The US Justice Department has started a probe into falsified versions of HIV drugs from several companies, including Gilead Sciences, GlaxoSmithKline and Johnson & Johnson, that have been intercepted in the market.
A report in the Wall Street Journal, citing people close to the matter, notes that the criminal investigation got underway late last year after a series of incidents in which counterfeits were discovered in the supply chain, including knockoffs of Gilead's Biktarvy and Descovy that reached the hands of patients.
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.
Gilead stepped up its response to the illegal activity by filing a lawsuit against dozens of defendants, including grey market distributors and individuals associated with them, claiming the network had sold more than $250m-worth of the fake meds.
According to the complaint, the counterfeits were mixed in with batches of genuine Gilead product with fake pedigrees to make the scam harder to detect, and used authentic Gilead bottles that were filled with completely different drugs.
After refilling the bottles, the scammers heat-sealed them with a replica of Gilead’s tamper-evident foil seal, says the drugmaker.
The WSJ says counterfeits of J&J's Symtuza have also been seized, although GSK's majority-owned HIV joint venture ViiV Healthcare told the newspaper it had not received any reports of diversion counterfeiting or trafficking of its medicines.
The Justice Department has declined to comment on the report.
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