- Category: HCV Treatment
- Published on Tuesday, 13 May 2014 00:00
- Written by Liz Highleyman
Children with hepatitis C treated with interferon-based therapy continued to show undetectable HCV viral load up to 7 years after achieving sustained virological response in the PEDS-C trial, researchers reported at Digestive Disease Week this month in Chicago.
While direct-acting antiviral agents are bringing about a revolution in the treatment of hepatitis C in adults, these new drugs have not yet been tested in children, and interferon-based therapy remains the standard of care for pediatric hepatitis C patients.
Kathleen Schwarz from Johns Hopkins University School of Medicine and colleagues looked at the long-term durability of treatment response among children treated with pegylated interferon plus ribavirin in the PEDS-C trial. They also looked at the effect of the IL28B gene, associated with interferon responsiveness, which was not yet discovered when the trial was done.
In this Phase 2/3 study, 114 children with chronic hepatitis C (ages 5-18 years; mean 11 years) received weekly pegylated interferon alfa-2a (Pegasys) injections, dosed according to size, for 48 weeks. In addition, they were randomly assigned to take either daily oral weight-based ribavirin (15 mg/kg/day) or placebo. After 24 weeks, non-responders in the placebo group crossed over to receive pegylated interferon/ribavirin for 24 or 48 weeks.
The overall sustained virological response (SVR) rates, or continued undetectable HCV viral load 24 weeks after completion of treatment, were 53% for children receiving pegylated interferon plus ribavirin versus 21% for those treated with pegylated interferon plus placebo(results were not reported by HCV genotype). This long-term follow-up analysis looked at PEDS-C participants 5 or 6 years after the main study.
- Only 38 patients, or about one-third of the initial study population, were available and willing to take part in the long-term follow-up analysis.
- Among the remainder, most were lost to follow-up, while others had moved, did not consent, had been re-treated for hepatitis C, or could not participate for other reasons.
- Among these 38 participants, 22 had achieved SVR in the PEDS-C trial while 16 were non-responders or relapsers.
- All participants who had achieved sustained response in PEDS-C continued to have undetectable HCV RNA 4 to 7 years later.
- Conversely, all patients who experienced treatment failure in PEDS-C had persistently detectable HCV viremia -- that is, they did not spontaneously clear the virus later.
- IL28B CC status was positively associated with achieving SVR.
Based on these findings, the researchers concluded, "The SVR achieved during treatment with [pegylated interferon + ribavirin] in children with chronic hepatitis C has excellent long-term durability."
Despite promising findings such as these, advocates continue to push for pediatric studies of new direct-acting hepatitis C drugs, which are much more effective and better tolerated in adults.
K Schwarz, JP Molleston, MM Jonas, et al. Long-Term Durability of Sustained Viral Response (SVR) in Children Treated for Chronic Hepatitis C (Peds C Trial). Digestive Disease Week (DDW 2014). Chicago, May 3-6, 2014. Abstract 649.