Dr. Antonio Craxi, Professor of Gastroenterology and Internal Medicine at the University of Palermo, Italy, and Director of Gastroenterology and Hepatology at the School of Internal Medicine, assisted in the completion of the guidelines. He presented it in detail at a press conference and claimed that it partly theoretically sets diagnostic and therapeutic standards for a specific group of patients. The guidelines were developed by a panel of experts who reviewed the scientific literature (as of December 2010) on the subject. In the absence of clinical data, the guidelines incorporate the experience and recommendations of experts. The guidelines include chapters on: diagnosis, treatment, follow-up during treatment, measures to improve treatment success, and factors to consider if treatment fails and the decision is made to return to treatment. Dr. Craxi emphasized that diagnosis must be based in part on the patient’s history and physical examination, and cannot be made by relying solely on serology to determine whether anti-HCV antibodies are present in the blood or the level of HCVRNA. He added, “It is critical that we determine whether liver biopsy is still necessary in assessing the severity of liver disease,” although biopsy remains the reference method for evaluating the extent of liver fibrosis, which most patients are reluctant to undergo because of the risk of complications. He said, “It is not advisable to make liver biopsy a prerequisite for all treatment.” And he noted that for patients with HCV genotypes 2 and 3, it is easier to clear the virus using current therapies and biopsies can be withheld. And biopsy is not always necessary for patients with the more difficult-to-treat genotypes 1 and 4, as other methods are available to determine the extent of liver fibrosis, such as transient elastography (FibroScan) and serum biomarkers. Eradication of Hepatitis C Virus Infection Is the Goal of Treatment Removing the virus from the body prevents complications such as liver fibrosis, cirrhosis, hepatocellular carcinoma, and death.Dr. Craxi said the ideal endpoint of treatment is a sustained viral response, which is judged by the absence of detectable HCV RNA in the patient’s blood at 24 weeks after the end of treatment. The current standard of care is polyethylene glycolated interferon alpha plus ribavirin in a combination therapy. The University of Palermo researcher said that a large number of studies have shown that the 2 commercially available pegylated interferons are equally effective, and either one can be recommended. He noted that the new guidelines take into account the virologic response to pegylated interferon/ribavirin-directed therapy, taking into account both the rate of response and the degree of viral suppression. “This is the first time that it has been made clear that genotype 1 patients with rapid response can receive 24 weeks of treatment [treatment can be extended] and that patients with delayed virologic response can go beyond 24 weeks.” Separate decision maps from the published guidelines, which will be published in the Journal of Liver Diseases, describe response-directed therapies for the treatment of HCV genotypes 1 and 4 and genotypes 2 and 3. Dr. Craxi noted that the previous U.S. guidelines were published 5 years ago and did not include response-guided therapy. In addition, it is now recommended that ribavirin doses be adjusted based on patient weight, as heavier weight is detrimental to response to therapy. The panel recommended follow-up of untreated patients with or without cirrhosis and retreatment of patients for whom prior therapy has not been effective, Dr. Craxi said, adding that new small-molecule drugs currently in development may be effective in drug-resistant patients, and for some of these patients, delaying treatment until new therapeutic agents are available may be worth a try, depending on their current health status.