What is Olysio - Simeprevir used for and what is it used for?
Olysio is an antiviral medicine that contains the active substance simeprevir . It is indicated in the treatment of chronic hepatitis C (protracted) in adults. Hepatitis C is an infectious disease that affects the liver, caused by the hepatitis C virus. Olysio is used in combination with other medicines.
How is Olysio - Simeprevir used?
Olysio can only be obtained with a prescription and treatment must be started and monitored by a doctor experienced in the management of chronic hepatitis C patients. Olysio is available in 150 mg capsules. The recommended dose is one capsule taken once a day with food for 12 weeks. Olysio should be used in combination with other medicines to treat chronic hepatitis C, including peginterferon alfa and ribavirin or sofosbuvir. Before starting treatment with Olysio, patients must have a blood test to determine which type of hepatitis C virus is responsible for the infection, since it is known that Olysio is less effective if the virus has a mutation (one modification of the genetic material of the virus) called Q80K. For more information, see the summary of product characteristics (included with EPAR).
How does Olysio - Simeprevir work?
The active substance in Olysio, simeprevir, blocks the action of an enzyme called "serine protease NS3 / 4A" within the hepatitis C virus, which is essential for virus multiplication. This action interrupts the multiplication of the hepatitis C virus and the infection of new cells. There are some varieties (genotypes) of hepatitis C virus: Olysio has been shown to be effective against genotypes 1 and 4.
What benefit has Olysio - Simeprevir shown during the studies?
Olysio has been studied in 3 main studies involving 1 178 patients with hepatitis C virus genotype 1. The first two studies included patients who had not been treated previously, while the third included patients whose infection was reappeared after interferon therapy. All three studies compared Olysio with placebo (a dummy treatment) used in combination with peginterferon alfa and ribavirin. The main measure of effectiveness was the number of patients whose blood tests showed no signs of the presence of hepatitis C virus 12 weeks after the end of treatment. Olysio has been shown to increase the proportion of patients without signs of the presence of hepatitis C virus in the blood:
- collectively examining the results of the first two studies, in about 80% (419 out of 521) of the patients who took Olysio the presence of hepatitis C was not found 12 weeks after the end of treatment compared to 50% ( 132 out of 264) of patients treated with placebo;
- in the third study, around 80% (206 out of 260) of patients who took Olysio did not find hepatitis C 12 weeks after the end of treatment compared to 37% (49 of 133) of patients treated with placebo.
An analysis of these studies showed that Olysio was less effective in a subgroup of patients with genotype 1a hepatitis C with Q80K mutation. Further studies carried out on patients with hepatitis C, genotype 4, and on patients with HIV co-infection have shown results consistent with those conducted on patients with genotype 1 infection. Olysio in combination with sofosbuvir was studied in a study in which they participated 167 patients showed that this combination (with or without ribavirin) cured genotype 1 hepatitis C in more than 90% of patients 12 weeks after the end of therapy. The study included patients with cirrhosis as well as patients who had not responded to previous therapy.
What is the risk associated with Olysio - Simeprevir?
The most common side effects of Olysio (which may affect 5 or more people in 100) are nausea, erythema, pruritus, dyspnoea (difficulty breathing), increased blood levels of bilirubin (a sign of liver problems) and photosensitivity reactions (response of the skin similar to a sunburn after exposure to light). For the full list of side effects and limitations, see the package leaflet
Why has Olysio - Simeprevir been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Olysio's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that, in both previously untreated and already treated patients, the addition of Olysio to peginterferon alfa and ribavirin therapy significantly increased the number of patients who no longer had signs of infection. The Committee also considered that the available data support the use of Olysio in combination with sofosbuvir in patients who cannot receive standard treatment, including peginterferon alfa. As for safety, Olysio was well tolerated and side effects are manageable
What measures are being taken to ensure the safe and effective use of Olysio - Simeprevir?
A risk management plan has been developed to ensure that Olysio 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 Olysio, 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 about Olysio - Simeprevir
On May 14, 2014, the European Commission granted Olysio a marketing authorization valid throughout the European Union. For the full EPAR and summary of the Olysio risk management plan, see the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Olysio therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 05-2014.
