AASLD, IDSA, IAS-USA release guidelines, launch website for management of HCV

The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, in collaboration with the International Antiviral Society-USA, announced the launch of HCVguidelines.org, a website that provides guidance for clinicians and patients dealing with hepatitis C virus infection.

Panel co-chair for AASLD and contributing author of the guidelines Donald Jensen, MD, of the University of Chicago Medical Center, moderated a press conference offering details about the site.

“An estimated 3 million to 4 million Americans have hepatitis C,” he said, adding that associated complications from liver disease have become the most common cause of hepatocellular carcinoma.

“As a result of recent changes in testing guidelines, many more patients will be diagnosed and are expected to be seeking treatment,” Jensen said, adding that the wealth of new information about the infection prompted the necessity of a comprehensive source of information.

Jensen highlighted the “great strides” that have been made in the treatment of HCV, noting that therapies may be effective in “nearly all” treated patients without the adverse events that have marked previous therapies. “Because of this, HCVGuidelines.org was created,” he said. The aim was “to provide the most current guidance in the treatment of hepatitis C virus infection. We developed evidence-based consensus recommendations.”

The guideline panel consisted of 27 specialists in liver disease and infectious diseases, plus a patient advocate. The first iteration consists of information on testing and linkage to care. The site includes details about therapies for new patients as well as guidance on re-treating those who have received unsuccessful prior therapy.

Panel co-chair for IDSA David Thomas, MD, of Johns Hopkins School of Medicine, discussed more details about the site and the state of HCV treatment.

David Thomas

“The next generation of direct-acting antivirals has the potential to treat and cure most patients with hepatitis C,” he said. “The information on the website will be of great value for practitioners well versed in the nuances of antiviral therapies, but also for those who are experienced or even new to treatment of hepatitis C.”

Specific drug combinations are outlined, some of which may be used with or without interferon depending on whether the patient is tolerant or intolerant to that approach.

“We recommend daily sofosbuvir (Sovaldi, Gilead Sciences) with ribavirin plus weekly pegylated interferon for 12 weeks for eligible patients regardless of subtype,” Thomas said. “For interferon-intolerant patients, daily sofosbuvir with simeprevir (Olysio, Janssen) with or without ribavirin for 12 weeks is recommended.”

He said some patients may be treated by a primary care provider and some should be referred to a specialist. The guidelines offer advice for clinicians treating patients in unique subgroups, such as those with HIV coinfection, renal failure, a liver transplant or decompensated liver disease.

Panel co-chair for IAS-USA Michael Saag, MD, of The University of Alabama at Birmingham, assured clinicians that the site will keep pace with the rapidly changing landscape of HCV.

Michael Saag

“The site will be updated regularly with additional recommendations as new drugs become available and FDA approved,” he said. “Different sections of the site will address who should be treated and the monitoring of patients who are on treatment.”

The panelists will stay up-to-date with published journals of sponsoring societies, according to Saag. “We will seek endorsements from other societies and expand as necessary to keep pace with updates,” he said.

Aiding clinicians

During a brief question-and-answer session, the panel was asked where the information was directed. “What we tried to do was approach this site as a phone call from a practitioner in the community,” Saag said. “I have a patient with X genotype, etc. The answer we would give would be from drugs available on the market now. We tried to make this as real-world as possible.”

Jensen said visitors are able to view a narrative beneath the boxed recommendations that provides the evidence and level of evidence. “Randomized controlled trials will be labeled as such,” he said.

Another question dealt with insurance coverage and cost of the drugs, to which Jensen replied that the first iteration does not contain such information. “We haven’t taken that into full consideration yet,” he said. “The guidelines are what we think is best for a patient who needs therapy at this time.”

Jensen said issues of coverage and cost are important for payers and from a public health perspective, and they will be dealt with in due time.

“Our committee is composed of panelists on the clinical side,” Henry Masur, MD, of the NIH, said. “We made our recommendations based on what we think is best practice for our patients. We would hope that those responsible for providing medications would follow best practices. We looked at the science.”

Henry Masur

Thomas said the next question the guidelines will address is how to treat new patients, rather than patients clinicians have already decided to treat. He suggested that it was necessary to deal with new indications for current patients first, before attempting to account for the hundreds of thousands of new diagnoses resulting from expanded screening protocols.

“This is the beauty of Web-based guidance,” Jensen said. “We can be nimble and address things quickly without waiting 18 months for new guidelines to come out.”

Jensen added that this streamlined flow of information benefits not just clinicians, but payers and patients.

Gary L. Davis, MD, of Baylor University Medical Center, said many gastroenterologists have not treated patients with HCV. “The regimens have been complicated and tolerability has been poor,” he said. “Because of this, in the past, some clinicians have avoided treating patients. Now we are not only identifying patients, but linking them to clinicians who are willing to treat them. The new therapies are so much better tolerated.

“If we don’t link patients to care, we won’t reduce morbidity and mortality of this disease,” Davis said.

Saag addressed the issue of off-label treatment. “What is important to keep in mind is that the FDA only will approve drugs that have gone through complete phase 3 rigorous testing,” he said. “But we can’t run a phase 3 on every possible combination or patient population. The advantage of this guideline is that it allows experts in the field to view emerging data and craft what falls short of an FDA-approved insert but is something that experts in the field would be using based on phase 2b or early phase 3 data that did not go forward.”

Broad package insert recommendations also may lend themselves to off-label use, according to Saag. “Drug A or drug B is approved for use as part of a combination regimen, but the combination is not necessarily specified,” he said. “The guidelines can give recommendations about which would work best in which specific situations. This is part of the value of this document.”

Thomas stressed the importance of HCV screening, particularly for individuals born between 1945 and 1965. Masur described the new therapies as “a revolution.” Saag added that the document is unique, and living, and assured the clinical community that they will be receiving the most up-to-date information possible. – by Rob Volansky

For more information:

www.hcvguidelines.org.

Disclosure: Please see www.hcvguidelines.org/full-report/methods-table-1-summary-process-and-methods-guidance-development for information regarding author disclosures.