Clinical Trials to Test Treatments for Hepatitis C and Liver DiseaseJul 7, 2014
Dr. Campsen: There's a new treatment available for hepatitis C without the horrible side effects, and we are preventing the recurrence of hepatitis C and the need for retransplantation of the liver due to reinfection. I'm Dr. Jeffrey Campsen. I'm a liver transplant surgeon at the University of Utah, and that's next on The Scope.
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Dr. Campsen: I'm here with . . .
Dr. Gallegos-Orozco: Dr. Juan Gallegos-Orozco. I'm an Assistant Professor of Medicine at the University of Utah School of Medicine, and I'm part of the liver transplant team.
Dr. Campsen: Juan, thanks for joining us today. The study that we're talking about today is a study that we're involved with for our patients that are receiving liver transplant for hepatitis C. What's exciting about it was that it's never been available, especially in the state of Utah, and its available now to our patients as a trial. The way that the trial is set up is that these patients are listed for liver transplant because of their cirrhosis, but they also have a Hepatitis C infection. They also probably have had a cellular cancer on top of it. They are then treated with the antivirals that you described, and hopefully the hepatitis C virus is cleared down to an undetectable level. At time of transplant, they receive their liver transplant and are given an immunoglobulin called Civacir that then continues after transplant. Hopefully, in combination of the antivirals before transplant, the liver transplant, and then the immunoglobulin after transplant will keep them from ever having hepatitis C again.
Dr. Gallegos-Orozco: Yes. This strategy is very exciting because following the footsteps of the hepatitis B immunoglobulin, which are antibodies against hepatitis B and was a big step forward in transplanting patients with hepatitis B, which is another kind of viral infection that can also cause chronic hepatitis, cirrhosis, and liver cancer. In hepatitis C, we're following this strategy, and our goal is to prevent the reinfection of the new or healthy liver that's being transplanted. The way we achieve that, like you mentioned, is not only with treatment before the transplant, but also with this immunoglobulin or antibodies against hepatitis C in an effort to neutralize any residual virus and, hence, preventing the reinfection of the transplanted liver. We hope that this strategy, in combination with the antiviral therapies, will ultimately lead us to prevent infection of hepatitis C, which, as you know, is a big problem in transplantation.
Dr. Campsen: It's a huge problem. So if you get a liver transplant and then the Hepatitis C comes back, it's basically a brand new infection in the liver transplant. It can really blossom to the point to where those patients won't survive the year after the liver transplant because the virus is so aggressive in how it comes back, which is demoralizing and tragic to everybody involved.
Dr. Gallegos-Orozco: I agree.
Dr. Campsen: Let's talk about this study. We started this study this past year, and we enrolled our first patient in the study. Can you tell us a little bit about him?
Dr. Gallegos-Orozco: Yes. This gentleman that we enrolled was a patient with chronic hepatitis C. He had developed cirrhosis and complications of his cirrhosis, and one of those complications was liver cancer. The patient was listed for liver transplant, and we followed him very closely during his course. We treated his liver cancer successfully, but he still required a liver transplantation. We knew that he had hepatitis C. He had the genotype one, which is one of the most difficult genotypes of hepatitis C to treat, and we were fortunate enough that we were able to get him through treatment with these new antivirals that did not require any interference. Just the combination of two pills that he took everyday for several weeks were good enough to decrease the amount of virus in his blood to basically undetectable levels.
At that time, a liver became available, and he was transplanted successfully with this healthy liver. Because of his participation in the trial, he also received this hepatitis C immunoglobulin or antibodies against hepatitis C, and he's completed the first six weeks of this treatment after transplant. So far, there's been no evidence of recurrence of hepatitis C in his blood, and his liver graft is doing very well.
Dr. Campsen: How exciting is that? Basically, what we did was we cured the hepatitis C if you can use that word. It's a strong word, but that's what I believe. We also cured him of his liver cancer, which is something that you probably couldn't have done a year ago.
Dr. Gallegos-Orozco: Correct. I agree, and I think that's a very exciting time, not only in the treatment of the hepatitis C overall, but certainly in the treatment of hepatitis C in our liver transplant patients.
Dr. Campsen: As with any medical procedure, there are concerns as to the safety of the procedure. Liver transplant in and of itself is a high-risk procedure. At the University of Utah, we have excellent outcomes, and our patients have done very well. However, when you add other new medications on top, there's a concern. Specifically for the Civacir trial, the hepatitis C immunoglobulin trial that we're speaking about today, I feel that it is a very low-risk procedure. How do you feel about it?
Dr. Gallegos-Orozco: I agree. So far, the evidence of the side effects from this clinical trial that we're participating in have shown that this procedure is safe and very well tolerated. It basically requires the patients that are participating to receive this immunoglobulin after an IV infusion, and they do that for several times during their first few weeks after liver transplant. So far, they've tolerated the procedure well. It hasn't been associated with any significant adverse events, and we feel that it's similar to the hepatitis B immunoglobulin and other types of antibodies that are used in medicine that overall it's a safe procedure. Of course, in the setting of the clinical trial, we're very vigilant about side effects, and we monitor our patients very, very closely.
Dr. Campsen: We're one of the centers that are involved in this trial. I think there's about 20 centers across the United States that are involved in the trial, and they're seeing very similar results to ours. Which are one, the safety profile of the drugs seems to be excellent, and then, two, the efficacy, meaning does it actually work, also seems to be very good. There are different arms of the study, but the study arms where the patients are actually getting the drug that we're talking about, no one's had a recurrence of the virus, which, I think, is an excellent result.
Dr. Gallegos-Orozco: I agree, and definitely, that's what we're wishing for with this, hepatitis C antibodies to prevent reinfection of the liver. So far, that's what the trial has shown.
Dr. Campsen: But with any study, it's the long-term follow-up that really makes the difference. So today we're talking about the early success of this, how excited we are to do something that we've never been able to do before, but, again, we're going to monitor it at a university setting along with our other universities that are involved and see if it truly is a therapy that will be used long-term.
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