The drugmaker Gilead Sciences on Wednesday announced a plan to allow six generic pharmaceutical companies in Asia and North Africa to make and sell at a lower price its groundbreaking drug lenacapavir, a twice-yearly injection that provides near-total protection from infection with H.I.V.
Those companies will be permitted to sell the drug in 120 countries, including all the countries with the highest rates of H.I.V., which are in sub-Saharan Africa. Gilead will not charge the generic drugmakers for the licenses.
Gilead says the deal, made just weeks after clinical trial results showed how well the drug works, will provide rapid and broad access to a medication that has the potential to end the decades-long H.I.V. pandemic.
But the deal leaves out most middle- and high-income countries — including Brazil, Colombia, Mexico, China and Russia — that together account for about 20 percent of new H.I.V. infections. Gilead will sell its version of the drug in those countries at higher prices. The omission reflects a widening gulf in health care access that is increasingly isolating the people in the middle.
Gilead charges $42,250 per patient per year for lenacapavir in the United States, where it is approved as a treatment for H.I.V. The company has said nothing about what lenacapavir will cost when used to prevent H.I.V. infections, a process called pre-exposure prophylaxis, or PrEP.
The generics makers — four companies in India, one in Pakistan and one in Egypt — are expected to sell it for much less. Researchers at Liverpool University found the drug could profitably be produced for as little as $40 per patient per year, if it were being purchased in large volumes.
The terms of the new deal are similar to agreements made in recent years by other large pharmaceutical companies for drugs to treat cancer, hepatitis, Covid and H.I.V. These agreements guarantee low-cost access in the poorest countries but exclude these large-population, middle-income countries, using World Bank national income-per-capita figures to decide who is included.
Wealthy people living in these countries may be able to buy the brand-name drugs at the prices the drug companies set, said Dr. Othoman Mellouk, an expert in access to medicines with the health equity advocacy group ITPC Global who is based in Morocco. But most people cannot, and it is they who are most vulnerable to diseases such as H.I.V., he said.
“It’s good for those countries who are included in the license, but we will see more and more inequality of access as new technologies are available for the richest and for the poorest — those who are going to struggle are those in-between,” Dr. Mellouk said.
Melissa Barber, who studies access to medicines with the Yale Collaboration for Regulatory Rigor, Integrity and Transparency, said that the licensing deal shut out some of the countries that would most benefit from broad, swift access to lenacapavir, countries where H.I.V. is spreading among marginalized groups such as migrants, sex workers and injecting drug users, who are likely to be reached through public health systems.
“The patient populations driving the epidemic are people very disconnected from the health system, people who are hard to get to: That’s the center of gravity of epidemic,” she said.
Mitchell Warren, executive director of the H.I.V. prevention organization AVAC, said the exclusion of Brazil, Peru, Mexico and Argentina from the generics deal was shocking since the clinical trials that proved the drug worked were conducted in those countries.
Gilead said it would provide the people who participated in the trial with lenacapavir “until it is available in their countries.”
“Eight thousand people in a dozen countries participated in those two trials, but they didn’t do it alone, they did it with their communities,” Mr. Warren said. “Those trial sites were chosen because that’s where epidemics were the most serious.”
The voluntary license has an unusual provision that prevents the generics makers from exporting their product to any country not covered in the deal — so, for example, Brazil’s public health system will not have the option of buying the cheap version of the drug from an Indian company.
Gilead has patented lenacapavir in Brazil. But countries have the right, under even conservative trade agreements, to issue what are called compulsory licenses, which override intellectual property protections.
However even if Brazil were to issue such a license for lenacapavir, the generics makers would be forbidden from selling to the Brazilian health system.
The Pan American Health Organization buys drugs in bulk for Latin American countries in order to bring down prices, but the Gilead patent will also shut Brazil out of that avenue to a more affordable medication.
Susana van der Ploeg, an intellectual property lawyer who works with a large Brazilian AIDS organization, called the provision “draconian.” The only remaining option is for Brazilian researchers to reverse-engineer the drug and set up production locally, she said. “And we will,” she said. “But it will take a long time, time when we could have been saving lives.”
Brazil has been left out of all the other drug licensing deals in recent years, and the toll is paid by the 25 percent of its people who live below the poverty line, Ms. van der Ploeg said. “It’s not sustainable for us to give to people new forms of medicine,” she said. “We are a huge country with a public health system and huge inequalities and a lot of vulnerable people, including those with H.I.V.”
A Gilead spokeswoman said the company was “exploring several innovative strategies to support access, including tiered pricing” to make the drug accessible as PrEP in Latin America.
Ms. van der Ploeg said she expected the company would offer a price far below what it charges in the United States — but still far above what the Brazilian public health system could pay.
There has been an urgent need for a more effective PrEP product because the existing H.I.V. prevention efforts, including oral PrEP drugs, have not proved effective at ending new infections among some of the most vulnerable groups. In 2023, there were 1.3 million new H.I.V. infections globally.
The hope is that a discrete injection just twice a year may be more appealing for people still vulnerable to the virus.
In late June, Gilead stopped a trial of lenacapavir early after a data review found that the drug had a stunning 100 percent efficacy rate. In a study of 5,300 cisgender women ages 16 to 25 in Uganda and South Africa, not a single one who received the injection contracted H.I.V.
A second trial of the drug, among gay men and trans and non-binary people 16 and older, found similarly astounding results: In September, Gilead announced that among 3,200 trial participants in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States, there were just two H.I.V. infections among those who got the shots.
“Signing these agreements so quickly for a new, potentially transformative product like lenacapavir, before any global regulatory submissions for PrEP, much less approval, is unprecedented in H.I.V.,” said Johanna Mercier, Gilead’s chief commercial officer. “It’s a clear symbol of our commitment to ending the epidemic for everyone, everywhere.”
The generic version of the drug could be available by late 2027, Mr. Warren said. In theory, six different companies will then be competing for large orders, driving down the price.
Until then, Gilead will be supplying the drug.
The company said it would submit the drug to regulators for approval before the end of this year, and provide lenacapavir at a “no profit” price in the countries covered by the voluntary licenses until the generics makers have their manufacturing in operation and their versions are approved by regulators. Gilead would not say what that price would be or what volumes it would supply.
The U.S. President’s Emergency Program for AIDS Relief and the Global Fund to Fight AIDS, Tuberculosis and Malaria are expected to be the two largest buyers of lenacapavir. They have indicated they can pay about $100 per patient per year.
Mr. Warren said he hoped the major global health agencies would work together to place orders large enough to have at least a million people on lenacapavir by the end of 2026, which would help send a clear signal to generics makers about the potential market for the product.
