New hep C drug approved by TGA
In clinical trials, adding sofosbuvir to interferon plus ribavirin in patients with genotype 1 reduced the duration of treatment from 48 weeks to just 12 weeks and increased cure rates to 90%.
Approved in the US in December last year and in Europe in January 2014, the drug works directly on the virus by halting the replication process in the liver. This means there are no non-target effects around the rest of the body.
The initial TGA registration for genotype 1 is for combined sofosbuvir with interferon and ribavirin. For genotypes 2 and 3, sofosbuvir has been TGA approved for use with ribavirin – eliminating the need for interferon therapy, which accounts for most of the side effects associated with existing treatments.
Professor Gregory Dore, head of the Viral Hepatitis Clinical Research Program at the Kirby Institute and a member of Gilead's medical advisory board, said it is an incredible, well-tolerated therapy and a major step