AASLD: Long-Term Outcomes Better With SVR

BOSTON -- Achieving sustained virologic response after treatment for hepatitis C is a boon to patients even 20 years down the road, researchers said here.

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 and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planne

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, reported Christopher 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 meeting here.

Action Points  

    * Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
    * Note that this study suggests that patients with chronic hepatitis C who achieve a sustained virological response have an excellent long-term prognosis and are extremely unlikely to experience relapse, hepatic decompensation, or hepatocellular carcinoma.

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 pretreatment 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 preexisting 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.

http://www.medpagetoday.com/MeetingCoverage/AASLD/23132

[nygirl7]

"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.


I cant think of anything to say except go big pharma go.  For anyone who thinks that treatment is too scary and the prospect of side effects is too great - this should tell a whole other story.

THANK YOU.

[willbb]

' Achieving sustained virologic response after treatment for hepatitis C is a boon to patients even 20 years down the road, researchers said here. '

You have to figure that  mentioning"  20 yrs. down the road"  it seems the word  CURE
is getting close!!  " go big pharma go"  -love that!!

[FlGuy]

The interesting parts to reports like these are the things that arent't mentioned. I'm curious about those 3 relapsers; "at 0.7, 6.4, and 6.5 years after therapy -- making for a 10-year relapse rate of 5.7%." and how they arrive at 5.7%.  What further investigation did they do on those 3?

And another one - "He said elastography readings, but not serum markers at the time of last follow-up, correlated with pretreatment liver fibrosis (P<0.001). "  I don't get that. Obviously referring to Fibroscan, I can't figure what "elastography...correlated with pretreatment liver fibrosis" means.  Is it that fibrosis after is equal to fibrosis before? I don't think so.

[willing]

sometimes it's easier to decode these things by looking at the original report (here abstract 228 on the aasld site) than the editorial rehash. The 5.7% is the 10 year relapse rate as calculated by a Kaplan-Meier survival curve estimate (e g
http://www.cancerguide.org/scurve_km.html)
That seems high, which suggests that though they followed for "up to 22yrs" for most it was quite a bit less.

Re the FS: "Transient elastography was successful in 75 pts and was normal ( 13.8) in 9%. Of 7 pts with cirrhosis before therapy, 6 had abnormal elastography at follow up. Elastography readings but not serum markers at the time of last follow up correlated with pre-treatment liver fibrosis (p=<0.001). "
I think what they're saying is that 6/7 cirrhotics still had abnormal FS (thus high correlation between the pre/post) but their serum markers were indistinguishable from those of the non-cirrhotics.

The recent report that's really sticking in my craw and I'd be grateful for any help in interpreting is that recent Lindhal study I posted on jmjm's thread . How can mega-dose rbv yield a 90% SVR rate in naives but essentially a 0% in non-responders - even though it WAS sufficient to get those NRs to EVR and EOT???

[willing]

looks like the MH software chocked on the angle brackets again - making that quote clear as mud. It's:

"Transient elastography was successful in 75 pts and was normal ( LT  7.0 kPa) in 60%; moderately elevated (7.1-13.8) in 31%; and in the cirrhotic range ( GT  13.8) in 9%. Of 7 pts with cirrhosis before therapy, 6 had abnormal elastography at follow up. Elastography readings but not serum markers at the time of last follow up correlated with pre-treatment liver fibrosis (p= LT 0.001). "

with all the ad revenue you'd think they could fix that instead of adding more useless B&Ws

[FlGuy]

Thanks for the interpretation.

I'll take a look at the Lindahl study later tonite or in the AM.  Playing the daddy role here in a while for a while.