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Title: German Study Finds Hepatitis C Care Generally Meets Current Recommendations, Produces Good Outcomes: Presented at HEP DART

"German Study Finds Hepatitis C Care Generally Meets Current Recommendations, Produces Good Outcomes: Presented at HEP DART"

By Bonnie Darves KOHALA COAST, HI -- December 16, 2005 -- Patients with hepatitis C who are treated with combination ribavirin and pegylated interferon (PEG-IFN) according to current recommendations under community-practice conditions have good outcomes, with rates of sustained virologic response (SVR) of approximately 66%, according to results of a large German study. The study's co-author Elmar Zehnter, MD, Gastroenterologist and Hepatologist, and Researcher in the BNG Hepatitis Group, Dortmund, Germany, presented the findings here on December 13[^th at the Frontiers in Drug Development for Viral Hepatitis HEP DART 2005 meeting.

"If patients are treated to recommendations, they have a good chance of cure, but what we know is that every week counts and patients must sometimes be encouraged to remain on therapy despite side effects," Dr. Zehnter said. "These 'real-life' results are very similar to those we've seen in the clinical trials, a fact that is very encouraging and shows that HCV treatment in Germany is at a high level."

Dr. Zehnter and colleagues presented data on the 2203 patients they have evaluated to date, who were treated in a total of 213 clinical office practices throughout Germany between September 2003 and October 2005. The patients had an average age was 40.3 years. They received 800-1200 mg/daily of ribavirin and 1.5 mcg/kg weekly of PEG-IFN for periods of 24 or 48 weeks, depending on their genotype.

Of the patients studied, 83.5% were Caucasian and 56.4% had genotype A. Fully 90% were treatment naïve at study inclusion, and 57 patients were HIV-coinfected, Dr. Zehnter noted. Nearly 20% were on narcotic-substitution during treatment.

Results show that 75% of the 1058 treatment-naïve patients had normalized alanine aminotransferase (ALT) levels at study end, compared to 57% of the 111 treatment-relapsed participants. The overall rate of SVR was 66%; it was 17% and 14%, respectively, in relapsed patients and non-responders. SVR for the 61 patients who underwent dose reduction was 55.7%.

The researchers hope to enroll a total of 2541 patients into this ongoing study, Dr. Zehnter noted, and will be replicated in the Canadian setting.

[Presentation title: Individualized Weight Adjusted Peginterferon Alfa-2b + Ribavirin in the Clinical Setting: the German Experience. Abstract 111]

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