Janssen warns of fake HIV drug Symtuza in US supply chain

Johnson & Johnson’s pharma division Janssen says that it has discovered falsified versions of its Symtuza HIV therapy in three pharmacies in the US.

Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) – part of an HIV franchise that is worth around $2bn in revenues a year to J&J – is indicated for the treatment of HIV in adults and adolescents aged 12 or over by the FDA.

It was first approved in 2018 and is positioned as a once-daily, single-tablet antiretroviral medicine both for newly-diagnosed patients and those who have previously been treated with other drugs.

That makes it particularly concerning that people living with HIV who might inadvertently receive the counterfeit could have a gap in their antiviral cover, potentially encouraging the development of resistant strains and leading to treatment failure.

Janssen said in a statement that it is working with the FDA “to prevent further distribution and to support the agency’s investigation into the reported instances.”

The pharmacies involved procured the counterfeit product from distributors that had not been authorised by Janssen, which exposes once again the vulnerabilities inherent in the US medicines supply chain.

The US is in the process of implementing the Drug Supply Chain Security Act (DSCSA), which aims to strengthen the country’s drug distribution supply chain by adding controls such as a national track and trace system and setting standards for licensing of wholesale distributors and third-party logistics (3PL) providers. That isn’t however due to come into full operation until 2023.

Janssen said it is confident that Symtuza obtained through authorized distributors is authentic and safe for use.

It seems possible at least that some of the counterfeit medicines could have got into the hands of patients, but Janssen says it is not aware of any reported adverse events related to the use of the fake product.

“Counterfeit medicines can place patient health at risk, and Janssen has implemented various approaches to combat counterfeiting,” it said in a statement.

“This includes working with stakeholders to secure the distribution system and implementing special packaging and printing techniques that make counterfeit product more difficult to produce and easier to identify.”

Genuine Symtuza tablets are yellow to yellowish-brown, capsule-shaped, film-coated tablets debossed with “8121” on one side and “JG” on the other side, says Janssen, adding that tablets in a Symtuza bottle that do not match this description should be reported.