December 13, 2013

Hepatitis C: Expensive cure in sight

Original article in German

Friday 13 December 2013

Rockville - The manufacturer Gilead has come under criticism because of the pricing of the hepatitis C drug Sovaldi. Each tablet with the active ingredient Sofosbuvir will cost U.S. $ 1,000. The critics hold for grossly overpriced.

The polymerase inhibitor Sofosbuvir is considered the current best medication for the treatment of hepatitis C. In combination with ribavirin and pegylated interferon Sofosbuvir achieved in clinical trials of up to 90 percent of patients with genotype 1, a "sustained virologic response" (SVR), which is equated with a cure.

Without Sofosbuvir chances are less than half as large and the therapy lasts twice as long. Genotype 1 is the most common variant in the industrialized countries. For genotypes 2 and 3 can even be dispensed to the accompanying interferon therapy.

However, these advantages over the existing treatment has its price. The wholesale price for Sovaldi should be 28,000 U.S. dollars per bottle. Each bottle contains 28 tablets, taken once daily. The price for Germany is not yet known. That means likely to be approved shortly after the EMA has issued a positive recommendation in November.

The high price of Sofosbuvir is not the result of a complex synthesis. The production cost is low. The pharmacologist Andrew Hill of the University of Liverpool she appreciated against Science at 68-136 U.S. dollars - and not for a tablet but for the total ration a 12-week therapy. The high sale price has a different reason, according to observers.

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Gilead has Sofosbuvir not self-developed, but bought from a small company and paid for it in January 2012 not less than 11.2 billion U.S. dollars. Hepatitis C is considered by manufacturers as a lucrative business in which many companies have to buy their own lack of innovation. Why should the many other resources that are currently in clinical trials are very expensive.

Most hepatitis C patients, there is, however, not in the industrialized countries, where today almost exclusively infect intravenous drug users (sexual transmission is also possible, but rare). The manufacturer speculate mainly on the treatment of an unknown number of people who iatrogenic before discovery of the virus and the test development infected with non-A, non-B hepatitis.

Most cases occur in poorer countries. Experts estimate the percentage to 90 percent.For these patients Sovaldi is priceless. The non-profit organization Treatment Action Group (which emerged from the ACT-Up movement of HIV-infected) therefore demands that the manufacturer provides the drug available at low cost.

Gilead has over Science signaled some willingness, but at the same time pointed out the "complex challenges" of a two-price policy. In fact, the cheaper delivery to patients could quickly lead to a black market in poorer countries.

Since decades later the hepatitis C leads to liver cirrhosis and cancer, many patients in developing countries are likely to be willing to ignore the personal risk, and low acquired drug to multiples of the price to sell more. © rme / aerzteblatt.de

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