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Info Service on Health Issues (Jul25/01) Penang, 17 Jul (Kanaga Raja) — A new study published in the medical journal The Lancet has revealed that the drug lenacapavir – a long-acting injectable for HIV prevention – could be produced for as little as $25 per person per year, potentially making it a “highly cost-effective intervention” in the fight against the HIV epidemic. The study, supported by the Make Medicines Affordable (MMA) campaign, led by the International Treatment Preparedness Coalition (ITPC) and partners, used established methodologies to estimate the production cost of generic lenacapavir. The authors of the groundbreaking study projected the cost of the active pharmaceutical ingredient using quotes from well-established vendors for the key starting materials combined with the most efficient route of synthesis. They then factored in formulation, overhead, and packaging costs as well as a 30% profit margin, with 27% tax on profit to project the cost-plus pricing of the finished pharmaceutical product. According to the authors, the cost of mass-producing generic medicines can be estimated from the cost of the active pharmaceutical ingredient plus conversion to the finished pharmaceutical product with packaging. This approach has successfully predicted prices eventually achieved for generic medicines for HIV, tuberculosis, and several others, they pointed out. For instance, the study noted that the hepatitis C drug daclatasvir was initially priced at $63,000 per treatment course in the United States of America. In 2014, it was predicted that daclatasvir could be made for $10-$30 per treatment; it now costs $19 for generic treatment, it said. The authors said their 2024 study projected that generic lenacapavir could be produced for $41 per person per year for ten million people. However, they said that since then, these costs have likely fallen. Based on their latest calculations, the authors found that generic lenacapavir can be produced for $35-$46 per person per year for two million people. According to the authors, with modest improvements and growth in demand, the cost of treatment could be reduced to $25 per person per year, if scaled up for five to ten million people. The authors projected that generic lenacapavir can be priced equal to or lower than current oral pre-exposure prophylaxis ((PrEP). “With funding to support mass production and global access, lenacapavir PrEP could be a highly cost-effective intervention to eliminate HIV,” they emphasized. The study featured in The Lancet comes as the World Health Organization on 14 July released new guidelines recommending the use of injectable lenacapavir twice a year as an additional PrEP option for HIV prevention. In what it viewed as a landmark policy action that could help reshape the global HIV response, the WHO said lenacapavir, the first twice-yearly injectable PrEP product, offers a highly effective, long-acting alternative to daily oral pills and other shorter-acting options. “With just two doses per year, lenacapavir is a transformative step forward in protecting people at risk of HIV – particularly those who face challenges with daily adherence, stigma, or access to health care,” it added. “While an HIV vaccine remains elusive, lenacapavir is the next best thing: a long-acting antiretroviral shown in trials to prevent almost all HIV infections among those at risk,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a news release. “The launch of WHO’s new guidelines, alongside the FDA’s recent approval, marks a critical step forward in expanding access to this powerful tool. WHO is committed to working with countries and partners to ensure this innovation reaches communities as quickly and safely as possible,” he added. According to WHO, the new guidelines come at a critical moment as HIV prevention efforts are stagnating, with 1.3 million new HIV infections taking place in 2024, disproportionately impacting key populations, including sex workers, men who have sex with men, transgender people, people who inject drugs, people in prisons, as well as children and adolescents. WHO said HIV remains a major global public health issue. By the end of 2024, an estimated 40.8 million people were living with HIV, with an estimated 65% in the WHO African Region. Approximately 630,000 people died from HIV-related causes globally in 2024, and an estimated 1.3 million people acquired HIV, including 120,000 children, it added. Meanwhile, in a post on its website on 15 July, the Make Medicines Affordable (MMA) campaign highlighted The Lancet study, pointing out that lenacapavir, administered just twice a year, has been shown to reduce HIV transmission to nearly zero. However, it said the drug’s high price remains a major barrier to access, with Gilead Sciences (which developed the drug) currently pricing it at over $28,000 per person annually in the US market. According to MMA, Joseph Fortunak, the lead author of the study and a Professor at Howard University, along with Andrew Hill, Senior Visiting Research Fellow at the University of Liverpool and a leading advocate for HIV treatment access, as well as a global team of researchers, emphasized the potential for lenacapavir to be a highly cost-effective intervention in the fight against HIV. The MMA post cited Hill of the University of Liverpool as saying: “We are at a moment where we could see the virtual elimination of HIV infections, but only if the drug is made affordable and widely available.” The authors of the study pointed out that six generic companies have signed royalty-free licenses with Gilead Sciences to manufacture and supply generic lenacapavir to 120 lower-income countries. However, they said that key middle-income countries and all high-income countries are excluded from this agreement. Gilead has committed to temporarily making treatment available for two million people in licensed countries at no profit, said the study. In the countries outside of this license, lenacapavir is sold for $25,395-$44,819 per person per year, while the expected launch price for lenacapavir PrEP is $25,000 per person per year, it added. “The need for affordable pricing for PrEP is acute given recent severe cuts to international aid, including a near- total de-funding of PrEP within the President’s Emergency Fund for AIDS Relief (PEPFAR),” said the authors. In its post, MMA pointed out that major regions with significant HIV burdens, such as parts of Eastern Europe, Central Asia, and most of Latin America, remain excluded from the licensing deals, leaving millions without access to this promising prevention tool. “The licensing deals exclude some of the countries with the highest rates of new infections,” Hill underlined. “Governments need to recognize that they have the power to negotiate fair prices or consider compulsory licenses to protect public health,” he said. MMA noted that advocates and experts have described Gilead’s current pricing as “utterly unaffordable” and a threat to public health. Professor Andrew Grulich from the Kirby Institute called Gilead’s pricing “absolutely crazy,” emphasizing that no health system can afford to implement lenacapavir widely at current prices, according to the MMA post. “Prevention drugs must be priced to reach as many people as possible – they cannot be treated like luxury therapies,” Grulich stressed. According to MMA, the authors of the study underscored the potential for generic lenacapavir to match or even undercut the price of existing oral PrEP regimens. MMA said with support from global health funders, pooled procurement strategies could help bring down costs and accelerate manufacturing at scale. “Scientifically, lenacapavir is the closest thing we have to a vaccine for HIV. But without affordable access, this breakthrough risks becoming a public health tragedy rather than a triumph,” Hill concluded. (The full study can be accessed at: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=5293409). +
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