Groups around the world are working hard to develop HIV vaccines, but in the meantime, Gilead Sciences reports that Truvada can significantly reduce the rate of new infections when used as a pre-exposure prophylaxis. With concerns over access, activists are asking the government to break the company's patent to end the HIV epidemic.

In a data analysis unveiled this week in Amsterdam, investigators found that in a five-year period after Truvada won an FDA approval for PrEP, use in the setting grew from seven people per 1,000 to 68 people per 1,000 in those at the highest risk. The team used data from all 50 U.S. states plus Washington, D.C., from 2012 to 2016.

Over that period, new HIV diagnoses fell from 15.7 per 100,000 people to 14.5 per 100,000 people among the general population, according to the analysis.

Originally approved in 2004, Truvada won its PrEP label expansion in 2012. In the PrEP setting, Truvada is indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV. Gilead is also researching Descovy for a PrEP indication, according to its annual SEC filing.

Meanwhile, activists are pushing federal authorities to break the drug's patent because of "pharmaceutical price-gouging" that has led to varying levels of access for those at risk of getting HIV. In a New York Times op-ed, James Krellenstein and Peter Staley, cofounders of Prep4All, wrote that in lieu of action from the government, activists have developed a "national strategy" to end the HIV epidemic.

They wrote that a "critical component of this plan is insisting that federal agencies use their statutory authority to break Gilead’s undeserved monopoly," noting that taxpayers and charities funded much of the clinical research supporting Truvada. According to the authors, less than 10% of people who could benefit from the drug in the PrEP setting are getting it. Dr. Aaron Lord, a physician at the New York University School of Medicine, also coauthored the op-ed.

"In under 40 years, we’ve lost more Americans to H.I.V. than to combat in all of our wars combined," the authors wrote. "Science has delivered answers, but Gilead’s greed and the government’s inaction are keeping it from those who need it most."

A Gilead spokesman said the company is "committed to ensuring that people who are at high risk for HIV infection have access to Truvada for PrEP." He noted that the company supports "comprehensive payer coverage" and maintains an access program for "qualified uninsured and underinsured people" in the U.S.

So far in 2018, 15,264 people have received Truvada for PrEP for free under the company's medication assistance program, according to Gilead. The company's representative said Gilead also works on issues aside from cost such as drug awareness and access to healthcare services.

Truvada's patent expires in 2021, according to company's SEC filing, but Gilead also has a patent settlement with Teva allowing that company to launch a generic at an undisclosed date.

A call by activists to break a drug patent isn't a new concept in the pharmaceutical industry. Astellas' prostate cancer drug Xtandi has faced similar calls for years, but so far the government has declined to break patents due to previous public research funding.  

The developments around Truvada come as Gilead and GlaxoSmithKline face off with their respective next-generation HIV drugs in a megablockbuster market. Just this week, GlaxoSmithKline presented new data to build its case for newly approved Juluca. Gilead's Biktarvy—approved in February—is carrying big expectations; analysts expect the drug to pull in $6 billion at peak.

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