Gilead had announced action back in July 2021 to investigate and litigate against those responsible for distributing counterfeit and tampered Gilead HIV medicine within the US supply chain.
As part of that action, in January 2022, US marshals and local law enforcement executed seizures at 17 locations in eight states, where thousands of bottles of Gilead-labeled medications were found.
The counterfeit treatments included Biktarvy (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg tablets) and Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets).
The latest action sees the company identify and name as defendants two individuals that Gilead claims are responsible for leading and orchestrating the counterfeit action.
The company stated, “Gilead’s ongoing investigation revealed that these two kingpins directed the initial sale of the counterfeits through suppliers created solely to sell counterfeit medications.”
The suppliers then delivered the product to pre-existing licensed gray-market distributors with an established pharmacy customer base.
In unsealed court documents, Gilead reveals that the counterfeiters used genuine bottles of Gilead HIV medication, but the bottles were not all filled with the correct medication.
In some cases, they contained completely different drugs, with laboratory testing revealing that they most commonly contained quetiapine fumarate, also known under the brand name Seroquel XR. The drug is a prescription anti-psychotic medication and is known to have serious potential side-effects.
The court documents stated, “One patient who unknowingly took Seroquel XR after receiving a counterfeit bottle of Biktarvy reported that the patient could not speak or walk afterwards. Patients who are prescribed quetiapine are warned against driving or operating machinery.”
As a result of Gilead’s latest action, the defendants allegedly responsible for distributing counterfeits are prohibited by court order from transacting in Gilead medicine.
The importance of HIV medication to Gilead
For Gilead, its HIV medications represent a significant part of its revenue. In full year sales for 2021, its portfolio of treatments earned $16.3bn (€16.6bn).
However, those sales are now falling due to the loss of exclusivity on two of its key products, Truvada (pre-exposure prophylaxis) and Atripla (efavirenz, emtricitabine and tenofovir disoproxil fumarate).
In September, the company found itself at the center of its own lawsuit, after it was accused of employing “unlawful strategies to stave off competition for its HIV medications.” The lawsuit alleges that Gilead conspired with generic drug manufacturer, Cipla, to maintain the prices of Truvada at ‘anticompetitive levels’.