PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Viracept?
Viracept is a medicine containing the active substance nelfinavir, available as an oral powder (50 mg / g) and in an oblong blue tablet (250 mg).
What is Viracept used for?
Viracept is an antiviral drug, indicated in combination with other antiviral medicines for the treatment of adult patients, adolescents and children over the age of three years with human immunodeficiency virus type 1 (HIV-1) infection, a virus that causes the acquired immunodeficiency syndrome (AIDS).
Doctors should prescribe Viracept only to patients who have already taken drugs belonging to the same class as Viracept (protease inhibitors) and only after having carefully considered the previous antiviral drugs taken by the patient and the possibility that the virus responds to the drug.
The medicine can only be obtained with a prescription.
How is Viracept used?
Treatment with Viracept should be started by a doctor who specializes in treating HIV infection. For patients over the age of 13, the recommended dose of Viracept is 1 250 mg twice a day or 750 mg three times a day, taken with food. The dose in children aged between three and 13 years depends on body weight. For those patients who are unable to swallow the capsules, oral powder is available. The correct amount of powder is measured using the special measuring cups provided in the package and by dissolving the powder in milk or artificial milk. Viracept should be used with caution in patients with liver or kidney problems. For more information, see the package leaflet.
How does Viracept work?
The active substance in Viracept, nelfinavir, is a protease inhibitor. It blocks an enzyme called protease that is involved in the reproduction of HIV. If the enzyme is blocked, the virus is unable to reproduce normally and the infection is slowed down. Viracept, taken in combination with other antiviral medicines, reduces the concentration of HIV in the blood and keeps it at a low level. Viracept does not cure HIV 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 performed on Viracept?
Viracept has been studied in combination with other antiviral medicines in two main studies involving 605 patients from the age of 13, who have HIV. In the first study Viracept in combination with stavudine (another antiviral drug) was compared with stavudine alone in 308 patients who had not previously taken stavudine or a protease inhibitor. In the second study, Viracept in combination with zidovudine and lamivudine (other antiviral drugs) was compared to the combination of zidovudine and lamivudine in 297 treatment-naïve patients (ie in patients who had not previously taken any antiviral medication for the treatment of the infection from HIV). The main measures of effectiveness were the changes in the concentration of HIV in the blood (viral load) and the increase in the number of T-CD4 cells in the blood (CD4 cell count). T-CD4 cells are a type of white blood cell that play an important role in fighting infections, but which are killed by HIV.
The efficacy of the Viracept dose taken two and three times a day in combination with stavudine and lamivudine was compared in three studies involving 635 patients. Most of these patients had not received protease inhibitors in the past. Viracept has also been studied in 37 children.
What benefit has Viracept shown during the studies?
Viracept, in combination with other antiviral drugs, was more effective than the comparator medicines in both main studies. After 24 weeks, Viracept showed greater reductions in viral load and an increase in CD4 cell counts compared to comparator medicines. No difference was found between the two doses of Viracept. In the second study, the viral load decreased by over 99% in patients who took the higher dose of Viracept than in 95% of subjects treated with the comparator medicines. CD4 cell counts increased by 150 and 95 cells / mm3 respectively.
Viracept has had similar reductions in viral load whether administered twice a day or administered three times a day. The study conducted on children showed that the drug produces similar concentrations of the active ingredient in the blood in both children and adults, with similar side effects and efficacy.
What is the risk associated with Viracept?
The most common side effect of Viracept (seen in more than 1 patient in 10) is diarrhea. For the full list of all side effects reported with Viracept, see the Package Leaflet.
VIRACEPT should not be used in people who may be hypersensitive (allergic) to nelfinavir or any of the other ingredients. Viracept should not be used in patients who are treated with any of the following drugs:
- rifampicin (for the treatment of tuberculosis);
- St. John's wort (vegetable preparation used in the treatment of depression);
- omeprazole (used to reduce the concentration of acid in the stomach);
- drugs that are metabolized in the same way as Viracept and that are dangerous if they reach high concentrations in the blood. For the full list of these medicines, see the package leaflet.
In patients taking Viractpt, doctors should consider the use of alternative medicines that accelerate the decomposition of Viracept, such as phenobarbital and carbamazepine (used to treat epilepsy). Care should be taken with the use of Viracept together with other drugs. For more details, see the package leaflet.
As with other anti-HIV drugs, patients receiving Viracept may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by reactivating the system immune). Patients with liver problems (including hepatitis B or C) may be at an increased risk of developing liver damage when treated with Viracept.
Why has Viracept been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Viracept's benefits in combination with other antiretrovirals outweigh the risks in the treatment of adult patients, adolescents and children aged three years or older with HIV-1 infection . The Committee therefore recommended that Viracept be given marketing authorization.
Viracept was initially authorized in "exceptional circumstances", because at the time the authorization was granted, for scientific reasons, only limited information was available. Since the company provided the additional information requested, the condition referring to "exceptional circumstances" was removed on 1 August 2001.
More information on Viracept
On 22 January 1998, the European Commission granted Viracept a marketing authorization valid throughout the European Union to Roche Registration Limited. The marketing authorization was renewed on 22 January 2003 and 22 January 2008.
The full EPAR for Viracept can be found here.
Last update of this summary: 07-2008.
