A Costly Cure for Hepatitis C

An article earlier this year in The Medical Letter (January 20, 2014) heralded FDA approval of the nucleotide polymerase inhibitor sofosbuvir (Sovaldi – Gilead) for use in combination with other antiviral drugs for treatment of chronic hepatitis C infection:

“Sofosbuvir (Sovaldi) appears to be the most effective drug available to date for treatment of chronic hepatitis C. In combination with other drugs, it has produced higher sustained virologic response rates with shorter treatment durations than the current standard of care. For some patients, at least, it offers the possibility of oral treatment without the debilitating side effects of interferon.”

Last week 3 articles published on-line in The New England Journal of Medicine reported that use of sofosbuvir in combination with the NS5A inhibitor ledipasvir (not FDA-approved to date) for 8 or 12 weeks resulted in rates of sustained virologic response of 94 to 99% without interferon, without ribavirin, and as an accompanying editorial pointed out, regardless of age, sex, race, HCV genotype, or previous treatment. Not one patient discontinued treatment because of side effects, which were mainly headache, nausea, and fatigue. And, because of the life cycle of this virus, resistant mutants are not expected to emerge.

So we have a cure for a disease now spread mainly by IV drug use that affects 3% of the world’s population and 3% of all US residents born between 1945 and 1965, that kills more people in the US than HIV infection, and that is a major cause of cirrhosis and hepatocellular cancer. But it costs too much. Sovaldi costs $1000 per tablet in the US ($84,000 for an 8-week course), and we have to assume that lepidasvir or other antivirals in the pipeline, when they are approved, will cost something like that too. Gilead, to its credit, is offering the drug in the developing world, where most of the cases are, for a fraction of the US price, but even here, something will have to be done to lower the cost.

Still, it’s a great day in the short history of this killer disease.

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  1. mark morgenstern says:

    this will save lots of lives ,prevent hospitals admissions, give a higher cure rate and give a better quality of life,prevent lots of liver transplants and we will have lots of less side effects then previous therapy regimens

  2. Steve Liles, PharmD says:

    The $84,000 cost cited is actually the WAC for the 12 week course of therapy.

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