A generic version of Gilead’s Truvada for PrEP is due on the market next year. The activists argue that will be a better alternative price wise.
Gilead Sciences is no stranger to criticism over its HIV programs. The company has been under fire from some HIV/AIDS activists over its HIV drug patents and pricing. Now, with the planned release of a new HIV drug, some critics are expressing concern over the pricing of the medication.
In April, Gilead submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for once-daily Descovy for HIV pre-exposure prophylaxis (PrEP). The filing is based on the results of the Phase II DISCOVER trial which evaluated the safety and efficacy of Descovy compared to Truvada in men and transgender women who have sex with men at high-risk for sexually acquired HIV infection. The sNDA was submitted along with a Priority Review Voucher, which means the regulatory agency could approve the drug as soon as September or October.
With the pending approval though, several patient advocacy groups are expressing concern over the potential pricing of the drug that is aimed at preventing those at risk from contracting HIV. The advocacy groups, Reuters reported this morning, are questioning whether or not Descovy for PrEP will be worth the cost, particularly as a generic version of another Gilead HIV prevention drug, Truvada, is expected on the market next year. The generic Truvada is made by Israel-based Teva Pharmaceutical. Not only are the advocacy groups expressing concern, but so too is the insurer Cigna, Reuters said.
Tim Horn, director of medication access and pricing at the National Alliance of State and Territorial AIDS Directors (NASTAD), told Reuters that his organization sees no reason to fight insurers and government programs for coverage of Descovy in favor of generic Truvada “provided there are guard-rails that do not deny access to Descovy for those who need Descovy.”
In May, Gilead announced it will annually donate 2.4 million doses of its HIV treatment Truvada for PrEP to the U.S. Centers for Disease Control and Prevention to provide treatment for uninsured Americans. Truvada for PrEP, which has a list price of $20,000, is used to reduce the risk of HIV infection in individuals who are at higher risk for HIV. It has been shown to reduce the risk of new infection by up to 97 percent when taken consistently. The annual donation pledge extends until 2030, the company said. If Descovy for PrEP is approved, Gilead said the donation would include that newer medication instead of Truvada for PrEP. It is estimated that about 200,000 of the 1.1 million people who are at risk for HIV in the United States already receive Truvada for PrEP.
While Truvada for PrEP is effective, it does have some concerning side effects, particularly for the kidneys and bones. In a statement to Reuters, Gilead said Descovy is safer than Truvada for PrEP and “offers more efficient delivery” of the antiviral components, which results in a higher concentration of the drug in the cells where HIV can occur.
Descovy was initially approved in 2016 in combination with other antiretroviral agents for the treatment of HIV infection in patients. Like Truvada, the approved version of Descovy has a list price of about $21,000.
The HIV market is expected to grow to $22.5 billion by 2025. Gilead Sciences has three of the top four best-selling HIV drugs on the market.
