Company: Gilead Sciences
2018 U.S. sales: $2.6 billion
Used for: HIV pre-exposure prophylaxis
As pricing activists mounted a patent battle—and even as the EU market for the HIV prevention-and-treatment drug threatens to dwindle—Gilead’s Truvada continued its stateside growth in 2018.
The Gilead therapy collected $2.6 billion in U.S. sales, an impressive 15% increase over the previous year, thanks to broader use as a prevention tool. Truvada treated roughly 202,000 pre-exposure prophylaxis (PrEP) patients in 2018, Gilead said, but could still benefit from more awareness to reach the roughly 1.1 million U.S. patients the CDC estimates could benefit from the therapy.
"We have a number of commercial programs aimed at helping populations disproportionately impacted by HIV, where utilization of Truvada for PrEP is low," said Laura Hamill, Gilead's VP of worldwide commercial operations, during a fourth-quarter earnings call. "While these investments (have) helped increase awareness, there is still so much more we can do."
While Gilead's HIV drugs have historically focused on treatment rather than prevention, the drugmaker is now reaping rewards in PrEP with Truvada and looking to expand even more with blockbuster follow-up Descovy. In March, Descovy survived a noninferiority study against Truvada in PrEP, offering hope that more than $2 billion of the older drug's revenue can be transitioned to Descovy when Truvada generics hit the U.S. market. Truvada's U.S. patent is set to expire in 2021.
In the meantime, Truvada continues to face criticism for its aggressive pricing, an accusation that has trailed Gilead for years.
Truvada’s U.S. growth last year came amid calls to invalidate Gilead’s patent, after activists said the company was pricing HIV patients out of treatment. In a New York Times op-ed published in July, James Krellenstein and Peter Staley, cofounders of Prep4All, pleaded with federal regulators to break Gilead’s “undeserved monopoly” on the PrEP market. Although that call wasn’t answered, a U.K. high court opted in September to overturn Gilead’s patent extension for Truvada, opening the market to cheaper generics.
Gilead also faced a lawsuit in California in May alleging that the company pumped sales of HIV drugs—including Truvada—which center on tenofovir disoproxil fumarate, a compound tied to bone and kidney risk, and shelved safer drugs in its pipeline.