AbbVie said it has obtained regulatory approval for an eight-week treatment using Mavyret (ingredient: glecaprevir/pibrentasvir), a hepatitis C drug for all six genotypes of the virus, regardless of cirrhosis symptoms.
The drugmaker also extended the drug’s indication to adolescents aged 12 or more, reducing treatment costs and improving access to treatment.
|AbbVie’ Mavyret, a hepatitis C treatment for all six genotypes of the virus|
The Ministry of Food and Drug Safety on Monday granted additional nod for the eight-week therapy of Mavyret for patients with chronic hepatitis C in genotype 1, 2, 4, 5, and 6 of the virus who are aged 12 or more, have no history of treatment, and accompany compensated cirrhosis.
“Last year, the release of Mavyret made the eight-week treatment of hepatitis C universal, regardless of virus genotype. Now, the treatment for patients accompanying cirrhosis has been shortened from 12 weeks to eight,” said Kim Ji-hoon, a professor at the Internal Medicine Department of Korea University Guro Hospital. “We can use the eight-week rapid treatment for all patients, with or without cirrhosis, in all virus genotype (except for genotype 3).”
As the World Health Organization (WHO) is calling for a national plan and implementation for the eradication of hepatitis C worldwide by 2030, broader treatment access for adolescents will greatly help Korea fight against hepatitis C, he added.
The regulatory approval was based on the result of the phase-3b EXPEDITION-8 study on patients with chronic hepatitis C accompanying compensated cirrhosis.
The result showed that 98.2 percent of the total patients reached sustained virologic response at 12 weeks posttreatment (SVR12), meaning their hepatitis C has been cured. Patients with compensated cirrhosis had virus genotype 1 (82.5 percent), genotype 2 (9.3 percent), genotype 4 (4.6 percent), genotype 5 (0.4 percent), and genotype 6 (3.2 percent). There were no patients who had to discontinue the treatment due to adverse reactions such as virological failure.
The extended indication for adolescent patients was based on the result of the DORA (Part 1) trial, which was an open-label study evaluating the safety and efficacy of Mavyret for eight or 16 weeks in adolescents aged between 12 and 18. The findings showed that 100 percent (N=47/47) of the adolescent patients reached SVR12.