The HIV shot that could change medicine is facing its biggest test: Getting to patients

Trials of lenacapavir, a drug developed by Gilead Sciences, show the twice-a-year shot is almost 100% effective at preventing HIV infection. Ihsaan Haffejee / AFP via Getty Images Gilead's lenacapavir shows near 100% efficacy in preventing HIV with twice-yearly shots, reports The Telegraph . Some Latin American countries face barriers to accessing lenacapavir despite running crucial trials. Beyond price, supply is constrained as Gilead works to scale up production of the sought-after shot. For the first time in the four-decade fight against HIV, there is a "miracle" drug that can all but eliminate the risk of infection, but in the Latin American countries where it was tested, most people can't afford it. Trials show that lenacapavir, made by Gilead Sciences, is almost 100% effective in preventing HIV infection . With just two shots a year, those taking it will avoid contracting the virus even when frequently exposed. The drug, which many believe could bring an end to the global HIV pandemic, costs $14,000 a dose in the United States . Gilead has agreed to license generic versions of the pre-exposure prophylaxis (PrEP) medication at around $40 a dose in 120 low- and middle-income countries, but many Latin American countries are being quoted a higher price. Brazil, Mexico, Argentina, and Peru are among those with serious HIV epidemics that do not qualify for the reduced price, despite having run some of the clinical trials that proved the drug works. Their status as "upper-middle income countries" means they are too rich to qualify for the cut-price generic version, and yet they remain too poor to pay the US price. Anger over the impasse spilled onto the stage at the opening ceremony of the International AIDS Society Conference in Rio De Janeiro this week. Activists waved posters and chanted protests — "Pharma greed is killing us!" "Pills cost lives!" "Latin America for the cure!" — to applause and cheers from the audience. Brazilian officials backed them. Dr. Alexandre Padilha, the country's health minister, told the room that negotiations with Gilead had stalled because the pharma giant wanted a price 10 times higher than that being paid by Indonesia and Thailand — both, like Brazil, upper-middle-income countries. "Innovation without access is not an innovation," he said. "It is an injustice." Gilead says it's negotiating with regional Latin American governments directly, but hasn't said what price it is asking, or indicated when a deal might land. Winnie Byanyima, Executive Director of UNAIDS, said Brazil had spent more than a year trying to strike a deal with Gilead, without success. Brazil "should not now be forced to stand in the back of the queue," she added. Some suspect Gilead is holding out because Brazil has a law that obliges the state to provide treatment, no matter the cost, if it's needed. Draurio Barreira, head of AIDS and TB at Brazil's health ministry, told The Telegraph that this constitutional guarantee may be working against it in price negotiations. The Telegraph, like Business Insider, is part of the Axel Springer Global Network . Because the government is legally obliged to provide treatment, manufacturers calculate that Brazil cannot walk away from a deal and price accordingly, he said. "They want the full price because the law will oblige the government to buy," he added, though he made clear that this was his own view, rather than something Gilead had confirmed. However, a spokesperson for Gilead said they did not "agree with that characterization," adding: "Consistent with our approach globally, Gilead follows the regulatory, pricing, and reimbursement processes established within Brazil's healthcare system and will continue working collaboratively with governments, communities, and regional partners to help bring this innovation to the people and communities that stand to benefit most from it." Frustration over the speed of the rollout of lenacapavir has dominated the Rio conference and threatens to damage Gilead's reputation. This is despite the company doing more in the area of HIV to innovate new drugs and make them available in volume than any other major company over the course of the AIDS pandemic. Gilead told The Telegraph it understood the "urgency" of expanding access to lenacapavir in Latin America and the Caribbean, adding that it already covers 24 countries in the region. It was in talks with Brazil but was prioritising countries with the "greatest HIV burden and even more limited financing capacity", said a spokesman. Innovation in the same category of long-lasting PrEP drugs from other companies might ultimately force prices down. On Tuesday, Fiocruz, Latin America's largest biomedical research and public health institution, tied to Brazil's ministry of health, signed a memorandum of understanding with MSD Brasil, Merck's local arm, to explore manufacturing alimatravir, a once-monthly oral pill in the same new generation of HIV prevention drugs. The drug is still in Phase 3 trials but potentially gives Brazil a route around the pricing standoff with Gilead if the trials are successful. The same day, it was announced that Brazil would incorporate ViiV healthcare's long-acting cabotegravir — a British-developed HIV prevention drug injected every two months — into its PrEP program through SUS, Brazil's Unified Health System, by the end of the year as the company had offered "an acceptable price," said Dr. Padilha. It will depend on a final agreement and review by Conitec, the advisory body for the country's health system. Long-acting PrEP products offer the single biggest opportunity to control the HIV virus that has evaded a vaccine for decades, experts say. They are easy to administer and track, and for people at high risk of infection, they remove the stigma of having to take a daily pill. Brazil is home to roughly 1 million people living with HIV, nearly 45% of all HIV cases in Latin America. Although the region's largest economy, it has just 6,000 people on long-acting PrEP out of 233,000 total PrEP users nationally, with the vast majority still reliant on daily pills. Latin America is also one of the few regions of the world where the HIV epidemic is moving in the wrong direction. UNAIDS data shows new infections in the region have climbed 25% since 2010, even as Sub-Saharan Africa cut infections by 62% over the same period. Supply, not just price, is the other major constraint, as the drug was only first licensed in its twice-yearly form in 2025, and manufacturing capacity is still building. Even in countries covered by Gilead's discounted license, doses remain scarce, with fewer than 250,000 people across the developing world now accessing the product. Byanyima of UNAIDs wants that scaled up to 20 million within three years — a target she argues is well within reach, pointing out that the world managed to vaccinate 4.5 billion people against COVID-19 in a single year. "This is not beyond the world's capacity," she said. "So I ask my friends at Gilead again, help us to change this." Gilead is famously a volume producer of HIV and other important developing world drugs and is likely to welcome the challenge. "Access discussions extend beyond pricing alone and involve regulatory pathways, implementation readiness, procurement mechanisms, and long-term sustainability," it told the Telegraph. "Gilead remains committed to working collaboratively with stakeholders across the region to expand access to lenacapavir for HIV prevention." This story originally appeared on The Telegraph and is courtesy of the Axel Springer Global Reporters Network, which harnesses the resources of the company's newsrooms to publish ambitious scoops, investigations, interviews, opinion pieces, and analysis. It allows journalists — including those from POLITICO, Business Insider, WELT, BILD, Onet, and Fakt — to collaborate on major stories for an international audience of hundreds of millions across platforms. Read the original article on Business Insider