Gilead Sciences has announced the removal of counterfeit and tampered Gilead-labeled HIV medications, including bottles labeled as Biktarvy® (bictegravir, emtricitabine, tenofovir alafenamide) and Descovy® (emtricitabine and tenofovir alafenamide), from the US supply chain.
Biktarvy is indicated as a complete regimen for HIV-1 infection in patients with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
Descovy is approved, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults and pediatric patients. It is also indicated in at-risk adults and adolescents for preexposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex.
In a statement, the Company noted that thousands of bottles of Gilead-labeled medication with counterfeit supply chain documentation have been seized. These products also had counterfeit elements such as patient leaflets and caps. Some of the seized product did not even contain the medication listed on the label. Over 85,000 bottles of counterfeit product had been sold to pharmacies over the course of 2 years.
To help ensure the authenticity of the product, Gilead has issued a consumer alert, which provides image of the real medications. The Food and Drug Administration (FDA) requires that Biktarvy and Descovy be dispensed in the original packaging.
A list of Gilead’s authorized distributors can be found here. Individuals who believe they have been dispensed a counterfeit product should report the medicine to their healthcare provider, pharmacy and Gilead Product Quality Complaints (1-800-445-3235, Option #2; [email protected]).
Adverse events related to a counterfeit drug should be reported to FDA’s MedWatch Program or Gilead (1-800-445-3235, Option #3).
Gilead announces actions to remove counterfeit HIV medications from US supply chain. News release. Gilead Sciences, Inc. January 19, 2022. Accessed January 20, 2022. https://www.gilead.com/news-and-press/company-statements/gilead-announces-actions-to-remove-counterfeit-hiv-medications-from-us-supply-chain