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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.

Announcer: Medical news and research from the University of Utah physicians and specialists you can use for a happier and healthier life. You're listening to The Scope.

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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Interviewer: You've been diagnosed with liver disease. How is that going to affect your diet? We'll talk about that next on The Scope.

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Interviewer: After you've been diagnosed with liver disease, dietary changes can make a difference. We're going to find out what you should be eating and what you should be avoiding right now, with Doctor Juan Gallegos. He's a liver expert at the University of Utah hospital. Tell us about diet and the importance of diet with liver disease.

Dr. Juan Gallegos: Thank you, Scot. It is very important because the liver receives most of the nutrition that you get through your mouth. It actually makes it into the blood from the small bowel and, then, that blood has to go and get through the liver. The liver cells, basically, detoxify your blood, and are very important in making proteins, making cholesterol, and it's basically like a chemical factory.

Interviewer: So, very important diet.

Dr. Juan Gallegos: Yes. Most of the time when I see patients in my clinic who have chronic liver disease, my main recommendation for them is, first, abstain from alcohol because we know alcohol has a direct toxic effect on the liver. So, if somebody already has liver disease, we strongly recommend that they abstain from alcohol so as not to damage the liver even further. In regards to any particular change in their diet, I do recommend that they try to eat healthy. Meaning, have adequate portions of fruits and vegetables, trying to limit their simple sugars, like a lot of flour, and bread, things of that nature. The other main thing, especially in patients that have very advanced liver disease, something we call cirrhosis, is to limit their salt intake because increased salt intake can lead to complications of liver disease or worsening of those complications, such as fluid build up in the abdomen, which we call ascites, or swelling of the legs and arms.

Interviewer: And why does that happen?

Dr. Juan Gallegos: Well, it happens because the liver is important in maintaining the amount of protein in our blood and, also, in maintaining the adequate amount of salt in our blood. So, when the liver isn't working well, there is an imbalance in those things that lead to people having low levels of protein in their blood, and that makes it easier for the water part of our blood to filter out, or go out of, the blood vessels and stay in the tissues and that causes ascites and swelling.

Interviewer: Is it the same thing with sugar, as well?

Dr. Juan Gallegos: It's a little bit different, but yes, the liver is very involved in sugar and metabolism. So people that have advanced liver disease can have sugar problems similar to diabetics.

Interviewer: So it sounds to me, essentially, the liver is just not doing its job the way it should be and you just have to be really careful because a normal functioning liver might be able to take the overload.

Dr. Juan Gallegos: Correct, that is true. It's just that the liver is so noble that it takes a lot of injury before it actually manifests itself as having problems. So, normally, people, when they get diagnosed, it tends to be later on in their disease course and that's where nutrition is so important.

Interviewer: All right. So we hear these things a lot. We hear nutrition is important. We hear that you should stop drinking because it can affect your liver. How important is it? It's like we hear it so often that I think a lot of people ignore it, so give us some context.

Dr. Juan Gallegos: Well, it is very important because we are what we eat, basically, and when you have a liver that's already damaged, or faulty, then, you don't want to increase the damage to that liver or make things worse and some of the symptoms that have to do with liver disease. The other important part is the alcohol issue. Even patients that have liver disease not related to alcohol, we know that the liver will be damaged by the alcohol intake, so that's why we recommend, in those cases, not to drink alcohol.
But, in those patients that have had injury to their liver because of significant alcohol intake, or now have what we call liver cirrhosis from alcohol, it is extremely important for them to stop their behavior and stop drinking alcohol because what is going to happen, if they continue to drink alcohol, is that their liver is going to get worse and their going to reach a point where their liver fails them and there's no way we can treat them anymore.

Interviewer: But one drink a day, that's not that big of a deal is it?

Dr. Juan Gallegos: Well, that's not big of a deal for a healthy person, that is true. In general, the recommendations are, for men, not to drink more than three or four drinks per day, and in women, as they are more sensitive to the effects of alcohol, the recommendation is not more than two drinks per day, but that's only for healthy people. In patients that have already liver disease, our recommendation is that there's really no minimal safe amount of alcohol and, hence, we tend to be more strict and say "No alcohol for you."

Interviewer: So when it comes to diet and alcohol, when you have liver disease, it makes a huge difference?

Dr. Juan Gallegos: It does. It makes a big difference. Of course, the other important part of it is making sure that you are being taken care of by the adequate medical provider and that you follow the recommendations, not only from a diet standpoint, but also if you're already on medications, to make sure that you follow those as well.

Interviewer: Like the difference of living and dying, living a great life and living a mediocre life; I mean how important are these things that we're talking about.

Dr. Juan Gallegos: It can be, especially in those patients with alcoholic liver disease. Continued use of alcohol will definitely result in, not only a very bad life quality, but, also, a shortened life and those people look forward to, basically, being in the hospital and dying in a very short period of time. And patients that have their types of liver disease, it might not be as dramatic, but, certainly, anything we can do to prolong their life and improve their quality of life, I think, is very important.

Announcer: We're your daily dose of science, conversation, medicine. This is The Scope. University of Utah Health Sciences Radio.

Interviewer: There's a brand new treatment for patients suffering from chronic or acute liver failure. We'll talk about that next on The Scope.

Announcer: Medical news and research from University of Utah physicians and specialists you can use for a happier and healthier life. You're listening to The Scope.

Interviewer: There's a brand new treatment that are suffering from alcoholic liver related failure. We're talking with Dr. Juan Gallegos. He's a liver expert here at the University of Utah Hospital. You're really about this new possibility of this treatment which is in clinical trial right now. Tell me a little bit about what's going on.

Dr. Juan Gallegos: Thank you very much Scott. Yes we are very excited to participate in this clinical trial of this new therapy for patients with severe alcoholic liver disease. We're interested in it because alcoholic liver disease is very, very frequent in the United States. It's estimated that about two-thirds to three-quarters of adults in the United States drink some alcohol, most of them do so very mildly and moderately, but a subset of patients drink heavily and these patients are at increased risk of developing liver disease. And most patients have heard about alcoholic Cirrhosis and probably that's one of the top three causes of liver failure in the United States leading to liver transplantation.
But there is another entity called acute alcoholic hepatitis, or excessive alcohol drinking leads to significant inflammation and liver damage which could cause the liver to fail, and those are the patients that we're interested in studying and treating in this trial because up to until now the mortality for these patients, meaning the number of patients that die from this disease is about 70% six months after the initial episode. So there's a very dramatic impact of this condition.

Interviewer: And up until this point really no way to treat it, is that correct?

Dr. Juan Gallegos: Well there are some ways to treat it and mainly trying to get these patients abstinent from alcohol and that's the mainstay of treatment. Also adequate nutritional support is very important, and there's a couple of medical therapies that we can use that is medical medications that can be used to treat these patients, but even with that the mortality is still around 30 to 40% at 3 to 6 months after this episode of alcoholic hepatitis.

Interviewer: Okay so this is a dialysis machine, just briefly explain what this machine does then and why you're so excited about it?

Dr. Juan Gallegos: We're very excited about it because this is a machine that yes in a way is a dialysis machine; basically it is able to replace at least for a few days the major function of the liver. So basically what this company has made is a special machine where we have cartridges that are full of human liver cells that are alive and then can actually maintain the liver function for these several days, and these liver cells are grown here in the United States, and they're put in the special cartridges that go into this dialysis machine for the liver. The amount of cells there in these cartridges is equivalent to about 500 grams of liver tissue. Which is about a third of a normal liver.

Interviewer: Does it act as a filter, all those liver cells?

Dr. Juan Gallegos: They not only act as a filter they actually make proteins that are important for the normal physiologic function of the body so they make proteins that help with the clotting factors, they detoxify certain chemicals that are only detoxified by liver cells that in a patient that has acute liver failure are not working.

Interviewer: Is it like a respirator is doing the lungs job eventually this machine would be able to do the livers job?

Dr. Juan Gallegos: So what it can actually do the livers job for a few days but not more than that. Other machines that don't use liver cells really they only act like you mention as filters.

Interviewer: So traditional dialysis would be one of those machines?

Dr. Juan Gallegos: Traditional dialysis in a sense is such a machine is just that traditional dialysis can be used for long periods of time, and substitute the kidney function. The liver function is a bit more difficult to replace, and that's why this is so exciting. So what we are trying to see if it's this machine can help these patients over the hump of the severe or acute liver failure so that they can actually survive this episode and go on to either recover from the alcoholic liver disease, or if they don't necessarily recover but maintain their sobriety for a few months they can then go on to be considered for liver transplantation which we would be the definitive treatment for this alcoholic liver disease.

Interviewer: Yeah so the ultimate goal is the liver transplantation. This machine is by no means something you would stay on for the rest of your life.

Dr. Juan Gallegos: Correct that is not the case it's only basically to treat the acute episode and get you over this acute problem so that over time either you recover because sobriety is very important in some of these patients actually recover and if they maintain sobriety their liver can get back to almost normal.

Interviewer: Really it will heal almost to precondition?

Dr. Juan Gallegos: It might, it depends on how advanced the condition is to begin with. So in those patients that already have severe liver disease, and on top of this have an acute insult they're less likely to recover, but there are patients that don't have a severe liver disease to begin with and if they can get over this acute insult they're livers will recover to a point where they might not require a liver transplant in the future. As long as they maintain their sobriety.

Interviewer: And this is cutting edge technology obviously because it's in trial, the FDA hasn't approved it yet.

Dr. Juan Gallegos: Correct.

Interviewer: The whole process you're going through is hoping to prove...

Dr. Juan Gallegos: Yes we're hoping to prove that this will increase the chances of patients surviving to the point that it will be better than what our current medical therapies are, and the FDA is very interested in this so they have allowed us to participate in this trial. It's a multi-centric trial in the United States, and there are other centers in Europe and other places of the world.

Interviewer: So if somebody was interested in this trial what would they have to do?

Dr. Juan Gallegos: Well generally it will be a physician, or somebody taking care of these patients, they would just need to contact us at the University of Utah. I am the principal investigator so I'm readily available as well as our research coordinators.

Interviewer: Any final thoughts on this topic?

Dr. Juan Gallegos: Well I think that it's important to recognize that alcoholic liver disease is a significant problem in the United States, and that episodes of acute alcoholic hepatitis can be deadly, and we're trying to improve that with this machine, and hopefully people out there will be interested in and contact us.

Announcer: We're your daily dose of science, conversation, medicine. This is The Scope, University of Utah Health Sciences Radio.

Dr. Tom Miller: You're a Baby Boomer, and you should be screened for hepatitis C. That's coming up next on Scope Radio. This is Dr. Tom Miller.

Man: Medical news and research from the University of Utah physicians and specialists you can use for a happier and healthier life. You're listening to The Scope.

Dr. Tom Miller: Hi. I'm here with Dr. Juan Gallegos today, and he is a member of the Division of Gastroenterology, a specialist in liver diseases, and he is going to talk to us today about the recommendation for screening in Baby Boomers for the virus hepatitis C. Morning, Juan.

Dr. Juan Gallegos: Good morning, Tom. Thanks for the invitation.

Dr. Tom Miller: Should people be screened for hepatitis C? And, if so, why?

Dr. Juan Gallegos: The Centers for Disease Control in the United States came up with a broad recommendation in 2013, or last year, that states that people that were born between 1945 and 1965, that is, the Baby Boomer era persons, be screened at least once in their life for the hepatitis C virus. The reason behind that is that we know that the hepatitis C virus is a significant health problem in the United States. It is estimated that there's about 5 million people infected in the United States with hepatitis C.

Dr. Tom Miller: Most of them Baby Boomers?

Dr. Juan Gallegos: Most of them are Baby Boomers, and, unfortunately, most of them don't even know about the infection.

Dr. Tom Miller: Why is that?

Dr. Juan Gallegos: The fact is that the infection does not cause any specific symptoms, and it takes many years after acquiring the infection before there's any liver disease issues.

Dr. Tom Miller: So this is a little bit unlike hepatitis A where when you develop hepatitis A, you have the whole jaundice, yellow skin, feel terrible. Many times, I guess you're saying, when you have hepatitis C, you're infected, and you don't know it.

Dr. Juan Gallegos: That is true. You don't really know at the time of infection that you acquired this infection, and it's only when you start developing symptoms of liver disease that you come to your doctor, and then we uncover that fact that you've had hepatitis C probably for many years or decades.

Dr. Tom Miller: Unlike hepatitis A where you become very sick, you then clear the virus and you're done with it, hepatitis C is just kind of silently working away on the liver to destroy it. Is that right?

Dr. Juan Gallegos: That is correct. Most patients that get infected with hepatitis C will go onto develop chronic infection of their liver, and that's why we call this chronic hepatitis. And, ultimately, a percentage of them will go onto develop liver cirrhosis and even liver cancer. Hepatitis C is currently the main cause of liver cirrhosis and the need for liver transplants in the United States, and it's also the main cause for liver cancer in the United States.
Over the last 10 to 15 years, the number of cases of liver cancer has increased significantly in the country, and also of note is that over the last 5 years or so, the number of deaths attributed to hepatitis C and cirrhosis have overcome the number of deaths attributed to HIV or AIDS.

Dr. Tom Miller: That's a big deal. How does one become infected with this virus?

Dr. Juan Gallegos: Generally, the infection is transmitted through blood or contaminated blood. So, generally, people that have had blood transfusions or organ transplants prior to the 1990's, and that's when we started testing for this virus and screening for it, or people that have had a history of intravenous drug use. Even once, many, many years ago, that can be the sole source of infection.

Dr. Tom Miller: What about other causes of infection? Intercourse, multiple partners, brushing your teeth, even?

Dr. Juan Gallegos: For example, high-risk sexual behaviors have been attributed as a cause of infection or sharing other contaminated things in your homes like toothbrush or razor blades. But that is much less common than blood transfusions or intravenous drug use.

Dr. Tom Miller: But the bottom line from the CDC is get screened. So if that's the recommendation from the CDC, how does the screening take place, and where does one go to get the screening?

Dr. Juan Gallegos: The screening should be for everybody born between 1945 and 1965 regardless of any of the risk factors that we discussed because we know that a lot of patients with hepatitis C don't have any of these risk factors. Nonetheless, they do have the infection.
The way to be screened is basically to ask your doctor if you could be screened, and it's a simple blood test where we check for antibodies or chemicals that your body makes to defend yourself. If they're positive, that means that in the past, you've been exposed to the hepatitis C virus.
Now, that doesn't necessarily mean that, that person has hepatitis C at this time. But we do another confirmatory test to see if there's any hepatitis C virus in the blood at this time.

Dr. Tom Miller: I've had patients who I mentioned that they should be screened for hepatitis C in accordance with the CDC guidelines and they've said, "Look, doc, I live a clean life. I don't have any risk factors. I don't really need to be tested." What do you think about that?

Dr. Juan Gallegos: 75 percent of all patients infected with hepatitis C in the United States were born in the Baby Boomer era, and many of them did not have any of the typical risk factors that we associate. So what I tell my patients or what I would say to your patient is, "You know, regardless of the fact that you've lived a very clean life and very good for that, but you should be tested because we might find out that you do have hepatitis C regardless of the absence of any risk factors in the past."

Dr. Tom Miller: And if you have hepatitis C, there is now effective treatment for that?

Dr. Juan Gallegos: Yes, that's the most important part of it. It's that we can now change the natural course of the hepatitis C virus infection with very effective therapies.

Dr. Tom Miller: Preventing liver failure and the need for a liver transplant.

Dr. Juan Gallegos: Yes.

Dr. Tom Miller: That sounds like a great idea. Thank you very much.

Man: We're your daily dose of science, conversation, medicine. This is The Scope, University of Utah Health Sciences Radio.