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Incivo approved to treat chronic hepatitis C

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


Incivo is used to treat chronic (long term) hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in combination with two other medicines, peginterferonalfa and ribavirin.
It is used in adults who have compensated liver disease (when the liver is damaged but is still functioning normally) including cirrhosis (scarring of the liver) either in previously untreated patients or in those who have already been treated with interferon alfa.
The medicine can only be obtained with a prescription.
Treatment with Incivo should be started and monitored by a doctor experienced in managing chronic hepatitis C infections.
Two Incivo tablets should be swallowed whole every eight hours with food for a period of 12 weeks. Treatment with ribavirin and peginterferonalfa will continue for a longer period, based on whether the patient has been treated before and test results during their Incivo treatment.
The active substance in Incivo, telaprevir, is a protease inhibitor. It blocks the action of an enzyme called NS3-4A protease in the hepatitis C virus, which is essential for its life cycle. This stops the hepatitis C virus from replicating in the infected host cells of the body. When Incivo is added to peginterferonalfa and ribavirin (the current standard treatment for hepatitis C) this increases the likelihood of the virus being killed.
The effects of Incivo were first tested in experimental models before being studied in humans.
Incivo was investigated in three main studies in patients infected with hepatitis C. The first study involved 1,095 previously untreated patients, and the second study involved 663 patients who had already been treated with peginterferonalfa and ribavirin but were still infected. Both studies compared Incivo with placebo (a dummy treatment) added to a course of peginterferonalfa and ribavirin. A third study compared the effects of giving peginterferonalfa and ribavirin for different lengths of time (either six months or one year) together with three months of Incivo treatment. 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 six months after the end of treatment.
In the first study, when Incivo was given for three months, 75% of patients tested negative for hepatitis C compared with 44% of patients receiving placebo. In the second study, 88% of patients receiving Incivo for three months tested negative for hepatitis C compared with 24% of patients receiving placebo. The third study showed that in patients treated with Incivo, giving peginterferonalfa and ribavirin for six months was as effective as giving these medicines for one year, since  92% of patients receiving them for six months tested negative for hepatitis C compared with 88% of patients receiving them for one year.
The most common side effects with Incivo (seen in more than 1 patient in 10) were anaemia (low red blood cell counts), nausea (feeling sick),  uthoriz, vomiting, haemorrhoids (piles), proctalgia (anal pain), pruritus (itching) and rash. 
Incivo must not be used in patients who are hypersensitive (allergic) to telaprevir or any of the other ingredients. Incivo must not be given in combination with several other medicines, including those which are affected by or affect the CYP3A gene and Class Ia or III antiarrhythmics. 
The CHMP considered that adding Incivo to standard treatment represents a major advance in treating the most common type of hepatitis C virus. The Committee noted that in previously untreated patients and patients who had already been treated, adding Incivo to standard treatment considerably increased the number showing no sign of infection after six months. In addition, treatment could be shortened for many patients and the benefits could be seen across different patient types with different degrees of liver damage.
The Committee noted that the main risks identified were severe rash and the possibility of the virus developing drug resistance, but considered that these risks were manageable. The CHMP therefore concluded that the benefits of Incivo were greater than its risks, and recommended it be granted marketing  uthorization.
The company that markets Incivo will provide all doctors who are expected to prescribe it with an educational pack containing important safety information on the main risks with Incivo, in particular the risk of rash and severe skin reactions.
The European Commission granted a marketing  uthorization valid throughout the European Union for Incivo on 19 September 2011.

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Prepared by: Laila Nour

Source :

European Medicine Agency


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