What is INCIVO® (Telaprevir)?
INCIVO® (also called Telaprevir) is a new type of treatment for people with chronic hepatitis C. It is a protease inhibitor (PI) that targets the life cycle of the hepatitis C virus. Protease inhibitors belong to a group of medicines called Direct Acting Antivirals (DAAs). These protease inhibitors must also be taken with interferon and ribavirin.
Who is it for?
INCIVO® (Telaprevir) has a licence to be used for adult patients with genotype 1 chronic hepatitis C virus unless you have decompensated liver disease (advanced cirrhosis):
- who are treatment naive (have not been treated before for hepatitis C);
- or who have previously been treated with interferon alfa (pegylated or non pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.
Your doctor or nurse will discuss potential treatments with you for your hepatitis C depending on the genotype of the virus you have.
I have genotype 2 or 3 chronic hepatitis C, can I have Incivo?
No, Incivo is only licensed for patients with genotype 1 chronic hepatitis C.
How do you take Incivo?
INCIVO® (Telaprevir) is available as two tablets that you take by mouth (orally) three times a day (8 hours apart) with food.
If you are prescribed INCIVO® (Telaprevir), your doctor or nurse will explain about the tablets and when you should take them. They can also advise you on what types of food you should plan to take with INCIVO® (Telaprevir).
Do you still have to take peginterferon alfa and ribavirin with Incivo or can it be taken on its own?
Incivo must be taken in combination with peginterferon alfa and ribavirin and only when it has been prescribed by a doctor or nurse.
How long should you take Incivo for?
Incivo will be taken for 12 weeks. However, if the virus does not respond well to Incivo in the first few weeks, your doctor or nurse may stop the Incivo.
Your doctor or nurse will advise you on how long you should take Incivo and your other medicines for. You should not stop Incivo unless your doctor or nurse tells you to.
Your doctors or nurses will arrange for you to have a blood test at week 4 which will measure the amount of hepatitis c virus you have in your blood.
Most patients respond well to Incivo in the first few weeks and will receive 12 weeks of treatment with Incivo.
If your virus is undectable at week 12 you will continue with peginterferon alfa and ribavirin for a further 12 weeks (24 weeks of treatment in total) unless you have been treated for your hepatitis C before in which case you may stay on treatment with peginterferon alfa and ribavirin for longer.
Some people will need to take peginterferon alfa and ribavirin for a total of 48 weeks but your doctor or nurse will discuss this with you on an individual basis.
Does it work?
Incivo can boost the success rate of clearing the virus from 50% to 80% and in some cases will shorten the time that a patient needs to be on treatment.
What side effects are there?
The most commonly experienced side effects in clinical trials were:
- Swollen veins in the rectum or anus (haemorrhoids)
- Pain in the anus or rectum
Side effects will be managed by your doctor or nurse. Never reduce the dose or stop taking any of your treatments without speaking to your doctor or nurse first. Once INCIVO® (Telaprevir) is stopped it cannot be restarted.
I’ve heard that rash is a problem with INCIVO® (Telaprevir). Is it?
55% people who took INCIVO® (Telaprevir) in clinical trials experienced a rash compared to 33% who received peginterferon alfa and ribavirin alone.
The majority (more than 90%) of rash was mild to moderate but in a small number of
patients, severe rash developed. Rarely, patients may have other symptoms with the rash
that may be a sign of a severe skin reaction.
You should contact your doctor immediately if you get a skin rash and your doctor should check your rash to determine how to manage it.
Also contact your doctor immediately:
If your rash worsens, OR if you develop other symptoms with a rash, such as:
- swelling of the face
- swelling of lymph glands,
- If you have a widespread rash with peeling skin which
- may be accompanied by fever, flu-like symptoms,
- painful skin blisters, and blisters in the mouth, eyes, and/or genitals.
If you experience any of the above you should contact your doctor immediately or go to a hospital with an Emergency department.
Contact your doctor immediately if you develop any of the following symptoms:
- shortness of breath
- light headedness
- and/or a feeling of heart racing
These may be symptoms of anaemia (a decrease in your red blood cells)
- Painful inflammation of the joints, most commonly the foot (gout)
- Problems with your eyesight
- Bleeding from the anus
- Swelling of the face
It is important to remember that Telaprevir is taken in combination with interferon and ribavirin, therefore the side effects associated with traditional treatment may still occur.(click here for interferon and ribavirin side effects)
Why do I need to take INCIVO® (Telaprevir) with food?
Incivo must always be taken together with food. The food is important to help absorption and get the right levels of medicine into your body. Examples of food that can be taken with Incivo are:
- Fatty cuts of meat
- Full fat cheese
- Oily fish
- Peanut butter
- Whole milk and cream
- Foods containing vegetable fats (e.g. chocolate)
Will INCIVO® (Telaprevir) affect the other medicines I am taking?
INCIVO® (Telaprevir) may affect other medicines and other medicines may affect INCIVO® (Telaprevir) including medicines bought without a prescription and herbal remedies.
It is very important to tell your doctor or pharmacist if you are taking or have recently taken other medicines including medicines obtained without a prescription and herbal remedies.
INCIVO® (Telaprevir) should not be taken with the following medicines and further advice should be sought from the doctor or nurse who prescribed INCIVO® (Telaprevir).
Ergot derivatives (dihydroergotamine, ergonovine, ergotamine,methylergonovine)
Silenafil or tadalafil
Midazolam or triazolom
St John’s Wort
INCIVO® (Telaprevir) should also be used with caution with other medications not listed and therefore you should tell your doctor or nurse about ALL medicines you are taking BEFORE being prescribed INCIVO® (Telaprevir).
Can I chew, dissolve or break the INCIVO® (Telaprevir) tablets?
No, tablets must be swallowed whole. Do not chew, break or dissolve the tablets before you swallow them. Tell your doctor or nurse if you have any problems swallowing whole tablets.
What if I miss an INCIVO® (Telaprevir) dose?
If you noticed the missed dose within 4 hours, take the missed prescribed dose with food immediately.
If you noticed the missed dose after 4 hours, SKIP the missed dose and resume the normal dosing schedule for the next dose. Do not take a double dose to make up for a forgotten dose.
What if I have taken more INCIVO® (Telaprevir) than I should?
Contact the doctor or nurse treating you, so they can advise you of what to do.
Unless the doctor or nurse tells you to, do not stop taking Incivo. If the doctor or nurse decides that you should stop taking Incivo, you cannot restart it.
How do I store INCIVO® (Telaprevir)?
The tablets should be stored in their original bottle. Keep the bottle tightly closed in order to protect them from moisture. The bottle contains a pouch of desiccant to keep the tablets dry.
Other useful information:
INCIVO® (Telaprevir) is not recommended during pregnancy and in women of childbearing potential who are not using contraception. Even more important, ribavirin which is taken with INCIVO® (Telaprevir), should NEVER be taken during pregnancy. Therefore, patients should use 2 effective contraceptive methods during treatment with INCIVO® (Telaprevir).