Mavyret’s 8-week indication approved in Korea

Quickly following the US label expansion, indication for adolescent added

Efficacy demonstrated in EXPEDITION-8 study, 98% recorded SVR12

A hepatitis C treatment Mavyret is to soon be available as an eight-week treatment in Korea, after its approval in the U.S.

 

After receiving an approval from the U.S.

 

Food and Drug Administration (FDA) first, AbbVie received an approval from Korean Ministry of Food and Drug Safety (MFDS) last month for another indication as an eight-week once-daily treatment for chronic hepatitis C virus (HCV) patients across all genotypes (GT 1 to 6) with compensated cirrhotic, who has never been treated before.

 

However, the drug is planning to follow a separate approval procedure for genotype 3 HCV.

 

Moreover, Mavyret now can be prescribed to treat pediatric patients over age of 12 with HCV.

 

The drug has been approved in the U.S.

 

as an eight-week pan-genotypic treatment for treatment-naïve patients without cirrhosis in August, 2017.

 

The indication expansion got a nod from the regulators based on evidence resulted in the Phase 3b EXPEDITION-8 study, a single-arm, open-label clinical trial evaluating the safety and efficacy of Mavyret in treatment-naïve adult patients with all six genotypes of chronic HCV and compensated cirrhosis.

 

In the study, an overall 98 percent (n=335/343) of patients achieved a sustained virologic response 12 weeks after treatments (SVR12).

 

The EXPEDITION-8 study had one reported case, out of 336 patients treated, for relapse, and found none of them discontinued treatment due to adverse reaction.

 

The indication expansion on adolescent patient from age 12 to 18 was based on results from Part 1 of DORA study, a single-arm, open-label clinical trial assessing the safety and efficacy of Mavyret in pediatric patients treated for eight or 16 weeks.

 

The study demonstrated 100 percent SVR12 in the adolescent patient group, proving the efficacy of the treatment successfully.

 

Professor Kim Ji Hoon of Korea University Guro Hospital stated, “With the launch of Mavyret last year, eight-week treatment for HCV of all genotypes is now a prevalent option for the disease.

 

But now with the new approval shortening the treatment duration from 12 weeks to eight weeks, patients with all genotypes of HCV, except for genotype 3, who has no experience of treatment can have a shorter treatment of eight weeks, regardless of cirrhosis.” Meanwhile, drug committees of all five major general hospitals in Korea, including Seoul National University Hospital, Severance Hospital, Samsung Seoul Hospital, Asan Seoul Medical Center and Seoul St.

 

Mary’s Hospital, passed Mavyret for prescription.

 

Similar to hepatitis B and alcohol, hepatitis C virus is a main cause of liver cancer.

 

About 70 to 80 percent of HCV cases progress to chronic hepatitis, and 30 to 40 percent of such case get worsen to cirrhosis and liver cancer.

 

Up to three or four years ago, only option for HCV treatment was combination therapy of injection and oral antiviral.

 

For the long treatment duration of six to 12 months, patients had to endure many adverse events, and even so, the treatment success rate was just around 50 percent.

 

The treatment success rate reached 90 percent and treatment duration was shortened to 12-to-24 weeks after orally taken direct-acting antiviral (DAA) was launched in the market.