Jen KatesVarmennettu tili

The broader context is that #PrEP, when used as recommended, is 99% effective at preventing HIV acquisition, per @CDC_HIVAIDS. See: https://www.cdc.gov/hiv/risk/estimates/preventionstrategies.html …

It's also key, along with increased access to treatment for those who are HIV+, to reducing new infections in the U.S.. These are two of the four main strategies of HHS' "Ending the HIV Epidemic: A Plan for America" Initiative. https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview …

Yet, few who could benefit use it: only about 224K of the 1.1 million people estimated to be at high risk of HIV in the U.S. (and who could benefit from PrEP) are accessing it. One barrier is price. Unlike w/HIV treatment, there is no dedicated federal grant program for PrEP.

Per the government's lawsuit, PrEP is one of the main revenue drivers for Gilead yet in response to demand, "Gilead has significantly increased the price it charges". PrEP's retail price in the U.S. is about $1800/mo (compared to about $30 in many peer countries).

The lawsuit states that CDC researchers are PrEP's "true and correct inventors" & that Gilead: -only provided drug samples for the research -has "refused to obtain a license from CDC" for the patented regimens -continues to sell Truvada for PrEP worldwide w/o paying CDC royalties

The suit offers a variety of evidence to support these claims, including communications between CDC and Gilead, public statements (including from this House oversight hearing: https://www.c-span.org/video/?460810-1/gilead-ceo-daniel-oday-testifies-truvada-hiv-prevention-drug-pricing …), and published research.

The suit talks about steps Gilead has taken to address access barriers including moving up the date in which it will permit marketing of generic PrEP in the U.S. but also discusses why this may not drive down price, including because of the entrance of Descovy just recently.

This is complex terrain. Gilead also offers patient assistance programs for accessing PrEP and recently announced it would donate PrEP for 200K uninsured individuals in the U.S. as part of the Ending the HIV Epidemic Initiative. (https://www.hhs.gov/about/news/2019/05/09/trump-administration-secures-historic-donation-of-billions-of-dollars-in-hiv-prevention-drugs.html …)

However, while patient assistance programs are critical for access (and not just for HIV), they do not address the underlying price issue (and can mask it).

The lawsuit could take several years to play out. Gilead will likely file a response. Generic PrEP will come onto the market next year. Also, PrEP will soon be offered at no-cost through most private plans (see this thread https://twitter.com/LindseyH_Dawson/status/1138494944736350213 …)

But none of this will address drug pricing more generally or the unique circumstances of the HIV drug market. And ultimately, the stakes are quite high given that PrEP can save lives. /end