November 3, 2010

AASLD: Long-Term Outcomes Better With SVR

By Kristina Fiore , Staff Writer, MedPage Today
Published: November 03, 2010
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine
 
BOSTON -- Achieving sustained virologic response after treatment for hepatitis C is a boon to patients even 20 years down the road, researchers said here.
 
In a cohort of patients who started treatment at the National Institutes of Health in 1984, none who achieved sustained response developed hepatocellular carcinoma, and all had improved measures of liver function in the long run, Chester Koh, MD, of the National Institute for Diabetes and Digestive and Kidney Diseases, and colleagues.

"Relapse was uncommon, there were no deaths due to liver disease, and no occurrences of hepatocellular carcinoma," Koh reported during an oral presentation at the American Association for the Study of Liver Diseases (AASLD) meeting here.
 
The short-term benefits of a sustained virologic response after therapy are established, but the long-term benefits are less defined. The goals, however, are clear -- prevent liver-related disability or early death.
 
To assess long-term changes in markers of disease activity and fibrosis, the researchers assessed a total of the first 103 patients to achieve sustained virologic response after being treated at the NIH using interferon alfa-2b or peginterferon, both with or without ribavirin.

They compared serum markers of hepatic inflammation, function, and fibrosis before treatment and at the patient's last visit.

Also, any patient seen since 2007 also had a transient elastography to assess liver composition.

Only three of the patients relapsed -- at 0.7, 6.4, and 6.5 years after therapy -- making for a 10-year relapse rate of 5.7%. The remaining 97% of patients maintained a virological response.

Of those 100 patients, 56 were men. There were 88 whites, four African-Americans, and eight Asians.

About 45% had genotype 1 virus; 53% had type 2 and 3 disease.

The researchers found that no patients died of liver-related causes during the 22-year study period, nor were there any cases of hepatic decompensation or hepatocellular carcinoma.

Koh said that the literature shows that these patients may still be susceptible to hepatocellular carcinoma, "but the rates are still low."

Noninvasive markers of liver disease all improved over time, Koh said, including changes in mean alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphotase (ALP), globulin, IgG, alpha fetoprotein, GGT, rheumatoid factor, platelet count, and AST-platelet ratio index (P<0.001 for all).

Among the 75 patients who had elastography, 60% had normal interpretations, 31% had moderately elevated histology, and 9% had tissue in the cirrhotic range, Koh reported.

He said elastography readings, but not serum markers at the time of last follow-up, correlated with pre-treatment liver fibrosis (P<0.001).

Among the seven patients who had cirrhosis before starting therapy, six had an abnormal elastography at follow up.

Koh said that despite long-term sustained virologic response, those with pre-existing cirrhosis still have evidence of hepatic fibrosis.

Arun Sanyal, MD, of Virginia Commonwealth University and president of AASLD, said the findings imply that once patients achieve a sustained response, it "is durable and extends survival."

"We now have data that strongly indicate hepatitis C is a curable disease," he said, referring also to new drugs in development.

Still, in this particular study, he noted that a similar analysis will need to be continued to determine the effects of those newer drugs and newer regimens.

Koh reported no conflicts of interest.

Primary source: American Association for the Study of Liver Diseases

Source reference:
Koh C, et al "Clinical, virological, biochemical outcomes after 20 years of sustained virological response (SVR) in chronic hepatitis C: The NIH experience" AASLD 2010; Abstract 228.

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