The launch of a new website by a group of medical organizations is expected to help physicians determine the best treatment options for patients who are infected with the hepatitis C virus (HCV), a condition that can lead to serious liver disease and complications such as liver cancer.
The rapid pace of drug development to treat HCV infection, though welcome, leaves many clinicians uncertain about the optimal approach to therapy and even which patients can benefit from treatment. The guidance provided through the new website, http://HCVguidelines.org, is expected to help fill this gap by offering up-to-date, evidence-based recommendations on the management of HCV infection.
“The presence of a readily available, frequently updated guidance document is a great service to providers and their patients, who will benefit from modern treatments that result in cure of hepatitis C virus up to 95% of the time,” said Michael Saag, MD, professor of medicine from the University of Alabama. Although about 15% to 25% of persons who become infected with HCV clear the virus from the body without treatment, most develop chronic infection. According to the US Centers for Disease Control and Prevention, an estimated 3.2 million US individuals have chronic HCV infection, many of whom will develop serious liver disease as a result. In the United States, HCV infection is the most common indication for liver transplantation and it is also linked closely with the risk of liver cancer.
New antivirals that selectively target HCV hold the potential to cure most patients with the infection. In addition to offering improved treatment outcomes, these direct-acting antiviral agents are much better tolerated than traditional regimens. In May 2011, the US Food and Drug Administration approved 2 such drugs, boceprevir and telaprevir, for treating certain patients with HCV infection. During the past few months, 2 additional direct-acting antivirals (sofosbuvir and simeprevir) have gained approval.
Expanded testing guidelines in the United States (including all adults born between 1945 and 1965) have led to the diagnosis of HCV infection in increasing numbers of patients who were previously unaware of their infection. The anticipated support provided by HCVguidelines.org, a collaborative effort among the American Association for the Study of Liver Diseases (AASLD), the Infectious Diseases Society of America (IDSA), and the International Antiviral Society–USA (IAS-USA), comes at a critical time as large numbers of recently diagnosed patients seek treatment.
The consensus recommendations for the screening, treatment, and management of patients with HCV infection featured on the website were developed by a panel that included more than 2 dozen experts. This detailed guidance is freely available for clinicians and others who need updated information on best practices for treating HCV infection. The website is expected to be of “great value” to clinicians, including both those who are well versed in the nuances of antiviral therapy and those who are new to the field, said David Thomas, MD, panel cochair for IDSA and professor of medicine from the Johns Hopkins University School of Medicine.
The panel envisions regular updates to the website as new treatment options and improved diagnostic tools become available. More than a dozen new drugs are under development, and the website will function as “a living document” in which recommendations will be adjusted as new treatments become available, said Saag, panel cochair for IAS-USA.
Previously, frequent complications and poor tolerability associated with traditional HCV drug treatment limited the number of clinicians who could treat affected patients. “There are not enough hepatologists and infectious diseases specialists to care for all those who can benefit from therapy,” said David Jensen, MD, professor of medicine at the University of Chicago Medical Center and panel cochair for AASLD. In the future, Jensen envisions certain aspects of HCV treatment being provided by primary care providers, also noting that telemedicine approaches have improved access in some areas.
Because completing phase 3 trials on every combination of therapy is not feasible, the panel crafted recommendations based on available data, including several phase 2b and early phase 3 trials. Specific guidance is provided on the use of direct-acting antivirals with and without interferon, weight-based ribavirin, and combinations of therapy. Several common clinical scenarios are also addressed, including patients with HCV infection who also are infected with HIV or who have renal failure.
The guidelines do not address costs; payment for these new therapies has been a barrier to care for some patients. “To me, it is noteworthy that we have a source of unbiased guidance and that the guidance is available within months of approval of the drugs,” said Thomas. “Right now, insurance companies are denying many prescriptions, and we hope that establishing a standard like this will give them a basis for approving.”
Thomas also stressed the importance of getting patients tested for HCV infection. “Advances in therapy are not helpful to a person who is not aware of being infected,” he said.