Combo Therapy With Ribavirin Superior in Children With Hep C

53 percent responded to PEG2a and ribavirin compared to 21 percent taking PEG2a and placebo

FRIDAY, Nov. 12 (HealthDay News) -- In children and adolescents with the hepatitis C virus (HCV), the combination of peginterferon alfa-2a (PEG2a) and ribavirin is effective for achieving sustained virologic response (SVR), according to a study published online Nov. 1 in Gastroenterology.

Kathleen B. Schwarz, M.D., of the Johns Hopkins University School of Medicine in Baltimore, and colleagues randomized children with HCV, aged 5 to 17 years, to treatment with either the combination of weekly PEG2a received subcutaneously and oral ribavirin twice daily or PEG2a and placebo. The study end point was SVR, defined as a lack of detectable HCV RNA persisting at least 24 weeks after ceasing therapy.

The researchers found that 53 percent of children treated with PEG2a and ribavirin achieved SVR compared to just 21 percent treated with PEG2a and placebo. SVR was achieved by all the children treated with the combination therapy who exhibited a rapid virologic response at week five, and in 65 percent of those with an early virologic response by week 12. However, three children without an early response still had a sustained response. Side effects, especially neutropenia, necessitated dose modification in 40 percent of the children.

"This prospective, randomized controlled trial has demonstrated that the addition of ribavirin to PEG alfa-2a significantly increases early as well as sustained response rates. Therapy with PEG2a plus ribavirin was superior to PEG2a plus placebo regardless of age, alanine aminotransferase levels, and degree of histologic severity," the authors write.

Hoffmann-La Roche provided support for study medications and central laboratory costs. Several of the study authors disclosed financial relationships with pharmaceutical companies.

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