Latest news with #CarlSchmid
The Hill
11 hours ago
- Health
- The Hill
FDA approves 6-month HIV prevention shot
Pharmaceutical company Gilead Sciences announced Wednesday the Food and Drug Administration (FDA) has approved its six-month, twice-yearly HIV PrEP injection, which was found in trials to be more than 99.9 percent effective among participants. Gilead's product Yeztugo, a form of lenacapavir, was approved for reducing the risk of sexually acquired HIV in adults and adolescents when injected twice a year. Lenacapavir is also marketed as Sunlenca, administered orally or through injection, as a treatment for HIV/AIDS in combination with other drugs. The drug is solely manufactured by Gilead. There are currently three available HIV PrEP options: two oral pills taken daily — Truvada and Descovy — and a long-acting injection called Apretude administered every two months. 'Yeztugo could be the transformative PrEP option we've been waiting for — offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,' Carlos del Rio, co-Director of the Emory Center for AIDS Research, said in a statement shared by Gilead. In a Phase 3, double-blind, randomized study, there were only two HIV infections among 2,179 participants who received Yeztugo subcutaneous injections twice a year. Lenacapavir is currently not approved for HIV prevention outside of the U.S., though it is approved for treating HIV in several countries. 'In the U.S., Gilead is working closely with insurers, healthcare systems and other payers with the goal of ensuring broad insurance coverage for Yeztugo,' the company said in a statement. 'Additionally, for eligible commercially insured individuals with commercial insurance, Gilead's Advancing Access® Co-Pay Savings Program will reduce out-of-pocket costs to as little as zero dollars.' Carl Schmid, Executive Director of the HIV+Hepatitis Policy Institute, called the approval a 'monumental advance in HIV prevention.' 'Long-acting PrEP is now not only effective for up to six months but also improves adherence and will reduce HIV infections—if people are aware of it and payers, including private insurers, cover it without cost-sharing as a preventive service,' said Shmid. 'Recent actions by the Trump administration to decimate HIV prevention jeopardize access to preventive measures such as PrEP,' he added. 'In fact, the president's budget zeroes out all CDC HIV prevention and surveillance funding, hampering our nation's ability to make people aware of and access new HIV prevention measures. Dismantling these programs means that there will be a weakened public health infrastructure and much less HIV testing, which is needed before a person can take PrEP.' The Hill has reached out to the White House for comment.
Yahoo
13 hours ago
- Health
- Yahoo
FDA approves new twice-yearly HIV shot. What to know
The Food and Drug Administration on Wednesday approved Gilead's HIV prevention drug lenacapavir, a twice-a-year injectable medication that clinical trials show prevents new infections. Gilead did not immediately say how much it will charge for the biannual shot, but company officials said it would be comparable to existing HIV prevention drugs. The drug will be marketed under the name Yeztugo. Advocates say the long-acting medication is promising because it's more convenient than existing HIV prevention drugs that must be taken daily. Giving people the option of a twice-a-year injectable is "a game changer, not only for the United States, but around the world," said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. Gilead officials lauded the FDA's approval of lenacapavir, which has been studied and developed over nearly two decades. "We now have a very real opportunity to end the HIV epidemic," said Daniel O'Day, chairman and CEO of Gilead Sciences. "Lenacapavir has shown to be remarkably effective and only needs to be given twice a year, which represents a whole new way of preventing HIV.' Pre-exposure prophylaxis, or PrEP, medications are sold as a daily pill under brand names Truvada and Descovy, as well as generic versions. Another injectable medication, Apretude, is taken every two months after two initial shots taken one month a part. The overwhelming majority of PrEP users take daily versions, but "it's hard to take a pill every day ... when it's for prevention," said Johanna Mercier, Gilead's chief commercial officer. "So we see adherence levels as low as 50% to 55%," which does not provide adequate protection for at-risk populations. People are more likely to stay on the medication if they only need to take the medication twice a year, rather than daily oral doses, Mercier said. In one study of women and adolescent girls in sub-Saharan Africa and Uganda, lenacapavir was 100% effective at preventing HIV infections. A second study reported the twice-a-year injections lowered the HIV infection rate by 96% in groups of cisgender men and gender-diverse people in the U.S., Argentina, Brazil, Mexico, Peru, South Africa and Thailand. Schmid said the studies show people are much more likely to take the medication as recommended when it's dosed twice a year compared to daily pills. "This makes it so much easier and better for adherence and also for people who have other challenges in their life like mental health issues, work or stigma, " Schmid said. Important read: Here's why most at-risk populations don't use HIV prevention drugs Mercier said the company intends to price the drug "in line with other branded medicines in this area." Out-of-pocket costs for uninsured patients who take Truvada and Descovy, which Gilead also markets, can range from $22,000 to $30,000 per year, according to an analysis by GoodRx, which provides pharmacy drug pricing information. Gilead expects health insurance companies will cover the full cost of lenacapavir as they do for other prevention medications. The U.S. Preventive Services Task Force, an independent advisory panel of national experts that evaluates medical treatments and services, assigned an "A" rating for PrEP medications when prescribed to adolescents and adults at increased risk of HIV. Under the Affordable Care Act, that means insurers must cover the full costs of the medication as preventive care. Still, activists say insurers have charged copays or other cost sharing from required lab tests and medical visits. People must test negative for HIV before starting the medication. While on the treatments, they must take routine tests for HIV, other sexually transmitted infections and kidney health. In case you missed: The Supreme Court may hinder access to this HIV prevention, gay sex drug. Why? Every year, more than 1 million people globally become newly infected with HIV, according to the World Health Organization. About 10 million worldwide need to take PrEP to meet global HIV prevention goals, WHO said. About 2.5 million take PrEP, WHO said. More than 39,000 U.S. residents were diagnosed with HIV in 2023, according to the Centers for Disease Control and Prevention. More than 4,700 deaths in 2023 were attributed to HIV, the virus that weakens the immune system and causes AIDS, the CDC said. A June study estimated as many as 2.2 million Americans could benefit from HIV prevention medications. Men account for nearly 80% of new cases, mostly involving gay or bisexual men, the CDC said. Research shows White patients are far more likely to take PrEP than their Black or Latino counterparts, even though White patients are less likely to get infected with HIV. Geographically, the South accounts for more than half of new HIV cases. "We hope to reduce those numbers and potentially get to a day when zero infections are reported," Mercier said. This article originally appeared on USA TODAY: FDA approves new twice-yearly HIV shot in bid to end epidemic
USA Today
13 hours ago
- Health
- USA Today
FDA approves new twice-yearly HIV shot. What to know
FDA approves new twice-yearly HIV shot. What to know Show Caption Hide Caption New COVID booster guidelines set by FDA for healthy adults under 65 The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65. The Food and Drug Administration on Wednesday approved Gilead's HIV prevention drug lenacapavir, a twice-a-year injectable medication that clinical trials show prevents new infections. Gilead did not immediately say how much it will charge for the biannual shot, but company officials said it would be comparable to existing HIV prevention drugs. The drug will be marketed under the name Yeztugo. Advocates say the long-acting medication is promising because it's more convenient than existing HIV prevention drugs that must be taken daily. Giving people the option of a twice-a-year injectable is "a game changer, not only for the United States, but around the world," said Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. Gilead officials lauded the FDA's approval of lenacapavir, which has been studied and developed over nearly two decades. "We now have a very real opportunity to end the HIV epidemic," said Daniel O'Day, chairman and CEO of Gilead Sciences. "Lenacapavir has shown to be remarkably effective and only needs to be given twice a year, which represents a whole new way of preventing HIV.' How does lenacapavir compare to other HIV prevention drugs? Pre-exposure prophylaxis, or PrEP, medications are sold as a daily pill under brand names Truvada and Descovy, as well as generic versions. Another injectable medication, Apretude, is taken every two months after two initial shots taken one month a part. The overwhelming majority of PrEP users take daily versions, but "it's hard to take a pill every day ... when it's for prevention," said Johanna Mercier, Gilead's chief commercial officer. "So we see adherence levels as low as 50% to 55%," which does not provide adequate protection for at-risk populations. People are more likely to stay on the medication if they only need to take the medication twice a year, rather than daily oral doses, Mercier said. What did the lenacapavir studies show? In one study of women and adolescent girls in sub-Saharan Africa and Uganda, lenacapavir was 100% effective at preventing HIV infections. A second study reported the twice-a-year injections lowered the HIV infection rate by 96% in groups of cisgender men and gender-diverse people in the U.S., Argentina, Brazil, Mexico, Peru, South Africa and Thailand. Schmid said the studies show people are much more likely to take the medication as recommended when it's dosed twice a year compared to daily pills. "This makes it so much easier and better for adherence and also for people who have other challenges in their life like mental health issues, work or stigma, " Schmid said. Important read: Here's why most at-risk populations don't use HIV prevention drugs How much will lenacapavir cost? Mercier said the company intends to price the drug "in line with other branded medicines in this area." Out-of-pocket costs for uninsured patients who take Truvada and Descovy, which Gilead also markets, can range from $22,000 to $30,000 per year, according to an analysis by GoodRx, which provides pharmacy drug pricing information. Gilead expects health insurance companies will cover the full cost of lenacapavir as they do for other prevention medications. The U.S. Preventive Services Task Force, an independent advisory panel of national experts that evaluates medical treatments and services, assigned an "A" rating for PrEP medications when prescribed to adolescents and adults at increased risk of HIV. Under the Affordable Care Act, that means insurers must cover the full costs of the medication as preventive care. Still, activists say insurers have charged copays or other cost sharing from required lab tests and medical visits. People must test negative for HIV before starting the medication. While on the treatments, they must take routine tests for HIV, other sexually transmitted infections and kidney health. In case you missed: The Supreme Court may hinder access to this HIV prevention, gay sex drug. Why? More than 1 million new HIV cases each year Every year, more than 1 million people globally become newly infected with HIV, according to the World Health Organization. About 10 million worldwide need to take PrEP to meet global HIV prevention goals, WHO said. About 2.5 million take PrEP, WHO said. More than 39,000 U.S. residents were diagnosed with HIV in 2023, according to the Centers for Disease Control and Prevention. More than 4,700 deaths in 2023 were attributed to HIV, the virus that weakens the immune system and causes AIDS, the CDC said. A June study estimated as many as 2.2 million Americans could benefit from HIV prevention medications. Men account for nearly 80% of new cases, mostly involving gay or bisexual men, the CDC said. Research shows White patients are far more likely to take PrEP than their Black or Latino counterparts, even though White patients are less likely to get infected with HIV. Geographically, the South accounts for more than half of new HIV cases. "We hope to reduce those numbers and potentially get to a day when zero infections are reported," Mercier said.
Reuters
18-03-2025
- Health
- Reuters
Trump administration weighing future of CDC's HIV prevention division
WASHINGTON, March 18 (Reuters) - The U.S. health department said on Tuesday it is reviewing the Centers for Disease Control and Prevention's HIV prevention division for overlap with other agencies but no final decision had been made about its future. The Department of Health and Human Services made the statement after the WSJ and NBC, citing unnamed sources, reported the division could be dismantled. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. The CDC's $1.3 billion Division of HIV Prevention is tasked with tracking infections across the United States and promoting testing and prevention, including the use of the HIV prevention medications, also known as PrEP. Carl Schmid, the executive director of the HIV+Hepatitis Policy Institute in Washington, told Reuters he had been told by a government agency source that the division might be shut down and that a decision would be made this week on the funding of HIV prevention at the CDC. Schmid, who co-chaired the Presidential Advisory Council of HIV/AIDS during President Donald Trump's first term, said he understood all of the division's funding is "up in the air". HHS, which oversees the CDC, said in a statement it was looking at all divisions for potential overlap as part of Trump's broader efforts to restructure the federal government and that no final decision had been made on the CDC's HIV Prevention Division. "If this decision is even made, this work would be continued elsewhere at HHS," a department official said. Another HHS agency, the Health Resources and Services Administration, contains the Ryan White HIV/AIDS Program which provides HIV health services to low-income people. The Trump administration's approach to HIV/AIDS policy is undergoing a broad shift. In January, the White House ordered an immediate halt to the distribution of HIV medications by U.S.-funded foreign clinics, disrupting treatment for millions worldwide.
