AASLD: Study Clarifies Pediatric HCV Treatment

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http://www.medpagetoday.com/MeetingCoverage/AASLD/11638

Medical News from

AASLD: American Association for the Study of Liver Diseases Meeting

AASLD: Study Clarifies Pediatric HCV Treatment

By , North American Correspondent, MedPage Today

Published: November 05, 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. 5 -- Children with hepatitis C can be treated using the same

drugs adults are given, results of the first major randomized trial in young

people indicate. Action Points

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

Explain to interested patients that little is known about appropriate treatment

for hepatitis C in children.

Note that this study showed that the same approach used in adults is both safe

and effective.

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.

Children ages five to 18 with hepatitis C should be treated with pegylated

interferon alpha2a and ribavirin, exactly as adults are, Kathleen Schwarz, M.D.,

of s Hopkins University School of Medicine, told a plenary session at the

American Association for the Study of Liver Diseases meeting.

Dr. Schwarz said an estimated 133,000 children in the U.S. have antibodies to

hepatitis C and about 66,000 of them are viremic. " They have a definite --

although as yet unquantified -- lifetime risk of cirrhosis and liver cancer, "

she said.

The current approved therapy for children is un-pegylated interferon plus

ribavirin, Dr. Schwarz said, which has a sustained virological response rate of

about 46%.

Pegylated interferon monotherapy has been shown to have exactly the same

response rate, Dr. Schwarz said, so she and her colleagues conducted the PEDS-C

trial to see what would happen if they added ribavirin to the mix.

They enrolled 114 children, with an average age of 10, and randomized them to

pegylated interferon at 180 micrograms per 1.73 meters squared once a week, plus

ribavirin at 15 milligrams per kilogram of body weight daily or a matching

placebo.

The children were treated for 48 weeks and followed for up to 76 weeks, Dr.

Schwarz said.

The proportion of children who had a sustained virological response was 53% for

those getting the combination and 21% for those on monotherapy, the researchers

found, a difference that was significant at P=0.001.

The same pattern was seen for most subgroups, Dr. Schwarz said, including males,

whites, non-whites, and those younger than 11.

Children with the difficult-to-treat genotype-1 had a response rate of 47% if

they got the combination and 17% if they got monotherapy, while the comparable

figures for other genotypes were 80% and 36%. The differences were significant

at P=0.003 and marginally significant at P=0.056, respectively.

Adverse events did not differ significantly between the two arms of the study,

Dr. Schwarz said.

Both groups had anemia and neutropenia that was significant (at P

[Guest guest]

http://www.medpagetoday.com/MeetingCoverage/AASLD/11638

Medical News from

AASLD: American Association for the Study of Liver Diseases Meeting

AASLD: Study Clarifies Pediatric HCV Treatment

By , North American Correspondent, MedPage Today

Published: November 05, 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. 5 -- Children with hepatitis C can be treated using the same

drugs adults are given, results of the first major randomized trial in young

people indicate. Action Points

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

Explain to interested patients that little is known about appropriate treatment

for hepatitis C in children.

Note that this study showed that the same approach used in adults is both safe

and effective.

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.

Children ages five to 18 with hepatitis C should be treated with pegylated

interferon alpha2a and ribavirin, exactly as adults are, Kathleen Schwarz, M.D.,

of s Hopkins University School of Medicine, told a plenary session at the

American Association for the Study of Liver Diseases meeting.

Dr. Schwarz said an estimated 133,000 children in the U.S. have antibodies to

hepatitis C and about 66,000 of them are viremic. " They have a definite --

although as yet unquantified -- lifetime risk of cirrhosis and liver cancer, "

she said.

The current approved therapy for children is un-pegylated interferon plus

ribavirin, Dr. Schwarz said, which has a sustained virological response rate of

about 46%.

Pegylated interferon monotherapy has been shown to have exactly the same

response rate, Dr. Schwarz said, so she and her colleagues conducted the PEDS-C

trial to see what would happen if they added ribavirin to the mix.

They enrolled 114 children, with an average age of 10, and randomized them to

pegylated interferon at 180 micrograms per 1.73 meters squared once a week, plus

ribavirin at 15 milligrams per kilogram of body weight daily or a matching

placebo.

The children were treated for 48 weeks and followed for up to 76 weeks, Dr.

Schwarz said.

The proportion of children who had a sustained virological response was 53% for

those getting the combination and 21% for those on monotherapy, the researchers

found, a difference that was significant at P=0.001.

The same pattern was seen for most subgroups, Dr. Schwarz said, including males,

whites, non-whites, and those younger than 11.

Children with the difficult-to-treat genotype-1 had a response rate of 47% if

they got the combination and 17% if they got monotherapy, while the comparable

figures for other genotypes were 80% and 36%. The differences were significant

at P=0.003 and marginally significant at P=0.056, respectively.

Adverse events did not differ significantly between the two arms of the study,

Dr. Schwarz said.

Both groups had anemia and neutropenia that was significant (at P