A drug that provides near-perfect protection against H.I.V. with shots just twice a year will be made available at $40 per patient annually in low- and middle-income countries, offering new hope for ending the H.I.V. epidemic.
Although current treatments can suppress H.I.V., there is no real cure, making affordable prevention crucial for turning back the virus. About 1.3 million people worldwide become infected with H.I.V. every year.
The drug, lenacapavir, is given as two shots every six months. Through two deals announced on Wednesday by philanthropic organizations, the shots would cost the same as daily oral pills to prevent H.I.V., making lenacapavir a realistic choice in countries with constrained resources.
“This is a game-changer,” said former President Bill Clinton, co-founder and chair of the board of the Clinton Health Access Initiative, which helped negotiate one of the new partnerships.
”It simplifies prevention for patients, doctors, and health systems alike,” he said.
Health ministers of African countries welcomed news of a lower price.
“By making lenacapavir available soon for just $40 a year, we’re seeing remarkable progress in long-acting H.I.V. prevention,” Rwanda’s health minister, Dr. Sabin Nsanzimana, said.
Yet the deals come at a time when deep cuts to global health programs are forcing low- and middle-income countries to make tough decisions about how to fund responses to their most urgent health priorities, including malaria, tuberculosis and malnutrition.
“Where are those dollars and rands and shillings going to come from to actually procure the product, even if it’s $40 per person per year?” said Mitchell Warren, executive director of the H.I.V. prevention organization AVAC.
Oral pills are extremely effective at preventing H.I.V. But many people find daily medication difficult. Concerns about safety, privacy and stigma also create obstacles, particularly for women, in low-income countries.
Long-acting drugs largely circumvent those hurdles. Lenacapavir, made by Gilead Sciences, is the second long-acting option for H.I.V. prevention. An alternative, cabotegravir (brand name: Apretude), is injected every two months and is made by ViiV Healthcare, GSK’s H.I.V. company.
Lenacapavir’s twice-yearly injections, with an effectiveness of more than 99 percent in clinical trials, have inspired enormous optimism.
“We have the recipe here for a really successful once-in-a-lifetime shift in the way we’ve done H.I.V. prevention, and that’s really exciting,” said Jirair Ratevosian, a senior fellow at the Duke Global Health Institute.
Both long-acting drugs had seemed out of reach for most countries. In June, when lenacapavir was approved in the United States, Gilead said the drug would be marketed as a preventative called Yeztugo at a list price of $28,218.
The list price for cabotegravir is comparable. British researchers have estimated that lenacapavir could be made for as little as $40 per patient per year.
Gilead announced last October that it would allow six companies to make generic copies of the drug for 120 low- and middle-income countries. The new price of $40 per patient annually will be available in only those countries.
Unitaid, an international organization that aims to make lifesaving drugs affordable, along with the Clinton Health Access Initiative and the research institute Wits RHI, negotiated a partnership with Dr. Reddy’s Laboratories, a generics manufacturer in India.
The Gates Foundation forged a second deal for lenacapavir with Hetero, also based in India and the largest manufacturer of H.I.V. drugs worldwide. Although the partnerships were negotiated separately, the organizations aligned their efforts, including the timing of their announcements.
“What we want is to have a generic market that is the right size, the right price, but also to have some competition” between manufacturers, Dr. Philippe Duneton, executive director of Unitaid, said.
Carolyn Amole, a vice president at the Clinton Health Access Initiative, said the $40 price was only a start.
“What we have done with this price agreement is get the product on a pathway to even further price reduction and greater affordability,” she said, adding that the lower price will move countries toward the goal of self-reliance.
Generic versions of lenacapavir will be available starting in 2027. The Global Fund and the President’s Emergency Plan for AIDS Relief, or PEPFAR, have also announced a plan to distribute lenacapavir to 2 million people by 2028 in up to a dozen countries.
But about 40 million people need to take preventive drugs to achieve epidemic control in sub-Saharan Africa, according to some estimates.
PEPFAR has funds appropriated for prevention that could provide ”bridge” funding until the generics kick in, said Asia Russell, executive director of the advocacy group Health GAP.
The State Department’s “vanity project” to get the drug to 2 million people will make barely a dent in that need, she added: “The U.S. has responded to the science with a whimper instead of a roar.”
The State Department did not immediately respond to a request for comment.
The new deals do not include some middle- and high-income countries, including Brazil, that together account for about 20 percent of new infections.
“The rest of the world needs to benefit from that price as well,” Ms. Russell said.
Bill and Melinda Gates Foundation, President’s Emergency Plan for AIDS Relief, Gilead Sciences Inc
Discussion about this post