A generic version of the drug has been approved by the FDA.
BY VICTOR MELAMED
The Food and Drug Administration has approved a generic version of Truvada, the drug used as pre-exposure prophylaxis (PrEP), aimed at preventing HIV-negative people from becoming infected with the virus, reports The Advocate.
Truvada, also used in HIV treatment in combination with other medications, is a mix of emtricitabine and tenofovir disoproxil fumarate.
The generic is made by Teva Pharmaceutical Industries of North Wales, Pa. Brand-name Truvada is a product of Gilead Sciences of Foster City, Calif.
Generic drugs are generally far cheaper than brand-name ones. The price is about $1,500 a month, or $18,000 a year, for the one-pill-daily dose of Truvada, as prescribed for PrEP, Medscape reports, with insurers and patient assistance programs covering much of the cost. Just when the generic will be available isn’t certain.
Tim Horn of Treatment Action Group told Poz, “Approval of a generic product doesn’t necessarily mean that product launch is imminent. … It’s not uncommon in patent settlement agreements for generics to negotiate language permitting full approvals months and years in advance of the settlement license date. Regardless, now is the time to start thinking seriously about the advantages as well as the drawbacks of generic products to prevent and treat HIV.”