Miriam E. Tucker

April 26, 2015

VIENNA — New hepatitis C treatment guidelines address cutting-edge direct-acting antiviral agents that offer a cure for most patients. Guideline authors from the European Association for the Study of the Liver (EASL) also take on the treatment of patients with complex disease in a climate of high drug costs and barriers to care.

The guidelines were published on the society's website a few days before the International Liver Congress, as reported by Medscape Medical News, so that participants could become familiar with them before the discussion here at the meeting.

"The main point is that we can cure the vast majority of patients now," said session cochair and guideline coordinator Jean-Michel Pawlotsky, MD, from the University of Paris-Est in France. "Even patients with the most severe disease are treatable," he told Medscape Medical News.

Patients with complicated disease remain a challenge, however, and the guidelines reflect the best information available in each area. "Most of the guidelines are evidence-based, but if there was no evidence, we had opinions," Dr Pawlotsky said in an interview, pointing out that the writing panel used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system when developing the guidelines.

The new European guidelines are in agreement with recommendations from the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, which were updated in December 2014. Session panelist Donald Jensen, MD, from the University of Chicago Medical Center, said he is reassured by this.

European Guidelines Echo American Release

"As I review the EASL guidelines and compare them with the AASLD and IDSA guidelines, I'm impressed, mostly with the similarities," Dr Jensen said. "I think the power of these guidelines is really based on the fact that our guidelines are very consistent along most of the lines of evidence, not only in terms of indications for treatment, but also in terms of the monitoring and identification of patients." He added, "I think the more that we're consistent, the more power these guidelines hold."

And where there are differences, Dr Jensen said, "it tells use these are areas that need more investigation."

The EASL guidelines provide treatment recommendations for each of the hepatitis C genotypes, including preferred regimens and less-optimal options for situations in which ideal treatments are too expensive or otherwise unavailable..

Of course, the high cost of the newer direct-acting oral antivirals and access to care were major topics of conversation at the meeting and during the guidelines session, where EASL governing board member Alessio Aghemo, MD, from the University of Milan, addressed the topic from the podium.

"Clearly, this is the biggest issue nowadays. We still have some areas where we have to get more data for the drugs, but the big issue in Europe and around the world is how to access care," Dr Aghemo said. The panel made the decision to call for increased hepatitis C screening despite the fact that the best treatments might be out of reach for many, he reported.

 
I think there's some work we can do to negotiate better prices.
 

"As a panel, we decided to call for increased screening and detection rates. This is still an issue in many countries in Europe, where most people who are infected don't know they have hepatitis C," he explained. "Every country has a different epidemiology," he cautioned. "You have to look at the data in your country and design a country-based specific screening strategy. This is the moment to do that."

Once they're screened, Dr Aghemo explained, the goal is to get more patients on treatment. "But of course the biggest issue limiting access to treatment is the pricing of drugs, which is still excessive. In most European countries, access to treatment is limited to patients with severe disease; this, of course, is not the optimal situation. You have to know the price in your country, and negotiate aggressively," he advised.

In Europe, Dr Aghemo pointed out, "the EU commission could negotiate better prices than a single state. I think there's some work we can do to negotiate better prices."

Cost-Cutting Measures

Dr Pawlotsky asked Dr Aghemo which cost-cutting option he preferred for the combination agents — shortening the treatment duration, a goal of many of the industry-sponsored trials, or lowering the price.

"I think it's better to lower the price," Dr Aghemo responded. "I don't feel the need to shorten treatment duration. I think it's a very commercial pharma-driven decision to go for ultra-short. Twelve weeks is a shorter duration than what we've had in the past, and I think that's the way to go. Lower the price and treat for 12 weeks."

Dr Jensen added that "shortening the duration can lower the price tag for that medication, but it comes potentially at the risk of having slightly more relapses. If shortening the duration allows us to keep the same sustained viral response rate, then everyone would be in favor of it, but if there's an increase in relapse, even if only a small amount, the added expense of retreating those patients almost counteracts the decision to save that initial cost."

He called for a cost-effectiveness analysis comparing truncated treatment with the retreatment of someone who has a relapse.

The guidelines also cover the goals and end points of therapy for genotypes 1 to 6, drug–drug interactions, monitoring, measures to improve treatment adherence, post-treatment follow-up, and the retreatment of nonsustained virologic responders.

Dr Pawlotsky has received grant and research support from Gilead, and has financial relationships with AbbVie, Achillion, BMS, Gilead, Janssen, and Merck. Dr Aghemo reports financial relationships with AbbVie, Gilead, Janssen, and Merck. Dr Jensen receives fees for manuscript preparation from Genentech.

European Association for the Study of the Liver (EASL) International Liver Congress 2015. Presented April 24, 2015.

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