What is Harvoni and what is it used for - ledipasvir, sofosbuvir?
Harvoni is an antiviral medicine indicated in the treatment of chronic (prolonged) hepatitis C in adults. Hepatitis C is an infectious disease that affects the liver, caused by the hepatitis C virus. Harvoni contains the active ingredients ledipasvir and sofosbuvir .
How is Harvoni used - ledipasvir, sofosbuvir?
Harvoni can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in managing patients with chronic hepatitis C. Harvoni is available as tablets containing 90 mg of ledipasvir and 400 mg of sofosbuvir. The recommended dose is one tablet once a day. There are more varieties (genotypes) of hepatitis C virus. Harvoni is recommended for use in patients with genotype 1 and 4 infection, and in some patients with genotype 3 infection. Duration of treatment with Harvoni and decision using the medicine alone or in combination with another medicine called ribavirin depends on the viral genotype and the type of liver problem observed in the patient, for example if the patient suffers from liver cirrhosis (scarring of the liver) or if hepatic dysfunction is present . For more information, see the package leaflet.
How does Harvoni - ledipasvir, sofosbuvir work?
The active ingredients of Harvoni, ledipasvir and sofosbuvir, block the action of two proteins that are essential for the multiplication of hepatitis C virus. Sofosbuvir blocks the action of an enzyme called "RNA-dependent RNA polymerase (NS5B)", while ledipasvir acts on a protein called "NS5A". By blocking these proteins, Harvoni stops the multiplication of hepatitis C virus and the infection of new cells. Sofosbuvir has been authorized under the Sovaldi name since January 2014.
What benefit has Harvoni - ledipasvir, sofosbuvir shown during the studies?
Harvoni has been examined in three main studies involving a total of about 2, 000 patients with hepatitis C due to genotype 1, without impaired liver function. In all three studies, the main measure of effectiveness was the number of patients whose blood test showed no evidence of hepatitis C virus 12 weeks after treatment. In these studies, patients were treated with Harvoni, with or without ribavirin, for 8, 12 or 24 weeks, depending on the characteristics of the patients. Approximately 94% up to 99% of patients treated with Harvoni monotherapy were negative for hepatitis C 12 weeks after the end of treatment. In most patients it was not necessary to add ribavirin. The results of the studies also showed that patients with compensated cirrhosis (scarring of the liver, but without liver failure) were more likely to eliminate the infection if the treatment was extended to 24 weeks. Patients with infection resistant to other antiviral medicines also benefited from prolonged treatment at 24 weeks. Data collected to support the use of the medicine showed that Harvoni taken in combination with ribavirin would benefit some patients with genotype 3 infection, as well as patients with genotype 1 or 4 infection and decompensated cirrhosis (scarring of the liver with reduced liver function) and / or patients undergoing liver transplantation.
What is the risk associated with Harvoni - ledipasvir, sofosbuvir?
The most common side effects of Harvoni (which may affect more than 1 in 10 people) are fatigue and headache. Harvoni should not be given in combination with rosuvastatin, a medicine used to treat high cholesterol, or products containing St. John's wort (a herbal preparation used to treat depression). For the full list of all side effects and restrictions with Harvoni, see the package leaflet.
Why has Harvoni - ledipasvir, sofosbuvir been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Harvoni's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP considered that treatment with Harvoni, with or without ribavirin, offers an enormous benefit to many patients with hepatitis C, including those who have undergone liver transplantation and / or who suffer from compensated cirrhosis. Despite the small number of studies conducted on patients with decompensated cirrhosis, they could benefit from prolonged treatment with Harvoni and ribavirin. As for safety, treatment is well tolerated.
What measures are being taken to ensure the safe and effective use of Harvoni - ledipasvir, sofosbuvir?
A risk management plan has been developed to ensure that Harvoni is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Harvoni, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Harvoni - ledipasvir, sofosbuvir
On 17 November 2014, the European Commission granted Harvoni a marketing authorization valid throughout the European Union. For the full version of EPAR and the summary of Harvoni's risk management plan, consult the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Harvoni, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 10/2014.
