AASLD: Metformin Effective Add-On in HCV Treatment

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http://www.medpagetoday.com/MeetingCoverage/AASLD/11662

Medical News from

AASLD: American Association for the Study of Liver Diseases Meeting

AASLD: Metformin Effective Add-On in HCV Treatment

By Bankhead, Staff Writer, MedPage Today

Published: November 06, 2008

Reviewed by Zalman S. Agus, MD; Emeritus Professor

University of Pennsylvania School of Medicine. Earn CME/CE credit

for reading medical news

SAN FRANCISCO, Nov. 6 -- In hepatitis C patients with insulin resistance,

metformin improved insulin sensitivity and virologic response when added to

interferon-ribavirin therapy, according to data from a multicenter Spanish

trial. Action Points

--------------------------------------------------------------------------------

Explain to interested patients that adding metformin to antiviral therapy

improved virologic response in HCV patients with insulin resistance.

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.

Women, in particular, benefited from the metformin add-on, Romero-Gomez,

M.D., of Valme University Hospital in Seville, reported at the American

Association for the Study of Liver Diseases meeting here.

" Peg-interferon alpha-2a plus ribavirin plus metformin should be the standard of

care in women with insulin resistance, as it significantly increases sustained

response, " said Dr. Romero-Gomez. " Insulin resistance seems to be a new target

in the management of hepatitis C. "

Patients with chronic HCV have a high risk of diabetes compared with uninfected

individuals or patients with hepatitis B infection. Eradication of HCV restores

glucose homeostasis in many patients, but insulin resistance or diabetes

depresses virologic response, said Dr. Romero-Gomez.

Whether restoration of insulin sensitivity before or during HCV therapy could

improve virologic response had not been determined, however.

To address that issue, the investigators enrolled 123 patients with genotype 1

HCV and homeostasis model of insulin resistance (HOMA) greater than 2.

The patients received standard peginterferon-alpha-2a/ribavirin antiviral

therapy plus metformin or matching placebo.

Metformin dosing began at 425 mg t.i.d for four weeks, followed by 850 mg t.i.d.

through week 48.

The primary endpoint was sustained virologic response (HCV RNA 4 (P=0.25)

Women who received metformin had a more robust early virologic response.

By week 12, the mean HCV RNA log10 had decreased from 6.53 to 1.64 in women

compared with 6.15 to 2.09 in men (P=0.021).

In contrast, the viral RNA level decreased from 6.42 to 2.42 among women in the

placebo group and from 6.53 to 2.15 among men, a nonsignificant difference.

Adverse events occurred in a similar proportion of patients in the two treatment

arms. The only significant difference was in the frequency of diarrhea (35.6% in

the metformin arm versus 10.9% with placebo, P=0.05).

The study was supported by Roche-Farma.

The authors reported no conflicts of interest.

Primary source: Hepatology

Source reference:

Romero-Gomez M, et al " Metformin with peginterferon alfa-2a and ribavirin in the

treatment of naive genotype 1 chronic hepatitis C paients with insulin

resistance (TRIC-1): final results of a randomized and double-blinded trial "

Hepatology 2008; 48(4):380A. Abstract LB6.

[Guest guest]

http://www.medpagetoday.com/MeetingCoverage/AASLD/11662

Medical News from

AASLD: American Association for the Study of Liver Diseases Meeting

AASLD: Metformin Effective Add-On in HCV Treatment

By Bankhead, Staff Writer, MedPage Today

Published: November 06, 2008

Reviewed by Zalman S. Agus, MD; Emeritus Professor

University of Pennsylvania School of Medicine. Earn CME/CE credit

for reading medical news

SAN FRANCISCO, Nov. 6 -- In hepatitis C patients with insulin resistance,

metformin improved insulin sensitivity and virologic response when added to

interferon-ribavirin therapy, according to data from a multicenter Spanish

trial. Action Points

--------------------------------------------------------------------------------

Explain to interested patients that adding metformin to antiviral therapy

improved virologic response in HCV patients with insulin resistance.

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.

Women, in particular, benefited from the metformin add-on, Romero-Gomez,

M.D., of Valme University Hospital in Seville, reported at the American

Association for the Study of Liver Diseases meeting here.

" Peg-interferon alpha-2a plus ribavirin plus metformin should be the standard of

care in women with insulin resistance, as it significantly increases sustained

response, " said Dr. Romero-Gomez. " Insulin resistance seems to be a new target

in the management of hepatitis C. "

Patients with chronic HCV have a high risk of diabetes compared with uninfected

individuals or patients with hepatitis B infection. Eradication of HCV restores

glucose homeostasis in many patients, but insulin resistance or diabetes

depresses virologic response, said Dr. Romero-Gomez.

Whether restoration of insulin sensitivity before or during HCV therapy could

improve virologic response had not been determined, however.

To address that issue, the investigators enrolled 123 patients with genotype 1

HCV and homeostasis model of insulin resistance (HOMA) greater than 2.

The patients received standard peginterferon-alpha-2a/ribavirin antiviral

therapy plus metformin or matching placebo.

Metformin dosing began at 425 mg t.i.d for four weeks, followed by 850 mg t.i.d.

through week 48.

The primary endpoint was sustained virologic response (HCV RNA 4 (P=0.25)

Women who received metformin had a more robust early virologic response.

By week 12, the mean HCV RNA log10 had decreased from 6.53 to 1.64 in women

compared with 6.15 to 2.09 in men (P=0.021).

In contrast, the viral RNA level decreased from 6.42 to 2.42 among women in the

placebo group and from 6.53 to 2.15 among men, a nonsignificant difference.

Adverse events occurred in a similar proportion of patients in the two treatment

arms. The only significant difference was in the frequency of diarrhea (35.6% in

the metformin arm versus 10.9% with placebo, P=0.05).

The study was supported by Roche-Farma.

The authors reported no conflicts of interest.

Primary source: Hepatology

Source reference:

Romero-Gomez M, et al " Metformin with peginterferon alfa-2a and ribavirin in the

treatment of naive genotype 1 chronic hepatitis C paients with insulin

resistance (TRIC-1): final results of a randomized and double-blinded trial "

Hepatology 2008; 48(4):380A. Abstract LB6.