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Innovations in hepatitis C treatments: The battle isn't over

Although Adrian M. Di Bisceglie, MD, FACP, is proud of the advancements made in hepatitis C treatments, he has come across a new challenge—ensuring patients do not become too complacent with their follow-up treatments.

It may have taken a village (or a multidisciplinary liver center at Saint Louis University) to achieve sustained virologic response in patients with HCV—but it may take many villages to ensure that patients understand the importance of regular screenings for hepatocellular carcinoma.

Adrian M. DiBisceglie

As professor of internal medicine, chief of hepatology and co-director of Saint Louis University Liver Center, St. Louis, Missouri, Di Bisceglie has spent the majority of his career studying hepatitis B — as well as non-A, non-B and later, C — and the HCC that can sometimes present in patients with HCV down the road. In a recent conversation with Healio, Di Bisceglie discusses how despite the innovations made in HCV treatment, patients are still vulnerable to related conditions such as cirrhosis, advanced fibrosis, HCC and advanced liver disease. Patients with cirrhosis are at particular risk for developing HCC, according to Di Bisceglie, and patients’ risk is directly proportionate to the severity of their cirrhosis.

Discuss your background and how you became interested in the epidemiology of infectious diseases, particularly HCV.

I am a hepatologist and liver specialist, first training in South Africa where HBV was, and still is, endemic. While there, I became increasingly aware of young men developing HCC that was related to HBV. I later completed a fellowship at the NIH and became involved in research for non-A and non-B hepatitis. During my time at the NIH, hepatitis C was discovered, and I included it in my research interests.

What is unique about you and your work as co-director of Saint Louis University Liver Center? How do you approach your work in a way that stands out from the rest?

With my co-director, Bruce Bacon, MD, we have quite a multidisciplinary liver center. Our members come from fields including gastroenterology, infectious diseases, pediatrics, molecular microbiology, biochemistry, radiology, pathology and surgery (for liver transplantation). In addition to being a clinical liver center where we see and treat patients with liver diseases and viral hepatitis, the liver center is also a research institute. The center’s multidisciplinary nature, coupled with its nearly 20 years of operation, is quite unique.

Now that a cure is available for the majority of patients with HCV, how do you manage them after successful treatment? What else do you monitor in your patients?

After patients are cured — otherwise referred to as a sustained virologic response (SVR), 3 months after stopping treatment — their future often depends on the severity and nature of the underlying liver disease. Having been at Saint Louis University for 25 years now, I have worked with many patients living with HCV who could not be cured with interferon and ribavirin. Patients who are now cured but do not have significant fibrosis or cirrhosis are usually released back to their primary care physician (if available), or a specialist who is treating other conditions they may have.

What screening measures do you use for HCC and other liver conditions?

I follow guidelines set by the American Association for the Study of Liver Diseases, which recommends periodic liver ultrasounds to screen for conditions every 6 to 12 months. More recent guidelines advise screening every 6 months, but in practice, I am satisfied if I can get an ultrasound performed every 6 to 12 months. Blood tests for measuring alpha-fetoprotein were used in the past but then taken out of the screening guidelines. I stopped testing for AFP as well; it can be prone to false positives, and its utility is questionable. However, testing for AFP has reappeared in the screening guidelines as an adjunct tool used with imaging.

How long do you monitor patients for HCC? Is there an endpoint to HCC monitoring?

At this stage, there is no known endpoint to HCC monitoring. We still see patients developing HCC several years out. Although the new treatments and cures are only a few years old, it is not that unusual to see patients develop HCC 2 or even 3 years out. We do know that over time, some patients with cirrhosis will have enough improvement in their liver disease that they will not have cirrhosis anymore; unfortunately, we do not know what to do with that information. For now, I think the research community is unanimous that patients still need to be followed indefinitely until we can show that their risk decreases after a certain period of time.

Does complying with ongoing screening become a burden for patients? How often do you perform follow-up appointments?

Follow-up appointments are about every 6 months. I believe it is not particularly burdensome for patients, but they sometimes encounter financial issues with the ultrasound. I explain the necessity of these ultrasounds by comparing them to annual mammograms for female patients screening for breast cancer. The comparison seems to help patients understand why they should continue with regular screenings.

If a patient develops HCC, what is your specific success rate if it is caught early?

The screening is not universally effective, which is something to be aware of. Even with the standard practice of an ultrasound every 6 months (with or without AFP blood tests), we may only detect approximately 75% to 80% of HCCs at an early enough stage where potentially curable treatments can still be administered. Assuming HCC is found early, though, I think that long-term survival for these patients is good — meaning a range of 60% to 80% at 5 years if the tumor is detected early enough for potential curative treatments.

What precautions do you suggest to your patients to help prevent HCC?

We advise patients on lifestyle changes but more for their general health and cardiac health. We also recommend that patients moderate alcohol intake; patients with diabetes need to have their diabetes under control as well. Patients are also advised to maintain a healthy weight — I explain to them that if they ever needed a liver transplant or major surgery, they need to be healthy enough to withstand that.

What always piques everyone’s interest is that coffee intake affects one’s risk of being diagnosed with HCC. Multiple studies suggest that ingesting three or four cups of coffee a day decreases the risk for HCC — it is worth having that conversation with patients.

Do you have any concluding thoughts about HCC or HCV that you would like to share with our readers?

Shortly after the introduction of interferon-free therapy, there were concerns that the rate of HCC after a cure was higher than expected and that these novel treatments might actually increase one’s HCC risk. I think that idea has been debunked. It seems clear now that what researchers observed was simply that we are treating patients with much more severe liver diseases than we ever used to with interferon and ribavarin, and those are the patients at risk for developing HCC. Even when we cure them, some may still have such advanced liver disease that their HCC risk remains. Therefore, I think it is important to emphasize that treatment is not increasing their risk.