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AbbVie’s hepatitis C drug Maviret gets expanded regulatory nod
  • By Shim Hyun-tai
  • Published 2020.08.03 17:51
  • Updated 2020.08.03 17:51
  • comments 3

AbbVie received the local regulatory approval on July 31 to shorten the treatment duration of Maviret (ingredient: glecaprevir/pibrentasvir) to eight weeks for patients with compensated cirrhotic chronic hepatitis C genotype (GT) 3 infection.

The Food and Drug Safety’s nod was based on the result of the phase 3b study EXPEDITION-8. The study evaluated the safety and efficacy of Maviret in untreated chronic hepatitis C patients with compensated cirrhosis from GT 1 to 6.

AbbVie’s hepatitis C medicine Maviret won the local regulatory nod to shorten treatment period to eight weeks in patients with compensated cirrhotic, chronic hepatitis C genotype (GT) 3 infection. (AbbVie)

The study showed that 335 out of 343 patients comprising all GTs, or 97.7 percent of the total, reached a sustained viral response 12 weeks after the treatment. None of these patients discontinued the treatment due to adverse events such as side effects.

“The shortened treatment duration to eight weeks is becoming standard therapeutic strategy with the appearance of Maviret in Korea,” said Professor Kim Ji-hoon of Department of Gastroenterology of Korea University Guro Hospital. “We can present an eight-week treatment strategy with or without cirrhosis in patients with all GTs who have no treatment history.”

“Hepatitis C is a severe infectious disease that can cause liver cancer and cirrhosis and lead 70 to 80 percent of all patients to progress to chronic hepatitis,” AbbVie Korea Medical Director Jung Soo-jin said. “There is no available vaccine so far, but it is possible to cure the disease with effective treatment after early diagnosis.”

The European Union approved the eight-week treatment for GT 3 in March. The U.S. Food and Drug Administration approved to shorten the treatment period to eight weeks for compensated cirrhotic patients with all GTs without treatment experience in September 2019.


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