Hepatitis C Drug to be Offered Soon in India at Only One Percent of Its Cost in USA

Patent holder and pharma major Gilead, announced voluntary licences with seven generic drug manufacturers in India to sell lower-cost versions of a $1,000-a-pill for hepatitis C treatment in poorer countries.

Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab, under the licensing agreement have the right to develop and market generic versions of sofosbuvir in 91 developing countries. However Indian manufacturers will not be allowed to sell sofosbuvir in Brazil, Russia, China, Thailand and many other middle-income countries.

Greg H Alton, executive vice president of Gilead says, "We believe in the capabilities of our partner companies for high quality, low cost, high volume manufacturing. The competition between them will bring down the price of the generic version of sofosbuvir and thus this partnership will help bring about better access to patients globally. Gilead will have no control over their pricing. Our partner companies will set their own prices,"

Gilead’s price per bottle of sofosbuvir is at $300 (28 pills meant for one month of treatment at one pill per day), which is about 1% of the US price. The Indian companies’ representatives said they would need to complete one production cycle to give an estimated price at which the drug available.

Sharing needles, receiving contaminated blood transfusions or having sex with an infected person are all various causes of the Hepatitis C virus.

According to the World Health Organization (WHO), approximately 350,000 people die of Hepatitis C-related liver diseases every year, and as many as four million people are newly infected each year. About 185 million of infected people across the world have no idea they have the disease. It is in most cases detected with diagnoses and discovered after a person develops cirrhosis, end-stage liver disease or liver cancer.

Dr.Christopher Barry, a well known Liver Transplant Surgeon from USA said to Medindia, "Until recently, chronic Hepatitis C Virus (HCV) infection was a very difficult disease to treat, and liver failure due to HCV cirrhosis has been the major indication for liver transplant in Western countries."

He added, "The advent of very effective HCV drugs has brought great hope and excitement, as the disease can be completely cured in 60-90% of cases. Sofosbuvir, a second generation HCV protease inhibitor drug manufactured by Gilead, is even more effective and with less side effects than the first generation drugs, but it is extremely expensive."

Medecins Sans Frontieres (MSF) pointed out that the Gilead licence excluded countries like China, Brazil and Ukraine considered to have the highest burden of people living with hepatitis C virus (HCV). Other countries with large HCV burden like Thailand, Malaysia, Peru, Argentina, Ecuador and Colombia have also been omitted from agreement.

The agreement essentially covers poorer countries where the burden is not as high, MSF pointed out. These countries would not have borne the burden of patent system, as they have been exempt from patent obligations. Prof Brook K Baker, senior policy analyst in the School of Law in Northeastern University pointed out, "Generic entrants might be particularly reluctant to serve all smaller volume, poorer countries because of the cost of registering their products and establishing distribution systems."

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MSF Access Campaign’s, Director of Policy and Analysis, Rohit Malpani, said, “We welcome the interest of generic companies to scale up production of new direct-acting antivirals and Gilead’s decision to make the final agreement public; however, a highly restrictive voluntary license that blocks millions of people with Hepatitis C from affordable prices is not acceptable. MSF hopes that excluded governments will take all relevant measures available under global trade rules and national patent laws to secure low-cost generic versions of these medicines."

A complete treatment course lasting 24 weeks costs Rs.50.4 lakh in the US. It was announced that Gilead will be offering voluntary licenses to Indian pharmaceutical companies to manufacture Sofosbuvir and sell for only Rs 1.1 lakh per treatment course (1% of the US cost). This is wonderful news for the over 18 million Indians infected with HCV.

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Source-Medindia