An Expensive New Drug for Hepatitis C

The next issue of The Medical Letter (January 20, 2014) includes an article on sofosbuvir (Sovaldi – Gilead), a new oral drug for treatment of hepatitis C. Sofosbuvir is not a me-too drug; it is the first of a new class (polymerase inhibitors), it appears to be more effective than older drugs, and it can be given (at least for some genotypes of the virus) without the old standby interferon, which must be injected and has side effects that many patients cannot tolerate. But the new drug costs too much: $84,000 for a 12-week course.

The News and Analysis section of the December 13th issue of Science had an interesting article on the subject of sofosbuvir’s cost, written by Jon Cohen. He points out that most of the 135 million to 185 million people estimated to have hepatitis C live in poor countries, which obviously will not be stockpiling this drug. Moreover, according to a UK pharmacologist whom Cohen quotes, the drug costs very little to make: $68 to $136 for a 12-week supply. The problem is that Gilead paid more than 11 billion dollars to acquire the company that first made it, and they need to get that back for their stockholders.

The world has been through this scenario once before, with HIV, and predictably the same legal and political challenges are being mounted. Gilead is exploring the possibility of differential pricing (the rustling in the background is the US Congress rushing to hold hearings) while vigorously defending its patent in India and elsewhere in the developing world. And we haven’t heard anything yet from US insurance companies. Our reviewers tell us that several other new drugs with promise of a high rate of cure for hepatitis C are waiting in the wings, so Gilead will not have endless time to recoup its 11 billion dollars.

To learn more about sofosbuvir, its efficacy and its side effects, look for the next issue of The Medical Letter.

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