April 10, 2014

New Hepatitis C Guidelines Are Evolving Documents

Medscape Medical News > Conference News

Miriam E. Tucker
April 09, 2014

LONDON, United Kingdom — New guidelines for hepatitis C virus infection from the World Health Organization (WHO) and the European Association for the Study of the Liver (EASL) will be released here at the EASL International Liver Congress 2014.

The WHO guidelines on the screening, care, and treatment of people with hepatitis C infection are the first-ever to take a public health approach primarily aimed at influencing policy in the developing world.

The EASL recommendations on the management of hepatitis C focus specifically on evidence-based treatment, and incorporate the anticipated approval of 3 new direct-acting antivirals in 2014 by the European Medicines Agency (EMA). They will be released April  11.

Both documents reflect recent developments in hepatitis C, and both are expected to require revision soon. "It's such a rapidly moving field that, even as we were developing the guidelines, we had to modify our schedule to include recommendations on the newest drugs," Dr. Stefan Z. Wiktor, team lead of the WHO Global Hepatitis Programme in Geneva, told Medscape Medical News.

The EASL document, which is being released online only, updates guidelines that were just issued in January.

Jean-Michel Pawlotsky, MD, PhD, director of the French National Reference Centre for Viral Hepatitis, told Medscape Medical News that this new EASL document constitutes recommendations rather than guidelines because of the need to circumvent the traditional long guideline development process, which "doesn't fit the HCV field any longer."

"At this stage, the field isn't stable enough to allow us to do it as a print version. We will regularly update the recommendations. It's a new strategy," said Dr. Pawlotsky.

Approximately 185 million people worldwide are infected with hepatitis C; about 150 million are chronically infected, and 350,000 to 500,000 die from hepatitis C complications each year. In Europe, from 7.3 million to 8.8 million people are infected with hepatitis C, and there are approximately 3 to 4 million new infections annually, according to an EASL statement.

Dr. Wiktor told Medscape Medical News that the WHO guidelines "are meant primarily to guide policymakers who are thinking of starting hepatitis C programs and who look to WHO for the official word on what is recommended. That is really the primary goal," he said, adding that the WHO document is targeted mainly at low- and middle-income countries.

The EASL recommendations are meant to impart the best science, said Dr. Pawlotsky. They are designed "to guide treatment decisions based on the available knowledge. It's really a clinical document."

The EASL recommendations also have a political purpose. "We want to help doctors put pressure on their national governments for access to care and reimbursement. It's a guidance for what should be done and not done," he explained.

WHO Guidelines

The WHO guidelines call for risk-based screening and follow-up testing for people with hepatitis C infection, and for screening and counseling related to alcohol use and other behaviors that increase transmission risk. The treatment guidelines address interferon injections and the new all-oral regimens, with acknowledgement that cost and access could limit options for low- and middle-income countries in the near term. The guidelines also emphasize prevention.

Dr. Wiktor told Medscape Medical News that he expects the prices of the new direct-acting antivirals to drop, as they did for HIV drugs. In fact, in some places they already have. Notably, Egypt has negotiated with Gilead to provide a 12-week treatment course of sofosbuvir — which costs $84,000 in the United States — for just $900.

"They were able to guarantee volume. That's what we're hoping these guidelines do — move countries to think about national programs that will give them more leverage with the pharmaceutical companies to make these drugs affordable," said Dr. Wiktor.

"We really hope that some of the big global health funders will step in and say, here's an opportunity to invest," he added. "The big difference with hepatitis C is that there is a cure. That's a very unusual situation for a chronic viral infection."

It is expected that the WHO's next official document on hepatitis C will be released in 2016, but an interim guidance is planned for the end of 2014. In the meantime, the WHO is working on guidance for hepatitis B.

EASL Recommendations

By the time they were issued in January, the EASL hepatitis C guidelines were already out of date. The online recommendations include the latest data pertaining to the 3 new direct-acting antivirals for hepatitis C, which are expected to be on the European market in the next few months for use as part of combination therapies.

Sofosbuvir, a nucleotide analogue inhibitor of hepatitis C RNA-dependent RNA polymerase, was approved in January. Simeprevir, a second-wave, first-generation NS3/4A protease inhibitor will be approved in May. Daclatasvir, an NS5A inhibitor, is likely to be approved in August or September, according to the EASL statement.

Next in line are investigational combinations from Gilead and AbbVie, Dr. Pawlotsky told Medscape Medical News. "It depends on the EMA. When they approve, we will update. We are reactive."

Dr. Wiktor has disclosed no relevant financial relationships. Dr. Pawlotsky has received grant and research support from Gilead; is on advisory boards for Abbott, AbbVie, Achillion, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Idenix, Janssen, Merck, Novartis, and Roche; and is on the speakers/teachers bureaus for AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Janssen, Merck, Novartis, and Roche.

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