TGA approves Harvoni

The Therapeutic Goods Administration (TGA) has approved ledipasvir/sofosbuvir (commercial name, Harvoni) for use in treating hepatitis C.

The Australian Pharmacy Guild daily newsletter, Pharmacy Daily said the approval was confirmed by the manufacturer, Gilead Sciences.

TGA is required before a drug can be listed with the Pharmaceutical Benefits Scheme (PBS).

Harvoni was recommended for listing by the Pharmaceutical Benefits Advisory Committee (PBAC) in its recent March meeting.

The PBAC will be considering additional new hepatitis C treatments at its meeting in July. These include:

Paritaprevir with ritonavir, ombitasvir and dasabuvir (Viekira Pak®) - for the treatment of hepatitis C, genotype 1
Paritaprevir with ritonavir, ombitasvir, dasabuvir and ribavirin (Viekira Pak-RBV®) for the treatment of hepatitis C, genotype 1

More Information (Hepatitis Australia)
http://www.hepatitisaustralia.com