Patients whose hepatitis C drugs has proven resistant to the newer antiviral agents, will now have a further option for therapy.
The TGA recently approved Vosevi (sofosbuvir and velpatasvir, Gilead) to treat adults with chronic hepatitis C genotypes 1-6 without cirrhosis or with compensated cirrhosis.
Up until now, there have been no approved treatments for patients with chronic hepatitis C who need re-treatment after treatment with an NS5A inhibitor. The medication is also approved for patients with genotype 1a or 3 who have not been cured with a sofosbuvir-containing regimen.
“Direct-acting antiviral regimens have transformed the treatment of HCV infection in Australia, providing the opportunity to eliminate HCV in Australia within a generation which is in line with the WHO HCV elimination goals,” said Professor Alex Thompson, director of the Department of Gastroenterology at St. Vincent’s Hospital, Melbourne and chair of GESA–ALA, in a statement.
“The availability of Vosevi will provide an important new therapeutic option that offers the potential for cure in these hardest-to-treat patients,” Professor Thompson said.
Studies on the drug revealed 96-98% of patients achieved a sustained viral response after 12 weeks on the treatment.
Common side effects included headache, fatigue, diarrhoea and nausea. Hepatitis B reactivation has been reported among patients who were not receiving hepatitis B treatment.
The drug is contraindicated for patients taking rifampin and rosuvastatin.