New partnerships bring price parity between lenacapavir and oral PrEP

A group of donors and partners is racing to ensure a breakthrough HIV prevention drug is inexpensive and broadly accessible. Lenacapavir, a preexposure prophylaxis injection, or PrEP, which offers protection for six months before another shot is needed, has shown nearly perfect efficacy in preventing HIV transmission and generated high levels of excitement around its potential to help hasten the epidemic’s end. Under two separate partnerships, both announced Wednesday at the United Nations General Assembly, India-based generic manufacturers are expected to produce the new injection at $40 per person per year for 120 low- and middle-income countries by as early as 2027 — that’s the same price as a year’s course of daily oral PrEP. One partnership is between pharmaceutical company Dr. Reddy’s Laboratories, Unitaid, the Clinton Health Access Initiative, or CHAI, and research institute Wits RHI. The other is between the Gates Foundation and the pharmaceutical company Hetero. “This is a massive step forward to jumpstart the market,” Mitchell Warren, executive director of AVAC, an international nonprofit that works to accelerate development and delivery of HIV prevention options, told Devex. The daily oral pill, first approved in 2012, is the most commonly used PrEP. But uptake has been slow. In 2023, just 3.5 million people received oral PreP at least once — but Trevor Mundel, president of global health at the Gates Foundation, told Devex it’s their goal to reach 10 million people with lenacapavir, saying that’s the scale of people on the drug needed to “turn off the tap of new infections.” There were some 1.3 million new HIV infections last year. It’s hoped a twice-a-year injection would be both less burdensome and more discreet than taking a daily pill, leading to increased uptake. One reason oral PrEP is inexpensive is that elements used are part of broadly produced antiretroviral treatments — not the case for lenacapavir. “The ability to protect someone for six months with a single injection, at the same cost as the currently available daily pills, is truly transformational,” said former President Bill Clinton, board chair and co-founder of CHAI, in a press release. Showing ‘what’s possible’ Lenacapavir costs more than $28,000 per person annually in high-income countries. But last October, Gilead, which developed the drug, granted voluntary licenses to six generic manufacturers. These new partnerships — working with two of those six manufacturers — hope to create a multipartner, multidonor supply strategy and competitive generic market. “Part of what we're trying to do is secure a launch price that can help unlock and remove one of the hurdles to early adoption,” Unitaid’s Director of Strategy Janet Ginnard told Devex. “It certainly shows what’s possible.” Two generic manufacturers is the minimum number to create competition and stability of supply, Mundel said. “Often, the generics are looking and waiting to see what their competitors are going to be doing. So it may not always be necessary to do the same deal with everyone, because they now have sort of a market incentive,” he said. Dr. Reddy’s Laboratories will receive financial, technical, and regulatory approval support. It will also work to optimize production of the drug’s active pharmaceutical ingredient. Unitaid provides financial support, while CHAI serves as the technical lead. “In the case of Lenacapavir, the [active pharmaceutical ingredients] are a big cost driver,” said Carolyn Amole, vice president of HIV, Hepatitis, and TB at CHAI. The Gates Foundation deal with Hetero Labs focuses on upfront funding and volume guarantees — a mechanism whereby a manufacturer is guaranteed purchase of a certain quantity, and if that doesn’t happen in the market, the donor makes up the difference. This deal also includes work to optimize the production process. The aim is for Hetero Labs to produce millions of doses of the drug. There are hopes that prices could be driven even lower than $40. Mundel speculated that within several years, the drug could sell for as low as $30 per dose. The lenacapavir regimen includes two injections accompanied by two tablets, and two tablets the following day. Every six months thereafter, a person would come in for injections. The accompanying pills are only necessary for when a person is being initiated on the drug. The Dr. Reddy’s agreement will bring the cost of those pills down to no more than $17, and the Hetero agreement is expected to bring them to around $15. These initial costs aren’t included in the $40 price announced in both partnerships. Beyond pricing, there are concerns around countries buying the product and governments’ capacity to deliver it. “Nobody has ever delivered an injectable to 10 million people in this way, as we certainly hope to do,” Mundel said. “There’s going to be a significant hurdle to overcome in creating that 10 million cohort, at least, that we want to see.” Partners are also working with governments to drive demand for and adoption of Lenacapivir. For example, the Gates Foundation has made more than $80 million in catalytic investments to accelerate market readiness, scale delivery, and shorten the timeline for generic entry — the largest part of which goes to Hetero. ‘Once-in-a-generation’ It typically takes about 10 years to bring drugs to market, but there have been a series of efforts to hasten the process in this case. After clinical trials showed high effectiveness last year, Gilead submitted regulatory dossiers quickly. The U.S. Food and Drug Administration approved the drug in June, the World Health Organization published guidance in July, and the European Medicines Agency granted approval in August. “We went from results in a clinical trial to having an approval of the product incredibly quickly,” CHAI’s Amole said. Recently, the U.S. government announced it will work with the Global Fund to Fight AIDS, Tuberculosis and Malaria to provide access to lenacapavir for at least 2 million people over three years. Gilead said it’s providing the drug at the cost of producing and delivering it, but at no profit. Amole said it’s “incredibly rare” to see all of these different pieces come together so quickly — including the negotiations of pricing deals. “Gilead is effectively launching their product in low- and middle-income countries at the same time as they launch in high-income countries — that’s almost unheard of,” she said. “It just really is actually a breakthrough product — it’s sort of a once-in-a-generation opportunity.” She added they are working in “early adopter” countries to support the rollout of Gilead’s product through the Global Fund and the U.S. President’s Emergency Plan for AIDS Relief, or PEPFAR. “We hope to be able to really build these markets with [the] use of the Gilead product over the next 18 months or so, when we then expect to have the generic available,” she said. And while there’s initial donor support, ultimately, there’s expectation that countries will buy lenacapavir, Amole said. “This pricing deal is a really critical step in making it possible for governments to purchase directly,” she said. Questions also remain about lenacapavir access in middle-income countries excluded from the voluntary licensing agreement. This includes countries such as Vietnam, Indonesia, the Philippines, and Brazil, Warren explained — and he estimated that approximately 15% of new HIV infections occur in countries excluded from the agreement. Lenacapavir vs. cabotegravir This isn’t the first HIV prevention injection: Cabotegravir, or CAB-LA, injected every two months, is produced by ViiV Healthcare, which is majority-owned by GSK. But the rollout of CAB-LA has been slow. Since it was first approved in 2021, it’s estimated that only about 15,000 people have started CAB-LA for PrEP worldwide. While ViiV Healthcare and the Medicines Patent Pool signed a voluntary licensing agreement for PrEP access in 90 countries in 2022, these generics haven’t yet reached the market. And there have been criticisms of the company’s handling of it. In 2023, Médicins Sans Frontières wrote: “ViiV’s continued lack of transparency around CAB-LA’s current available supply and how they plan to distribute the drug geographically pose barriers to accessing this medicine, particularly in [low- and middle-income countries.]” Furthermore, while some donors have purchased CAB-LA from ViiV, the drug is expensive: The PEPFAR-negotiated cabotegravir price is $180 per person, per year. While Viiv signed a voluntary licensing agreement following regulatory approval, Gilead directly licensed companies to make generic lenacapavir before receiving Food and Drug Administration approval. “It has proven to be faster,” Warren said. “That saved over a year of time.” Given this, generics for Lencapavir and CAB-LA are expected to reach the market at about the same time, Warren said. A GSK spokesperson told Devex the company “moved at pace” to enable generic access to its drug, noting it signed with the Medicines Patent Pool only five months after the drug’s first global approval — and that because it was the first company to license a long-acting medicine for HIV, there were no clear public health guidelines or recommendations to support the rollout. The spokesperson said other manufacturers will benefit from implementation studies and partnerships that GSK supported to start the rollout of CAB-LA. The spokesperson added that CAB-LA is available at a not-for-profit price in low- and middle-income countries — and that the company committed to make at least 2 million doses available in 2025–2026, of which half a million vials in 17 countries have already been supplied. GSK estimates that generic versions of the drug will be available in 2027.