Latest news with #HIV-prevention
NBC News
2 days ago
- Health
- NBC News
FDA approves powerful new HIV drug
The Food and Drug Administration approved a new, highly effective HIV-prevention medication. The drug nearly eliminated HIV's spread among people given an injection twice a year in clinical trials. NBC News medical fellow Dr. Akshay Syal details how soon people will have access to the drug.
NBC News
2 days ago
- Health
- NBC News
FDA approves powerful HIV drug that nearly eliminated spread in clinical trials
The Food and Drug Administration has approved a highly effective new HIV-prevention medication, Gilead Sciences reported Wednesday. In clinical trials, the drug nearly eliminated HIV's spread among people given an injection every six months. Called lenacapavir, the highly effective drug has inspired feverish anticipation among advocates for HIV prevention. The hope is the medication could accelerate the stubbornly slow decline of HIV transmission in the United States. 'This is the single best opportunity in 44 years of HIV prevention,' said Mitchell Warren, executive director of the HIV advocacy nonprofit group AVAC. Lenacapavir, which is given by health care workers in clinics, is significantly more effective than the existing oral HIV-prevention drugs, experts said, because it appears to address the challenges of sticking to a daily pill regimen for people who are at high risk of HIV. Gilead's chairman and CEO, Daniel O'Day, suggested in a statement Wednesday that lenacapavir could 'end the HIV epidemic once and for all.' Lenacapavir was approved after astounding results in Gilead's large clinical trials of the drug. The trials randomly assigned people at risk of HIV to receive either lenacapavir injections every six months or daily Truvada, a pill form of pre-exposure prophylaxis, or PrEP. Among gay and bisexual men and transgender people, the lenacapavir group had an 89% lower HIV rate than a group taking Truvada and a 96% lower rate than Gilead estimated would have been expected absent any PrEP. In a similar trial among cisgender women in sub-Saharan Africa, no one who received lenacapavir contracted HIV. The drug the first in a new class of antiretrovirals which block HIV from infecting and making new copies of itself inside the immune cells it targets. Lenacapavir was first approved in 2022, under the brand name Sunleca, for use with other medications to treat highly drug resistant strains of the virus. All forms of PrEP work in the same way: If enough of the drug is present in the body when a person is exposed to HIV, it's highly effective at preventing the virus from taking hold and establishing a lifelong infection. Lenacapavir is so long-acting, it only needs to be injected twice a year. However, lenacapavir's use as PrEP against HIV emerges into a political climate that experts warn could derail progress against the virus' spread. The Trump administration's recent sweeping cancellations of research grants and its severe cuts to the Centers for Disease Control and Prevention's staffing have dramatically affected the HIV-prevention field in particular. HIV experts are concerned that lenacapavir's full potential might remain unrealized. Lenacapavir's cost could be another hurdle if health insurance companies don't pay for the new drug. Health insurers, at least in the near term, might decline to cover lenacapavir in favor of other forms of PrEP, including the cheaper generic version of Truvada pills, which cost as little as $30 per month. Or insurers might impose higher copays for lenacapavir, said Elizabeth Kaplan, director of health care access at Harvard Law School's Health Law and Policy Clinic. A pending Supreme Court decision concerning a pillar of the Affordable Care Act could also be a barrier to insurance coverage for medications that prevent HIV. The ACA, or Obamacare, mandates no-cost coverage for certain preventive interventions like PrEP. Mixed success for PrEP drugs Older forms of PrEP have had mixed success. Truvada, also made by Gilead, was the first approved PrEP drug in 2012, followed by a similar oral medication from the company, Descovy, in 2019. They have steadily gained popularity among gay and bisexual men, who, according to the CDC, account for 7 in 10 new HIV cases and comprise the overwhelming share of PrEP users. However, considering how much higher the HIV rate is among Black and Latino gay men compared with their white peers, PrEP use among men of color has remained disproportionately low. Experts believe PrEP has most likely hastened HIV's considerable decline among white gay and bisexual men, but the HIV rate among Black and Latino gay and bisexual men has persisted at markedly high rates. In addition, when they are prescribed PrEP, Black gay men are less likely to take the pill regimen as prescribed. When they are taken daily, Truvada and Descovy each slash HIV risk by at least 99%. But inconsistent use diminishes PrEP's effectiveness. In late 2021, ViiV Healthcare's Apretude was approved as an injectable PrEP given every two months. Despite being much more effective than Truvada at lowering HIV cases across a population of gay and bisexual men and transgender women in a major clinical trial, Apretude has gained scant traction until recently. About 21,000 people are taking it, ViiV reported. It's possible that, in part, people have been alienated by the requirement to visit a clinic every two months for Apretude, instead of every three months for an oral PrEP prescription. Lenacapavir has the potential, but will it deliver? Lenacapavir offers an alternative for people who won't or have trouble remembering to take a pill every day, and it reduces the number of required annual clinic visits from four to two. According to CDC estimates, during the decade after PrEP's debut, the annual HIV transmission rate declined by only 17%, from 38,300 cases in 2012 to 31,800 cases in 2022. Much of the decline occurred since 2018, with case numbers falling by 12% during that four-year period. In 2019, the Trump administration launched the Ending the HIV Epidemic, or EHE, initiative, which has since targeted nearly $3 billion in new spending to combat HIV, including by promoting PrEP, in 48 hot-spot counties in particular. The target jurisdictions had a swifter 21% decline in estimated HIV transmissions from 2018 to 2022. In a study published in October, CDC investigators reported that PrEP use has risen steadily since 2014 and that about 200,000 people were receiving some form of it during any month of 2023. But that is only a small fraction of the 1.5 million gay and bisexual men who are good PrEP candidates, according to estimates in a new CDC study published in May. The crucial question is whether a critical mass of people who otherwise wouldn't have stuck to an oral PrEP regimen can routinely be provided lenacapavir while they are at risk of HIV. Dr. Susanne Doblecki-Lewis, chief of the division of infectious diseases at the University of Miami Miller School of Medicine, is the site principal investigator for the lenacapavir clinical trial in gay men and a separate trial in people who inject drugs. She said lenacapavir could mitigate HIV-related racial disparities, provided it is made 'available easily and at low or no cost to people who can benefit from it who are uninsured or underinsured.' But, she said, 'if there are barriers, like complicated prior authorizations or high copays that will prevent people from easily starting it, we could see disparities just get worse.' Political challenges The Trump administration's 2026 budget request seeks a $1.5 billion, or 35%, cut for domestic HIV funding. That includes shuttering the CDC's $794 million HIV-prevention division, although some remnants of it are apparently meant to be folded into a new federal health department, along with a maintained $220 million in EHE funding. Much of the CDC's HIV-prevention and -surveillance budget is distributed in grants to state and local health departments and nonprofit organizations. Severe federal budget cuts would most likely hobble those entities' efforts to educate at-risk populations and doctors about lenacapavir and provide services to facilitate its use. Another hurdle for prescribers is whether they can ensure that people at risk of HIV return for lenacapavir shots twice yearly. Two recent studies, one published in May and another presented at a conference in March, found that fewer than half of oral PrEP users stay on it for six months or longer. Historically, the National Institutes of Health has funded research to help implement new forms of PrEP, examining weak spots and devising interventions. But the Trump administration's campaign to slash NIH spending has had a severe impact on HIV research, including PrEP, according to a dossier of canceled grants compiled by a Harvard researcher. A federal judge ruled Monday that some such NIH grant terminations were 'arbitrary and capricious' and 'void and illegal.' But the temporary win for researchers doesn't mean the NIH under Trump will necessarily become newly hospitable to grant proposals concerning PrEP implementation. Johanna Mercier, Gilead's chief commercial officer, said in an interview this month that the company has been pushing insurers to cover lenacapavir. She expressed optimism for ultimately widespread coverage of the drug. Gilead will cover up to $7,200 annually in out-of-pocket costs for insured people receiving lenacapavir. And its patient assistance program will provide it free to low-income uninsured people. There is otherwise a patchwork system nationally that can often aid the uninsured in covering the required clinic visits and lab tests. Tristan Schukraft, CEO of the popular PrEP-focused telehealth company Mistr, said it intends to begin offering lenacapavir immediately through its storefronts in seven major urban gay neighborhoods. The company has also formed partnerships with a nationwide network of community-based clinics that can provide the shots, including to people without insurance. 'We're ready,' Schukraft said.
Time of India
11-06-2025
- Health
- Time of India
Trump admin set to destroy vital HIV meds and contraceptives worth $12 million following closure of USAID
The Trump administration may destroy $12 million worth of HIV and birth control medicines. These medicines were bought by USAID, a U.S. government group that helps people in poor countries. Trump closed USAID in January, and since then, the medicine has been left unused in warehouses in Belgium and the UAE, according to The Washington Post. Now, officials are being told: 'Sell the medicine or trash it', according to someone familiar with the case. The supplies have 26 million condoms, 2 million birth control shots, millions of birth control pills, hundreds of thousands of implants, and over 50,000 bottles of HIV-prevention medicine., as per reports. These were supposed to go to 18 different countries, but now they may never get them. A senior U.S. State Department official told The Independent the story is 'fake news' and full of errors. But Dr. Atul Gawande, who worked at USAID before, said destroying the medicine is something he just can't imagine. Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like This Man Revealing His Strategy To Earn Upto 3K-5K Daily Income thefutureuniversity Learn More Andrew Natsios, a former USAID head, called the idea 'crazy' and said, 'Why not just give the medicine to people instead of throwing it away?' Trump stopped USAID's spending because he said it was 'not in line with American interests.' The Trump team also plans to ask Congress to cut $8.3 billion from global aid programs, including for climate and LGBTQ+ support, as per the report by The Independent. Big consequences Experts say ending USAID could stop progress on fighting AIDS. AIDS-related deaths could rise from 6 million to 10 million in the next 5 years. 3.4 million more kids could lose a parent to AIDS. 600,000 more babies could be born with HIV by 2030. Live Events Prof. Francois Venter, a top HIV doctor from South Africa, said, 'The progress we made in 20 years will be reversed.' Hadja, a 27-year-old mom in Uganda, told The Independent she already lost access to her HIV medicine. She said, 'Without medicine, our lives become shorter. If I die, my children will suffer,' according to The Independent. FAQs Q1. Why might HIV and birth control medicines be destroyed? Because USAID was shut down and the medicines are stored with no plan to send them out. Q2. What could happen if these medicines are not used? More people could get sick and die from AIDS, and many children could lose their parents.
Yahoo
06-06-2025
- Politics
- Yahoo
Friday's Mini-Report, 6.6.25
Today's edition of quick hits. * I guess returning Kilmar Abrego Garcia to U.S. soil wasn't impossible after all: 'Kilmar Abrego Garcia has been returned to the U.S. to face federal human smuggling charges in Tennessee, the Justice Department said Friday, in a case that became emblematic of the combined coarseness and incompetence behind the Trump administration's immigration crackdown.' * In this 6-3 ruling, all of the Republican-appointed justices sided with the White House: 'A divided Supreme Court on June 6 said Elon Musk's Department of Government Efficiency can access to the data of millions of Americans kept by the U.S. Social Security Administration. The court paused a judge's order blocking DOGE from getting the data, which includes Social Security numbers, medical and mental health information, tax return information and citizenship records.' * Harvard's winning streak continues, but the White House's relentless offensive is ongoing: 'A federal judge on Thursday temporarily blocked President Donald Trump's efforts to block visas for foreign students planning to attend Harvard, after the Ivy League college filed a legal challenge.' * No one benefits from misguided steps like these: 'More than $12 million worth of contraceptives and HIV-prevention medications purchased by the U.S. government as aid for developing countries under programs thathavesince been discontinued will probably be destroyedunless officials sell or otherwise off-load them, an examination by The Washington Post found.' * The White House vs. the ICC: 'The Trump administration is slapping sanctions on four judges at the International Criminal Court over the tribunal's investigation into alleged war crimes by Israel in its war against Hamas in Gaza and in the West Bank.' * It's not a great sign when no one seems to know who's leading the CDC: 'The CDC, a $9.2 billion-a-year agency tasked with reviewing life-saving vaccines, monitoring diseases and watching for budding threats to Americans' health, is without a clear leader.' * This effort fell short, but it was interesting to see Republicans scramble: 'House Oversight Committee Democrats have once again failed to subpoena Elon Musk to testify on Capitol Hill. The panel rejected the minority party's request Thursday morning for the former DOGE chief to appear before lawmakers in a party-line, 21-20 votes.' * Should we assume that a generous settlement in this civil suit is inevitable? 'Five members of the Proud Boys, once convicted of masterminding the Jan. 6 breach of the U.S. Capitol, are accusing the federal government and FBI employees of violating their rights in connection with their prosecutions in a new lawsuit. ... The suit seeks $100 million in punitive damages.' * A New Jersey health official's recent inspection at the Trump National Golf Club in Bedminster did not go well: 'For more than three hours, the inspector tallied enough violations — a faulty dishwasher, poorly stocked sinks, improperly stored raw meat — to give the club a score of 32 out of 100, one of the lowest ratings earned by any establishment in Somerset County this year.' * Noted without comment: 'For sale at the White House: one bright red Tesla Model S. Should run fine; the owner just seems to have had buyer's remorse. Less than 24 hours after President Trump and Elon Musk engaged in a rancorous public spat, Mr. Trump has decided to sell the red Tesla he got in March, according to a White House official speaking on condition of anonymity because the person wasn't authorized to speak publicly.' Have a safe weekend. This article was originally published on
Yahoo
05-06-2025
- Health
- Yahoo
Trump team set to destroy $12m worth of HIV drugs and contraceptives that were bought before closing USAID
Roughly $12 million worth of HIV-prevention drugs and contraceptives purchased by the U.S. Agency for International Development will likely be destroyed after President Donald Trump dismantled the organization, according to a report. These drugs have been sitting in distribution centers in Belgium and the UAE since January, when Trump ended the agency's spending, The Washington Post reported. Now, negotiators have been instructed to sell the drugs or else they'll be thrown out, according to the outlet. 'The mandate that [the USAID negotiator] has been given is 'get us money for it, and if you can't do that, we're just going to trash it,'' someone with knowledge of the situation told the Post. These supplies include more than 26 million condoms, 2 million doses of injectable birth control, millions of packages of oral birth control, hundreds of thousands of implantable contraceptive devices, and over 50,000 vials of a drug that prevents HIV contraction, the Post reports. Some of these supplies were earmarked for 18 countries, meaning those governments may never get the aid even though it was already purchased, according to the Post. When contacted for comment, a senior State Department official told The Independent that the Post has 'once again delivered fake news' and the 'story is full of inaccuracies.' Atul Gawande, a former assistant USAID administrator, told the Post the potential destruction of these drugs is 'inconceivable.' Meanwhile, Former USAID head Andrew Natsios called the decision 'nuts.' 'At this point, just give it away instead of destroying it, for heaven's sakes,' he told the Post. Trump cut off USAID funds in January, saying the organization that provides humanitarian aid abroad is 'not aligned with American interests.' The Trump administration is also poised to ask Congress for $8.3 billion in cuts to foreign aid efforts, which range from climate work to LGBTQ+ programs, The Independent previously reported. The decision has derailed the projected end of the AIDS pandemic and means the number of AIDS-related deaths could jump from six million to 10 million in the next five years unless aid is reinstated, The Independent previously reported. Data projections indicate there will be 3.4 million more orphans who have lost at least one parent to AIDS, and 600,000 more newborns could contract HIV by 2030. 'All the gains that we've seen over the last 20 years will start being steadily reversed,' Professor Francois Venter, a leading HIV doctor at the University of Witwatersrand in Johannesburg, previously told The Independent. Hadja, a 27-year-old mother of three in Uganda, previously told The Independent she has lost access to lifesaving medication since Trump effectively shut down USAID. 'Our lives depend on medicine – without it, our lives are shortened,' she said. 'If I die, my children will suffer.'
