July 6, 2012
Hep C Treatment Failure Can Still Mean Less Liver Inflammation
Hepatitis C treatment is typically seen as an all-or-nothing approach—nothing short of a sustained virologic response (SVR), or cure, will benefit people living with the virus. New data, however, suggest that even among those who don’t achieve an SVR, but who do see a substantial drop in hep C viral loads during treatment, there may be a reduction in inflammation associated with liver disease.
This encouraging finding, published ahead of print by the American Journal of Gastroenterology, is based on data from an older 1.050-patient clinical trial dubbed the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) study.
The primary goal of HALT-C was to determine whether 3.5 years of ongoing treatment with pegylated interferon (peg-IFN) monotherapy could slow liver disease progression—notably the development of liver cancer, liver failure or death—in people living with hepatitis C virus (HCV) who weren’t able to achieve an SVR using peg-IFN plus ribavirin.
According to the original results from the study, published in the journal Gastroenterology in January 2009, those who continued on long-term maintenance therapy with peg-IFN were no less likely to experience serious liver disease or death than those who did not receive additional treatment.
What remained unclear, however, is whether failed treatment—either during the peg-IFN/ribavirin “lead-in” period or during the long peg-IFN monotherapy maintenance period—was a complete wash for people who remained uncured of their infection.
In turn, study investigator Chihiro Morishima, MD, of the University of Washington in Seattle and her colleagues turned their attention to 834 participants from HALT-C who had liver biopsy results before starting peg-IFN/ribavirin treatment and then 1.5 years after being randomized to either peg-IFN maintenance therapy or no therapy with observation.
Morishima’s team used the biopsy specimens to look for changes in fibrosis scores and in histology activity index (HAI) scores—a measure of inflammation, which can lead to scarring of the liver.
Looking specifically at 657 patients who received full-dose peg-IFN and ribavirin lead-in therapy, HAI improvements were noted in the biopsy samples collected 1.5 years after being randomized in the study.
The improvements were highly statistically significant in one particular group of patients, dubbed responder relapsers, who saw their HCV viral loads reduced substantially during treatment but were unable to maintain an undetectable viral load after stopping therapy. These statistically significant improvements in HAI scores were just as likely to be seen in those who didn’t receive peg-IFN maintenance therapy compared with those who did.
Among all 834 patients followed for an average of six years, Morishima and her colleagues reported that those who achieved HAI improvements as a result of treatment were more likely to see other improvements as well. For example, among those with moderate-to-severe fibrosis at baseline, those with improved HAI scores at the 1.5-year mark had less liver fibrosis progression than those who didn’t experience HAI improvements.
In conclusion, the authors explain, there may still be advantages to failed treatment, notably among responder-relapsers. “Reduced hepatic inflammation,” they write, “was associated with profound virological suppression during lead-in treatment with full-dose peginterferon/ribavirin and with decreased fibrosis progression and clinical outcomes, independent of randomized [maintenance] treatment.”
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