AASLD publishes updated practice guidelines on hepatitis C

On Monday, September 26, 2011, the American Association for the Study of Liver Diseases published online at its journal Hepatology's website (http://onlinelibrary.wiley.com/doi/10.1002/hep.24641/full) an update to its practice guidelines for hepatitis C – "An Update on Treatment of Genotype 1 Chronic Hepatitis C Virus Infection: 2011 Practice Guideline by the American Association for the Study of Liver Diseases." AASLD is the premiere organization for research and education in the area of liver disease. The authors of the update are Marc Ghany, David R. Nelson, Doris B. Strader, David L. Thomas, and Leonard B. Seeff, all of whom are thought leaders in the field of hepatology.

The guidelines are noteworthy because they address treatment of patients with hepatitis C using two recently FDA approved drugs – telaprevir and boceprevir. Both long-awaited drugs were approved by the FDA in May 2011, are direct acting antivirals (DAA), and improve cure rates for patients with hepatitis C genotype 1. In addition, both drugs are in the forefront of a wave of new drugs that will reach the market in the near future. According to AASLD President T. Jake Liang, MD, "The AASLD has been very proactive in modifying our HCV guidelines to reflect this change. Ever since we knew of the improved treatment response with the addition of DAAs, the AASLD Practice Guideline Committee has moved quickly to update the existing guideline. Just 4 months after the official approval of the first two DAAs, the updated guideline is available on the website of our journal Hepatology."

DAAs promise great hope, but AASLD has expedited the writing and review of its practice guideline because those drugs do require a level of expertise for practitioners if optimum outcomes can be reached. In addition, treatment schedules will be complex and different for each DAA. The newly approved treatment schedules have more side effects than pegylated interferon and ribavirin, and should be managed carefully. The drugs are intended for use only in combination with pegylated interfreron and ribavirin, and if not used in combination with those drugs, treatment will be ineffective and will cause emergence of antiviral-resistant mutants that could be difficult to treat subsequently.

Dr. Liang said, "The DAAs will likely change the landscape of treatment for hepatitis C. However a note of caution is necessary to remind all of us that the treatment regimens are complicated and different. They are associated with more side effects than the standard peginterferon and ribavirin combination, and therefore need careful management."

Some of the concerns noted by AASLD are:

• They are only approved for use in patients with HCV genotype 1.
• They are not approved for use in post-transplant recurrent HCV.
• They are not approved for use in HIV/HCV coinfected patients.
• They are not approved for use in children.

Gary Davis, MD, Chair of AASLD's special interest group on hepatitis C acknowledges the complexities the new DAAs pose, but is still optimistic about these recent developments and the promise of new drugs. Dr. Davis said, "Hepatologists, gastroenterologists, and others who treat patients with chronic hepatitis C now have the option of two newly approved drugs that directly interfere with the ability of the hepatitis C virus to persist in the patient. Administration of these drugs is not straight-forward and increases the complexities of patient management. The new AASLD guidelines review how and when to use these agents in the clinic. This timely document should be a great asset in the management of our patients with hepatitis C."

Dr. Liang echoes those sentiments, adding, "The approval of DAAs for treatment of hepatitis C reflects an important milestone in our efforts to combat the global public health burden of viral hepatitis."