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New York, March 28, 2019 – A front-page article in the Washington Post on Wednesday has revealed that the U.S. Centers for Disease Control and Prevention (CDC) owns patents on TDF/FTC (marketed under the brand name Truvada) as pre-exposure prophylaxis (PrEP) but has mysteriously failed to enforce them. 

The revelation comes following months of advocacy by PrEP4All to call attention to the existence of the patents. Gilead has been infringing on these patents with no repercussions. By not effectively enforcing them, the CDC has not only allowed vulnerable communities to remain at the mercy of Gilead’s unethical pricing on TDF/FTC, they’ve also failed to claim billions in penalty payments from Gilead– resources that could easily fund a national PrEP program as part of the current administration’s initiative to end HIV as an epidemic in highly affected jurisdictions in the U.S.

Given this new information, HIV/AIDS advocates and organizations must demand that the CDC exercise their PrEP patent rights to dramatically scale up PrEP in the U.S. as a key strategy of this initiative. PrEP4All has disseminated a sign on letter calling for just that, and we encourage all our partners to follow their lead.

At current PrEP prices, the $291 million increase in proposed funding for the Department of Health and Human Services (HHS) to end HIV as an epidemic in the President’s FY20 budget is not likely to go far in facilitating access for the estimated 1.2 million individuals who could benefit from PrEP in the U.S. In 2018 the average wholesale price for a month of Truvada in the U.S. was $2,011; by comparison the Global Fund’s recent listed price available to grant recipients in 63 countries via their Pooled Procurement Mechanism is $4.75 for a month’s supply. Even with significant discounts through the 340B program, the new funding proposed by the administration will not be enough to sustainably scale up PrEP access.

Widescale, unfettered, affordable access to PrEP is key for reining in HIV. PrEP has been proven to be upwards of 99% effective in preventing the sexual transmission of HIV, and evidence from scale up through government intervention in other countries is demonstrating its powerful contribution to ending the HIV epidemic. Treatment availability and testing in New South Wales (NSW), Australia has remained consistently high in recent years, but it wasn’t until a government funded program provided PrEP to over 7,000 gay and bisexual men that true progress was achieved. A recent study from the Kirby Institute at the University of New South Wales found that following the 2016 PrEP scale up, NSW saw a one third decline in the number of new diagnoses among men who have sex with men.

It will be impossible to widely implement PrEP in a similar way as part of the new HHS initiative unless the CDC enforces its PrEP patents. In Australia, the EPIC-NSW trial was only scalable after negotiating a more affordable rate for a 2000 person-year supply of Truvada from Gilead and a 5400 person-year supply of generic TDF/FTC from Mylan; in England, a similar initiative which is providing PrEP to 10,000 individuals engaged in a competitive drug procurement process involving generic manufacturers in addition to Gilead in order to reduce the price and bring the total cost of the trial below £10 million (USD $13.2 million) for 3 years.

Were the CDC to effectively slash the cost of TDF/FTC at a time where public outrage on drug pricing is at an all-time high, taxpayer dollars for HHS would go much further. However, the benefits would go far beyond just the new federal initiative; the enormous cost of PrEP also creates problems for insured individuals around the country. It is no secret that barriers like prior authorization requirements and high copays are imposed on high-priced medications such as Truvada by public and private payers in order to limit their use. A recent study of young gay and bisexual men in Chicago found that one third of those who started PrEP discontinued it within a six month period, with 9% of those individuals listing cost and 20% listing insurance coverage as their reason for dropping PrEP. TAG helped lead a successful fight against problematic PrEP policies issued by UnitedHealthcare in 2017, however addressing every coverage challenge within the extremely complex U.S. healthcare coverage “system” simply isn’t feasible for advocates.

The CDC has everything it needs to dramatically lessen these financial barriers and more effectively use anticipated new HHS funding to get access for hundreds of thousands of Americans who need PrEP. We stand with PrEP4All and call on advocates to urge and pressure CDC Director Robert Redfield to immediately enforce these patents to facilitate access for insured and uninsured individuals across the U.S., and provide a real opportunity to end HIV as an epidemic for all affected communities.

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