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Boston Globe
10 hours ago
- Health
- Boston Globe
Boston transit operator to borrow $939 million as deficit looms
Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up HEALTH CARE Advertisement The world's only twice-a-year shot to prevent HIV could stop transmission — if people can get it A vial of lenacapavir, an injectable HIV prevention drug, at the Desmond Tutu Health Foundation's Masiphumelele Research Site, in Cape Town, South Africa, which was one of the sites for Gilead's lenacapavir drug trial. Nardus Engelbrecht/Associated Press The United States has approved the world's only twice-a-year shot to prevent HIV, the first step in an anticipated global rollout that could protect millions — although it's unclear how many in the United States and abroad will get access to the powerful new option. While a vaccine to prevent HIV still is needed, some experts say the shot made by Gilead Sciences — a drug called lenacapavir — could be the next best thing. It nearly eliminated new infections in two groundbreaking studies of people at high risk, better than daily preventive pills they can forget to take. Condoms help guard against HIV infection if used properly but what's called PrEP — regularly using preventive medicines such as the daily pills or a different shot given every two months — is increasingly important. Lenacapavir's six-month protection makes it the longest-lasting type, an option that could attract people wary of more frequent doctor visits or stigma from daily pills. — ASSOCIATED PRESS Advertisement DEALS Nippon Steel completes its acquisition of US Steel A view of the United States Steel Mon Valley Works Clairton Plant, in Clairton, Pa. Ted Shaffrey/Associated Press Nippon Steel has completed its acquisition of US Steel, the companies said Wednesday, more than a year after it was first announced. Soon after Nippon announced its plans to acquire US Steel in December 2023, the company, based in Pennsylvania, a swing state in the presidential election, became part of a game of political football. The powerful United Steelworkers union pushed back against the deal, and President Biden blocked it over national security concerns. Last month, President Donald Trump, who had opposed the deal while he was on the campaign trail, said he had approved a transaction that granted the White House a golden share in the company, giving it extraordinary control over the new company as part of a national security agreement. Trump and the companies have frequently referred to the deal as a partnership over the past several weeks, fueling mystery on Wall Street and in Washington over its nature. — NEW YORK TIMES SOCIAL MEDIA Trump will sign an order extending deadline for TikTok's Chinese owner to sell app The TikTok app page on a smartphone in New York on Jan. 15. Gabby Jones/Bloomberg President Trump will sign an executive order this week to extend a deadline for TikTok's Chinese owner to divest the popular video sharing app, the White House announced Tuesday. Trump had signed an order in early April to keep TikTok running for an additional 75 days after a potential deal to sell the app to American owners was put on ice. 'As he has said many times, President Trump does not want TikTok to go dark,' White House press secretary Karoline Leavitt said in a statement. 'This extension will last 90 days, which the Administration will spend working to ensure this deal is closed so that the American people can continue to use TikTok with the assurance that their data is safe and secure.' It will be the third time Trump has extended the deadline. — ASSOCIATED PRESS Advertisement LEGAL Purdue Pharma's $7 billion opioid settlement could advance soon after states back it OxyContin pills arranged for a photo at a pharmacy in Montpelier, Vt. Toby Talbot/Associated Press OxyContin maker Purdue Pharma's latest plan to settle thousands of lawsuits over the toll of opioids could soon move forward after every US state involved agreed to it. A judge on Wednesday said he planned to issue a ruling on Friday on a plan for local governments and individual victims to vote on it. Government entities, emergency room doctors, insurers, families of children born into withdrawal from the powerful prescription painkiller, individual victims and their families, and others would have until Sept. 30 to vote on whether to accept the deal, which calls for members of the Sackler family who own the company to pay up to $7 billion over 15 years. The settlement is a way to avoid trials with claims from states alone that total more than $2 trillion in damages. Thousands of local governments and other groups have also sued Purdue. If approved, the settlement would be among the largest in a wave of lawsuits over the past decade as governments and others sought to hold drugmakers, wholesalers, and pharmacies accountable for the opioid epidemic that started rising in the years after OxyContin hit the market in 1996. The other settlements together are worth about $50 billion, and most of the money is to be used to combat the crisis. — ASSOCIATED PRESS Advertisement TECH WhatsApp denies Iran's claim that it is spying for Israel A WhatsApp icon is displayed on an iPhone. Martin Meissner/Associated Press Iran's state broadcaster Tuesday urged people to remove WhatsApp from their phones, claiming that the messaging app was collecting user information and sending it to Israel as the two countries trade military strikes. 'WhatsApp and Instagram are collecting information about individuals and are providing the Zionist enemy with their last known location and communications, tagged with the names of individuals,' the Iranian state television network said, referring to Israel. It did not provide evidence for its claims. WhatsApp, in a statement Tuesday, said the allegations were false. 'We're concerned these false reports will be an excuse for our services to be blocked at a time when people need them the most,' the statement said. 'All of the messages you send to family and friends on WhatsApp are end-to-end encrypted, meaning no one except the sender and recipient has access to those messages, not even WhatsApp.' — NEW YORK TIMES ARTIFICIAL INTELLIGENCE Amazon CEO Jassy says AI will reduce its corporate workforce in the next few years Andy Jassy, chief executive officer of Inc., at an event in New York on Feb. 26. Michael Nagle/Bloomberg Amazon CEO Andy Jassy anticipates generative artificial intelligence will reduce its corporate workforce in the next few years as the online giant begins to increase its usage of the technology. 'We will need fewer people doing some of the jobs that are being done today, and more people doing other types of jobs,' Jassy said in a message to employees. 'It's hard to know exactly where this nets out over time, but in the next few years, we expect that this will reduce our total corporate workforce as we get efficiency gains from using AI extensively across the company.' — ASSOCIATED PRESS AUTOMOTIVE Honda recalls more than 259,000 cars across the US due to brake pedal issue The Honda logo. Gene J. Puskar/Associated Press Honda is recalling more than 259,000 of its cars across the United States due to a problem that can cause the brake pedal to shift out of position, potentially interfering with a driver's ability to stop or slow down. According to documents published by the National Highway Traffic Safety Administration, the recall covers certain Honda Pilots between model years 2023 and 2025 — as well cars under the automaker's luxury Acura brand: 2021-2025 Acura TLX and 2023-2025 Acura MDX vehicles. As a remedy, Honda says authorized dealers will inspect the vehicles covered by this recall and replace the brake pedal assembly if necessary, free of charge. Per the NHTSA's report, the company estimates 1 percent of these vehicles have this issue. — ASSOCIATED PRESS Advertisement AVIATION Families of 737 crash victims urge rejection of Boeing deal Family members of victims of the Ethiopian Airlines Boeing 737 MAX 8 crash held a sign as President and CEO of Boeing Kelly Ortberg testified before the Senate Commerce, Science, and Transportation Committee on April 2 in Washington, D.C. Win McNamee/Getty Family members of people killed in two fatal crashes of Boeing Co.'s 737 Max jets urged a federal judge to reject a proposed deal the company reached with US prosecutors that would allow the planemaker to avoid a criminal charge. Lawyers for 15 families argued Boeing should stand trial for criminal conspiracy as the government had originally planned, to hold the company more accountable for the deaths of 346 people, according to a court filing Wednesday. The US Justice Department in May asked US District Judge Reed O'Connor in Fort Worth to dismiss the case as part of a proposed settlement reached with Boeing. Under the deal, the planemaker agreed to pay more than $1.1 billion in fees and fines, while taking steps to strengthen internal quality and safety measures. In return, the company will avoid criminal prosecution. — BLOOMBERG NEWS
WIRED
21-02-2025
- Health
- WIRED
This New Drug Could Help End the HIV Epidemic—but US Funding Cuts Are Killing Its Rollout
Feb 21, 2025 2:26 PM Lenacapavir, a twice yearly injection that prevents HIV transmission, was named the breakthrough medicine of 2024. But without US foreign aid dollars, its delivery to millions worldwide is under threat. Photograph: AP Photo/Nardus Engelbrecht After a lifetime on the frontiers of the fight against HIV, Linda-Gail Bekker could finally see the end of the epidemic in sight. For decades, HIV experts had dreamed of an elusive vaccine to block the ongoing chain of infections, which still sees more than 1 million people worldwide contract the virus annually. Bekker, a 62-year-old medical professor from the University of Cape Town, had helped identify a drug that could do just that. But now, thanks to the Trump administration's executive orders, it's unclear when—or possibly even ever—this breakthrough medicine will see the light of day. At the AIDS 2024 conference held in Munich last July, Bekker had triumphantly unveiled the results of a momentous clinical trial she had led, called PURPOSE 1. It showed that lenacapavir, an antiretroviral developed by the pharmaceutical company Gilead Sciences, could prevent sexual transmission of HIV with 100 percent efficacy by disrupting the function of the virus's capsid protein, which allows it to replicate. Even more remarkably, compared with existing daily pre-exposure prophylaxis (PrEP) pills, which do a similar job, injections are only required every six months. While not strictly a vaccine, lenacapavir promises to be the next best thing. It was named as 2024's 'Breakthrough of the Year' by the prestigious journal Science, and Gilead promptly committed to manufacturing 10 million doses by 2026, enough to treat 2.5 million people, ahead of anticipated regulatory approval later this year. A collaborative effort between the medicines-financing initiative The Global Fund and PEPFAR, the US government's global HIV/AIDS program, had pledged to procure 2 million of those doses over the course of three years, which would be directed toward countries with the highest incidence of HIV, most notably in sub-Saharan Africa. But with President Donald Trump's decision to freeze all foreign aid funding, this plan has been left in tatters. 'There's despondency and a sense of tragedy,' says Bekker. 'Because just as we've had the breakthrough, we also see the taps turning off of resources. We had a laid-out map where the product would be supplied via PEPFAR and The Global Fund while we wait for generics [cheaper off-label versions of lenacapavir] to come online, which will take 18 months to two years. And at this moment, that plan is falling through in front of our eyes.' While a temporary 90-day waiver has been issued for PEPFAR funding, this has only reinstated funding for life-saving antiretroviral treatments for HIV-positive individuals. Existing forms of PrEP are covered, but only for pregnant or breastfeeding women. There have been no indications that the planned purchase of lenacapavir will be fulfilled. According to Kenneth Ngure, an HIV-prevention expert in Kenya and president-elect of the International AIDS Society, the loss of PEPFAR funding for prevention represents a major setback in the world's ability to control HIV. 'Even if The Global Fund partners with others, they will probably not be able to reach the number of doses they had promised,' he says. 'We have this potential game-changer, which could accelerate the end of HIV as a public health threat, and yet it looks like access will be highly compromised.' For Ngure and others, there is a sense of history repeating itself. The major limitation of PrEP is that adherence is notoriously poor, with studies showing that target groups often struggle to access or forget to take daily pills and feel stigmatized doing so. 'We know that particularly for young people, taking a daily oral PrEP pill is challenging,' says Bekker. 'We've tried all sorts of things, like sending text messages. São Paulo is even giving PrEP in a dispensing machine. But it's sometimes very difficult to take something daily when you're not sick and you're doing it for prevention.' Longer-acting injectables have long been viewed as a better way forward, and in 2021, the HIV field was galvanized by promising trial results for cabotegravir, a form of injectable PrEP that only needed to be administered every two months, with a trial demonstrating that people receiving this drug had 90 percent less risk of contracting HIV compared with oral pills. Yet access has been the major hurdle. Last month a new study revealed that while regulators in 53 countries have approved cabotegravir, rollout has been painfully slow. Generic versions of the jab are not expected to become available until 2027. In Africa and Asia, where cabotegravir is most needed, the only access so far has been through so-called Phase 4 or implementation science studies, which attempt to understand more about the real-world challenges of offering a new drug by dispensing it to a few thousand people. And also as a consequence of orders coming out of the White House, a number of these Phase 4 studies have abruptly ceased. 'They're very concentrated in East and Southern Central Africa,' says Bekker. 'Some of them were PEPFAR supported, and with the stop-work order, these studies have ground to a halt.' The frustration for researchers like Bekker is that while long-acting injectables are extremely effective at blocking HIV transmission, to end the epidemic, their rollout needs to be as rapid and as wide-reaching as possible. She points out that to prevent over a million new infections each year, these jabs need to be targeted at HIV hotspots and administered on a scale of millions—exactly as the plan with lenacapavir was proposing. 'We've seen with both cabotegravir and oral PrEP that if you get a new tool, but roll it out gently, that will not impact the epidemic,' says Ngure. 'The number of new infections still outpaces the impact of the tool. You need something which is potent and to roll it out fast.' With lenacapavir, things were supposed to be different. Gilead has partnered with six generic drugmakers, which have been licensed to produce enough of an off-label supply of lenacapavir to cover 120 countries. Estimates have suggested that if the global demand exceeded more than 20 million doses, the manufacturing costs could fall to just $35-40 per person per year. However, Bekker says that PEPFAR was expected to be a significant buyer, and without its financial clout the commercial viability of manufacturing generic lenacapavir at vast scales is in doubt. 'It requires a nice healthy demand to ensure that for each of the generic companies, it's going to be worth their while,' says Bekker. 'We are all hoping that governments [across sub-Saharan Africa] are writing the generic product into their budgets for the future, but the reality is that in the interim, we were relying on donor funding. Even my country, South Africa, which has a good GDP and funds 80 percent of its HIV response, is already purchasing antiretrovirals for 6 million individuals annually. I would imagine it will take them some years to be able to mobilize the money for lenacapavir as well.' With PEPFAR seemingly now focused primarily on the treatment of existing patients, at the expense of prevention, clinicians like Nomathemba Chandiwana, a physician-scientist at the Desmond Tutu Health Foundation in South Africa, are concerned that the infection rate will begin to rise rather than fall, something which will have a marked public health impact across the African continent and beyond. Speaking at last week's NCD Alliance Forum in Kigali, Chandiwana explained that the consequences of new infections are not solely related to HIV itself. Research is increasingly showing that people living with long-term HIV infections, even those controlled by antiretroviral treatment, are at a greater risk of developing metabolic conditions such as hypertension, obesity and type 2 diabetes, a disease burden which is already on the rise in sub-Saharan Africa. 'HIV itself disrupts your metabolism, as do many of the antiretrovirals,' says Chandiwana. 'We see the same chronic diseases in people living with HIV as we do in the general population, but at an earlier age and in an accelerated fashion.' Because of this, there is also a need for a new generation of HIV treatments, and one concept being explored was to use lenacapavir as a foundation of future combination therapies for those already with the virus. As well as potentially alleviating some of the metabolic side effects, it was hoped that this could lead to treatment protocols that did not require HIV-infected individuals to take daily medication. 'Various ideas have been mooted,' says Bekker. 'Could you combine bimonthly cabotegravir with a six-monthly lenacapavir injection [as a form of viral suppression], so you'd only come in six times a year for treatment, and it would all be injectable? There's a weekly antiretroviral pill in the works, and could you combine that with a six-monthly injectable? This could be very liberating for people, as they tell us all the time how stigmatizing it is to need to take daily medication.' Yet many of these studies are now in doubt, as Bekker says they were expected to be funded by US resources. 'It's not just PEPFAR; we're also worried about restrictions being placed on other sorts of research funding, such as the National Institutes of Health,' she says. 'It's just going to get harder to innovate and move progress forward.' According to Ngure, there is still hope that other donors may emerge who can support The Global Fund in procuring lenacapavir, while Bekker says she is exploring new options for funding HIV prevention and research through European agencies, and possibly donor funding from sources in Scandinavia, Japan, and Australia. At the same time, she believes that the events of the past month have illustrated that African countries need to become capable of funding more preventative efforts themselves. 'Somehow Africa needs to step up and contribute to the fight,' she says. 'I think that's the big question. How much we can also contribute on this continent through countries which haven't necessarily been able to cover a big amount of research and development but in the future need to.' At the same time, she is afraid that without the same resources coming from the US, the unique opportunity provided by lenacapavir could be lost. 'It's incredible that this has happened just as we've had the breakthrough,' she says. 'I think this is going to set us back many years and ultimately cost a lot more in public health spending. Because ultimately, if we can bring this epidemic under control more quickly, it's going to save the planet more money in the long run, and save lives too.'
