What is Viramune?
Viramune is a medicine containing the active substance nevirapine. It is available as white and oval tablets (200 mg), and as an oral suspension (50 mg / 5 ml).
What is Viramune used for?
Viramune is an antiviral drug. It is indicated in combination with other antiviral medicines for the treatment of patients with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
The medicine can only be obtained with a prescription.
How is Viramune used?
Viramune should be administered by a doctor experienced in treating HIV infection.
Viramune should never be administered alone, but taken in combination with at least two other antiviral medicines. Since the medicine can cause severe skin reactions, the treatment should start with a dose of 200 mg once a day for two weeks, before increasing the dose to the standard dose of 200 mg twice a day. It is advisable not to increase the dose until the complete dose is taken twice a day before the complete disappearance of any rash. If the patient cannot switch to a dose of twice a day within the first four weeks of starting treatment with Viramune, alternative treatments should be found.
For patients under the age of 16 and with a body weight less than 50 kg or with a body surface area (calculated based on weight and height) of less than 1.25 m2, an oral suspension is available, which can be dosed according to weight or the patient's body surface. For more information, see the package leaflet.
How does Viramune work?
The active substance in Viramune, nevirapine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks the activity of reverse transcriptase, an enzyme produced by the HIV-1 virus that allows it to infect and reproduce. By blocking this enzyme, Viramune, taken in combination with other antiviral drugs, reduces the amount of HIV-1 in the blood, keeping it at a low level. Viramune does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
What studies have been carried out on Viramune?
Viramune was examined in five studies involving a total of 1 956 adults. Studies have compared Viramune, taken in combination with zidovudine and didanosine (other antiviral drugs), with other antiviral drugs. Viramune, taken alone (alone) or in combination with one or two other antiviral drugs, has also been studied in two studies involving 478 children. The main measures of effectiveness were the change in the concentration of HIV in the blood (viral load) and the increase in the number of CD4 T cells in the blood (CD4 cell count), as well as the number of patients showing a worsening of the disease or who had died. CD4 T cells are white blood cells that play an important role in fighting infections, but which are killed by HIV.
What benefit has Viramune shown during the studies?
Viramune, taken in combination with two other antiviral drugs, was more effective than preparations based on two drugs. In the 398 adults who had previously been treated for HIV infection previously, Viramune in combination with zidovudine and lamivudine induced a 38% reduction in viral load after 48 weeks, whereas in the group of patients treated with zidovudine and lamivudine without Viramune there was an increase of 28%. In the 151 naïf patients (subjects who had never previously undergone a cure for HIV infection), the viral load precipitated by 99% in the group treated with three drugs compared to the 96% decrease recorded in the group treated with two drugs after 40 -52 weeks of therapy. In addition, greater increases in CD4 cell counts and lower risk of disease or death were observed in adults treated with three drugs. Similar results have been found in HIV-1 infected children.
What is the risk associated with Viramune?
The most frequently reported undesirable effects related to Viramune therapy (seen in between 1 and 10 patients in 100) are rash, allergic reactions, headache, nausea, hepatitis (inflammation of the liver) and signs of liver disorders in the blood. Viramune has been associated with serious side effects, including Stevens-Johnson syndrome and toxic epidermal necrolysis (both life-threatening allergic reactions to skin and mucous membranes), severe hepatitis and liver failure, and severe allergic reactions. Patients should be carefully monitored during the first 18 weeks of treatment to readily identify the signs of these side effects. In addition, blood tests should be performed regularly to monitor liver function throughout the treatment. For the full list of all side effects reported with Viramune, see the Package Leaflet.
Viramune should not be used in people who may be hypersensitive (allergic) to nevirapine or any of the other substances. It must not be used in patients with severe liver disorders or signs of liver problems in the blood or in patients taking St. John's wort (a herbal preparation used to treat depression). You should not restart treatment with Viramune in patients who in the past have had to stop taking it because of a skin rash, allergic reactions or hepatitis, or where you have seen signs of hepatic distress while taking Viramune and then reappeared in conjunction with further intake of the drug.
As with other anti-HIV drugs, patients taking Viramune may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (inflammatory symptoms caused by the reactivation of the immune system) . Patients with liver problems (including hepatitis B or C infection) may be at a high risk of developing liver damage if they are treated with Viramune.
Why has Viramune been approved?
The Committee for Medicinal Products for Human Use (CHMP) has determined that Viramune's benefits are greater than its risks in combination with other anti-retroviral medicines to treat adults,
teenagers and children of all ages infected with HIV-1.
The committee noted that most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs, a type of antiviral drug) and that insufficient data are available on the use of combination therapy including an inhibitor of protease (another type of antiviral drug) after Viramune therapy. The Committee therefore recommended that the product be granted marketing authorization.
Viramune was initially authorized in "exceptional circumstances", because for scientific reasons only limited information was available at the time the authorization was granted. Since the pharmaceutical company provided the additional information requested, the condition referring to "exceptional circumstances" was removed on 11 July 2002.
Other information about Viramune:
On 5 February 1998, the European Commission granted Viramune a marketing authorization valid throughout the European Union to Boehringer Ingelheim International GmbH. The marketing authorization was renewed on 5 February 2003 and 5 February 2008.
For the full EPAR version of Viramune click here.
Last update of this summary: 09-2009.
