What is Epclusa and what is it used for - Sofosbuvir - Velpatasvir?
Epclusa is an antiviral medicine indicated in the treatment of chronic (long-term) hepatitis C in adults. Hepatitis C is an infectious disease caused by the hepatitis C virus that affects the liver.
Epclusa contains the active ingredients sofosbuvir and velpatasvir.
How is Epclusa - Sofosbuvir - Velpatasvir used?
Epclusa can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the management of patients with chronic hepatitis C.
Epclusa is available as tablets containing 400 mg of sofosbuvir and 100 mg of velpatasvir. There are more varieties (genotypes) of the hepatitis C virus: Epclusa can be used to treat hepatitis C caused by all the genotypes of the virus. The recommended dose is one tablet once a day for 12 weeks.
Epclusa is given together with another medicine, called ribavirin, in patients with decompensated liver disease (when the liver is not functioning properly). The addition of ribavirin to Epclusa may also be considered for patients with compensated liver cirrhosis (scarring of the liver that is nevertheless able to function properly) and infection of the hepatitis C virus of genotype 3, a more difficult variant to to deal. For more information, see the summary of product characteristics (included with EPAR).
How does Epclusa - Sofosbuvir - Velpatasvir work?
The active ingredients of Epclusa, sofosbuvir and velpatasvir, 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 polymerase NS5B RNA-dependent", while velpatasvir acts on a protein called "NS5A". By blocking these proteins, Epclusa 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 Epclusa - Sofosbuvir - Velpatasvir shown during the studies?
Epclusa was examined in three main studies involving a total of 1 446 patients infected with hepatitis C (genotypes 1 to 6) whose liver was still able to function adequately, but some of whom suffered from cirrhosis compensated hepatic 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. Considering the results of the studies as a whole, 98% of patients (1 015 of 1 035) who had taken Epclusa for 12 weeks were negative for the virus 12 weeks after the end of treatment.
A further study was conducted on 267 patients infected with hepatitis C whose liver was unable to function properly (Child-Pugh class B cirrhosis). The results showed that the patients treated for 12 weeks with Epclusa in combination with ribavirin achieved the best results, with about 94% of patients (82 of 87) tested negative for the virus 12 weeks after the end of treatment, compared to 84% of patients treated with Epclusa alone.
What are the risks associated with Epclusa - Sofosbuvir - Velpatasvir?
Epclusa must not be used together with the following medicines, which can reduce the levels of sofosbuvir and velpatasvir in the blood and, consequently, the effectiveness of Epclusa itself:
- rifampicin, rifabutin (antibiotics);
- carbamazepine, phenobarbital, phenytoin (medicines for epilepsy);
- St. John's wort (a vegetable preparation used against depression and anxiety).
For the full list of restrictions and side effects reported with Epclusa, see the package leaflet.
Why has Epclusa - Sofosbuvir - Velpatasvir been approved?
Epclusa monotherapy has been shown to be highly effective in eliminating the hepatitis C virus from the blood of patients whose liver was able to function properly. Virus elimination was observed for all genotypes, including genotype 3, and was very high even in patients whose liver was not able to function properly (Child-Pugh class B cirrhosis), when they were treated with Epclusa in combination with ribavirin. Epclusa was well tolerated and showed a favorable safety profile.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Epclusa's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Epclusa - Sofosbuvir - Velpatasvir?
The summary of product characteristics and the package leaflet includes recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Epclusa.
Other information on Epclusa - Sofosbuvir - Velpatasvir
For the full EPclus of EPPAR please consult the website of the Agency: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Epclusa therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
