Gilead cracks down on fake versions of popular HIV drugs Biktarvy, Descovy being sold at US pharmacies

Counterfeit versions of two of Gilead Sciences’ most popular HIV drugs are circulating in the U.S., threatening the health of people taking them.

Gilead’s original Biktarvy and Descovy have been replaced by fake versions at some pharmacies, Gilead warned Thursday. Unauthorized distributors were able to sell fake drugs to retailers; and then, “genuine Gilead bottles” were filled with fake tablets, the company said.

Gilead has alerted potentially impacted pharmacies and is working with the FDA, pharmacies and legal authorities to remove problematic pills from circulation and to prevent future distribution, the company added.

Gilead didn’t disclose the number of pharmacies affected or where they are located. The drugmaker didn’t immediately reply to a request for further comments.

Counterfeit medicines may not live up to the same quality standard as authentic drugs. The finished products of falsified drugs may not have the correct amount of active ingredient or may contain impurities. 

Approved by the FDA in 2018, Biktarvy quickly became the industry's best-selling HIV med and a key growth driver for Gilead. In the first half of 2021, the drug brought in $3.82 billion worldwide, a nearly 16% increase over the same period last year.

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Descovy, which is combined with other drugs to treat HIV and used by itself as a PrEP option to prevent infection, brought in sales of $794 million in the first six months of 2021. The haul was down from last year’s level mainly because reduced use of PrEP during the COVID-19 pandemic and slow patient switching.

Gilead is currently trying to get PrEP takers onto Descovy after its older version Truvada went generic. The main selling point for Descovy is that it uses the safer TAF version of the tenofovir component.

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Gilead’s statement followed a similar one by Johnson & Johnson late last year. In December, the New Jersey conglomerate’s Jassen unit alerted (PDF) the public that counterfeit versions of its complete HIV regimen Symtuza had been distributed to three pharmacies. Symtuza also includes the same TAF and emtricitabine ingredients that are used in Biktarvy and Descovy.

The COVID-19 pandemic appears to have fueled the circulation of counterfeit drugs. The ongoing public health crisis has caused disruptions to legal drug supply chains and has limited regulatory enforcement activities, the Organization for Economic Co-operation and Development noted in a recent report (PDF).