Gilead Sciences will work with pharmaceutical manufacturers to produce and sell generic lenacapavir for pre-exposure prophylaxis (PrEP) in 120 resource-limited countries with high HIV incidence rates, the company announced this week.

Advocates welcomed the news, but some argue that the agreements should not be limited only to low- and lower-middle-income countries, as upper-middle-income countries, such as Brazil and Russia, account for some 40% of new HIV diagnoses.

“The licensing agreements enabling generic versions of the HIV prevention drug, lenacapavir, in certain countries is an important step forward, but large parts of the world remain excluded, including countries where trials were conducted,” International AIDS Society president Beatriz Grinsztejn, MD, PhD, said in a statement. “We are hopeful that the speed with which these agreements were reached will be maintained, and that the rest of the world will soon benefit from similar agreements to make lenacapavir more affordable and offer a further potent option in the HIV prevention toolbox.” 

As previously reported, two studies recently showed that lenacapavir injections administered every six months are highly effective for preventing HIV acquisition. The PURPOSE 1 trial, which enrolled more than 5,300 young cisgender women in Africa, showed that lenacapavir injections were significantly more protective than daily PrEP pills. None of the women randomly assigned to lenacapavir acquired HIV.

The parallel PURPOSE 2 trial showed that lenacapavir PrEP also works well for gay and bisexual men and transgender and nonbinary people. The twice-yearly injections significantly reduced HIV incidence compared with the background rate and were superior to daily oral PrEP. There were two new infections among the 2,180 trial participants assigned to lenacapavir.

Researchers, public health experts and advocates have hailed lenacapavir PrEP as a game-changer in the effort to end HIV but cautioned that its potential would only be realized if it is accessible to the people who need it most worldwide. ViiV Healthcare’s Apretude (injectable cabotegravir), which is administered every other month, is currently the longest-acting approved PrEP option.

Lenacapavir (sold as Sunlenca) is currently approved only as part of a combination treatment regimen for people with multi-drug-resistant HIV. Gilead plans to submit data from the two PrEP trials to the Food and Drug Administration and regulatory authorities in other countries by the end of the year, which could lead to an expanded indication for HIV prevention in 2025.

Well in advance of this approval, advocates and global health leaders have been pressuring the company to offer lenacapavir PrEP at an affordable price. Lenacapavir for HIV treatment costs around $4,000 per month, while generic versions of oral PrEP can cost as little as $20 per month. A study presented at the International AIDS Conference this summer showed that the price of lenacapavir could be brought down to around $40 per year with voluntary licensing and competition between generic suppliers.

Licensing Agreements

According to Gilead’s news release, the company has signed non-exclusive, royalty-free voluntary licensing agreements with six companies that produce generic medications (Dr. Reddy’s Laboratories Limited, Emcure, Hetero and Mylan in India; Eva Pharma in Egypt; and Ferozsons Laboratories Limited in Pakistan). All have previously collaborated with Gilead to produce high-quality generic versions of medications for HIV or other infectious diseases.

The generic manufacturers will supply lenacapavir for both prevention and treatment of highly resistant HIV in 120 mostly low- and lower-middle-income countries. Gilead said that it would price lenacapavir “at no profit to the company,” and indicated that it would supply the drug itself until the new manufacturers can fully meet demand. While capacity is being scaled up, Gilead will prioritize 18 countries that account for around 70% of the HIV burden among the 120 countries (Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia and Zimbabwe).

“Given the transformative potential of lenacapavir for prevention, our focus is on making it available as quickly and broadly as possible where the need is greatest,” said Gilead chairman and CEO Daniel O’Day. “Gilead teams have been working with urgency to bring on high-volume generic manufacturers now, so that we can ensure a rapid transition to these voluntary license partners after lenacapavir for PrEP is approved.”

But some advocates think the agreements do not go far enough. Upper-middle income countries and even high-income countries may not be able to provide lenacapavir PrEP to everyone who could benefit at its full commercial price. Many people at risk for HIV in these countries are from marginalized groups that largely rely on publicly funded health care coverage.

Notably, none of the partner generic manufacturers are in Latin America, which includes middle-income countries with substantial HIV epidemics. The exclusion of Argentina, Brazil, Mexico and Peru is particularly problematic because the PURPOSE 2 trial was conducted at sites in those countries.

“We applaud Gilead for licensing [lenacapavir] without waiting for registration, which should be the norm. We are battling a pandemic, and the speed at which generic versions come to market will dictate whether this medicine can really be transformative,” UNAIDS Executive Director Winnie Byanyima said in a statement.

“Much more work is still urgently needed to ensure that no one who needs lenacapavir is left behind and that Gilead’s commitment to rapid, affordable access is fulfilled. The exclusion of many middle-income countries from the licenses is deeply worrying and undermines the potential of this scientific breakthrough,” she continued. “Leaving no one behind is how to unlock lenacapavir’s full potential, fulfill Gilead’s promise, protect a generation from HIV and bring forward the end of the AIDS pandemic.”

Gilead has not yet announced a commercial price for lenacapavir for HIV prevention, though it has suggested that it would be lower than the current treatment price and may involve tiered pricing based on countries’ income levels. The six voluntary licensing partners will set their own prices for generic lenacapavir, and competition between them may drive down the cost. PEPFAR (the U.S. President’s Emergency Program for AIDS Relief) and the Global Fund to Fight AIDS, Tuberculosis and Malaria, which are expected to be the largest purchasers of lenacapavir for PrEP, have indicated they can pay around $100 per person per year.

Even in wealthy countries, cost can be a barrier to PrEP access. The Affordable Care Act requires insurers to cover PrEP at no cost, but coverage of Apretude has been inconsistent.


“Despite making up 39% of new diagnoses, Black people make up only 14% of PrEP users, and if future modalities such as long-acting injectables don’t address the unnecessarily high cost of medication, as well as lab and provider coverage, we will be having the same discussions about racial disparities in uptake years from now,” PrEP4All communications and mobilization manager Michael Chancley said in a statement.

“[Gilead’s] announcement speaks to the power of global advocates who have built a movement around access to long-acting injectable HIV prevention options,” added PrEP4All executive director Jeremiah Johnson. “Advocates should feel energized and motivated to see this fight through; to make sure that no community is left behind in accessing comprehensive HIV prevention options, domestically or globally.”

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