What is Rebetol?
Rebetol is a medicine that contains the active substance ribavirin. It is available as capsules (200 mg) and as an oral solution (40 mg / ml).
What is Rebetol used for?
Rebetol is indicated for the treatment of adult patients and children starting from three years with hepatitis C (liver disease caused by hepatitis C virus infection) of chronic type (protracted). Rebetol should never be used on its own (monotherapy), but exclusively in combination with an interferon (another type of medicine used to treat hepatitis).
In adults, Rebetol can be used in naïve patients (never treated before) or in subjects in whom a previous treatment including any type of interferon alpha, with or without ribavirin, had no effect. Rebetol is used in combination with both interferon alfa-2b and peginterferon alfa-2b (also for adult patients with HIV, human immunodeficiency virus). In children and adolescents, Rebetol can only be used in patients naïve without HIV infection and only in combination with interferon alfa-2b.
The medicine can only be obtained with a prescription.
How is Rebetol used?
Treatment with Rebetol should be started and monitored by a doctor experienced in the treatment of chronic hepatitis C. The dose of Rebetol depends on the patient's body weight and ranges from three to seven capsules per day in subjects with a body weight of more than 47 kg. In lower weight patients, the oral solution is used at a dose of 15 mg per kilogram of body weight per day. Rebetol should be taken daily with meals, in two separate doses (morning and evening). 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, see the package leaflet.
How does Rebetol work?
The active substance in Rebetol, ribavirin, is an antiviral medicine that belongs to the class of "nucleoside analogues". Rebetol was designed to interfere with the production or action of viral DNA and RNA, necessary for viruses to survive and multiply. Rebetol alone (alone) is ineffective in eliminating the hepatitis C virus from the body.
What studies have been performed on Rebetol?
In adults, the use of Rebetol has been tested in treatment-naïve patients and in patients with treatment experience:
- in treatment-naïve patients, Rebetol was tested in combination with interferon alfa-2b on 1, 744 patients and in combination with peginterferon alfa-2b in 1, 580 patients. Furthermore, two studies examined the use of Rebetol in combination with either type of interferon in 507 patients with concurrent HIV infection;
- in patients with experience with Rebetol treatment was analyzed in combination with interferon alfa-2b in 345 patients who had relapsed (whose disease had reappeared) following undetectable hepatitis C virus levels after undergoing a previous cycle of interferon administered alone;
- Rebetol has also been tested in combination with peginterferon alfa-2b in 1 354 patients who had not responded to previous treatment with interferon and ribavirin. This study included patients who had not responded to previous treatment and patients who had relapsed.
In children and adolescents three to 16 years old, Rebetol in combination with interferon alfa-2b has been studied in 70 treatment-naïve patients.
In most studies, the main measure of effectiveness was the amount of virus in the blood before and after 24 or 48 weeks of treatment as well as at the follow-up visit (24 weeks later). Some studies have also looked at signs of improvement in liver conditions.
What benefit has Rebetol shown during the studies?
In treatment-naïve adults, Rebetol in combination with interferon alfa-2b was more effective than interferon alfa-2b alone: at the follow-up visit (48 weeks) a response to the combination treatment was found in 41% of subjects compared to 16% of patients who had only taken interferon alfa-2b. The efficacy of Rebetol was greater when given in combination with peginterferon alfa-2b than in combination with interferon alfa-2b. Rebetol in combination with peginterferon alfa-2b was also effective in the treatment of hepatitis C in patients with concomitant HIV infection.
In relapsing patients after previous treatment with interferon, response control rates were 37% with the combination of Rebetol and interferon alfa-2b and 4% with interferon alfa-2b alone.
In the study of patients who had not responded to a previous combination treatment, approximately one fifth of patients responded to the new treatment with Rebetol and peginterferon alfa-2b.
In children and adolescents, 49% of patients responded to Rebetol associated with interferon alfa-2b after 48 weeks.
What is the risk associated with Rebetol?
The most common side effects with Rebetol used in combination with interferon alfa-2b or peginterferon alfa-2b (seen in general in more than 1 patient in 10) are viral infections, pharyngitis (sore throat), anemia (decreased number red blood cells), neutropenia (low levels of white blood cells, fighting infection), hypothyroidism (insufficient activity of the thyroid gland), anorexia (loss of appetite), depression, insomnia, emotional lability (mood changes), anxiety, reduced salivation, headache, dizziness, decreased concentration, cough, dyspnea (difficulty breathing), nausea, diarrhea, abdominal pain, vomiting, alopecia (hair loss), itching, dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the injection site including inflammation, fatigue, fever, chills, symptoms fluens, asthenia (weakness), malaise, irritability, weight loss and reduced growth rate. For the full list of all side effects reported with Rebetol, see the Package Leaflet.
Rebetol should not be used in people who may be hypersensitive (allergic) to ribavirin or other ingredients in the medicine. Rebetol should not be administered to:
- pregnant women or breastfeeding women;
- patients with serious medical conditions, including serious heart, kidney or liver disease;
- patients suffering from certain blood changes affecting hemoglobin (the protein in red blood cells that carries oxygen throughout the body);
- patients with a history of immune system disorders or who take drugs that reduce the activity of the immune system;
- children and adolescents with a history of severe mental illness, especially severe depression, suicidal thoughts or suicide attempts.
For the full list of usage restrictions, see the package leaflet.
Because treatment with Rebetol associated with interferon alfa can cause side effects such as depression, patients should be carefully monitored during treatment.
Why has Rebetol been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Rebetol's benefits are greater than its risks for the treatment of chronic hepatitis C virus infection, as part of a combined regimen of peginterferon alfa-2b therapy (adults), including treatment-naïve patients with clinically stable HIV co-infection, or interferon alfa-2b (adults, children from three years and adolescents). The Committee therefore recommended the granting of the marketing authorization for Rebetol.
Other information on Rebetol:
On 7 May 1999, the European Commission granted a marketing authorization valid throughout the European Union for Rebetol to SP Europe. The marketing authorization was renewed on 7 May 2004 and 7 May 2009.
The full EPAR for Rebetol can be found here
Last update of this summary: 05-2009.
