Gilead warns of falsified HIV drugs in US supply chain

Gilead Sciences has said that "tampered and counterfeit" versions of its big-selling HIV drugs Biktarvy and Descovy have been discovered in US drug distribution channels that have reached pharmacies.

According to the pharma company, unauthorised distributors sold the falsified packs of Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and Descovy (emtricitabine/tenofovir alafenamide) to pharmacies. The counterfeits are reported to have been put in genuine Biktarvy bottles with counterfeit foil induction seals or labels.

In a statement, Gilead said that the tablets in the seized bottles were "incorrect", but for now there's no word on what they contained.

Falsified medicines sometimes contain no active ingredients at all, actives in the incorrect dose, or other ingredients than those on the label, and they may contain contaminants and hazardous substances .

In the case of HIV therapies, taking falsified medicines can raise the risk that virus levels will not be kept under control and could develop resistance, leading to treatment failure.

"The authenticity and safety of Gilead-branded medicines can only be secure when obtained directly through Gilead's authorized distributors," said the company.

"Gilead continues to work closely with the FDA, pharmacies, and legal authorities to remove counterfeit and tampered medication from circulation and to prevent future distribution of these medications."

It's the second case of falsified HIV drugs in the US supply chain in recent months, coming after Johnson & Johnson's pharma division Janssen said that it discovered fake versions of its Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) product in three US pharmacies last December.

Gilead said that authentic Biktarvy tablets are purplish-brown, capsule-shaped pills with "9883" on one side and "GSI" on the other, while genuine Descovy tablets are blue, rectangular, and with "225" on one side and "GSI" on the other.

Pharmacists should make sure that dispensed 30-count bottles of Biktarvy or Descovy are received in bottles that are white plastic, with white plastic caps, and Gilead-branded labels, it added.