Surprise FDA Approval of Generic Truvada Is a 'Wakeup Call' for Activists

The surprise approval of generic Truvada (tenofovir disoproxil fumarate and emtricitabine) by the U.S. Food and Drug Administration (FDA) on June 9 left patients, advocates and doctors scrambling to understand exactly when the generic will become available and how much it will cost.

After weeks of speculation, both of those questions remain unanswered -- locked behind a confidential settlement agreement between TEVA, the generic company, and Gilead, the innovator. In theory, generic Truvada could enter the market any time from late 2017 to 2021, Tim Horn, deputy executive director of HIV and HCV Programs at Treatment Action Group (TAG), told

But the approval itself has been a "wake-up call" for activists and clinicians, forcing them to focus on the implications of a generic Truvada, the only drug approved as pre-exposure prophylaxis (PrEP), said Horn. The moment the generic becomes available, PrEP will suddenly become much more affordable, which will fundamentally alter HIV prevention campaigns around the country, he explained.

"The point is, generic products are coming, and we need to be ready for that," said Horn. "We want to have time for policy landscaping, to ensure systems are in place for maximized coverage. If that happens quickly, we are caught off guard." In this case, the news came as a surprise because Gilead's patent on one of Truvada's component drugs, emtricitabine, does not expire until 2021.

Today, Truvada for PrEP costs $1,300 per month. Although PrEP is seen as an important new weapon in HIV prevention campaigns nationwide, uptake has been limited. Yet, clearly there's demand for PrEP, Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition (AVAC), told

Although PrEP has only been approved for five years, "over 125,000 people are accessing and using oral PrEP," said Warren.

A generic version could help more at-risk, HIV-negative people gain access, as generics typically create a cost savings of 70%, Horn explained. The savings potential is "huge," agreed Warren. In Africa, he said, generic versions of Truvada led to an almost 80% reduction in cost.

"We don't know if those numbers will be relevant for the U.S. marketplace, but given how expensive the list price is for Truvada, one can be more hopeful that, as generics become available, the price will go down," Warren said.

An FDA approval typically means that a drug will soon become available, leading to an initial surge of optimism that the generic might come to the market earlier than expected. Typically, explained an FDA spokesperson, "Federal patent laws frequently determine the earliest date the FDA can approve generic drug products." Yet, the spokesperson continued, a generic company can seek FDA approval prior to brand-name patent expiry if that generic company challenges the patent when it submits its application to the FDA.

The FDA's approval does not mean that Truvada has lost its market exclusivity. Gilead has since insisted that "a generic version of Truvada will not be immediately available," noting that the drug's component parts are still patent protected. Meanwhile, a TEVA spokesperson confirmed that Gilead and TEVA have "a settlement that controls our entry for which the terms are confidential," adding "we are pleased with the FDA's decision and look forward to supporting these patients with generic medicines when we are otherwise able to."

Based on the patent expiry dates of Truvada's component parts and the fact that the settlement terms remain confidential, Horn predicted that commercialization of generic Truvada could happen any time between December 2017 and 2021, but said, "It's hard to say for certain."

The FDA's approval of generic Truvada prompted some to worry that Gilead would begin to roll back its treatment assistance program for PrEP, an important means of accessing the medication for many who cannot pay for PrEP upfront.

Yet, a company spokesperson confirmed that "at this time, there are no planned changes to our co-pay or medication assistance programs," and reaffirmed Gilead's commitment "to helping ensure access to our medications for people both at risk of or living with HIV."

Truvada is approved as both an HIV treatment and as PrEP. Although its availability as a low-cost generic would have a positive impact on access among HIV-positive patients, its most dramatic effect would be among HIV prevention campaigns.

"On the HIV treatment side, we have safety net programs are in place that prevent people from falling through the cracks," said Horn. "On the PrEP side it's not so clear."

In addition, added Warren, PrEP is more than just a pill: It's an entire prevention program that requires quarterly HIV testing, linkage to a care provider and other services.

Thus, said Warren, "While price has certainly been an issue, it is not the only issue."

The recent confusion over generic PrEP should galvanize the prevention community and encourage privately and publicly funded prevention programs to start incorporating low-cost PrEP into their prevention programs more extensively, Horn said.

"Generic Truvada is a chance for us to ask what is possible," Horn said. "Can we develop some really robust public health programs, particularly in a time where there is a grave danger that the current system we have in place might be taken away from us? How do we strengthen programs to take advantage of lower costs generics to maximize access?"