Originally Published June 15, 2015
While conducting a workshop in New England, I was
asked a question about genotype 3 treatment for people who are
treatment experienced and had cirrhosis—a question I am frequently
asked. At this time, we do not have an interferon-free treatment with
high cure rates for this particular group of people with hepatitis C.
This is an unmet medical need for a large group of people in the United
States and Worldwide. I am asked this question at almost every
workshop, which surprises me.
There are many drugs in
development that hold the promise to solve this problem. In the
meantime, there is a solution—the combination of Sovaldi, pegylated
interferon and ribavirin. When I bring up interferon, I get the cringe
reaction. It is a very understandable reaction. However, there are a
couple of serious points to consider:
Cirrhosis can be a
life-threatening event. You do not want to wait—If you have genotype 3
and cirrhosis you should consider taking action now
Genotype 3 leads to the formation of steatosis (fatty liver)—successful treatment reduces or eliminates steatosis
Steatosis can accelerate HCV disease progression—by itself steatosis can lead to cirrhosis
People with genotype 3 are at increased the risk for liver disease progression and liver cancer
Pegylated interferon and ribavirin can be difficult to tolerate, but the majority of side effects occur after 12 weeks
The side effects of pegylated
interferon and ribavirin can be managed successfully especially if the
medical provider and patient are proactive
The current standard of care for genotype 3 is the
combination of Sovaldi (sofosbuvir) plus ribavirin for 24 weeks. The
cure rates for treatment experienced patients without cirrhosis are
85%, but for treatment experienced patients with cirrhosis the cure
rates are 60%. Clearly, genotype 3 patients who are treatment
experienced with cirrhosis are in need of better treatment options. I
have listed below two studies that include treatment of Sovaldi,
pegylated interferon plus ribavirin. Note: I only
included the information about the cure rates of the genotype 3
treatment experience patients with cirrhosis treated for 12 weeks.
A recently published study in Hepatology
“Sofosbuvir with Peginterferon-Ribavirin for 12 Weeks in Previously
Treated Patients with Hepatitis C Genotype 2 or 3 and Cirrhosis,” –E
Lawitz et al. showed very high cure rates.
Note: There were 47 genotype 2 and 3 patients included in the study. Only genotype 3 results are listed below.
There were a total of 24
genotype 3 patients with and without cirrhosis. All were treated for
12 weeks with Sovaldi (sofosbuvir), pegylated interferon plus
The cure rates were the same for
those with cirrhosis 83% (10 of 12 pts) and without 83% (10 of 12 pts)
in the genotype 3 patients.
The second study was presented
at EASL 2015 “Sofosbuvir Plus Peg-IFN/RBV for 12 Weeks vs
Sofosbuvir/RBV for 16 or 24 Week in Genotype 3 HCV Infected Patients
and Treatment-Experienced Cirrhotic Patients with Genotype 2 HCV: The
BOSON Study,” –R Graham et al.
study was a large study of 592 genotype 3 treatment naïve/experienced
patients without and without cirrhosis. I will only list the treatment
experienced patients with cirrhosis who were treated for 12 weeks with
Sovaldi (sofosbuvir), pegylated interferon plus ribavirin and the
comparator arm of the treatment experienced patients with cirrhosis who
received Sovaldi plus ribavirin without pegylated interferon.
After 12 weeks of treatment the
group of patients who were treated with Sovaldi, pegylated interferon
plus ribavirin achieved a cure rate of 86% (30 of 35 pts) compared to a
cure rate of 47% (17 of 36 pts) for those who received Sovaldi plus
ribavirin but without pegylated interferon.
The most common side effects were flu-like symptoms, fatigue, and anemia.
addition of pegylated interferon to Sovaldi and ribavirin almost
doubled the cure rates for people with genotype 3 in both studies who
had cirrhosis and who were treatment experience. The best strategy is
to talk with your medical provider and come up with a plan to get
treated as soon as possible, seek a possible cure and stop hepatitis C
in its tracks.
Labels: Genotype 3, GT3