Reactions Are Mixed as Gilead Announces PrEP Donations, Early Launch of Generic

Shortly after Gilead quietly announced that a generic version of its pre-exposure prophylaxis (PrEP) pill Truvada (emtricitabine/tenofovir disoproxil fumarate) will come to market a year ahead of schedule in September 2020, HHS announced that the pharma giant has pledged to donate Truvada for up to 200,000 people for up to 11 years. The agreement will last until at least 2025 and possibly through 2030.

Gilead will provide the medication to those who are at risk for HIV and uninsured, including those in the states and counties identified as priority areas in the Trump administration’s plan to end the HIV epidemic in the country.

“Securing this commitment is a major step forward in the Trump administration’s efforts to use the prevention and treatment tools we have to end the HIV epidemic in America by 2030,” said HHS Secretary Alex Azar in a statement. He added, “The majority of Americans who are at risk and who could protect themselves with PrEP are still not receiving the medication.”

There are an estimated 1.2 million people in the United States who could benefit from the prevention pill, but just 100,000 take it, due in large part to awareness, access, and pricing issues.

In an interview with The American Journal of Managed Care^®, Michael Kharfen, senior deputy director, HIV/AIDS, Hepatitis, STD, and TB Administration, Washington, DC, health department, called the announcement a positive step in the right direction to getting more people on the pill and preventing new infections.

In addition to providing the pill to hundreds of thousands of people who could benefit, the initiative can also help safety-net providers like the Washington, DC, health department reallocate resources with the money it currently dedicates to purchasing the drug to distribute to patients. These reallocated resources could go toward awareness and educational campaigns for PrEP, as many people are not on the pill because they don’t know their risk or don’t know about the pill, explained Kharfen.

Gilead will donate Truvada until its second-generation HIV preventive medication Descovy (emtricitabine/tenofovir alafenamide) is available. Recent data have shown that tenofovir alfenamide and tenofovir alfenamide—containing products have a lower risk of bone and kidney toxicities compared with tenofovir disoproxil fumarate equivalents. However, according to Kharfen, these benefits are associated with long-term use of products, whereas most people taking PrEP are taking them for limited durations; therefore, the benefits of the new formulation are not as substantial. Currently, Descovy is approved for the treatment of HIV.

Having Descovy enter the market will also send a message to managed care plans that often don't currently cover Truvada because they are only aware of its use as HIV treatment.

Since Gilead gained FDA approval for Truvada as HIV treatment in 2004, the cost of the drug has continued to rise each year. The pill now costs about $1675 a month, or approximately $20,000 per year, drawing criticism from HIV activists who say that the drug can be manufactured for a fraction of the price. Because of this, some are saying Gilead’s decision to offer PrEP is not enough and that prices should be cut.

Activists have also called for the CDC to reach a deal with Gilead over Truvada, with activists arguing that because tax money funded some of the research, CDC should collect royalties, which could be leveraged to expand access to the pill. CDC currently collects a small royalty from Mylan for its generic version of the pill, which is sold in Europe and Australia.

“The HIV community has been very vocal about this, and I think it’s gained even more ground, frankly, with renewed federal attention to HIV,” said Kharfen.

Skepticism was also raised by HIV activists following Gilead’s announcement that Teva Pharmaceutical’s generic version of Truvada will to come to market a year early. PrEP4All Collaboration’s Aaron S. Lord, MD, released a statement on Wednesday saying: “Even their announcement today leaves Gilead with exclusive rights to Truvada as PrEP for another 15 months and Teva as the only generic manufacturer on the US market. 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.”

In a Facebook post, HIV activist Peter Staley wrote that the news wasn’t actually news at all, as “Starting in December 2017, the FDA approved the applications from four companies to sell generic versions of Truvada (TDF+FTC), but Gilead settled out of court with all four to keep them off the market until 2021. They have just admitted they cut a sweeter deal with Teva, giving them first dibs on generic Truvada before the other three companies (Amneal, Aurobindo and Mylan).”

While the price of Truvada and its competition remains under scrutiny, Kharfen said that Gilead has worked with health departments and communities in other ways, including through their patient assistance program and providing funding to communities to offer education and outreach.