EASL Pre-Congress HCV Interview: Dr P. Gaglio

Posted on April 19, 2015

What are your thoughts on birth cohort screening for hepatitis C? Should it be mandated by law?

Dr. Gaglio: Sure, well I think that birth-cohort screening is an absolutely forward progress in terms of the screening of Hepatitis C, largely due to the fact that risk-based screening has been very ineffective. So, [birth-cohort screening] has been mandated by law and the problem becomes how do you police that. So, clearly in the state of New York it has been mandated that Hepatitis C screening should be provided to people born between 1945 and 1965, and I think that the difficulty at the current time is really how to enforce that.

What challenges would you anticipate having to overcome in order to accommodate the anticipated increase in HCV patient referrals due to birth cohort screening? 

Dr. Gaglio: Well, I think that depends on what area of the country you’re in. So, as an example, in the Bronx it’s been known for quite a while that the prevalence of Hepatitis C is quite high. So we in our practice have not seen a large uptick in the number of new referrals, because doctors have been screening for Hepatitis C for many, many years. So one could argue that doctors in parts of the country where the screening has not occurred, will be seeing an uptick of newly diagnosed Hepatitis C patients. We have not been seeing that. In fact, there is no effect at all on our practice from the screening guidelines in terms of referrals.

What issues do you commonly encounter when attempting to provide timely and effective clinical care to HCV-infected patients referred to you from the community?

Dr. Gaglio: So we have a large number of hepatologists, fellows, and mid-level providers. So because of that, we have not had an issue in taking care of these patients.

To what extent do you believe that community based healthcare providers should be treating hepatitis C, and why?

Dr. Gaglio: Well, there is no question that in many cases a patient in the community will feel uncomfortable about being referred to someone else. It’s a new place, they don’t know how to get there, there are challenges with parking, etc. If I was a private practice, and I was cognizant of the ability to figure out how to diagnose the disease and direct the patient for treatment, particularly given the availability of oral Hep C treatments and their use in persons who don’t have decompensated liver disease, then these patients could be potentially treated in the community. And in many parts of the country there is a distance between your specialists, who are liver specialists, and the private practice. It may be that the best way to serve the community as a whole is to have doctors in the community manage these patients.

In your opinion, is the cost of newer oral HCV regimens going to introduce socioeconomic and ethical considerations into the treatment of HCV?

Dr. Gaglio: Well, I think that ideally if we were in a perfect world, everybody who was tested for Hepatitis C virus and was actively replicating the virus would be eligible for therapy. Clearly, the cost of medicine has produced a very difficult problem, such as the problem of getting approval for a medication, especially in patients who have less advanced liver disease. So, the ethical issue is more driven by the cost of the medicine and how patients are being stratified by the insurance company. We have had many denials of patients who would meet indications for therapy, and we have gone through multiple appeals and hours and hours of writing letters and we have been unsuccessful for some of our patients who are really deserving of therapy.

How do you think the treatment of populations with limited resources will be affected?

Dr. Gaglio: Well, I think that the assumption is going to be that because of universal healthcare, with Obama-care, everyone will have insurance. So, I think that the companies who are making Hep C meds have had, to this day, have had pretty good patient support programs. So, we’ve clearly got patients who have compromised insurance and who are in compromised socio-economic status and they are being treated.

What are your thoughts on targeting access to newer oral HCV regimens to specific populations such as active injection users or incarcerated individuals?

Dr. Gaglio: I think that this is a difficult issue because here you’re kind of defining group behavior and we should be thinking about individual behavior. So, we’ve treated IV drug users with Hepatitis C who unfortunately have re-infected themselves, and we have treated those with Hepatitis C who are free and clear of the virus who are going to produce a situation where they are much less likely to infect others, so individual behavior is more important than like a blanket discussion of group behavior.

What are your thoughts on restricting hepatitis C therapy to patients with advanced fibrosis or severe complications and/or symptoms?

Dr. Gaglio: This shouldn’t be happening, because I think what a lot of people lose sight of are the non-liver associated complications and the non-liver associated symptoms that improve quite dramatically, in patients with Hepatitis C who are treated. And, as an example, and I always bring this up, I had a patient with relatively mild Hepatitis C who got put on therapy, and about 2 weeks into treatment, the patient called and said I want to come in and get my “HCV viral load” tested because I feel so incredibly well, and in fact, when we checked for HCV, this patient had cleared the virus. And this patient told me that they were better able to think, and to concentrate, and they didn’t have muscle aches or body pains or other symptoms. So, in fact when that patient came in, the patient’s extrahepatic, non-liver symptoms had improved dramatically when they cleared virus, and I’ve seen this in other patients too, I’ve seen that 50-60 times, that the patient’s quality of life improves dramatically when they clear the virus. So it’s not only about protecting against the liver manifestations of Hepatitis C, there are also non-liver manifestations of Hepatitis C that are dramatically improved when you clear the virus.

What is of interest to you at EASL? Regarding the upcoming EASL meeting, is there any data or any research coming out that you’re interested in seeing?

Dr. Gaglio: Clearly there is going to be a lot of more mature data presented about using Harvoni and other newer regimens in different patient populations. So clearly, it’s going to be very interesting to look at the post-transplant data, and also the HIV/Hep-C co-infected data, the decompensated patient data, and also data in patients who have less decompensated disease, as well as the concept of using different combinations for shorter periods of time. These are all things that are going to be quite interesting.

For more information on ILC-EASL 2015 Hepatitis abstracts and others to be presented at The International Liver Congress™, please click here to review the Congress abstract e-book.

Paul J. Gaglio, MD, is a Professor of Clinical Medicine at the Albert Einstein College of Medicine in Bronx, NY. He joined the faculty in December 2007 to assist in establishing a new liver transplantation program at Montefiore Medical Center, and now serves as Montefiore’s medical director of Adult Liver Transplantation.

He received his bachelor’s in Physiology and Italian from Rutgers College in New Brunswick, NJ, and his M.D. from UMDNJ-New Jersey Medical School. He completed an internship and residency at Mount Sinai Medical Center in New York City, and a digestive disease/liver transplantation fellowship at New Jersey Medical School. The author of multiple manuscripts, book chapters, and abstracts, he has also participated in numerous research trials related to the therapy of hepatitis B and C, liver transplantation, and treatment of liver failure. He is a Fellow of the American College of Physicians and the American Gastroenterological Association, and his research interests include models to enhance liver regeneration, novel treatments of hepatitis B and C, natural history of hepatitis C in liver transplant recipients, and non alcoholic fatty liver disease.

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