Incivo - telaprevir

What is Incivo - telaprevir?

Incivo is a medicine that contains the active substance telaprevir. It is available as tablets (375 mg).

What is Incivo used for - telaprevir?

Incivo is used in the treatment of hepatitis C (a liver disease due to hepatitis C virus infection) chronic (long-term) in combination with two other medicines, peginterferon alfa and ribavirin.

The medicine is used in adult patients with compensated liver disease (when the liver is damaged but still functioning regularly), including cirrhosis (scarring of the liver), which has never been treated previously or which has previously been treated with interferon alfa.

The medicine can only be obtained with a prescription.

How is Incivo used - telaprevir?

Treatment with Incivo should be started and monitored by a physician experienced in the treatment of chronic hepatitis C infections.

The administration involves the intake of two tablets of Incivo, ingested whole every eight hours with food for a period of 12 weeks. Treatment with ribavirin and peginterferon alfa will last longer depending on whether the patient was previously treated and the results of tests performed during Incivo treatment.

How does Incivo work - telaprevir?

The active substance in Incivo, telaprevir, is a protease inhibitor. It blocks the action of an enzyme in the hepatitis C virus, called the NS3-4A protease, essential for its life cycle. This prevents the hepatitis C virus from replicating in the organism's infected host cells. If Incivo is associated with peginterferon alfa and ribavirin (the current standard treatment for hepatitis C), the possibility of eliminating the virus is increased.

What studies have been carried out on Incivo - telaprevir?

The effects of Incivo were first tested in experimental models before being studied in humans.

Incivo has been studied in three main studies on patients with hepatitis C. The first study involved 1095 patients who had not been treated previously and the second study involved 663 patients who had already been treated with peginterferon alfa and ribavirin, but were still infected. Both studies compared Incivo with placebo (a dummy treatment) added to a course of peginterferon alfa and ribavirin. A third study compared the effects of the administration of peginterferon alfa and ribavirin for different time periods (six months or one year) together with treatment with Incivo lasting three months. In all three studies, the main measure of effectiveness was the number of patients whose blood tests showed no signs of hepatitis C virus six months after the end of treatment.

What benefit has Incivo - telaprevir shown during the studies?

In the first study, in which Incivo was given for three months, 75% of the patients tested negative for hepatitis C compared to 44% of patients who took the placebo. In the second study, 88% of patients who had been treated with Incivo for three months were negative for hepatitis C compared to 24% of patients who took the placebo. The third study showed that in patients treated with Incivo, the administration of peginterferon alfa and ribavirin for six months was as effective as the administration of the latter for a year, since 92% of the patients who took them for six months was negative for hepatitis C compared to 88% of patients who had taken them for a year.

What is the risk associated with Incivo - telaprevir?

The most common side effects with Incivo (seen in more than 1 patient in 10) were anemia (low number of red blood cells), nausea, diarrhea, vomiting, haemorrhoids, proctalgia (anal pain), itching and rash. For the full list of all side effects reported with Incivo, see the package leaflet.

Incivo should not be used in people who may be hypersensitive (allergic) to telaprevir or any of the other ingredients. Incivo should not be given in combination with several other medicines, including those that are affected by or affect the CYP3A gene and class Ia or III antiarrhythmics. For the full list of limitations, see the package leaflet.

Why was Incivo approved - telaprevir?

The CHMP considered that the addition of Incivo to standard treatment represents an important advance in the treatment of the most common type of hepatitis C virus. The Committee noted that in previously untreated patients and in those who had already been treated, the addition of Incivo to standard treatment considerably increased the number of those who showed no signs of infection after six months. Furthermore, the treatment could be shortened for many patients and the benefits could be found in different types of patients with different degrees of liver damage.

The committee found that the main risks identified were the severe rash and the possibility that the virus developed drug resistance, but considered that these risks were manageable. The CHMP therefore concluded that the benefits of Incivo outweighed its risks and recommended that it be given marketing authorization.

What measures are being taken to ensure the safe use of Incivo - telaprevir

The company that markets Incivo will provide all the doctors who will prescribe the medicine with informative material containing important safety information regarding the main risks associated with Incivo, in particular the risk of rash and severe skin reactions.

More information on Incivo - telaprevir

On 19 September 2011, the European Commission issued a marketing authorization for Incivo, valid throughout the European Union.

For more information on Incivo therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Last update of this summary: 08-2011.