Abbvie’s hepatitis C treatment Mavyret (ingredient: glecaprevir/pibrentasvir) obtained sales approval in Korea Friday.
In August, Mavyret became the first drug approved by the U.S. Food and Drug Administration for an eight-week treatment for patients without cirrhosis and who are new to the treatment.
Under the existing therapies, the Korean Association for the Study of the Liver (KASL) had recommended more than 12 weeks of treatment. The association reflected Mavyret as a treatment option on its guidelines for hepatitis C treatment revised last year.
Mavyret is a combination drug, using an NS3/4A protease inhibitor glecaprevir and an SN5A inhibitor pibrentasvir. The medicine treats patients infected with hepatitis C virus (HCV) of genotype 1 to 6. Patients can take three Mavyret oral tablets, with food, once a day.
Patients without cirrhosis are recommended to take the tablets for eight weeks. Those with cirrhosis can take them for 12 to 16 weeks, depending on the symptoms of the disease.
Mavyret showed 92-100 percent cure rate of hepatitis C during clinical trials on 2,300 chronic hepatitis C patients. The names of the clinical trials are ENDURANCE-1, ENDURANCE-2, ENDURANCE-3, ENDURANCE-4, EXPROITION-1, EXPEDITION-4, SURVEYOR-1, and MAGELLAN-1.
After three months of treatment, the most common side effects were a headache, tiredness, and nausea. Patients with chronic kidney disease also can use the drug.
Abbvie conducted ENDURANCE trials on patients without cirrhosis, and EXPEDITION studies, on those without cirrhosis or patients with compensated cirrhosis.
After an eight-week treatment, patients without cirrhosis had a high sustained virologic response (SVR) of 97.5 percent. Patients with the disease also had a high SVR after 12 weeks of treatment.
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