Antiviral 'Cocktail' Better than Single Drug for Children with Hepatitis C

[Guest guest]

http://www.infectioncontroltoday.com/news/2010/11/antiviral-cocktail-better-than\

-single-drug-for-children-with-hepatitis-c.aspx

Antiviral 'Cocktail' Better than Single Drug for Children with Hepatitis C

Children with hepatitis C fare decidedly better with a supercharged combination

of two antiviral drugs than with the usual and standard single-drug regimen,

according to research led by investigators at the s Hopkins Children Center.

“Our findings indicate that when it comes to getting rid of the hepatitis C

virus, the combination therapy seriously outperforms the single-drug therapy and

its effects appear to endure well after stopping the treatment,” says lead

investigator Kathleen Schwarz, MD, a gastroenterologist and director of the

Pediatric Liver Center at Hopkins Children’s.

The results of the study, published online in the journal Gastroenterology,

indicate that the combination is more than twice as effective in eliminating the

liver-ravaging viral infection as the single-drug approach. Unlike its more

stubborn cousin hepatitis B, the hepatitis C virus can be eradicated from the

body with antiviral medications, stopping its harmful activity, a key factor in

preventing liver damage.

The research, which involved 112 children, ages 5 to 17 years, treated at 11

U.S. hospitals, is believed to be the first large-scale, head-to-head comparison

of the dual vs. single-drug approach in pediatric patients. The findings are

particularly important, the scientists say, because treatment protocols in

children with hepatitis C have not been studied well.

Of the 112 children, 57 received standard medication — weekly injections with

long-acting pegylated interferon, or PEG interferon — plus a placebo, while 55

got a combination of PEG interferon injections and daily pills containing the

antiviral drug ribavirin (RV). After the year-long treatment, patients treated

with the PEG-ribavirin cocktail cleared the infection at a rate two and a half

times greater than children receiving PEG interferon injections alone (53 vs. 21

percent). Viral clearance occurs when a child’s blood is free of viral traces at

the end of the treatment, and sustained viral clearance, or full eradication,

occurs when the blood remains clear for at least six months after stopping

treatment. Full viral eradication is the hallmark of effective therapy and was

where the greatest differences between the two approaches emerged. Children on

the combination therapy were less likely to relapse after stopping treatment —

17 percent of them did — than children on the single-drug regimen (45 percent).

In all, 41 of the 112 patients achieved complete viral eradication, and all of

them continued to do well without medication at the one- and two-year check-ups.

The researchers will continue to monitor these children for five years after

stopping therapy.

Twenty-eight of the children receiving the PEG-placebo combination who didn’t

respond to treatment after six months were offered treatment with the

PEG-ribavirin combination. Nearly half of them (13) responded well and had

undetectable viral loads at the end of a six-month treatment, and 11 of the 13

remained clear of infection six months after stopping the treatment. Children

who responded well to standard PEG therapy continued on the same treatment.

The investigators note that because past research has shown ribavirin’s harmful

effects on the fetus, it should be avoided or used cautiously during pregnancy.

The blood-borne hepatitis C virus is a leading cause of liver cancer, second

only to hepatitis B, and a top reason for liver transplantation. An estimated

132,000 U.S. children are infected with the hepatitis C virus, and nearly 42,300

of them have a chronic infection, the researchers say.

Another s Hopkins investigator involved in the study is andra

Valsamakis, MD. Other institutions involved in the research include the

University of Florida College of Medicine; Seattle Children’s Hospital; Indiana

University School of Medicine; Children’s Hospital of Philadelphia; Children’s

Hospital Boston; University of California San Francisco; Children’s National

Medical Center, Washington, D.C., Cincinnati Children’s Hospital; University of

Colorado; and Columbia University Medical Center.

The study was funded by the National Institutes of Health and the Food and Drug

Administration. Manufacturer Hoffman-La Roche supplied the medications for the

study and funded the lab costs and the data coordination for the study.

[Guest guest]

http://www.infectioncontroltoday.com/news/2010/11/antiviral-cocktail-better-than\

-single-drug-for-children-with-hepatitis-c.aspx

Antiviral 'Cocktail' Better than Single Drug for Children with Hepatitis C

Children with hepatitis C fare decidedly better with a supercharged combination

of two antiviral drugs than with the usual and standard single-drug regimen,

according to research led by investigators at the s Hopkins Children Center.

“Our findings indicate that when it comes to getting rid of the hepatitis C

virus, the combination therapy seriously outperforms the single-drug therapy and

its effects appear to endure well after stopping the treatment,” says lead

investigator Kathleen Schwarz, MD, a gastroenterologist and director of the

Pediatric Liver Center at Hopkins Children’s.

The results of the study, published online in the journal Gastroenterology,

indicate that the combination is more than twice as effective in eliminating the

liver-ravaging viral infection as the single-drug approach. Unlike its more

stubborn cousin hepatitis B, the hepatitis C virus can be eradicated from the

body with antiviral medications, stopping its harmful activity, a key factor in

preventing liver damage.

The research, which involved 112 children, ages 5 to 17 years, treated at 11

U.S. hospitals, is believed to be the first large-scale, head-to-head comparison

of the dual vs. single-drug approach in pediatric patients. The findings are

particularly important, the scientists say, because treatment protocols in

children with hepatitis C have not been studied well.

Of the 112 children, 57 received standard medication — weekly injections with

long-acting pegylated interferon, or PEG interferon — plus a placebo, while 55

got a combination of PEG interferon injections and daily pills containing the

antiviral drug ribavirin (RV). After the year-long treatment, patients treated

with the PEG-ribavirin cocktail cleared the infection at a rate two and a half

times greater than children receiving PEG interferon injections alone (53 vs. 21

percent). Viral clearance occurs when a child’s blood is free of viral traces at

the end of the treatment, and sustained viral clearance, or full eradication,

occurs when the blood remains clear for at least six months after stopping

treatment. Full viral eradication is the hallmark of effective therapy and was

where the greatest differences between the two approaches emerged. Children on

the combination therapy were less likely to relapse after stopping treatment —

17 percent of them did — than children on the single-drug regimen (45 percent).

In all, 41 of the 112 patients achieved complete viral eradication, and all of

them continued to do well without medication at the one- and two-year check-ups.

The researchers will continue to monitor these children for five years after

stopping therapy.

Twenty-eight of the children receiving the PEG-placebo combination who didn’t

respond to treatment after six months were offered treatment with the

PEG-ribavirin combination. Nearly half of them (13) responded well and had

undetectable viral loads at the end of a six-month treatment, and 11 of the 13

remained clear of infection six months after stopping the treatment. Children

who responded well to standard PEG therapy continued on the same treatment.

The investigators note that because past research has shown ribavirin’s harmful

effects on the fetus, it should be avoided or used cautiously during pregnancy.

The blood-borne hepatitis C virus is a leading cause of liver cancer, second

only to hepatitis B, and a top reason for liver transplantation. An estimated

132,000 U.S. children are infected with the hepatitis C virus, and nearly 42,300

of them have a chronic infection, the researchers say.

Another s Hopkins investigator involved in the study is andra

Valsamakis, MD. Other institutions involved in the research include the

University of Florida College of Medicine; Seattle Children’s Hospital; Indiana

University School of Medicine; Children’s Hospital of Philadelphia; Children’s

Hospital Boston; University of California San Francisco; Children’s National

Medical Center, Washington, D.C., Cincinnati Children’s Hospital; University of

Colorado; and Columbia University Medical Center.

The study was funded by the National Institutes of Health and the Food and Drug

Administration. Manufacturer Hoffman-La Roche supplied the medications for the

study and funded the lab costs and the data coordination for the study.