The US Food and Drug Administration (FDA) has approved the use for ledipasvir/sofosbuvir (Harvoni) for people with hepatitis C genotypes 4, 5 and 6, as well as people with HIV.

 It also approved the use of ledipasvir/sofosbuvir plus ribavirin for 12 weeks as an alternative to 24 weeks of ledipasvir/sofosbuvir for treatment-experienced people with genotype 1 hepatitis C with cirrhosis.

Ledipasvir/sofosbuvir was first approved by the FDA for treating hepatitis C genotype 1, in October 2014.

Recommended treatment durations are:

• Genotype 1 treatment naive, with or without cirrhosis - 12 weeks
• Genotype 1, treatment experienced, without cirrhosis - 12 weeks
• Genotype 1, treatment experienced, with cirrhosis - 24 weeks
• Genotype 4, 5 or 6, treatment naive and treatment experienced, with or without cirrhosis - 12 weeks

Ledipasvir/sofosbuvir was approved by the Australian Therapeutic Drugs Administration (TGA). It was also recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) for inclusion in the Pharmaceutical Benefits Scheme (PBS) but to date, is still waiting to be listed by the Federal Government.