainty over PEPFAR's funding that's an issue, but the uncertainty over our funding," Sands said, adding that the group's first priority is treating people already infected with the deadly virus. Much will depend on the success of the Global Fund's effort to raise $18 billion to fund its work from 2027-2029. The U.S. is its largest donor, committing $6 billion in the previous funding round. It is unclear what the U.S. may provide this round, or whether other big governments will step up. UNAIDS estimates that the permanent discontinuation of HIV prevention and treatment programs supported by PEPFAR would lead to an additional 6.6 million new HIV infections between 2025 and 2029. The U.S. State Department, which oversees PEPFAR, did not respond to a request for comment. Gilead declined to comment on its manufacturing cost for lenacapavir, whose U.S. price is likely to be on par with current preventive medications at around $25,000 per year. ViiV Healthcare's Apretude, an injection given every two months, costs about 124.20 pounds ($168) in low- and middle-income countries. Mitchell Warren, executive director of the AIDS nonprofit AVAC, estimates the eventual annual cost at $100-$120. The lower the price, the more people who could receive it, he said. Warren said PEPFAR could still participate, and others may come forward. The Gates Foundation and the Children's Investment Fund Foundation are "actively involved in all of these conversations," he said, as is the Elton John AIDS Foundation. Linda-Gail Bekker of the University of Cape Town, who led lenacapavir clinical trials in South Africa and Uganda, said she was elated when she first saw the findings. "The huge feeling I have now is one of incredible dismay," said Bekker of uncertainty over the Trump administration's commitment to PEPFAR and HIV prevention in poor nations. "It felt like the stars were aligning, and one of the stars has fallen out of the sky."
