The World Hepatitis Day, observed on 28th July 2014, came with exciting news of arrival of a new drug with one pill a day for just 12 weeks claiming almost complete cure. A hope for the millions of hepatitis C patients worldwide!
Hepatitis, means the inflammation of the liver, usually refers to a group of viral infections that affects liver. Though there are five main hepatitis virus – Type A, B, C, D and E which are responsible for causing illness including deaths, Type B and C lead to chronic disease and are the most common cause of liver cirrhosis and cancer. While there is safe and effective vaccine available for Type B virus, there is no vaccine for Type C virus (Hepatitis C Virus). HCV is most commonly transmitted through exposure to infective blood. Hepatitis C infection may occur through transfusion of HCV contaminated blood or blood products, contaminated injections during medical procedures and through injection among drug users. The sexual transmission is possible but is less common.
Hepatitis C is known as silent epidemic as it produces few symptoms for years. Even many patients don’t know that they are sick. About 5 to 20 per cent of the people initially infected develop cirrhosis only after 20 years. A figure in the year 2010 shows that India has 18.2 million hepatitis C virus infections. Around 30-50 per cent of the Indian patients need this new treatment. If left untreated it leads to cirrhosis or liver cancer. Currently, it is treated with combination of daily drugs and up to 48 weeks of weekly injection of interferon which comes with the risk of devastating side effects. This prevents many from continuing the medications. Its cure rate is also just 50 per cent. If the patients failed to get response, they have no alternative. The new drug, sofosbuvir (sovaldi), has lot of promises. It needs to be used in combination with other drug: (ribavirin) or (interferon and ribavirin) but with high cure rate of 90 per cent and less side effects. Sovaldi’s 12 weeks course is more manageable and likely to provide better adherence due to less side effects, short course and non-injectable option.
The sovaldi is marketed by a USA based pharmaceutical company, Gilead Sciences, at a price of USD 1,000 per pill at USA. Sovaldi alone costs USD 84,000 for the entire 12 weeks course. But the whole treatment cost per patient is around USD 1,00,000 as it is to be used in combination with other medications. The price becomes unaffordable in USA itself and the many states are restricting its use. The US insurance companies are rationing the treatment and urged the doctors not to offer this medicine to all patients who need. The situation in Europe is no better. The cost of 12 weeks treatment in Europe is around USD 68,000. The French health minister is urging the European Union to collectively negotiate for a lower price. The cost of a course of therapy of sovaldi is around USD 67,000 in Germany and the same costs around USD 55,000 in UK and Canada. The Egyptian government is successfully negotiating with the Gilead to provide a 12 weeks course at USD 900 per patient in public health facilities.
The sovaldi is viewed as one of the best launches as it fetched a very high return in just six months of marketing. The independent researchers find it difficult to understand this high price as the company invested just USD 11 billion for its development. Gilead got the drug through the acquisition of Pharmasset which developed the drug. In addition to pricing issue raised by activists and civil societies, Gilead’s sovaldi is involved in a patent tangle with AbbVie, Roche and Merck. Roche filed infringement suit and its claim is based on the pre-existing relationship with Pharmasset, the company developed the drug. AbbVie has proactively applied for patent for combination products which include the Gilead’s product. Gilead filed suit against Merck after the latter sought a royalty of 10 per cent on the sale of sovaldi claiming that sovaldi infringes on its patent that cover certain compounds. In India too its patent application has some issues. The Indian Patent Act allows pre-grant opposition which allows any interested group to challenge a patent application before the patent is granted. The civil societies and Natco - a pharmaceutical company - have used this clause and the final verdict is awaited. Now it does not have a patent in India.
It is not the price alone that is responsible for its access to Indian patients. India is reported to have imported sovaldi worth more than rupees one crore. The imported drug costs around Rs. 15 lakh for a month’s treatment and for full course it is about Rs. 45 lakh. There is a need of clinical trials in Indian patients to prove its safety and efficacy. That means another additional costs and delay in getting the treatment with this medicine. But this is our legal requirement.
Discovered in 1989, hepatitis C virus infects an estimated 185 million people worldwide and more than 80 per cent live in low and middle income countries. A powerful new drug, sofosbuvir (sovaldi), is finally approved to cure this lethal hepatitis C. While the affordability of the new drug is a concern for the USA itself, its accessibility to the patients in poor countries will remain a distant dream! When majority of the patients needing treatment belong to middle- and low- income countries, such high priced medicine is nothing but a public health travesty! Through compulsory licensing (CL) generic manufacturing perhaps would be a solution!
(The authors are with Department of Pharmacy, Annamalai University, Annamalai Nagar, Tamil Nadu 608 002)