HCV recommendations updated to include patients with limited resources

The HCV treatment recommendations website, www.hcvguidelines.org, today launched a new section to aid clinicians in treatment of specific patient populations.

The guidelines are a collaborative effort by the American Association for the Study of Liver Disease (AASLD) and the Infectious Diseases Society of America (IDSA), along with the International Antiviral Society-USA (IAS-USA).

The section is called, “When and in Whom to Initiate HCV Therapy,” and is designed to help the clinical community prioritize treatment for patients who will derive the most benefit, according to a joint statement from IDSA and AASLD. It also contains information on who to treat to most effectively limit further transmission of HCV.

Barbara Murray

The three organizations held a teleconference to launch the site. Barbara Murray, MD, president of the IDSA, moderated the session and introduced the speakers, which included: Donald Jensen, MD, of University of Chicago Medical Center and Panel co-chair for AASLD; David Thomas, MD, of Johns Hopkins School of Medicine and panel co-chair for IDSA, who discussed when and in whom to initiate HCV therapy; HCV Next Chief Medical Editor Michael Saag, MD, of The University of Alabama at Birmingham and Panel co-chair for IAS-USA, who discussed how the guidelines will be used; and Henry Masur, MD, of the NIH and IDSA Hepatitis Task Force, who discussed what is coming next for the guidelines.

Jensen highlighted the fact that the three organizations advocate for broad and comprehensive intervention for all patients with HCV, but spoke plainly about the need to treat some patients before others.

David Thomas

“We can’t possibly treat all three to four million people with this disease in the US, so we have to make some decisions about who to treat,” he said.

From a clinical perspective, patients with severe liver disease are at the top of the list, according to Jensen. Specifically, he said that patients with advanced fibrosis or cirrhosis, along with those who have had a liver transplant, represent the populations with the greatest need for urgent treatment.

“Those with less degree of fibrosis but who have life threatening complications of liver disease or more systemic manifestations of HCV can also benefit,” he added. “That is how we think of highest level of urgency.”

Michael Saag

Patients with less scarring in the liver and fewer systemic symptoms do not require as immediate or urgent treatment, according to Jensen.

“There is no question that treating and curing HCV can markedly reduce the progression of cirrhosis and the incidence of liver cancer, decrease the need for transplant and reduce the all-cause mortality of chronically infected patients,” he said. “It can also reduce transmission and spread of virus to others.”

Cost issues

A number of journalists in the session raised questions about the relationship between the cost of direct-acting antiviral (DAA) therapy and the recommendation to prioritize patients. More specifically, they asked why cost is not taken into consideration in the recommendations.

Thomas said that the main task for the panel was to determine optimal treatment approaches for patients. However, he added: “Determining the cost of these drugs is out of our purview. It is not in our control. We can only control the clinical side. We hope that these cost factors will sort themselves out.”

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Saag spoke more broadly on the issue of cost. “Even though it is certainly not the intention of the guidelines to give direction on who the payers should cover, my hope would be that over time, the cost of the medications will come down and the payers will come around to realize that severely restricting access to care by not paying for medications that are desperately needed is not a way forward or a way to serve the public,” he said.

Drug development is moving quickly, and cheaper and improved therapies may be are likely coming soon, according to Jensen.

“It may actually beneficial for patients with less severe disease to wait for better treatments,” he said, adding that approximately 30% of patients with HCV will never progress to cirrhosis, which is further justification for waiting to treat.

The panelists encouraged clinicians to evaluate each patient’s specific disease stage and risk factors before making recommendations.

Living document

The website, initially launched on Jan. 30, was developed by a panel of 27 experts in liver disease and infectious diseases and a patient advocate. It has been described as a “living document” that will be updated as frequently as possible to keep pace with ongoing advances in HCV diagnosis and therapy.

Murray noted the collaborative and evidence-based nature of the site and added that, to date, it has garnered 190,000 visits and nearly 750,000 page views have been logged.

“These numbers indicate that the site has already become a useful tool for those on the front lines of HCV treatment,” she said.

Masur said that committees and subcommittees responsible for the guidelines will continue to meet regularly to keep pace with new information from medical journals, the FDA and other relevant sources.

“The chapters which are currently on the website will be modified promptly when new information warrants an update,” he said. “New chapters will be added if information warrants a new chapter.”

Saag said that another rationale for the living document is that with so many people infected, there is going to be an increasing need for providers who are up-to-date on how to treat HCV: “There are not enough hepatologists or gastroenterologists to treat all of these patients. We hope to create enough of a workforce to get these people into care and treated and cured. It will be a tall order. These guidelines will help educate those who are experts in new and emerging trends, but also perhaps those who are new to the treatment of HCV on how to handle the number of patients coming our way.” – by Rob Volansky

Disclosure: Jensen, Masur, Saag and Thomas report no relevant financial disclosures.