With HIV rates in the U.S. holding steady, health officials are looking to drugmakers for help containing its spread. Now Gilead Sciences—which has faced its fair share of pricing criticism over the years—is ready to contribute Truvada to the government's infection-fighting effort.

Gilead will donate 2.4 million bottles of Truvada, its HIV drug that's approved to help prevent infection, to the Centers for Disease Control and Prevention as part of a campaign to drive down infection rates. Gilead also pledged donations of Descovy, its next PrEP hopeful, up until 2030 if it receives an FDA nod as a preventative.

Gilead Chief Patient Officer Gregg Alton said the donation would pair with a nationwide effort to end the disease’s social stigma and boost uptake of preventative treatment.

"We believe today’s donation, combined with efforts to address the root causes of the epidemic, such as racism, violence against women, stigma, homophobia and transphobia, can play an important role in ending the HIV epidemic in the United States, particularly in parts of the country with the highest burden of disease," Alton said.

Only about 1 in 5 of the roughly 1.1 million Americans at risk of contracting HIV now take Truvada, the company said. The drug is approved in the U.S. for HIV-negative individuals in combination with safe sex to reduce the risk of sexually acquired HIV.

Despite Truvada’s long run as a treatment and prevention agent, Gilead is bracing for earlier-than-expected generic rivals in the U.S. next year. The med delivered $2.6 billion in U.S. sales in 2018, making it a hefty target for copycat drugmakers.

In a recent quarterly filing, Gilead said a Teva Pharmaceutical copy was set for launch in September 2020 as part of an agreement between the two companies—a year ahead of Gilead’s earlier projection. Truvada is scheduled to lose patent protection in 2021.

But Truvada’s loss could become Descovy’s gain—provided Gilead can move quickly—thanks to a new round of data showing the newer drug matched its predecessor in preventing HIV infections. With those results in hand, SVB Leerink's Geoffrey Porges told investors Gilead was prepared to transition around $2 billion of Truvada’s sales to Descovy before the older drug’s loss of exclusivity in 2021.

While Descovy scored higher than Truvada in terms of patient safety, it didn’t score quite as well in bone density and renal failure effects, Porges said. Descovy’s $18,000 per year price tag could prove a challenge for Gilead's patient-switching aims, because it'll be facing lower-cost Truvada generics.

With its patent protection coming to an end, Truvada will ride out the next year with exclusivity as activists continue to call for federal authorities to break up the drug’s monopoly on the PrEP market, which they say has locked out some people at high risk of HIV infection.

Even after Gilead moved up Teva’s copycat launch date, PrEP4All activist Aaron Lord, a physician at the New York University School of Medicine, said the move was not enough to open the market to patients who could not afford preventative treatment.

"Even their announcement … leaves Gilead with exclusive rights to Truvada as PrEP for another 15 months and Teva as the only generic manufacturer on the U.S. market," Lord said. "This will do little to reduce the price in a way that will increase access, and PrEP4All remains suspicious of the terms and lack of transparency surrounding the Teva settlement." 

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