Gilead names ‘kingpins’ in counterfeit HIV med lawsuit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Two Florida men, Lazaro Roberto Hernandez and Armando Herrera, were named as “kingpin defendants” in recently unsealed court documents and accused of setting up and controlling a series of “fly-by-night” wholesalers to sell the counterfeit meds.

Ann Donnelly

Back in August, US district judge Ann Donnelly froze the assets of more than 50 newly named defendants, according to the unsealed documents, including Hernandez and Herrera.

Gilead first filed suit back in July 2021, and earlier this year alleged that defendants have sold more than 85,000 bottles of counterfeit Gilead meds. The defendants allegedly sold authentic-looking bottles, purchased illegally from patients, with counterfeit documentation, according to a new complaint. In some cases, those bottles contained completely different drugs, either a generic painkiller or high-dose tablets of the antipsychotic Seroquel.

The antipsychotic can cause sedation, drowsiness and other serious problems when taken in combination with other drugs or at high doses. One patient who unknowingly took the antipsychotic after receiving a counterfeit bottle of Biktarvy was unable to speak or walk afterward, Gilead said in its first complaint.

While federal law requires prescription drugs to come with a pedigree, or a document tracking every sale, defendants allegedly distributed bottles with falsified pedigrees that claimed to trace the counterfeits to an authentic source.

“Gilead will continue to work closely with the U.S. Food and Drug Administration (FDA), pharmacies and the Department of Justice to remove counterfeit and tampered medication from circulation and to prevent future distribution of counterfeit medications,” the company said in a statement on Wednesday.

Biktarvy was approved for the treatment of HIV back in 2018, and Gilead spent a priority review voucher a year later to get Descovy on the market for both treatment and prevention. The drugs earned Gilead $2 billion and $397 million in the US last quarter, respectively.

“Individuals who believe they have been dispensed a counterfeit Gilead medication should immediately report the medicine to their healthcare provider, pharmacy and Gilead Product Quality Complaints,” Gilead said Wednesday.

Authentic Biktarvy tablets are purplish-brown and capsule-shaped with the numbers “9883” written on one side and “GSI” on the other, according to Gilead. Descovy tablets are blue and rectangular with “225” on one side and “GSI” on the other.

Gilead has issued a list of trusted distributors, including the big firms Cardinal Health, AmerisourceBergen and McKesson.

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