July 6, 2011
Jonathan McCone, M.D.
Recently, the U.S. Food and Drug Administration announced the approval of two drugs for hepatitis C virus (HCV) treatment, Incivek (telaprevir) and Victrelis (boceprevir) -- the first new HCV therapies in 10 years. This news is exciting for many people living with HCV, but especially so for African Americans.
HCV, a blood-borne disease that damages the liver, affects almost 4 million Americans (many of whom are also living with HIV), and African Americans account for almost 22 percent of those cases. Historically, with older HCV therapies, African Americans haven't had much success. But these new drugs appear to significantly increase the odds that treatment will work. For instance, when Victrelis was studied specifically in African Americans, researchers found that the African Americans who took the drug along with standard HCV treatment showed a significant increase in the odds that their HCV infection would be treated and cured.
I spoke with Jonathan McCone, M.D., the lead researcher of the African-American cohort in which Victrelis was studied, about this breakthrough drug and the importance of getting screened for HCV.
Can you explain what HCV is and how one contracts it?
HCV is a disease caused by a virus that infects the liver. Essentially, the liver kills itself. In time, it can lead to permanent liver damage as well as cirrhosis, liver cancer and liver failure.
People who are at risk are people who received blood transfusions before 1992 (because labs were not checking for HCV in the blood before then), people who have gotten stuck with infected needles, intravenous drug users who share infected needles, and people who have received piercings and tattoos with used needles that are infected.
This basically is not a sexually transmitted disease, unless there is blood involved. [Editor's note: Blood can be involved during many types of sex or foreplay, including anal sex and fisting; even a small amount of blood entering a microscopic cut on the body can potentially put a person at risk for infection.] You don't get it by kissing or breathing. It's generally a blood-to-blood illness, but if it's not specially checked for, it's not picked up. That doesn't mean that damage isn't occurring.
Can you tell us a little bit about Victrelis?
Victrelis is the first new medicine in a decade that has been approved in treating HCV. It's a pill that must be taken three times a day along with the other treatment: a once-a-week interferon shot and another twice-a-day pill [whose generic name is ribavirin]. You need all three forms of medicine to reap the benefits of the treatment. Victrelis will not work without the other treatments.
The most important thing to know is that HCV can be cured. Before Victrelis, we were seeing overall cure rates of just 40 percent in Caucasian Americans and only 23 percent cure rates in African Americans. But when we added Victrelis, African Americans who didn't have cirrhosis of the liver improved two-fold.
Why would cirrhosis make a difference in the success of HCV treatment?
If someone has cirrhosis, advanced damage is occurring. The liver tries to fight the virus by releasing cells to attack it. But what ends up happening is that virus kills those cells, and then turns the cells into scar tissue. The more scar tissue, the harder it is for the liver to do what it's supposed to do. The more advanced the disease, the harder it is to treat HCV.
I've seen patients who didn't know they had HCV and for 20 to 30 years their livers were getting worse and worse. If your disease gets really advanced, you might need a liver transplant or end up dying. This is why you have to get tested and treated early.
What are some of the side effects of HCV therapy, including Victrelis?
The most common side effects from HCV treatment are fatigue, anemia, feeling like you have the flu, headache, depression, weight loss and being irritable. But the good thing is that when people begin therapy, doctors check for all of these side effects and know how to modify certain things.
With Victrelis, there have been some complaints about having a metallic taste, but from what we know, it's not an overwhelming taste.
How long does HCV therapy usually last?
Before Victrelis, therapy usually lasted for one year in hopes to achieve a cure. But we have found that when Victrelis was added, for most patients, therapy time was cut down to six months. That's half the time.
Yes, there are a lot of pills and side effects to deal with. But I tell my patients, "You don't have a virus that gives a cold, you have a virus that makes you get a liver transplant and will kill you. Now you only have to take it for six months to reduce your [HCV] viral load and even cure your disease so you can enjoy your life. That's worth it all."
Why have African Americans had such little success with past HCV therapies?
Genetics. People who have good configurations of [a gene called] IL28B have a higher chance of being cured of HCV when on therapy. And what we have found is that African Americans were most likely to have bad configurations of IL28B, so even when they adhered to the therapy and did everything right, the treatment was less likely to be successful.
But when Victrelis was added to the existing therapies, even the people who had bad configurations had a better chance of being cured than without Victrelis. This is why this is such great news for the African-American community.
Is there a vaccine for HCV?
No, there is no vaccine for HCV. There are vaccines for hep A and B, though.
This is why it's important to get tested and get tested early. It's estimated that 75 percent of people who have HCV don't even know they have it. They are walking around, feeling good, but little do they know that damage is being done to their liver.
Also, doctors need to do a better job in making sure that they screen people and stop assuming who they think are the usual HCV suspects. Just like, at the age of 50, people are receiving colonoscopies, baby boomers should be getting routinely checked at 50 [for HCV] too.
This transcript has been edited for clarity.
Kellee Terrell is the former news editor for TheBody.com and TheBodyPRO.com.