What is PegIntron?
PegIntron is a medicine that contains the active substance peginterferon alfa-2b. It is available as a powder and solvent for solution for injection and in a single-use pre-filled pen, both containing 50, 80, 100, 120 or 150 micrograms of peginterferon alfa-2b for 0.5 ml.
What is PegIntron used for?
PegIntron is indicated for the treatment of adult patients with hepatitis C (an infection of the liver and caused by the hepatitis C virus) of chronic type (protracted). PegIntron is used in patients who still have good liver function but who show signs of the disease (increased transaminases [liver enzymes] and presence of markers of infection in the blood, such as viral RNA or antibodies against the virus). It can be used in patients also suffering from HIV (human immunodeficiency virus). The optimal use of PegIntron is in combination with ribavirin (an antiviral drug). This combination is indicated both in treatment-naïve patients (i.e. never previously treated) and in patients in whom a previous therapy comprising any type of interferon alpha, with or without ribavirin, has not responded. PegIntron can be used on its own (monotherapy) if the patient is intolerant or cannot take ribavirin.
The medicine can only be obtained with a prescription.
How is PegIntron used?
PegIntron treatment should be started and monitored by a doctor who has experience in the treatment of patients with hepatitis C. PegIntron should be given as a subcutaneous injection (under the skin) once a week. In monotherapy the dosage regimen is 0.5 or 1 microgram per kilogram of body weight per week, while in combination with ribavirin the dose is 1.5 micrograms per kilogram per week. The duration of treatment depends on the condition of the patient and his response to treatment, and can vary from 24 weeks to a year. In case of side effects it may be necessary to adjust the dosage. For more information on the dosage, see the Summary of Product Characteristics, which is also included with the EPAR.
PegIntron should be stored in a refrigerator (2 ° C-8 ° C).
How does PegIntron work?
The active substance in PegIntron, peginterferon alfa-2b, belongs to the group of "interferons". Interferons are natural substances produced by the body to help it cope with attacks such as viral infections. The mechanism of action of alpha interferons in viral diseases is not
still completely known; however, it is believed that they act as immunomodulators (substances that modify the immune responses, that is to say defense, of the organism). Alpha interferons can also stop the proliferation of viruses.
Peginterferon alfa-2b is similar to interferon alfa-2b, already available in the European Union (EU) under the name IntronA. In the medicine PegIntron, interferon alfa-2b was "pegylated" (ie coated with a chemical called "polyethylene glycol"). This allows to slow down the elimination time of the substance from the body and, therefore, to administer the drug less frequently. The interferon alfa-2b contained in PegIntron is produced by a method known as "recombinant DNA technique": that is, it is obtained from a bacterium in which a gene (DNA) has been inserted that makes it capable of producing interferon. The replacement interferon acts like naturally produced interferon alpha.
How has PegIntron been studied?
The use of PegIntron monotherapy in patients with chronic hepatitis C has been examined in a study of 1, 244 adults with treatment naïve. PegIntron used once a week for 48 weeks (0.5, 1 or 1.5 micrograms / kg) was compared with interferon alfa-2b given in 3 million international units (IU) three times a week. The use of PegIntron with ribavirin has been studied for over 48 weeks in 1, 580 treatment-naïve patients. In this study two regimens were compared: PegIntron in combination with ribavirin and interferon alfa-2b in combination with ribavirin. Two other studies examined the use of PegIntron in combination with ribavirin in 565 patients also with HIV and in a further study the use of this combination was observed in 1 354 patients in whom a previously inclusive treatment of interferon alfa (pegylated or non-pegylated) had not responded or in which the disease had recurred after the treatment.
The main measure of effectiveness was the concentration of hepatitis C RNA virus present in the blood before and during the treatment as well as in the control period, after 24 weeks.
What benefit has PegIntron shown during the studies?
In the first study, PegIntron was more effective than interferon alfa-2b. The number of patients without viral RNA circulating after 24 weeks of treatment was higher among subjects treated with PegIntron than those treated with interferon alfa-2b: 46% of subjects who received PegIntron in 1.5 micrograms / kg / week compared to 24% of patients who took the comparator.
The combination of ribavirin with PegIntron (one injection per week of 1.5 micrograms / kg) was more effective than the combination with interferon alfa-2b (3 million IU three times a week): at the end of the study had responded to treatment a greater number of patients (65% compared to 54%).
The combination of PegIntron with ribavirin was also effective in the treatment of hepatitis C in patients with concurrent HIV infection. In the study involving patients who had not responded to previous treatment, about one fifth responded to treatment with PegIntron in combination with ribavirin.
What is the risk associated with PegIntron?
Side effects with PegIntron (seen in more than 1 patient in 10) are viral infections, weight loss, depression, irritability, insomnia, anxiety, difficulty concentrating, emotional instability (mood swings), headache, dry mouth ( dry mouth), dyspnoea (difficulty breathing), pharyngitis (sore throat), cough, vomiting, nausea, abdominal pain, diarrhea, anorexia (loss of appetite), alopecia (hair loss), itching, dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), inflammation at the injection site, reaction at the injection site (pain and redness), dizziness, fatigue, chills, fever, flu-like symptoms and asthenia (weakness). For the full list of all side effects reported with PegIntron, see the Package Leaflet.
PegIntron should not be used in people who may be hypersensitive (allergic) to interferon or other ingredients in the medicine. PegIntron should not be administered to:
- patients with a history of severe heart disease;
- patients with serious medical conditions;
- patients suffering from autoimmune disease (a disease in which the body attacks its own structures);
- patients with severe liver problems;
- patients with thyroid disease, if not controlled;
- patients with epilepsy or other problems affecting the central nervous system;
- HIV patients with signs of severe liver disease.
In combination with ribavirin, PegIntron should not be used in patients with kidney problems.
For the full list of usage restrictions, see the package leaflet.
Why has PegIntron been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that PegIntron's benefits are greater than its risks for the treatment of adult patients with chronic hepatitis C who have elevated transaminase levels without hepatic decompensation and who are positive for HCV- Serum or anti-HCV RNA, including clinically stable HIV-naïve treatment patients. The Committee therefore recommended the granting of the marketing authorization for PegIntron.
Other information on PegIntron:
On 25 May 2000, the European Commission issued a marketing authorization for PegIntron, valid throughout the European Union, to SP Europe. The marketing authorization was renewed on 25 May 2005.
The full EPAR for PegIntron can be found here.
Last update of this summary: 11-2007.
