Lenacapavir Sodium

In recent years, Gilead Sciences' most profitable product, Biktarvy, has been the flagship of the company. However, as the patent for this HIV medication is set to expire in 2033, Gilead has unveiled a highly praised strategy at its HIV investor conference, aimed at consolidating its leadership in HIV treatment for the next decade and beyond. Gilead's star product, lenacapivir, an antiviral drug for multidrug-resistant HIV, is currently marketed under the name Sunlenca. Phase III studies have shown "unprecedented efficacy," demonstrating its significant potential as a long-acting pre-exposure prophylaxis (PrEP) option. Gilead plans to launch the drug in summer 2025 and expects to submit a marketing application this year. The report indicated that among more than 9,000 participants in the lenacapivir trial, over 99.5% remained HIV-negative. The HIV pharmaceutical company positions its biannual option as a disruptor in the PrEP market, committing to a "thoughtful and innovative approach" to reach underserved consumers and "transform HIV prevention" comprehensively. Citigroup analysts noted that while the drug is projected to generate $125 million and $500 million in revenue in 2025 and 2026, respectively, Gilead particularly needs a "targeted approach" to penetrate the currently underrepresented PrEP market, focusing on overseas markets. Leerink analysts foresee similar challenges, given that the PrEP market is predominantly limited to white men who have sex with men and are receiving HIV treatment. Analysts indicated that to expand the treatment population, Gilead may need to work on eliminating stigma around the disease and improving healthcare infrastructure in certain countries. Gilead has developed a game plan with unique strategies tailored to different global markets. The company is already working to overcome current market limitations by conducting studies involving transgender men, transgender women, non-binary individuals, and cisgender men. Nonetheless, in the U.S. alone, Gilead aims to target 44% of HIV-infected individuals who are not achieving viral suppression through PrEP, with a goal to expand the U.S. PrEP market to over one million people by the mid-2030s. Despite the ambitious targets, Leerink believes this is an achievable task, as lenacapivir is a "special" product. In addition to the monotherapy lenacapivir, Gilead has secured seven new HIV treatment regimens before the end of 2033, including 12 new molecules and 11 combination therapies, one of which relies on Merck's islatravir. Citigroup analysts acknowledged that these seven approvals would "greatly protect" the exclusivity that Biktarvy is about to lose. While Biktarvy is ambitious, Leerink analysts maintain that given Biktarvy's established antiviral expertise and capabilities, the company is "uniquely positioned to execute such a broad and diverse HIV development plan and R&D engine." The California-based pharmaceutical company reminded investors that this expertise dates back to the early 21st century, starting from Truvada, the first PrEP drug in 2012, and extending to Biktarvy, which has become the "most prescribed" HIV treatment ever. Now, with lenacapivir waiting for approval, Gilead could seize long-acting leadership from GlaxoSmithKline, which currently markets its Apretude, a PrEP option administered every two months. Mizuho analysts previously projected that lenacapivir could achieve peak sales of around $4 billion.

TUESDAY, Dec. 3, 2024 -- In a population of cisgender men, transgender women, transgender men, and gender-nonbinary persons, the incidence of HIV is lower with receipt of twice-yearly subcutaneous lenacapavir compared with daily oral emtricitabine-tenofovir disoproxil fumarate (F/TDF), according to a study published online Nov. 27 in the New England Journal Medicine . Colleen F. Kelley, M.D., M.P.H., from the Hope Clinic of the Emory University School of Medicine in Decatur, Georgia, and colleagues randomly assigned cisgender men, transgender women, transgender men, and gender-nonbinary persons to receive subcutaneous lenacapavir every 26 weeks or daily oral F/TDF in a 2:1 ratio in a phase 3 trial. The modified intention-to-treat analysis included 3,265 participants: 2,183 were assigned to lenacapavir and 1,088 to F/TDF. The researchers found that HIV infections occurred in two and nine participants in the lenacapavir and F/TDF groups, respectively (0.10 and 0.93, respectively, per 100 person-years). In the screened population (4,634 participants), the background incidence was 2.37 per 100 person-years. In the lenacapavir group, the incidence of HIV infection was significantly lower than the background incidence and the incidence in the F/TDF group (incidence rate ratios, 0.04 and 0.11, respectively). There were no safety concerns reported. Overall, 1.2 and 0.3 percent of the lenacapavir and F/TDF groups, respectively, discontinued the trial regimen due to injection site reactions. "Twice-yearly lenacapavir offers an efficacious choice for prevention of HIV infection, which may increase preexposure prophylaxis uptake," the authors write. Several authors disclosed ties to biopharmaceutical companies, including Gilead Sciences, which manufactures lenacapavir and funded the study.