Since the beginning of 2014 there is a new hope for patients with hepatitis C: the FDA approved the new drug sofosbuvir (Sovaldi, Gilead Sciences, Inc). Hepatitis C is a widespread disease which affects 1 out of 60 people in the United States and up to 1 out of 5 people in some low income countries such as Egypt.
It is caused by a virus, hepatitis virus C, which attacks the cells of the liver and, slowly, over the years, modify them such that they can no longer function properly. This prevents the liver to perform its normal functions of blood purification and synthesis of substances essential for the functioning of all the other organs of the body.
Hepatitis C is transmitted through contact with blood or other biological fluid. Contaminated instruments and needles are infections means especially amongst drug users. Once the virus starts to replicate in liver cells, it is very difficult to heal and 75% of people after the acute infection become chronically ill. Up to this time standard therapy comprised interferon, used in cases of active and rapidly progressive disease. This therapy, however, ensures success in only 20% of cases and has numerous complications. In case of failure, the only other option (not always feasible) is liver transplantation. In December 2013, the FDA approved a new drug: sofosbuvir (Sovaldi, Gilead Sciences, Inc). This is very promising in terms of effectiveness. It has been shown to cure the disease in up to 95% of cases when combined with interferon.
The advantages of sofosbuvir are considerable: it can be consumed orally, in combination with other antiviral drugs already in use, and the standard treatment lasts 12 weeks (much shorter than standard therapy cycle with interferon, which lasts 6 months minimum). Up to here we have given you the good news, but now comes the bad. Sovaldi, in fact, is sold at a considerable price: in the USA the cost for a course of treatment is up to $ 1000 per tablet and about $ 84,000 for a therapeutic cycle. Moreover, a new association of sofosbuvir and ledipasvir is being evaluated by FDA for commercialization. This could be the first treatment completely administrable orally that promises to eliminate the need for interferon. This new therapy could be even more expensive, media say. Public opinion reacted with strong objections to the cost of this new, promising drug. In fact, the risk is that the price of insurance will jumps high and that Medicaid dries in a short time. Members of Congress have started a joint investigation into how the maker, Gilead Sciences, settled on its price.
Gilead Sciences has not retracted the terms of sale in the United States, but said it had entered into agreements with local manufacturers to produce low-cost, generic drug to be sold in developing countries.
We look forward, therefore, to know whether the strong protests of the political world and insurance convince Gilead Sciences to revise the selling price of a drug that can change the lives of so many people.