The fake tablets could be dangerous, bringing “serious and sometimes life-threatening health risks,” according to the pharma giant. Counterfeit and tampered meds might not contain the proper active ingredients or the correct quantities of them, and they may contain impurities.
The Biktarvy and Descovy tablets in question were sold to pharmacies by distributors not authorized to sell Gilead’s products. At the pharmacies, “genuine” Gilead bottles were filled with the counterfeit tablets. What’s more, the company reports, the bottles’ foil seals have been tampered with, and the bottles are incorrectly labeled.
Gilead did not say how many pharmacies were affected, but the drug manufacturer is working with the Food and Drug Administration (FDA) and law enforcement to ensure the fakes are removed from shelves and more counterfeits don’t make their way into the supply chain.
Biktarvy is a once-a-day single-tablet HIV treatment regimen that consists of three meds: bictegravir, emtricitabine and tenofovir alafenamide (the latter is an updated version of tenofovir disoproxil fumarate). Biktarvy was approved in May 2018. As Fierce Pharma reports, Biktarvy earned Gilead $3.82 billion in the first half of this year—marking a 16% growth from the same period in 2020 and making it the best-selling HIV med on the market.
To learn more about the med in POZ, click #Biktarvy, where you’ll find headlines such as “Confirmed: For Black Americans, Biktarvy Effectively Controls HIV” and “Biktarvy 101.”
Descovy, meanwhile, includes two HIV meds: emtricitabine and tenofovir alafenamide. The tablets are taken with other meds as part of an HIV treatment regimen. Descovy is also taken daily alone as pre-exposure prophylaxis (PrEP), a highly effective HIV prevention medication for HIV-negative people at risk of contracting the virus. It is an updated version of Truvada. To learn more, see “What’s the Difference Between Truvada and Descovy for PrEP?” as well as the POZ Basics on HIV Prevention.
Sales of Descovy in the first half of 2021 were $794 million, a drop from last year, according to Fierce Pharma, which adds that the decrease is linked to fewer people taking PrEP or switching to Descovy from Truvada during COVID-19. Descovy was approved for PrEP in October 2019 and for HIV treatment in 2015.
For a collection of POZ content on this HIV med, click #Descovy and you’ll find articles such as “PrEP Programs Face Devastating Loss of Funding for HIV Prevention.”
How can you tell whether tablets and bottles of Descovy and Biktarvy are authentic? In its press statement, Gilead offers the following tips:
- Authentic Biktarvy tablets are purplish-brown, capsule-shaped pills with “9883” embossed on one side and “GSI” on the other.
- Authentic Descovy tablets are blue, rectangular pills with “225” embossed on one side and “GSI” on the other.
- The FDA requires that Biktarvy and Descovy are dispensed in original packaging. Confirm that your dispensed 30-count bottle of Biktarvy or Descovy are received in bottles that are white plastic, with white plastic caps, and Gilead-branded labels.
- Confirm that your Biktarvy and Descovy were dispensed from a pharmacy that sources Gilead medicine directly from Gilead authorized distributors. A list of Gilead’s authorized distributors can be found here.
The pharma manufacturer further advises that “individuals who believe they have been dispensed a counterfeit and/or tampered Gilead medication should immediately report the medicine to their doctor and pharmacy and Gilead Product Quality Complaints (800-445-3235, Option #2; QualityComplaints@gilead.com). If an individual is experiencing any side effects that may be related to a Gilead medication or to the use of a counterfeit drug, that person should immediately contact their health care provider and is additionally encouraged to report the event to FDA’s MedWatch Safety Information and Adverse Event Reporting Program (800-FDA-1088 or www.fda.gov/medwatch) or Gilead (800-445-3235, Option #3). Websites selling counterfeit and/or tampered medicines may be reported to the FDA. Health care professionals are encouraged to report sales solicitation of suspect drug products by emailing DrugSupplyChainIntegrity@fda.hhs.gov and by calling the FDA’s Office of Criminal Investigations (OCI) at 800-551-3989 or a local OCI field office.”
Gilead isn’t the only HIV drugmaker to try to stop fake versions of its HIV medications from entering the market. In December 2020, Janssen warned that counterfeit versions of Symtuza were found in three U.S. pharmacies. Fierce Pharma points out that a recent report found that fake and tampered meds could become a growing problem because the COVID-19 pandemic has disrupted supply chains and regulations.
To learn more about HIV treatment and antiretrovirals, visit the POZ Basics on HIV Medications and be sure to check out POZ’s 2021 HIV Drug Chart, a quick reference tool that compares HIV treatments and includes images of the meds.