Lenacapavir Sodium

The ECDC’s 2025 HIV Surveillance Report has found that 54% of patients diagnosed with HIV in 2024 were diagnosed too late to receive fully effective treatment. Image credit: Corona Borealis Studio via Shutterstock.com. A European 2025 HIV/AIDS surveillance report has revealed that countries within the continent are currently failing to test and treat HIV early. The annual report, published by the European Centre for Disease Prevention and Control (ECDC), was released on 27 November 2025 but looks at 2024 data. While the report identified a small downturn in HIV cases between 2023 and 2024, testing gaps were still highly prevalent. This is evidenced by the fact that 54% of patients with HIV across the World Health Organization (WHO) European region in 2024 were unable to receive optimal treatment due to late diagnosis. This is notable as patients with a delayed HIV diagnosis are less likely to gain the full benefits of antiretroviral (ART) therapies. Currently, ART therapies are the mainstay treatment option for patients diagnosed with HIV, as they can suppress viral load and prevent transmission. According to the annual report, 105,922 HIV diagnoses were made across the WHO European region in 2024, which includes 53 countries. Of those receiving late diagnoses, the highest proportion were heterosexual patients – especially men – as well as people that inject drugs. As current testing initiatives across Europe are currently failing to diagnose a majority of patients early, the ECDC noted that the 2030 goal of ending AIDS as a public health threat could be in jeopardy. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence To ensure this goal is achieved, the ECDC and the WHO’s European division are calling for the scale-up and routinisation of HIV testing across the continent, with a key focus on self-testing and community-based options. According to Hans Henri P. Kluge, WHO regional director for Europe, tackling the silent HIV crisis will involve “removing the deadly barriers of stigma and discrimination” that currently discourage individuals from seeking out a HIV test. Meanwhile, Pamela Rendi-Wagner, director of the ECDC, stressed the importance of innovating testing strategies, while “ensuring rapid linkage to care” to improve patient outcomes. A major hit to global HIV treatment efforts came this year came when President Donald Trump cut a large amount of funding for foreign aid. This impacted HIV, malaria and tuberculosis treatment services in low-income countries supported by the United States Agency for International Development (USAID). Trump also trimmed financial support for the president’s Emergency Plan for AIDS Relief (PEPFAR). The plan has become a major pillar in fighting the global HIV/AIDS response, providing testing services, antiretroviral treatment and education programmes. HIV treatments advance Currently, HIV remains a major threat to public health, with the WHO estimating that 40.8 million were living with the disease globally at the end of 2024. However, there are a wide range of effective ART options available to patients, meaning that those with access to medications have a similar life expectancy to an individual living without HIV. The most widely prescribed ART is currently Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), which had a strong financial showing in Q2 2025, with sales jumping 9% to $3.5bn. While the drug’s patent is up for expiry as early as October 2027, GlobalData analysts predict that no other HIV therapy is likely to surpass Biktarvy in terms of commercial success. Alongside Biktarvy, Gilead has found a new key asset in Yeztugo (lenacapavir), which the US Food and Drug Administration (FDA) approved as a biannual pre-exposure prophylaxis (PrEP) for patients at risk of HIV in June 2025. While this treatment is only suitable as a preventive measure, GlobalData analysts note that the therapy is set to revolutionise the HIV landscape. Now, some companies are looking to cure HIV completely. This includes American Gene Technologies, which is currently looking to take its potentially curative cell therapy, AGT103-T, to additional trials after a Phase I study yielded promising results . The International AIDS Vaccine Initiative is also working towards a preventive vaccine for HIV, which has seen an adenovirus vaccine enter Phase I clinical trials in Africa. Currently, the jab is being tested in both HIV-positive and HIV-negative individuals. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

Merck secured another win on Wednesday in its plan to bolster its HIV portfolio. The pharma giant said its two-drug combination was non-inferior to a three-drug package in a Phase 3 trial in adults with HIV-1 who were not previously on antiretroviral treatment. Merck said the study of the single-tablet combination of doravirine and islatravir met the primary efficacy hypothesis at week 48. The safety of DOR/ISL was also “comparable” to the three-drug combination of Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide, or BIC/FTC/TAF). Both are once-daily regimens. DOR/ISL is already under FDA review for a different patient population : people with HIV who are already on an antiretroviral regimen. The regulatory body is slated to decide whether to approve the treatment in that population by April 28 . Merck hopes DOR/ISL will become part of a broader HIV portfolio that could be a $5 billion business . Its existing medicines in the space made $412 million in revenue in the first half of this year, but it’s studying additional combinations and a once-monthly oral PrEP that just entered Phase 3. Merck has been involved in HIV science since the early days of the epidemic, and brought the protease inhibitor Crixivan to market in 1996. Multiple HIV treatment options now exist, and companies like Gilead and GSK’s ViiV make long-acting HIV medicines, but for different patient populations. Merck’s existing HIV work is a small piece of the pharma’s efforts to pad the revenue gap that will come from Keytruda’s patent cliff. Merck has spent more than $19 billion this year on acquisitions, namely for respiratory biotech Verona Pharma and influenza antiviral developer Cidara Therapeutics . The new Phase 3 data will be presented at a future medical conference. Merck said it plans to use the data in applications to health regulators. With the non-inferiority results, Merck hopes to go up against Biktarvy, which brought in $3.7 billion in sales for Gilead in the third quarter of this year. “These data support the potential for this regimen to be a meaningful treatment option for virally suppressed people living with HIV who are looking to switch to a new regimen or people who have not previously been on antiretroviral therapy to start treatment,” Merck Research Laboratories chief medical officer Eliav Barr said in a press release. Merck chief marketing officer Chirfi Guindo said on an investor call in July that the company believes DOR/ISL will be “the preferred switch option for many individuals.” Guindo said the drug combination provides “robust viral control” and a “high barrier to resistance.” Doravirine is an approved HIV medicine known as Pifeltro and part of an HIV pill marketed as Delstrigo. Islatravir, meanwhile, is in multiple clinical trials assessing whether it can be a once-daily or weekly treatment for HIV when paired up with other medicines. The drug is in Phase 3 with Gilead’s lenacapavir as a potential once-weekly oral treatment. Islatravir is also in a Phase 2b in combination with Merck’s ulonivirine, an experimental non-nucleoside reverse transcriptase inhibitor (NNRTI). That pairing is “back on track,” Luisa Stamm, Merck’s associate VP and section head for HIV, said in an interview with Endpoints in July. The drug combo had a safety signal for a prior Phase 2, but Merck is now looking at a lower dosing schedule to assuage concerns.