Gilead Sciences, Inc. recently announced that the European Commission has finally granted marketing authorization for their novel hepatitis C treatment Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), which is the first and only once-a-day oral tablet capable of treating most chronic HCV infections of genotype 1 and 4 in adult patients. The drug is now cleared for marketing in all 28 countries of the European Union (EU). The drug is a combination of an NS5A inhibitor (ledipasvir) and a nucleotide analog polymerase inhibitor (sofosbuvir). A single formulation of sofosbuvir was licensed by the commission in January 2014 under the brand name Sovaldi®.

Both drug components by themselves are known hepatitis C treatments. This combination drug is beneficial in adult patients who have never received prior HCV treatment, or have experienced a decrease or cessation in response to other treatments. Harvoni® is recommended for both cirrhotic and non-cirrhotic infections, and may be prescribed between 12 to 24 weeks, depending on history of treatments received, extent of cirrhosis, and noted genotype:

• Non-cirrhotic, treatment-naïve, genotype 1: 8 weeks
• Decompensated cirrhosis, cirrhosis and/or prior treatment failure: Combination with ribavirin for 24 weeks
• Genotype 3 patients with cirrhosis and/or prior treatment failure: Combination with ribavirin for 24 weeks
• Patients with HCV who have HIV co-infection

“Genotype 1 patients living with hepatitis C in Europe and the physicians who treat them have been waiting for further treatment advances” said Graham Foster, Professor of Hepatology, Queen Mary University of London.  “With Harvoni, we have the potential to change the way we treat people living with the most prevalent form of hepatitis C in Europe.”

The marketing authorization was preceded by an accelerated review from the European Medicines Agency. The European Commission granted approval after reviewing the results of a series of Phase 3 clinical trials (ION-1, ION-2 and ION-3) that examined 2,000 adult patients with HCV genotype 1, with compensated liver disease. The 3 studies evaluated the performance of Harvoni® when administered over 8, 12, or 24 weeks, with or without a combination with ribavirin.

Participants of Harvoni®’s clinical trials did not experience any serious adverse effects. The most common observations during treatment were fatigue and headaches compared to those receiving a placebo.

It was in October 2014 that Harvoni® was licensed by the US Food and Drug Administration and Health Canada, followed by a November 2014 approval in New Zealand. The drug’s regulatory approval in Japan and Switzerland are still being processed and reviewed.