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 medicine to treat patients infected with human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS).
The medicine can only be obtained with a prescription.
How is Combivir used?
Combivir therapy should be initiated by a physician experienced in the treatment of HIV infection.
In adults and adolescents weighing 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 the body weight. Children weighing less than 14 kg should take separate oral solutions containing lamivudine and zidovudine. Children taking Combivir should be closely monitored for side effects.
Combivir can be taken with or without food. Theoretically, the tablets should be swallowed whole, but patients who cannot do so 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 vary their doses due to kidney, liver or blood problems, medicines containing lamivudine or zidovudine should be used separately.
For more information, see the package leaflet.
How does Combivir work?
Both of the active substances in Combivir, lamivudine and zidovudine, are nucleoside reverse transcriptase inhibitors (NRTIs). Both work 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, keeping it at a low level. Combivir does not cure HIV infection
or AIDS, but it can delay damage to the immune system and the onset of AIDS-associated infections and diseases.
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 submitted information from previous studies for the combination of the two substances. The company also compared the tablet containing the two active substances with those containing lamivudine and zidovudine separately in 75 adults and adolescents who had never previously received treatment for HIV infection. The main measures of effectiveness were the change in the concentration of HIV in the blood (viral load) and 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.
To support its recommendations for Combivir doses in children, the company presented information from studies on lamivudine and zidovudine blood levels in children taking the medicines separately. He also presented information on the expected blood levels of the two substances in children taking the two substances in one tablet.
What benefit has Combivir shown during the studies?
Combivir was effective in reducing viral load and inducing an increase in CD4 counts. Previous studies had shown that the two active substances, lamivudine and zidovudine, taken in combination, can reduce viral load and lead to increased counts. of CD4 cells after a maximum of one year of treatment.
In the new study, patients taking Combivir and those taking the two active substances 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 into the body just like the separate tablets. In addition, the recommended doses of Combivir in children produced levels of the two active substances similar to those found in adults.
What is the risk associated with Combivir?
The side effects that may occur most often with Combivir (seen in more than 1 in 10 patients) are diarrhea and nausea. For the full list of side effects reported with Combivir, see the Package Leaflet.
Combivir must 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 must not be given to patients with low neutrophil counts (a type of white blood cell) or anemia (low red blood cell count). Combivir must not be taken concomitantly with some other medicines. See package leaflet for further information
As with other HIV medicines, patients receiving Combivir may be at risk for lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (inflammatory signs and symptoms caused by reactivation of the system 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 offspring of mothers treated with Combivir during pregnancy, mitochondrial dysfunction (damage to 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 combination antiretroviral therapy for the treatment of HIV infection and recommended that it be given a Marketing Authorization. product.
Other information about Combivir:
On 18 March 1998 the European Commission granted Glaxo Group Ltd a "marketing authorization" for Combivir, valid throughout the European Union. The "marketing authorization" was renewed on 18 March 2003.
For the complete version of the Combivir EPAR click here.
Last update of this summary: 09-2008.
The information on Combivir published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
