Zepatier, a drug that treats hepatitis C genotype 1 in people with end-stage renal disease, has been withdrawn from the March meeting of the Pharmaceutical Benefits Advisory Committee (PBAC).
It is expected that manufacturer MSD will submit the drug for consideration at the July PBAC meeting.
Canada is the first country to approve the drug which is available from Canadian pharmacies from February. The US Food and Drug Administration (FDA) recently approved Zepatier for treatment of hepatitis C genotypes 1 and 4.
Zepatier was granted FDA breakthrough therapy designation for the treatment of chronic hepatitis C genotype 1 infection in patients with end stage renal disease on haemodialysis and for the treatment of chronic HCV genotype 4 infection.
Zepatier is a fixed dose combination of elbasvir and grazoprevir in a single pill. It is a direct acting anti-viral (DAA) drug shown in trials to be highly effective against hepatitis C, with cure rates around 95 per cent.
Treatment protocol in Canada specifies its use with or without ribavirin depending on individual circumstances, for periods of eight to 16 weeks.
It is expected that MSD will resubmit its application, with additional information, to the PBAC's July meeting.
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