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The Liver Meeting
November 18, 2013
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Telaprevir with ribavirin appears effective for transplant patients with HCV, preliminary data suggest

WASHINGTON — A combination of twice-daily telaprevir along with pegylated interferon alfa-2a and ribavirin is generating positive results in liver transplant patients with hepatitis C virus, a speaker said here.

“This interim analysis of the REFRESH study suggests that telaprevir and [peginterferon alfa-2a and ribavirin] treatment in liver transplant recipients with hepatitis C infection is promising and may have an acceptable safety profile when used in conjunction with tacrolimus or cyclosporine,” Kimberly Ann Brown, MD, of Henry Ford Hospital in Detroit said at The Liver Meeting.

Kimberly Ann Brown, MD

Kimberly Ann Brown

The two-part, open-label, prospective, multicenter study is analyzing 46 noncirrhotic liver transplant recipients (mean age, 57 years) with genotype 1 chronic hepatitis C virus infection. Week 16 results were presented at the meeting.

Patients were assigned 1,125 mg telaprevir twice daily, 180 mcg of peginterferon per week and 600 mg ribavirin daily for 12 weeks, after which they received peginterferon and ribavirin for 36 weeks. Tacrolimus and cyclosporine doses were initially maintained then reduced as the study continued.

Despite previous antiviral therapy in 70% of patients along with strong immunosuppresants related to liver transplant, 23 of 43 patients (53%) had undetectable levels of HCV RNA at week 4, and 18 of 30 patients (60%) had undetectable levels at week 12.

Furthermore, adverse effects were found to be manageable with no moderate, severe or serious rashes reported, and no rejections, cases of autoimmune hepatitis or deaths. Grade 2/3 creatinine toxicity was demonstrated by 12 patients.

Final data from the analysis will be reported when all patients have completed the study, Brown said.

Disclosure: Brown reports no relevant financial disclosures.

For more information:

Brown K. #3: Twice-Daily Telaprevir in Combination with Peginterferon Alfa-2a/Ribavirin in Genotype 1 HCV Liver Transplant Recipients: Interim Week 16 Safety and Efficacy Results of the Prospective, Multicenter REFRESH Study. Presented at: The Liver Meeting 2013; Nov. 1-5, Washington.