Sofosbuvir patent rejection offers chance of affordable effective hepatitis C treatment as studies highlight possibilities of drug

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Legal petition to India’s patent office by Delhi Network of Positive People and Initiative for Medicines, Access & Knowledge (I-MAK), opposing pharmaceutical company Gilead’s application for a patent that would prevent generic versions of the drug from being produced without license from the company in India.

This is turning out to be a big week for hopes of treatment and cures for some of the 185 million people worldwide living with hepatitis C, and for possibilities of lowering global incidence of the liver-damaging, cancer-causing disease. First, two studies added to what is known about the potential of a drug used in new treatments for the virus to cure more people, faster. Then a decision in India opened the way for more people who need the drug to get it.

The drug is sofosbuvir, which offered great promise when it was approved more than a year ago by the U.S. Food and Drug Administration. With a 90-percent cure rate, it cut the challenging six-month treatment time for hepatitis C in half, greatly increasing the odds of completing treatment and lowering rates of new infections. But with a more than $80,000 price tag, It brought its own challenge, and low odds that the people who needed the drug most would get it. Even after pharmaceutical company Gilead offered a licensing agreement to manufacturers in India that would make the drug available for about $2000 per treatment in some low- and middle-income countries, it seemed destined to remain out of reach for the vast majority of people with chronic hepatitis C, including those who live in countries where that price is unaffordable, and who live in the more than 50 middle-income countries with significant rates of hepatitis C that were left out of that deal.

The decision by India’s patent office, reported by Reuters Wednesday, rejecting Gilead’s application to limit production of the drug there, could change that, allowing sofosbuvir to be produced for about $100 for a three-month course of treatment. That decision could save from $30- to $60 billion in treatment costs, according to Initiative for Medicines, Access & Knowledge, one of the entities, along with Delhi Network of Positive people, and Indian generic drug maker Natco Pharma Ltd., opposing Gilead’s patent application.

The news follows that of a study, announced by the National Institute of Allergy and Infectious Diseases and published in The Lancet Monday, that found sofosbuvir, as part of a three-drug regimen, can cure patients in a quarter of the time previous treatments required — ridding 38 of 40 clinical trial volunteers of the virus  in six weeks. The other study, also released Monday in the Journal of Infectious Diseases found that hepatitis C patients who are also infected with HIV also tolerate a sofosbuvir treatment regimen well, increasing their chances of completing treatment.

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