The U.S. Food and Drug Administration has approved the first generic version of Truvada, a combination pill used for both HIV treatment and prevention, but it will not soon hit pharmacy shelves, advocates said.
"While the FDA approval reminds us that generic versions of commonly used HIV drugs are coming, we still have some time to figure out how to embrace the cost-saving potential of generics while minimizing the headaches that can accompany their arrival," Tim Horn, deputy executive director of the Treatment Action Group, told the Bay Area Reporter.
On June 8 the FDA announced that it had approved a generic version of Gilead Sciences' Truvada co-formulation containing tenofovir disoproxil fumarate and emtricitabine. Truvada is one of the most widely used components of antiretroviral therapy and is the only product approved for PrEP. The generic version is produced by Teva Pharmaceuticals.
Appearance on the FDA's approved generic drug list indicates that the agency considers generic tenofovir/emtricitabine to be "bioequivalent and therapeutically equivalent" to the branded Truvada pill – meaning equally safe and effective – but it does not override patent protections.
Gilead's patent on tenofovir disoproxil fumarate expires in July, but the patent on emtricitabine remains in effect until 2021. The company also has a longer patent on tenofovir alafenamide, a newer formulation that causes less bone loss and kidney toxicity.
"It's important to note that there are a number of factors involved in commercialization that are not tied directly to FDA approval," Gilead associate director Ryan McKeel told the B.A.R. "A generic version of Truvada will not be immediately available."
Last week's FDA announcement took many experts by surprise, given that the emtricitabine patent still stands, but others noted that certification of generic products sometimes comes months or years before patents run out.
Some have suggested that a legal settlement between Teva and Gilead could dictate when generic tenofovir/emtricitabine will become commercially available, but advocates are not privy to the details of such an agreement.
"Given the secrecy of the settlements challenging Gilead's patents, it's hard to know exactly when the generics may be registered and sold, but it may be awhile," longtime medication access advocate Ethan Guillen told the B.A.R. "We know that in poor countries generic Truvada is well under a hundred dollars – the system here is built to keep prices artificially high. As a community we need to fight for a just system that gives us the drugs we need at affordable prices."
While many people living with or at risk for HIV look forward to the availability of cheaper generic products, advocates caution that this could lead to discontinuation of patient assistance and co-pay programs that help people pay for Truvada for treatment or PrEP.
"The potential for cost savings with generic contenders is considerable, but they also come with challenges, such as public and private insurers tightening restrictions on access to brand-name drugs, and an end to co-pay assistance programs for brand-name drugs with generic competitors," Horn told the B.A.R.
For the time being, no changes to Gilead's payment assistance programs appear imminent.
"Gilead believes Truvada for PrEP is an important HIV prevention tool and we remain committed to helping ensure access to our medications for people both at risk of or living with HIV," McKeel said.