Valerie DeBenedette is managing editor of Drug Topics.
The company is donating enough drugs for 200,000 patients for up to 11 years, but does it make up for the high price of the drug?
The maker of Truvada (emtricitabine and tenofovir disoproxil fumarate) has announced it will donate enough of the drug to help prevent HIV infection in a large number of patients, for the next 11 years. The manufacturer, Gilead Sciences, is making the donation to the CDC “in support of national efforts to help prevent HIV and end the epidemic,” the company says in a statement.
The donation is being met with gratitude by the Trump Administration, which plans to end HIV in the United States by 2030, but it was also met with criticism over the high cost of the drug, about $20,000 per year. AIDS activists would prefer to see a steep price reduction, which would help more people get the drug.
“The majority of Americans who are at risk and who could protect themselves with PrEP are still not receiving the medication. This agreement will help close that gap substantially and deliver on President Trump’s promise to end the HIV epidemic in America,” says Alex Azar, the secretary of Health and Human Services, in a statement.
Peter Staley, a member of the PrEP4All Collaboration, wrote on his Facebook page: “So Gilead Sciences donates 2.4 million bottles of PrEP to the CDC starting 7 years after approval? We know Truvada costs $4 a bottle to make, so this donation costs them only $9.6 million a year. But no lowered price, so they keep selling $3 billion of Truvada a year!”
“Don’t get me wrong, this is exactly the kind of public health program Prep4All has been calling for. We are thrilled at this expanded access to those who need it most. But generic PrEP might reach 3 to 4 times as many people,” he wrote.
Truvada’s price is a barrier to more widespread use of Truvada and PrEP. In Africa, a generic version of Truvada that is made in India costs $60 a year. Gilead has sued several generic companies over the drug’s patent and settled with undisclosed terms. Lower-cost versions of Truvada are not expected until the end of next year. According to Stat, a Truvada patent is held by the CDC, which collects royalties from Mylan from sales of a generic version of Truvada that is sold in Europe and Australia. Gilead says that patent is not valid in the United States.
The donation from Gilead extends to 2030, and will transition to Descovy (emtricitabine 200 mg, and tenofovir alafenamide 25 mg), another Gilead drug that is in phase 3 studies for use in PrEP. Descovy will be coming onto the market at about the same time as generic versions of Truvada become available.
Truvada is approved to prevent transmission of HIV at a dosage of one tablet a day (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate). The treatment is called pre-exposure prophylaxis, or PrEP. An estimated 1.1 million people in the United States are at risk for contracting HIV, but only about 270,000 people use PrEP.