A new drug called Harvoni, to treat chronic hepatitis C virus genotype 1 infection (HCV), has been approved by the Food and Drug Administration (FDA), but it comes with a hefty cost, at $1125 per pill . That means that a 12 week regimen will cost $94,500. Though it is anticipated that a good number of patients will be cured of their infection within an eight week regimen, for a cost of $63,000. While this might seem outrageously expensive, the drug’s maker claims it will save tens of thousands of dollars over the length of treatment, when compared with prior treatment methods.
Harvoni is the first drug treatment for HCV of its kind, a single-dose pill that could result in a much shorter, and less expensive treatment course for HCV patients. The newly-approved drug is a combination pill, combining two drugs (sofosbuvir and lepidasvir) for a much simpler method of treatment.
HCV is an inflammatory viral disease that can cause liver failure or damage. The most common type, genotype 1, is estimated to infect nearly 32 million Americans, and 130-150 million people worldwide, killing 500,000 people each year. Some common symptoms of latent HCV are cirrhosis of the liver, internal bleeding, jaundice, abdominal fluid accumulation and other infections. Most people infected with HCV do not know it until the liver damage manifests, which could take years to notice.
Harvoni is the third drug to be approved by the FDA this year, along with simeprevir and sofosbuvir (packaged under the names Olysio and Solvaldi, respectively). It is the seventh drug to be designated as a “breakthrough drug.” To be classified as a breakthrough drug, evidence must suggest substantial improvements in tests subjects with serious or life-threatening conditions.
Three clinical trials took place to test Harvoni’s efficacy. The first of the trials was conducted on patients who had not received treatment in the past. In this trial, 94 percent of those who received the drug for 8 weeks, and 96 of those who received the drug for 12 weeks achieved sustain virologic response (SVR). The second trial was conducted on patients with and without symptoms, and yielded even more impressive numbers. 94 percent of patients who received the drug for 12 weeks, and 99 percent of those who received the drug for just 24 weeks achieved SVR. Less than two years ago, the minimum course of treatment lasted 48 weeks. Harvoni has also tested with fewer side effects than preceding treatments, most often symptoms as minimal as headache and fatigue.
Harvoni is marketed by Gilead, a company based in Foster City, CA. The company is expected to earn nearly $12 billion in HCV drug sales globally in 2014. This is the same company which garnered criticism for selling Solvaldi for $1000 a pill in the US, but in other countries. Chances are that many of the same criticisms will be brought up with this latest combination drug due to the high price tag attached.