icon-folder.gif   Conference Reports for NATAP  
  NIH HCV Consensus Development Conference
June 10-12, 2002
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Re-treatment of Patients with HCV Excerpted from NIH HCV Consensus Development Conference Draft Report (June 2002)
Reported by Jules Levin
  Patients who may benefit from re-treatment include those whose HCV infection failed to achieve SVR. Decisions regarding re-treatment should be based upon: (1) previous type of response, (2) the previous therapy and the difference in potency of the new therapy, (3) the severity of the underlying liver disease, (4) viral genotype and other predictive factors for response, and (5) tolerance of previous therapy and adherence.
Relapsers achieve an initial end of treatment response (ETR) for their HCV disease, but it is not sustained over time (i.e., no SVR). Nonresponders never achieve an EVR, ETR, or SVR. Among the nonresponders, there is a subset of persons who have a substantial reduction of HCV RNA (1 to 2 log units or more) during therapy, and who can be categorized as partial responders.
Even in the absence of SVR, treatment may be associated with improved histology. Preliminary results suggest that overall only 15 to 20 percent of nonresponders treated with standard interferon/ribavirin combinations achieved an SVR on re-treatment using PEG- interferon with ribavirin. Patients with genotypes 2 or 3 have better response rates to re-treatment than genotype 1.
The ability to achieve SVR following re-treatment with PEG-interferon/ribavirin in patients who relapsed following interferon monotherapy or standard interferon/ribavirin therapy is currently being evaluated. However, in cases where the same regimen has been used for re-treatment, virtually all patients relapse again after treatment is stopped. Extending the duration of re-treatment without changing the dose or regimen may reduce the relapse rate, but this has not yet been proven prospectively.
Patients whose HCV infection does not respond to the current optimal therapy with PEG- interferon and ribavirin present a significant problem, particularly in the presence of advanced fibrosis or cirrhosis. The possible role of maintenance therapy with PEG-in terferon alone in preventing further progression of cirrhosis, clinical decompensation, or development of hepatocellular carcinoma is currently the focus of a large-scale, multicenter United States trial, HALT-C. Until the results of HALT-C or similar studies are available, the role of long-term, continuous therapy with PEG-interferon (or ribavirin or both) for nonresponders must be considered experimental.
Knowledge of the severity of the underlying liver disease is important in recommending re-treatment. Patients with advanced fibrosis or cirrhosis are at increased risk for developing hepatic decompensation and should be considered for re-treatment, especially if they were originally treated with interferon monotherapy. For the re-treatment of patients with intermediate degrees of fibrosis and disease activity, clinicians should consider the factors enumerated above.