Consensus guidelines for the management of hepatitis C infection.

At prevalence of 2.7% in the early 1990's, it is estimated that approximately 500,000 people in Saudi Arabia have been exposed to the hepatitis C virus (HCV). Over 80% of such individuals remain infected and most of them progress to chronic hepatitis C (CHC), cirrhosis, and/or hepatocellular carcinoma (HCC). The incidence of newly acquired hepatitis C infection in Saudi Arabia has declined with the recent reported prevalence of approximately 1%. This decline is largely due to the early implementation of testing of blood donors for HCV. However, it is pertinent that measures are taken to identify patients already infected and offer treatment to those with good prognostic factors. Hepatitis C genotype 4, the most predominant genotype in Saudi Arabia (62%) has been resistant to conventional interferon (IFN) therapy and sustained response rate to combination therapy with IFN plus ribavirin (RBV) has been poor. The recently completed Ministry of Health (MOH) clinical trial reports improved sustained virological response (SVR) rate of 65.2% among week 12 early responders of HCV genotype 4 chronic hepatitis patients using pegylated (PEG)-IFN alfa-2a (40 KD) plus RBV. This encouraging process calls for a change in patient management towards a more community-based approach. With the aim of assessing these changes and defining a management strategy for HCV infected patients in Saudi Arabia, a consensus conference was held and consensus guidelines issued. The final recommendation will be made available to all MOH, tertiary and non-government hospitals in the Kingdom to provide uniform care to all CHC patients. Based on the SVR of the above mentioned clinical trial, the committee recommends treatment for patients with histologically proven CHC, with elevated serum alanine aminotransferase (ALT) and positive HCV ribonucleic acid (RNA). Patients with normal serum ALT may not be treated if liver histology is normal or reveals only minimal changes. Patients with decompensated cirrhosis should not be treated. Hepatitis C virus genotype 4 patients should be treated with combination therapy of PEG IFN alfa-2a (180 μg/week) plus RBV (1000 - 1200 mg daily according to body weight) for 48 weeks. Patients with HCV non-genotype 4 may also be treated with combination therapy of PEG-IFN plus RBV, but genotypes 2 and 3 patients can be treated for 6 months only. Stringent monitoring for virological biochemical responses is eminent and provides the opportunity to interrupt treatment at week 12 in non-responders. A strong counseling program should be available for untreated patients, relapsers and non-responders. An exit program for liver transplantation should also be set up. It is likely that some of the consensus recommendations will have to be revised in the short-term, as the results of ongoing studies become available. Future research in advances in diagnosis, pathogenesis, natural history, management and prevention should be encouraged and newer therapies for CHC patients should be sought for non-responders.