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Gilead Sciences, the manufacturer of Truvada, the only drug authorized to prevent HIV infection, will give enough to treat 200,000 patients a year for 11 years, federal officials said Thursday. health.
Officials from the Ministry of Health and Social Services said the donation was granted "following discussions between the Trump administration and Gilead".
The drug is taken once a day to prevent infection with H.I.V., a strategy called pre-exposure prophylaxis or PrEP. It is estimated that one million Americans are at risk of infection and should take the drugs, but about 270,000 do so.
HIV. Activists and experts have had mixed reactions to the news. Some felt that the donation was a good start, but they claimed that it only covered one-fifth of the needs in the United States.
The high cost of Truvada has been described as a major obstacle to the fight against the spread of H.I.V. Critics say that among low-income Americans, this is partly why the AIDS epidemic has been going on for so long.
A significant price cut for Truvada – and the drug Gilead to replace him, Descovy – would do much more to protect Americans in danger, they said. Truvada now costs about $ 20,000 a year in the United States.
Gilead seems to follow the pattern established in 2001 by other pharmaceutical companies. While millions of Africans have died of AIDS because their drugs cost as much as $ 20,000 a year, drug manufacturers have refused to reduce their prices.
But companies have offered to give limited quantities of H.I.V. drugs – while lobbying the governments of the United States and Europe to ensure that generic medicines manufactured in India are kept out of the market.
The tactic eventually failed and Indian societies now provide almost all of H.I.V. drug addicts. In Africa, generic Truvada is sold around $ 60 a year.
Gilead has sued several companies that have attempted to introduce generic versions in the United States. The company settled each suit, but kept the details secret. Its rivals stayed out of the market, which provoked strong criticism from the company.
A cheaper generic version of Truvada is expected next year. Gilead will donate Truvada until Descovy is approved for H.I.V. prevention, then switch patients to the new drug.
Descovy contains a new version of tenofovir, the active ingredient in Truvada. Once approved, Descovy will be protected by a patent for many years. Gilead said it would also cost $ 20,000.
Alex M. Azar II, secretary of health and social services, who announced the announcement with Gilead on Thursday night, said the deal would last until 2025 or even until 2030.
"Securing this commitment is a major step in the Trump administration's efforts to use the prevention and treatment tools we have to end the H1V virus. epidemic in America by 2030, "he said.
Dr. Rochelle P. Walensky, who led a Massachusetts General Hospital team that analyzed the costs of the Obama administration's AIDS plan and the cost of the Trump plan, said the agreement with Gilead was "A noble effort – but it covers less than 20% of the people who need it. "
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"Let's call a cat a cat," she says. "The real cost of Truvada is about $ 60 a year. If you really wanted to cover everyone, you would reduce the price. "
"If I put my cynical hat on, I think it's like that they're sure to grow the Descovy market," she added. "This will promote the idea that Descovy is better – and I'm not sure it's a dialogue we want to present."
Although Truvada is considered a very safe medicine, it can cause kidney problems and loss of bone density in some patients. Descovy seems to cause less of these effects, but it increases cholesterol levels more than does Truvada.
Peter Staley, one of the founders of PrEP4All, a group that advocates for wider access to Truvada, called the arrangement "promising but depressing."
Since it costs little to do Truvada, he says, the donation will cost Gilead less than $ 10 million a year.
The Department of Justice is investigating Gilead's failure to pay royalties from the Center for Disease Control and Prevention for the work it has done to develop Truvada as H.I.V. preventive.
Gilead earns over $ 3 billion a year worldwide through Truvada. As a result, royalties to the federal government could cost up to $ 1 billion, Staley said.
"Neither the announcement of Azar nor Gilead let it be known whether this is part of an investigation by the Department of Justice," said Mr. Staley.
"In addition, it will not reduce Gilead's sales and is a very cheap marketing program for Descovy," he added.
Descovy's production is expected to cost a lot less than Truvada's, "said Mitchell Warren, executive director of AVAC, an AIDS prevention organization. TAF, the active ingredient of Descovy, is more potent than TDF, that of Truvada. It takes less.
"It shows you the basics of pricing pharmaceuticals," Warren said. "We urgently need a lower price, and it is disappointing that it took so long."
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