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Active Substance: ledispavir 90 mg / sofosbuvir 400 mg
Common Name: ledispavir 90 mg / sofosbuvir 400 mg
ATC Code: J05AX65
Marketing Authorisation Holder: Gilead Sciences International Ltd
Active Substance: ledispavir 90 mg / sofosbuvir 400 mg
Status: Authorised
Authorisation Date: 2014-11-17
Therapeutic Area: Hepatitis C, Chronic
Pharmacotherapeutic Group: Antivirals for systemic use

Therapeutic Indication

Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adults and in adolescents aged 12 to < 18 years (see sections 4.2, 4.4 and 5.1).

For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.

What is Harvoni and what is it used for?

Harvoni is an antiviral medicine used to treat adults and children from 12 years of age with chronic (long-term) hepatitis C, an infectious disease that affects the liver caused by the hepatitis C virus.

Harvoni contains the active substances ledipasvir and sofosbuvir.

How is Harvoni used?

Harvoni can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.

Harvoni is available as tablets which contain 90 mg ledipasvir and 400 mg sofosbuvir. The recommended dose is one tablet taken once a day. There are several varieties (called genotypes) of hepatitis C virus and Harvoni is recommended for use in patients with virus of genotypes 1, 4, 5 and 6 and for some patients with genotype 3. The duration of treatment with Harvoni and whether it is used alone or in combination with another medicine called ribavirin depends on the genotype of the virus and the nature of the liver problems patients have, for example if they have liver cirrhosis (scarring) or their liver is not working properly.

For further information, see the package leaflet.

How does Harvoni work?

The active substances in Harvoni, ledipasvir and sofosbuvir, block two proteins essential for the hepatitis C virus to multiply. Sofosbuvir blocks the action of a protein called ‘NS5B RNA-dependent RNA polymerase’, while ledipasvir targets a protein called ‘NS5A’. By blocking these proteins, Harvoni stops the hepatitis C virus from multiplying and infecting new cells.

Sofosbuvir has been authorised as Sovaldi since January 2014.

What benefits of Harvoni have been shown in studies?

Harvoni has been investigated in three main studies involving a total of around 2,000 adult patients infected with hepatitis C of genotype 1 whose liver function was normal. In all three studies, the main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 12 weeks after the end of treatment.

In these studies, patients were given Harvoni, with or without ribavirin, for 8, 12 or 24 weeks, depending on the characteristics of the patients. Around 94% to up to 99% of patients given Harvoni alone had no sign of the virus 12 weeks after the end of treatment. The addition of ribavirin was not needed for most patients.

Results of the studies also showed that patients who have compensated cirrhosis (scarring of the liver but the liver continues to work adequately) had a higher likelihood of clearing the virus when treatment was extended to 24 weeks. Patients whose infection was resistant to other antiviral medicines could also benefit from extending treatment to 24 weeks.

Supportive data showed that Harvoni in combination with ribavirin would be of benefit for some patients with genotype 3 virus.

Benefit of Harvoni was also shown for patients with genotype 4, 5 and 6, for those with decompensated cirrhosis (when the liver does not work adequately) and for those who had received a liver transplant.

Harvoni is also being investigated in a study in children aged 3 to 18 years infected with hepatitis C. Results from 100 patients aged 12 to 18 years (all of whom had hepatitis C genotype 1) showed that 98% of them had no sign of the virus 12 weeks after the end of treatment. Results in children aged below 12 years are not yet available.

What are the risks associated with Harvoni?

The most common side effects with Harvoni (which may affect more than 1 in 10 people) are tiredness and headache. Harvoni must not be used together with the cholesterol medicine rosuvastatin. It must also not be used together with the following medicines which can reduce the effects of Harvoni:

  • rifampicin and rifabutin (antibiotics);
  • carbamazepine, phenobarbital and phenytoin (medicines for epilepsy);
  • St John’s wort (a herbal preparation used to treat depression and anxiety).

For the full list of all side effects and restrictions with Harvoni, see the package leaflet.

Why is Harvoni approved?

The European Medicines Agency decided that Harvoni’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Agency considered that treatment with Harvoni, with or without ribavirin, is highly beneficial for many patients with hepatitis C virus, including those who have had a liver transplant and/or who have compensated or decompensated cirrhosis. Regarding safety, the treatment is well tolerated.

What measures are being taken to ensure the safe and effective use of Harvoni?

The company that markets Harvoni will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Harvoni. This study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Harvoni have also been included in the summary of product characteristics and the package leaflet.

Further information can be found in the summary of the risk management plan.

Other information about Harvoni

The European Commission granted a marketing authorisation valid throughout the European Union for Harvoni on 17 November 2014.

For more information about treatment with Harvoni, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.