The Liver Meeting 2014: The Take Home

Every year at The Liver Meeting, an international group of experts convene to discuss the latest in hepatology. HCV Next had the opportunity to sit down with leading experts in the field while onsite at The Liver Meeting. You saw Take Home notes from co-Chief Medical Editor, Ira M. Jacobson, MD, Vincent Astor distinguished professor of medicine at the Joan Sanford I. Weill Cornell Medical College; and HCV Next Editorial Board member, Stevan A. Gonzalez, MD, MS, attending physician in the division of hepatology at Baylor University Medical Center, Dallas, in December’s issue.

In this Web exclusive, Steven L. Flamm, MD, medical director of liver transplantation at Northwestern Memorial Hospital and professor of medicine and surgery at Northwestern University Feinberg School of Medicine, gives his Take Home points.

Steven L. Flamm

Steven L. Flamm, MD

In this meeting, there were many different themes in hepatitis C.

First, what is happening with real-life usage of the newer medications? It seems that the study results never equate to what happens in real life so we always want to know what happens in the real world.

There are studies here from TARGET and the TRIO network that are looking at the real-life results of patients being treated with these all-oral medications and they both show the same thing: the sustained virologic response rates are lower in real life than they were in the trials. The drop-out rates are a little lower, not surprisingly. And the adherence rates are not as high.

The HCV TARGET consortium included 101 patients treated with sofosbuvir-simeprevir combination, with and without ribavirin. In those groups, the SVR4 rate was 90%, with a 6% relapse rate. Cirrhotic patients receiving this regimen experienced an SVR4 rate of 86%, compared with 94% for non-cirrhotics.

In the TRIO network, 922 patients, considered more difficult-to-treat, showed a small drop in cure rates from 95% in the clinical trial to 88% in the real-world data.

These were encouraging results, but they point to a very important factor in the future: We in the health care field have to really concentrate on adherence to maximize sustained response rates in real-life settings.

Second, we are starting to get more information about some of the patient populations that have not yet been examined, such as the decompensated liver patients, the post-liver transplantation patients, patients experiencing renal failure in the usage of the new all-oral medications. Some of the unmet medical needs are being given more information.

In my own study, I showed results from using sofosbuvir, ledipasvir and ribavirin in patients with decompensated cirrhosis, an important patient population not yet investigated in a carefully controlled clinical trial. These patients are nearing liver transplantation or nearing death.

In the end, it didn’t matter if the patients received 12 weeks or 24 weeks of therapy; they were equivalent.

The sustained virologic response was 87% in the 12-week Child’s B regimen and 89% in the 24-week Child’s B regimen compared with 86% in the 12-week regimen for Child’s C and 90% for the 24-week Child’s C.

Patients improved clinically, with improvement seen by week 4 in bilirubin and albumin levels, MELD scores, Child’s Pugh scores, ascites and encephalopathy.

This is a very important study and has widespread implications for the treatment of patients with advanced liver disease in hepatitis C. These are very ill patients and if we have products that can halt the progression of hepatitis C in this unmet medical need, it will be very helpful and hopefully delay liver transplantation and improve mortality in the long run.

Then, you’re seeing information about emerging therapies yet. We’re talking a lot about the recently approved and soon-to-be approved medical therapies, such as the Abbvie regimen set for approval next month. Merck has a therapeutic regimen that will likely emerge on the market a year or so from now. Gilead has some newer products. And other companies are developing products that may be more potent and efficacious.

Yet, despite combined potencies in trials such as C-SWIFT, treatment durations do not seem to be shortened to the once-desirable 4 week timeframe. It doesn’t prove, but it does suggest that there will be a limit. We won’t be able to continue to shrink therapy down to very short levels. What that limit is, we don’t know. At least now with very powerful therapies, it seems we won’t be able to go down to 4 weeks or even 6 weeks.