What is Combivir?
Combivir is a medicine containing two active substances: lamivudine (150 mg) and zidovudine (300 mg). It is available as white, capsule-shaped tablets.
What is Combivir used for?
Combivir is an antiviral drug. It is used in combination with at least one other antiviral drug for the treatment of patients with human immunodeficiency virus (HIV) infection, the virus that causes acquired immune deficiency syndrome (AIDS).
The medicine can only be obtained with a prescription.
How is Combivir used?
Treatment with Combivir should be started by a doctor who has experience in the treatment of HIV infection.
In adults and adolescents with a body weight of at least 30 kg, the recommended dose of Combivir is one tablet twice a day. In children with a body weight between 14 and 30 kg, the number of tablets and half tablets to be taken depends on body weight. Children weighing less than 14 kg should take separate oral solutions containing lamivudine and zidovudine. Children taking Combivir should be monitored carefully for side effects.
Combivir can be taken with or without food. In theory, the tablets should be swallowed whole, but patients who cannot do it can crush them, add them to a small amount of food or drink and take them immediately. In the case of patients who have to stop taking lamivudine or zidovudine or who have to change doses due to problems with their kidneys, liver or blood, it is necessary to use medicines containing lamivudine or zidovudine separately.
For more information, see the package leaflet.
How does Combivir work?
Both the active ingredients of Combivir, lamivudine and zidovudine, are nucleoside reverse transcriptase inhibitors (NRTIs). Both act in the same way, blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows the virus to infect cells and reproduce. Combivir, taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level. Combivir does not cure HIV infection
or AIDS, but can delay the damage to the immune system and the onset of infections and diseases associated with AIDS.
How has Combivir been studied?
Since zidovudine has been available in the European Union (EU) since the mid-1980s and lamivudine has been authorized in the EU since 1996 (Epivir), the company presented information obtained from previous studies for the combination of the two substances. The company also compared the tablet containing the two active ingredients with those containing lamivudine and zidovudine separately in 75 adults and adolescents who had never previously been treated for HIV infection. 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) after 12 weeks of treatment. CD4 T cells are white blood cells that play an important role in fighting infections, but which are killed by HIV. The company also looked at how the single tablet is absorbed by the body compared to the separate tablets.
In support of its recommendations for Combivir doses in children, the company presented information taken from studies on the levels of lamivudine and zidovudine in the blood in children taking the drugs separately. He also presented information on the expected blood levels of the two substances in children taking the two substances together in one tablet.
What benefit has Combivir shown during the studies?
Combivir was effective in reducing the viral load and inducing an increase in the CD4 count. Previous studies have shown that the two active ingredients, lamivudine and zidovudine, taken in combination, can reduce the viral load and induce an increase in CD4 cell counts after a maximum of one year of treatment.
In the new study, patients treated with Combivir and those treated with the two active ingredients taken separately showed similar reductions in viral load. After 12 weeks, the viral load had dropped by more than 95%. The two groups also showed a similar increase in CD4 cell counts. The single tablet was absorbed by the body just like the separate tablets. Furthermore, the recommended doses of Combivir in children produced levels of the two active ingredients similar to those found in adults.
What is the risk associated with Combivir?
The side effects that may occur more often with Combivir (seen in more than 1 patient in 10) are diarrhea and nausea. For the full list of all side effects reported with Combivir, see the Package Leaflet.
Combivir should not be used in people who may be hypersensitive (allergic) to lamivudine, zidovudine or any of the other substances. Since it contains zidovudine, the medicine should not be given to patients with low neutrophil counts (a type of white blood cell) or anemia (low red blood cell count). Combivir should not be taken in conjunction with some other medicines. See the package leaflet for further information
As with other anti-HIV drugs, patients receiving Combivir may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (inflammatory signs and symptoms caused by system reactivation). immune). Patients with liver problems (including hepatitis B or C) may be at an increased risk of developing liver injury when treated with Combivir. Like all other NRTIs, Combivir can also cause a condition called lactic acidosis (accumulation of lactic acid in the body) and, in the children of mothers treated with Combivir during pregnancy, mitochondrial dysfunction (injuries to the cellular constituents that produce energy that can cause blood problems).
Why has Combivir been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Combivir's benefits are greater than its risks in antiretroviral combination therapy for the treatment of HIV infection and recommended that it be given marketing authorization. product.
More information on Combivir:
On 18 March 1998, the European Commission issued a marketing authorization for Combivir, valid throughout the European Union, to Glaxo Group Ltd. The marketing authorization was renewed on 18 March 2003.
The full EPAR for Combivir can be found here.
Last update of this summary: 09-2008.
