Statement |

MSF response to the U.S. Food and Drug Administration approval of the drug sofosbuvir

MSF response to the U.S. Food and Drug Administration approval of the drug sofosbuvir, to be marketed by Gilead for the treatment of hepatitis C 

Public health groups have moved to block unwarranted patents in India

Pricing in developing countries a serious concern

Sofosbuvir, a ‘direct-acting antiviral’ for hepatitis C, results in significantly higher cure rates in a shorter period of time than current therapy, and for some genotypes of hepatitis C, eliminates the need to use the injectable drug pegylated interferon, which is difficult to administer and causes multiple side effects. Sofosbuvir will be priced exorbitantly, with estimates of up to $80,000 for a 12-week treatment course in the US. While prices in developing countries are still unknown, they are likely to far exceed what patients and governments can afford.

MSF has begun treating several patients in India with hepatitis C (who are co-infected with HIV), using today’s available drugs, but would like to access sofosbuvir for patients in India and several other countries to make expanding treatment in its medical projects feasible.

A ‘patent opposition’ for sofosbuvir was filed in India on 21 November 2013 by the legal group I-MAK, Initiative for Medicines, Access & Knowledge, in an effort to ensure more affordable versions of the drug can be made in India, which is often called the ‘pharmacy of the developing world.’ 

Further, a recent study released by researchers at Liverpool University at the American Association for the Study of Liver Diseases conference in November found that sofosbuvir is relatively simple and cheap to produce, at $68-$136 for a 12-week treatment course, making the prices Gilead is projected to charge all the more unacceptable.  At the projected price of up to $80,000 per treatment course, it would cost as much as $256 billion to treat all 3.2 million people infected with hepatitis C in the US alone. Even at a fraction of such prices, these drugs will be priced out of reach of governments and millions of people in developing countries. 

“This drug is of public health importance but it won’t do much good if it’s unaffordable for the more than one hundred million people with hepatitis C in developing countries. We know from our experience treating HIV in developing countries that treatment must be simple and affordable, so we urge Gilead to act so that a full treatment course plus diagnostics costs no more than $500 in developing countries. We are very worried that Gilead will charge exorbitant prices in countries that are classified as ‘middle-income,’ even though they are home to around 75 percent of the world’s poor.  Using patents to block affordable versions of sofosbuvir and pricing this drug out of reach of the most vulnerable groups who need it most is simply putting profits before people’s lives.”
- Dr. Jennifer Cohn, Medical Director, MSF Access Campaign