HARVONI (sofosbuvir/ledipasvir), fixed combination of of direct-acting antivirals

• HARVONI has Marketing Authorisation in the treatment of chronic hepatitis C in adults infected with genotype 1, 3 and 4 HCV.
• It may provide a cure for the majority of patients with hepatitis C, with or without extrahepatic manifestations. Treatment with HARVONI should be offered as a priority in all patients whose hepatic disease is at fibrosis stage F3 or F4 and in certain special populations. Patients infected with genotype 3, in whom early treatment is recommended, are specifically mentioned. Patients at fibrosis stage F2 should also receive new treatments promptly. In F0 or F1 patients, treatment may be delayed according to the progression of the disease and the patient’s situation.
• It provides a minor improvement in the treatment of chronic genotype 1, 3 and 4 hepatitis C compared with the other sofosbuvir combination products that are currently available, on account of:

-  its high virological efficacy, which is similar to that observed for the other available sofosbuvir combination products (sofosbuvir + daclatasvir and sofosbuvir + simeprevir), but with a better level of evidence,

-  its safety and acceptable level of risk of resistance and drug interactions.

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