Sovaldi counterfeits in the market?

SovaldiThe public is being warned to beware of counterfeit versions of Gilead Sciences' hepatitis C virus therapy Sovaldi after a factory producing them was shut down in Pakistan.

The Drug Regulatory Authority of Pakistan (DRAP) raided a facility in the Kahuta Industrial Area of Islamabad operated by a company known as Everest. The owner of the company has however insisted that the sofosbuvir tablets were legitimate generics and that he had applied to DRAP for a license to sell the drug.

Whatever the provenance of the Pakistan-made sofosbuvir, it is inevitable that criminals will start to produce knock-offs of Sovaldi (sofosbuvir), which exploded onto the market in 2014 and - thanks to a clear clinical advantage over older therapies and pent-up demand - racked up sales of  $10bn in the year.

Sovaldi and other new directly-acting antiviral drugs are proving immensely popular because they can allow HCV patients to sidestep the use of interferon alfa, an injectable therapy associated with significant side effects that is also not as effective as the new generation of oral treatments.

Those benefits come with a hefty price tag - tens of thousands of dollars per course of therapy in the developed world - although Gilead has agreed to license the high-priced medicine to several generic drugmakers for sale in low-income countries, including India's Natco Pharma which has started selling a low-cost version in Nepal.

Meanwhile, a number of drugmakers outside that license agreement have already started selling the drug. This week, Bangladesh-based Incepta Pharmaceuticals started selling a Sovaldi product priced at just $900 per course, a fraction of the price in the US.

Pakistan is an obvious location for the production of counterfeit HCV drugs as the country is a hot-spot for the infection with around 6 per cent of the 182m population (around 10m people) suspected to be harbouring the virus.

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