The HIV-prevention pill Truvada has established itself as a new battleground in the ever-present debate over high drug prices in the United States. The Centers for Disease Control (CDC) estimates that only a small fraction of the 1.1 million people in the United States who could benefit from Truvada are actually taking it—in part because of the drug’s nearly $2,000-a-month price tag.
The CDC recommends Truvada for anyone who is at substantial risk for HIV. Generally speaking, that includes members of society’s most vulnerable groups, such as gay and bisexual men, transgender women, and people who inject drugs. Yet the HIV-prevention pill isn’t reaching those groups.
Black and Latino Americans make up the majority of new HIV infections each year but account for the smallest portion of Truvada prescriptions. Data released by the CDC last year found that “in 2015, approximately 500,000 African-Americans and nearly 300,000 Latinos across the nation could have potentially benefited from PrEP based on CDC clinical guidelines. However, only 7,000 prescriptions were filled at retail pharmacies or mail order services for African-Americans and only 7,600 for Latinos during a similar time period (September 2015 — August 2016).”
Earlier this month, President Donald Trump announced that the Department of Health and Human Services (HHS) had brokered a deal with Gilead, the maker of Truvada, for the company to give a free supply to approximately 200,000 patients for the next decade. On Twitter, Trump wrote that Gilead’s “historic donation” will help “achieve our goal of ending the HIV epidemic” by 2030—a public health initiative he announced in his 2019 State of the Union address.
But Gilead’s charitable donation wasn’t enough to quell a mounting tide of anger directed at the company. Within a week of the announcement, Gilead was hit with a lawsuit contending that it illegally conspired to keep its drug prices artificially high in the United States. Meanwhile, Gilead’s CEO was asked to testify before the U.S. House Oversight and Reform Committee to justify recent Truvada price hikes.
Gilead’s donation was “a nice gesture,” Dr. Michael Saag, an HIV researcher at the University of Alabama at Birmingham and a member of the Presidential Advisory Council on HIV/AIDS, told Rewire.News. But, he said, what “most providers really want is … prices that are reasonable and affordable.”
Gilead did not respond to request for comment, but an HHS spokesperson said that the impact of the donation will “extend well beyond” 200,000 patients per year because “by stopping the spread of HIV to one patient, others benefit, too, including that person’s loved ones and friends.”
Truvada is a powerful HIV medicine, comprised of two HIV drugs blended together into a single pill. When Truvada was first approved in 2004, Gilead charged $800 for a one-month supply.
At the time, it was used exclusively as a treatment for people who are already HIV-positive. But by 2010, scientists realized that if you give the drug to people without HIV, they become protected from the virus—even after condomless sex with an HIV-positive partner. Using HIV antiretrovirals as a prevention strategy is called pre-exposure prophylaxis, or PrEP.
Truvada was officially approved as PrEP in 2012. Despite the medical advancement it represented, the rate of new HIV infections dipped only slightly from 2012 to 2016, eventually plateauing at around 40,000 new infections per year.
Since 2012, Gilead has steadily raised Truvada’s price in the United States. Today, it costs $1,780 per month. Elsewhere in the world, Gilead sells a generic version for less than $50 per month. In Australia, the drug is available for $8 per month.
HIV activists insist that the federal government could negotiate for better Truvada pricing, pointing out that much of the initial research was funded by taxpayer money and that the CDC holds patents related to the use of Truvada for PrEP.
The CDC has been “asleep at the wheel,” said James Krellenstein, co-founder of the PrEP4All Collaboration. “These problems regarding the price of Truvada really point to a failure by the CDC and by the U.S. federal government to do something.”
Now, tired of the political brouhaha, some doctors are advocating for a radical new approach: sidestep expensive Truvada and prescribe generic HIV drugs that are chemically similar instead. Truvada remains expensive because it is protected by a brand-name patent. But Saag and others argue there’s good evidence that some cheaper generic HIV medicines will be just as effective as Truvada at creating a cloak of protection against the HIV virus.
The Food and Drug Administration (FDA), the government agency that approves new medicines, has signed off on other generics that are chemically similar to Truvada, including one of Truvada’s stand-alone ingredients—a drug called tenofovir disoproxil fumarate (TDF). Now, some physicians argue that an alternative TDF-based drug regimen—or even TDF alone— could be safely prescribed as PrEP for patients who cannot afford Truvada and are not eligible for Gilead’s charity and assistance programs.
Now, some physicians argue that TDF-based drugs could be safely prescribed as PrEP for patients who cannot afford Truvada and are not eligible for Gilead’s charity and assistance programs.
“If you’re really up a tree, you would be on evidence-based grounds to use TDF” for HIV-prevention, Dr. Jeanne Marrazzo, director of the Division of Infectious Diseases at the University of Alabama at Birmingham’s School of Medicine, said to Rewire.News.
According to the drug price comparison website GoodRx, generic TDF is available in the United States for less than $50 per month, whereas Truvada costs around $1,750 per month.
Although Truvada is the only drug approved by the FDA to be used as a pre-exposure HIV prevention medicine, doctors are allowed to prescribe other medications at their own discretion—a practice called “off-label” prescribing.
According to an FDA spokesperson, “with few exceptions, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.”
Though it might seem radical to start giving patients TDF-based drugs off-label, some doctors say that desperate times call for desperate measures. For many of their patients, they say, the only other option is to rely on Gilead’s charity and assistance programs.
“We’re in a war,” Saag said, “and the virus and infection rates are winning.”