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HepC Newsletter  Dema-@aol.com
 Jun 04, 2009 08:48 PDT 

NATAP http://natap.org/
_______________________________________________



DDW: Interferon Has Long-Term Histological Benefits in HCV - Good
Percentage of Patients Who Had SVR Had Improved Fibrosis (from Jules: but we
already knew this from previous studies)

MedPage Today
June 03, 2009



-- Patients who declined treatment and those who underwent treatment but
failed to respond had similar increases in both inflammation and fibrosis of
the liver (P<0.001 for all comparisons). There were no differences between
the two groups at follow-up.

Factors that predicted fibrosis progression were the changes in total
inflammation and interface hepatitis from baseline (P<0.005 for both), and the
degree of interface hepatitis at baseline (P<0.05).

The findings remained the same regardless of the degree of scarring at
baseline.

In patients who had a sustained virologic response, inflammation and
fibrosis of the liver both improved over time.

Of patients who had early scarring, or portal fibrosis, at baseline and
had a sustained virologic response, 73% lacked any fibrosis at follow-up
while 20% remained unchanged.

Of patients who had bridging fibrosis on the first biopsy and had a
sustained virologic response, 35% were free from fibrosis at follow-up. Some 23%
had reduced fibrosis, while 38% remained unchanged, and 4% progressed to
cirrhosis.

And of patients who started out with cirrhosis and had a sustained
virologic response, half improved: 10% had no fibrosis at follow-up. while 10% had
improved to portal fibrosis, and 30% had improved to bridging fibrosis.

"The results of our study show that in patients who respond to treatment,
the use of interferon or peginterferon in addition to ribavirin is very
effective," Dr. Sterling said. --
CHICAGO, June 3 -- A single course of interferon-based therapy, with or
without ribavirin, produces long-term improvements in liver histology in
patients with hepatitis C (HCV) who completely clear the virus, researchers
found.


Action Points

* Explain to interested patients that this study showed long-term
improvements in inflammation and fibrosis only in HCV patients who had a sustained
virologic response to standard therapy.


* Note that this study was published as an abstract and presented orally
at a conference. These data and conclusions should be considered to be
preliminary until published in a peer-reviewed journal.

Patients who had a sustained virologic response had significant reductions
in inflammation and fibrosis of the liver five or six years after
receiving treatment, Mitchell Shiffman, M.D., of Virginia Commonwealth University,
reported at Digestive Disease Week here.

Even half of the patients who had cirrhosis improved if they responded to
therapy.

"We used to think that once you had cirrhosis, it was sort of a done deal,
and no matter what happened, you couldn't get any improvement," said
co-investigator Richard Sterling, M.D., also at Virginia Commonwealth. "But this
study now confirms that some of those patients can actually resolve their
liver scarring and inflammation."

Conversely, patients who declined or did not respond to treatment had
significantly more inflammation and worsened fibrosis on a follow-up biopsy.

Several studies have shown that patients with chronic HCV can develop
increased liver fibrosis over time. But the long-term impact of
interferon-based therapy (in patients with and without a sustained virologic response)
remained unknown, Dr. Sterling said.

Uncontrolled studies have shown that patients with a sustained virologic
response have improvements in liver histology following a single course of
interferon-based therapy, he said.

There has even been some suggestion that patients who do not have a
response to therapy have reduced scarring in the short term, he said.

To explore the issue, Drs. Shiffman and Sterling and their colleagues
began a prospective, longitudinal cohort study in 1991.

They included all patients who had a liver biopsy and either declined
treatment (46 patients) or received a single course of interferon-based
therapy, with or without ribavirin (287 patients).

All patients received a follow-up biopsy five or six years later. Most
studies looking at the effect of therapy on liver histology have only followed
up at 24 or 48 weeks, Dr. Sterling said.

The patients who decided not to undergo treatment generally had mild
disease, as indicated by lower inflammation and fibrosis scores and lower serum
alanine aminotransferase.

Of those who underwent treatment, 185 did not have a sustained virologic
response and 102 did.

Patients who declined treatment and those who underwent treatment but
failed to respond had similar increases in both inflammation and fibrosis of
the liver (P<0.001 for all comparisons). There were no differences between
the two groups at follow-up.

Factors that predicted fibrosis progression were the changes in total
inflammation and interface hepatitis from baseline (P<0.005 for both), and the
degree of interface hepatitis at baseline (P<0.05).

The findings remained the same regardless of the degree of scarring at
baseline.

In patients who had a sustained virologic response, inflammation and
fibrosis of the liver both improved over time.

Of patients who had early scarring, or portal fibrosis, at baseline and
had a sustained virologic response, 73% lacked any fibrosis at follow-up
while 20% remained unchanged.

Of patients who had bridging fibrosis on the first biopsy and had a
sustained virologic response, 35% were free from fibrosis at follow-up. Some 23%
had reduced fibrosis, while 38% remained unchanged, and 4% progressed to
cirrhosis.

And of patients who started out with cirrhosis and had a sustained
virologic response, half improved: 10% had no fibrosis at follow-up. while 10% had
improved to portal fibrosis, and 30% had improved to bridging fibrosis.

"The results of our study show that in patients who respond to treatment,
the use of interferon or peginterferon in addition to ribavirin is very
effective," Dr. Sterling said.

Dr. Shiffman reported receiving research grants from Gilead Sciences,
GlaxoSmithKline, Human Genome Sciences, Roche, Schering-Plough, Vertex
Pharmaceuticals, Biolex, Valeant, Pfizer, Idenix, and Wyeth Pharmaceuticals,
consulting or advising for Roche, Andys, Schering-Plough, Vertex, and Pfizer, and
serving as a speaker for Roche and Schering-Plough.

Dr. Sterling reported no conflicts of interest.

Primary source: Digestive Disease Week
Source reference:
Shiffman M, et al "The long term effects of interferon based (IFNTx)
therapy on hepatic histology in patients with chronic hepatitis C virus: results
of a five year prospective evaluation on fibrosis progression and fibrosis
regression" DDW 2009; Abstract 7.
*********************
Retreating chronic hepatitis C with daily interferon alfacon-1/ribavirin
after nonresponse to pegylated interferon/ribavirin: DIRECT results
_http://www.natap.org/2009/HCV/060209_03.htm_
(http://www.natap.org/2009/HCV/060209_03.htm)

CDC New Hepatitis Disease Surveillance
_http://www.cdc.gov/hepatitis/Statistics.htm_
(http://www.cdc.gov/hepatitis/Statistics.htm)

TELAPREVIR IN HEPATITIS C GENOTYPE-1-INFECTED PATIENTS WITH PRIOR
NON-RESPONSE, VIRAL BREAKTHROUGH OR RELAPSE TO PEGINTERFERON-ALFA-2A/B AND
RIBAVIRIN THERAPY: SVR RESULTS OF THE PROVE3 STUDY
_http://www.natap.org/2009/EASL/EASL_20.htm_
(http://www.natap.org/2009/EASL/EASL_20.htm)

EASL Analysis, New Oral HCV Drugs What's Expected
_http://www.natap.org/2009/EASL/EASL_85.htm_
(http://www.natap.org/2009/EASL/EASL_85.htm)

Revised Prescription Shows Promise for Hepatitis C Re-Treatment
_http://www.hepatitis-central.com/mt/archives/2009/06/revised_prescri.html?e
ml=hepcen81_
(http://www.hepatitis-central.com/mt/archives/2009/06/revised_prescri.html?eml=hepcen81)

Adding Boceprevir to HCV Combination Therapy Doubles Success Rate
_http://www.hepatitis-central.com/mt/archives/2009/05/adding_boceprev.html?e
ml=hepcen81_
(http://www.hepatitis-central.com/mt/archives/2009/05/adding_boceprev.html?eml=hepcen81)


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