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Eval period for HCV treatment shortened to 12 weeks from 24

By Lee, Hye-Kyung | translator Alice Kang

23.06.29 09:09:34

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Reflects the HCV treatment standards in the latest practice guidelines



The evaluation period used to determine the efficacy of chronic hepatitis C treatments has been reduced in Korea.

The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) revised the 'Clinical Trial Evaluation Guidelines for Chronic Hepatitis C Treatments' on June 29 to align Korea¡¯s clinical trial efficacy evaluation standards with the international standards and reflect the standard treatment method for chronic hepatitis C treatments.

The main revisions included ¡ãchanging the evaluation period of major efficacy evaluation indices, ¡ãsetting toxicity test exemption standards for combination drugs, and ¡ãreflecting the latest chronic hepatitis C standard of care to the guidelines.

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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