New Hepatitis C drug, a big boon for domestic players

The World Health Organization estimates that 150 million people globally are chronic HCV patients

April 18, 2014 10:22 pm | Updated November 16, 2021 07:23 pm IST - MUMBAI:

The spread of Hepatitis C virus (HCV) has long been a cause for concern in developing countries as the liver disease, if untreated, can cause liver cirrhosis and liver cancer and has a high mortality rate.

But a break-through drug by U.S. pharmaceutical giant, Gilead, with its sofosbuvir (brandname Sovaldi), is offering succour with a very high cure rate. It is a direct-acting antiviral (DAA) administered orally and is considered a breakthrough as existing treatment is injection-based and has severe side effects. Treatment time is reduced from 24-48 weeks to 12 weeks without side effects.

It is available in select markets. It was launched at $84,000 per patient in the U.S., $50,000 in France and $34,000 in the U.K.

The World Health Organization (WHO) estimates that 150 million people globally are chronic HCV patients and it claims 500,000 lives annually. The highest patient count is in China (29.7 million), India (18.2 million), Egypt (11.8 million) and Indonesia (9.43 million).

Leena Menghaney, Access Campaign India Coordinator, MSF (Doctors without Borders), told this correspondent that sofosbuvir in combination with existing drugs had a 90 per cent cure rate.

It is believed that India, “the generic pharmaceutical capital of the world” can once again come to the rescue. India first earned the above sobriquet in the late 1990s when it supplied generic versions of high-priced AIDS drugs to patients in sub-Saharan Africa at a fraction of then prevailing prices.

Gilead is reportedly already talking to Indian generic manufacturers to licence them to sell sofosbuvir in about 60 countries. But major markets where the disease is prevalent are excluded from the voluntary licence, said Ms Menghaney.

“They offered it to some Non-government organizations (NGOs) here at $1,000 per patient. In India, though, the public sector does not provide that service and the price is way too high”.

There are worries about a patent being granted in India as once granted, generic makers are bound by it. Outfits like Delhi Network of Positive People (DNP+) and Initiatives for Medicine and Access to Knowledge (I-Mak) filed pre-grant opposition to the patent here.

Sofosbuvir can be produced generically in India and marketed at very affordable prices. Produced generically, experts feel it can cost as low as $130 per patient and the opportunity would be huge for Indian manufacturers.

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