Soon, the FDA will be announcing its decisions regarding approval of two new hepatitis C drugs. Since the advisory panel unanimously recommended both of these drugs, FDA approval is expected.
The first drug is Johnson and Johnson’s (Janssen) simeprevir, a protease inhibitor. Simeprevir is for adults with hepatitis C genotype 1 adults. It is used with peginterferon and ribavirin for 12 weeks, and then the patient continues with peginterferon and ribavirin for another 12 weeks.
The second drug is Gilead’s sofosbuvir, a polymerase inhibitor. The application for this drug has two different regimens:1) Sofosbuvir in combination with peginterferon and ribavirin for treatment-naïve adults with genotype 1 or 4, and 2) Sofosbuvir with ribavirin for the treatment of adults with genotypes 2 or 3. The data showed a high response rate for genotype 2 patients with 12 weeks of treatment, and good response rates with 24 weeks of treatment for most genotype 3 patients. At this point, it is up to the FDA to determine the recommended treatment length.
In the meantime, genotype 1 patients are wondering if they should wait for all-oral, interferon-free hepatitis C treatments, which will likely be available in late 2014 or early 2015, or go with one of these new, shorter interferon-based treatments. Some patients are also weighing whether they should wait until ribavirin-free regimens are available.
If you are among those waiting, these words are for you. I am deeply concerned that some hepatitis C patients are delaying treatment too long. This year I witnessed a startling number of patients who were unable to enroll in clinical trials after finding out they had cirrhosis with complications that made them ineligible to participate. The degree of their liver damage was a complete surprise, because they assumed a stage 1 or 2 liver biopsy from ten or fifteen years ago would not have advanced to cirrhosis. Unfortunately, fibrosis often accelerates with age and duration of infection, and is not a linear progression.
Perhaps this doesn’t alarm you, but here is something else to consider—a study presented at the 2013 Liver Meeting showing that a virological cure for hepatitis C patients who had previously developed significant fibrosis, could still continue to be at risk for fibrosis/cirrhosis and liver cancer. In short, those that delay treatment may go through treatment, clear the virus, but still suffer some of the tragic consequences. (AASLD 2013: Long term survival of liver fibrosis after virological cure in patients with chronic hepatitis C: The avenue of the scars? by Thierry Poynard)
These new treatments are worth waiting for, but only if the delay does not put patients at significant risk. Your medical provider can help you determine if it is safe for you to wait. If you have not checked in with your medical provider recently, there is no time like the present to make an appointment.