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Gilead CEO defends HIV drug Truvada's price, insists CDC patents invalid

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Gilead CEO defends HIV drug Truvada's price, insists CDC patents invalid

Daniel O'Day, the fairly new head of Gilead Sciences Inc., was on Capitol Hill to defend the price of his company's HIV drug Truvada and disputed allegations that anyone other than the California-based manufacturer had invented the medicine.

The ongoing rivalry between the Democratic and Republican heads of the House Oversight and Reform Committee was also on full display at the sometimes heated May 16 hearing — the second session held by the panel in recent months to examine high drug prices.

"We want truth. We want to know why it is that the prices are going up astronomically," said Rep. Elijah Cummings, D-Md., the committee's chairman.

But Rep. Jim Jordan, R-Ohio, the ranking member, said the Democrats were more interested in trying to "strong-arm private companies making breakthrough discoveries, all because they are upset at how markets work."

"We will never make real advancements in public health if the plan is to use false pretenses to attack and vilify those that are making game-changing scientific breakthroughs," he said.

Jordan had made similar accusations in letters to a dozen drugmakers in April, telling them Cummings' drug pricing probe was aimed at harming the companies' stock prices — an allegation the committee chairman disputed.

A number of Democrats also took issue with Jordan's characterization of the hearing, including Rep. Ayanna Pressley of Massachusetts.

"This is not the vilifying of profit. This is about the vilifying of choosing profit over people," she said.

Some of the witnesses at the hearing, including Robert Grant, a professor of medicine at the University of California San Francisco, told lawmakers that academic researchers, the U.S. government and the Bill & Melinda Gates Foundation had more to do with bringing Truvada to patients as a drug to prevent HIV than did Gilead.

Grant said the U.S. government and the Gates Foundation spent hundreds of millions of dollars on researching the components in Truvada, while Gilead was a "reluctant partner" until demand for the drug in the U.S. hit a tipping point.

He noted the Centers for Disease Control and Prevention holds patents related to Truvada but has opted not to enforce them.

"We the public, we the people, developed this drug, we paid for this drug," said Rep. Alexandria Ocasio-Cortez, D-N.Y., the lawmaker who initially called for the hearing.

But O'Day, a former longtime Roche Holding AG executive who took the reins of Gilead in March, argued the CDC's patents were not valid and said his company alone invented Truvada, though he acknowledged it relied on some government-funded research.

Moneymaker

Truvada is a combination of two drugs — emtricitabine and tenofovir disoproxil fumarate — and was initially approved in 2004 by the U.S. Food and Drug Administration to treat HIV, or the human immunodeficiency virus, a disease that attacks the body's immune system, specifically the CD4 cells. HIV is the virus that causes AIDS — acquired immunodeficiency syndrome.

In 2012, the FDA granted Gilead approval to market Truvada as a pre-exposure prophylaxis, or PrEP, treatment to prevent HIV transmission.

The drug, which is currently the only FDA-approved medicine for PrEP, has been shown to reduce the risk of HIV in people at high risk of the infection by up to 92%, though that efficacy was demonstrated when the medicine was taken consistently.

But Truvada's high U.S. cost has put the drug out of the reach of many Americans, some of the witnesses told the Oversight Committee.

In 2004, the list price for Truvada was about $800 per month. The price is now nearly $1,800 per month, despite the medicine not undergoing any changes.

The drug has been a big moneymaker for Gilead, which has recorded about $36 billion in revenue from the medicine — $3 billion in 2018 alone.

Some of the witnesses on the panel noted that Truvada for PrEP is already available in other countries in generic forms for less than $10.

Truvada is at the heart of a government effort aimed at ending the HIV epidemic in the U.S. by 2030.

The goal of the initiative, unveiled in February, is to decrease the number of new HIV infections by 75% in the next five years and by 90% over the next decade.

With the push for Truvada to be prescribed to hundreds of thousands more Americans under the government's initiative, Gilead stands to boost its profits even further, though the company has pledged to donate up to 2.4 million bottles of the drug for the effort — enough to cover about 200,000 people for up to 11 years.

Gilead recently decided to let a generic version of Truvada come to the market in September 2020 — a year earlier than what it had agreed to under a patent settlement deal with Teva Pharmaceutical Industries Ltd., which won FDA approval of the lower-cost version in 2014.

Access problematic

Jordan insisted the government's new initiative to eliminate HIV, Gilead's donation and having a generic next year would resolve the access problems.

But Cummings and the HIV patient advocates who testified said those efforts were not enough to address the current access problem and did nothing to lower Truvada's current price.

The CDC has estimated that more than 1.1 million people in the U.S. are at a high enough HIV risk to warrant PrEP, but fewer than 150,000 have ever received it, Rochelle Walensky, chief of infectious diseases at Massachusetts General Hospital and a professor of medicine at Harvard Medical School, told lawmakers at the May 16 House hearing.

About 75% of the Americans who have received Truvada as PrEP are gay white men, while only about 10% are people of color, Walensky told members of the committee.

Yet, about 80% of the 39,000 new HIV infections in the U.S. are in people of color, 42% of whom are African-American, she said.

"I think we need to put PrEP in the water to get this epidemic under control in the places that don't have access to PrEP," Walensky said.

Data also have shown that 34% of people on PrEP do not take it beyond a year, she said.

Truvada has not made a significant dent in lowering HIV infections because of access and adherence issues, Walensky said.