Doctor explains a combination of drugs that cuts down on the number of rejected liver transplants

What is the function of the liver?

Dr. Marino: The liver is actually the largest organ that is inside our abdomen, and it is so large that it basically occupies the right upper portion of the abdomen of any human being. It is extremely important because anything we eat or drink eventually goes through the liver. The liver metabolizes the food and makes all the proteins and other things that are essential for our life.

The liver, when it is healthy, its surface is very smooth and soft. When the liver becomes sick, the surface becomes bumpy and hard, and the liver is not able to metabolize the food that we eat. It is not able to deal with proteins or other things we need for our life.

What causes a liver to fail?

Dr. Marino: Mainly virus including infection with hepatitis B, hepatitis C, and then there are other diseases that are related to congenital problems that you may be born with. The liver may fail because the development of the liver during the fetal time is not perfect, but in the Western society, hepatitis C and hepatitis B are the most important causes of liver failure.

What are your options when your liver fails?

Dr. Marino: The liver is really a large organ, and because of that, in order to have a transplant, you must have a failure of almost 75 percent of the organ. If 25 percent of the liver is still capable to work, then you can have enough metabolism to sustain a relatively healthy life. When the liver fails completely, the only solution is to replace the organ because it is essential to our life, and you do that through the transplant.

What is the rate of transplant rejection?

Dr. Marino: Rejection is the most important problem from the time transplants started in the late 1950s because when you put an organ inside of a human being, the immune system has a tendency to reject it. It recognizes the new organ as a foreign body and reacts with rejection. Now we use different drugs, which are much more sophisticated from the drugs that were used in the early ’60s and ’70s, which were mainly steroids. Now we have very good drugs that have less side effects and are tolerated much better. Still, though, rejection happens in at least 30 percent of patients undergoing a liver transplant. So any strategy aimed to decrease the rate of rejection is very important.

What did this study try to accomplish?

Dr. Marino: We are actively involved in developing new strategies to control and actually to prevent rejection from happening. In this study, we used two drugs. One is called tacrolimus, and the other is called basiliximab. Basically these two drugs used in combination allowed us to have a significant decrease in the rejection. The drugs were given at the time you start the transplant operation, and then a second dose four days later. Through these drugs, which are very powerful, you contain much better control of rejection. Actually, you prevent rejection from happening. Comparing our patients to other patients transplanted with different anti-rejection treatment, we had only 12-percent rejection compared to about 40 percent, which is the usual incidence of rejection. So, it is a significant improvement.

How long did you follow the study participants?

Dr. Marino: We studied this new combination of drugs in 50 patients, and we followed them for three years. We were actually very pleased because the survival of these patients with very low incidence of rejection of three years is 88 percent. So almost 90 percent of the patients are alive and doing very well three years after the transplant. If you think about the fact that the average survival from liver transplantation is one year in the United States, I think that this is a significant improvement.

What is the status of the drugs now? Have they been FDA approved?

Dr. Marino: The first drug tacrolimus was FDA approved in 1994, after it was used for several years in Pittsburgh. The other drug basiliximab was mainly studied in kidney transplantation, and this is the first study that uses this drug with tacrolimus in liver transplantation. So any patient can be treated with this combination of drugs, because both drugs are FDA approved and are commercially available in this country and in Europe.

Why is this combination of drugs a medical breakthrough?

Dr. Marino: This new combination of drugs is really a breakthrough in transplantation because it allows a significant reduction in rejection and also excellent outcomes with almost 90 percent of liver transplant recipients doing well after three years. I believe that the most important area of research nowadays is aimed to allow excellent quality of life years after a transplant to our patients. A transplant is now not any longer a treatment to save a life momentarily, it is now a treatment to give an excellent quality of life back to our patients for many, many years to come.

Are there risks or side effects associated with this drug combination?

Dr. Marino: We did not identify any important side effects. Actually, none of the patients who received this combination of drugs were suffering from a side effect that resulted in stopping the drugs. Obviously, there will probably be patients who will have less tolerance to these drugs than other patients, but in general, it’s a very safe and well-tolerated combination of drugs.

Is there anyone who cannot take this drug because of a condition, or is it safe for everyone?

Dr. Marino: A result of our study shows that the combination of these two drugs is very safe for everybody. Currently, we use these drugs in combination with a very low dose of steroids, and we think it is possible to eliminate the steroids and use only these two drugs. But, this is what we are studying in the next few years so we cannot really comment on this at the present time.

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