HHS vs. Gilead: The Future of PrEP and HIV Prevention

Earlier this year, the U.S. Department of Health and Human Services filed a lawsuit against drug manufacturer Gilead, the company responsible for developing Truvada, or pre-exposure prophylaxis (PrEP). When taken daily, the drug prevents the HIV virus from taking root in HIV negative patients, but the drug isn’t exactly cheap. Patients with health insurance may get the pill for free, but others may have to pay up to $2,000 a month.

HHS is suing Gilead for patent infringement in hopes of releasing a generic version of PrEP, but the company argues it should maintain sole access to the profits of the drug so it can recoup all the money that’s been spent on research and development. However, HHS helped develop the drug with Gilead, using taxpayer money, no less. Learn more about this contentious showdown between HHS and Gilead and what it could mean for the future of HIV prevention.

Who Owns PrEP?

The Department of Health and Human Services owns thousands of patents. Normally, the department will license these patents to drug manufacturers in exchange for royalties, but Gilead never paid up. A recent study of Gilead shows the company owes the federal government over a billion dollars in overdue royalties. The complaint filed in court accuses Gilead of acting in bad faith when it started developing the drug with the help of HHS. The department accuses Gilead of engaging in “malicious, wanton, deliberate, consciously wrongful, flagrant” conduct. The department is also suing Gilead for damages, so the company could end up paying more than the overdue royalties if the HHS lawsuit holds up in court.

Gilead maintains that the department’s lawsuit is invalid. Even though the company used HHS funds to develop the drug, Gilead maintains it should retain full ownership of the profits. To diffuse its critics, the company announced earlier this year that a generic version of PrEP will be available in the U.S. as early as September 2020, but critics worry Gilead will still be in control of the price of the drug.

Putting an End to HIV

From the government’s perspective, suing Gilead could be a way to gain leverage over the company. With these funds in hand, HHS could release its own generic version of PrEP at a lower cost, helping millions of Americans access the drug that otherwise may not be able to afford it. HHS could also use the lawsuit to negotiate down the price of PrEP.

Around 40,000 people still get HIV infections every year here in the U.S. The Trump Administration recently declared war on HIV and AIDS in the U.S., hoping to get rid of the virus completely by the year 2030. Suing Gilead may help expedite this process.

Activists argue Gilead has been inflating the cost of PrEP for years. The drug can be manufactured for as little as $6 a pill, but Americans end up paying around 250 times that amount, raising the cost of care for high-risk patients. Non-profit groups have been urging HHS to break up Gilead’s profits for years. Finally, the government heeded their concerns.

HIV Prevention for All

To help decrease the number of new HIV cases in the U.S., HHS recently announced the development of a new program called Ready, Set, PrEP, which will supply at-risk patients with free doses of PrEP. In order to qualify, patients must prove they are HIV negative, have a prescription for PrEP, and be uninsured. Individuals can find a provider and sign up for the program at www.getyourprep.com or by calling the toll-free number 855-447-8410.

According to HHS Secretary Alex Azar, the program is expected to benefit up to 200,000 patients a year. Currently, just 18% of the 1.2 million people that could benefit from this drug have a prescription. Many of these individuals, including those most at risk of contracting HIV such as African American gay and bisexual men, do not have access to the drug or lack knowledge of its existence.

As these lawsuits play out in court, HHS will continue fighting for the rights of uninsured and underinsured patients that need access to HIV prevention. By cooperating in the Ready, Set, PrEP program, Gilead is working to increase access to the drug, but more needs to be done if the U.S. is going to eradicate HIV by 2030. Stay tuned as we follow this story in the months to come.