Gilead to Donate Truvada to CDC to Help With HIV PrEP in US

Kerry Dooley Young

May 13, 2019

Gilead Sciences Inc said it intends to donate as many as 2.4 million bottles of emtricitabine/tenofovir disoproxil fumarate (Truvada) annually to federal efforts to prevent HIV infections.

That move did not assuage activists, who continued to press for the introduction of robust generic competition to drive down the cost of the treatment.

Still, the White House greeted a May 9 announcement from Foster City, California-based Gilead as a positive step forward. Gilead said it intends to provide the donated drug supply to the Centers for Disease Control and Prevention (CDC), which will then work to make it available to people who lack medical insurance. The Department of Health & Human Services (HHS) said this donation may cover as many as 200,000 individuals each year.

HHS said the agreement with Gilead will last until at least the end of 2025 and might last until 2030. The Trump administration has been pressing drugmakers to make their products more affordable to consumers. They claimed the Gilead donation as a win for public health in the fight against HIV.

The list price for Truvada can run to $20,000 per patient a year, HHS said. That puts it beyond the means of many people who could use the drug to prevent HIV infections.

"The majority of Americans who are at risk and who could protect themselves with PrEP [pre-exposure prophylaxis] are still not receiving the medication," said HHS Secretary Alex Azar in a statement.

President Donald Trump tweeted on May 9 in praise of the agreement, saying that his administration secured "a historic donation of HIV prevention drugs."

Activists Want More

But the donation did not put an end to calls to lower the price of Truvada. Activists have been calling for some time for government action to make a cheaper version of the medicine more widely available.

"Working with pharma is not how we are going to achieve universal PrEP access," tweeted nonprofit ACT UP of New York on May 9. "The U.S. taxpayer funded the research to this prevention drug. The government must leverage their power to #BreakThePatent once and for all."

While Gilead has been losing sales of Truvada in foreign markets to generic competition, it has kept it at bay in the United States. Gilead has scrapped with generic drugmaker Teva Pharmaceuticals over the years about that firm's bid to sell its version of Truvada.

Gilead last week announced in a filing with the Securities and Exchange Commission (SEC) that Teva will be able to put a version of Truvada on the US market on Sept. 30, 2020. That's a year earlier than had previously been expected.

Sales of Truvada-based products in the United States in first 3 months of 2019 slipped to $795 million, compared with $935 in the first 3 months of the previous year, Gilead said in the SEC filing.

That's a reduction of about 18% in domestic sales, which Gilead attributed to patients switching to newer regimens containing tenofovir alafenamide. Gilead has been testing a combination of emtricitabine and tenofovir alafenamide (Descovy) for HIV PrEP. If the drug is approved for PrEP by the FDA, the company said in the release that it would transition from Truvada to Descovy for the annual donation.

In Europe, Truvada-based products sales fell by about 55% when comparing the first 3 months of this year to the same period in 2018. They dropped to $129 million from $286 million, Gilead said in the SEC filing. Gilead attributed this European decline to patient switching to newer drugs regimens and to generic competition.

Patent Debate

In the United States, activists are continuing to press for a more rapid introduction of generic version of Truvada than Gilead envisions.

The PrEP4All Collaboration has called on the CDC to leverage patents regarding the use of Truvada to prevent HIV to bring down the cost of the drug. The group, which includes The Global Health Justice Partnership at Yale Law School and Public Citizen, said Truvada costs less than $4.50 per month to manufacture.

The collaboration has urged the CDC to press for patent royalty payments, which it said could fund a "universal PrEP program to dramatically reduce the number of new HIV infections in the country."

Democrats in Congress and Sen. Bernie Sanders (I-Vt.) also have pressed the CDC to push for greater consideration of the federal investment in Truvada.

The House Committee on Oversight and Reform will hold a May 16 hearing on the drug, titled "HIV Prevention Drug: Billions in Corporate Profits After Millions in Taxpayer Investments."

In April, Sanders and five Democrats joined Sen. Debbie Stabenow (D-Mich.) in a letter pressing HHS and the CDC to explore ways to leverage the federal government's contribution to Truvada.

"We are deeply concerned that a drug company is marketing a product that appears to potentially be infringing upon patents owned by the United States Government and selling it at a price that makes the drug unaffordable for many Americans," they wrote in the letter.

The senators said in April that while the HHS secretary has been in negotiations with Gilead, no agreement had been reached to allow the government to make use of these patented methods.

"When the government holds a patent, licenses should be granted on terms that make it economically viable for industry to develop drugs, but allow the government to recoup its investment and fund further research as well as ensure that drugs developed using government-owned patents are affordable," the senators wrote.

In contention are three US patents awarded to CDC scientists for work related to using Truvada to prevent HIV infection; Nos. 9,044,509, 9,579,333, and 9,937,191, according to the annual SEC filing Gilead made in February for 2018.

Gilead said in the filing that it had been in contact with HHS "about the scope and relevance of the patents."

The company also said that it did not believe the patents are valid "because the patent office was not given the most relevant prior art and because physicians and patients were using the claimed methods years before the Centers for Disease Control and Prevention filed the applications for the patents."

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