What is Kivexa?
Kivexa is a medicine that contains two active substances, abacavir (600 mg) and lamivudine (300 mg). The medicine is available in orange, capsule-shaped tablets.
What is Kivexa used for?
Kivexa is an antiviral drug. It is used in combination with at least one other antiviral drug for the treatment of adults and adolescents over 12 years of age with HIV (human immunodeficiency virus) infection, the virus that causes acquired immune deficiency syndrome (AIDS).
The medicine can only be obtained with a prescription.
How is Kivexa used?
Kivexa must be prescribed by a doctor experienced in treating HIV infection. The dose of Kivexa is one tablet once a day, with or without food. The medicine should only be prescribed to patients weighing more than 40 kg. Patients needing abacavir or lamivudine dosage adjustments should take the drugs separately. Kivexa should not be prescribed to patients with severe liver problems and is not recommended in patients with severe kidney problems.
Patients with mild or moderate liver problems should be closely monitored by their doctor. Kivexa should be used with caution in patients over 65 years of age. For more information, see the package leaflet.
Patients taking Kivexa should receive the appropriate alert card, which summarizes the main information on the safety of the medicine.
How does Kivexa work?
The two active ingredients of Kivexa, abacavir and lamivudine, are nucleoside reverse transcriptase inhibitors (NRTIs). Both act in a similar way by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows the virus to infect cells and generate other viruses. Kivexa, 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. Kivexa does not cure HIV infection or AIDS but may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
The two active ingredients have been available in the European Union (EU) since the late 1990s: abacavir obtained marketing authorization under the Ziagen brand in 1999 and lamivudine under the Epivir brand in 1996.
How has Kivexa been studied?
Kivexa has been studied in three main studies involving 1 230 patients. At the time Kivexa was approved, abacavir was authorized at a dose of 300 mg twice a day. Therefore, the studies compared abacavir taken at 600 mg once a day and 300 mg twice a day, in combination with lamivudine and one or two other antiviral drugs. Two studies used the active ingredients taken separately while the third used a tablet containing the combination for the dose once a day. The main measure of effectiveness was the change in the level of HIV in the blood (viral load) after 24 or 48 weeks of treatment.
What benefit has Kivexa shown during the studies?
The two doses of abacavir, taken in combination with lamivudine and other antiviral drugs, have proved equally effective in reducing the viral load. In the first study, 253 (66%) of the 384 patients taking abacavir once a day had a viral load below 50 copies / ml after 48 weeks, compared to 261 (68%) of the 386 who took them twice a day . The tablet with the combination taken once a day also had an equivalent efficacy to that of the medicines taken twice a day in reducing the viral load in 24 weeks of therapy.
What is the risk associated with Kivexa?
The most common side effects of Kivexa (found in a number between 1 and 10 patients in 100) are hypersensitivity (allergic reactions), rash, nausea, vomiting, diarrhea, abdominal pain, headache, arthralgia (joint pain), muscular disorders, cough, nasal symptoms, fever, lethargy, exhaustion (tiredness), insomnia (difficulty sleeping), general malaise, anorexia (loss of appetite) and alopecia (hair loss). For the full list of all side effects reported with Kivexa, see the Package Leaflet.
Hypersensitivity reactions (allergic reactions) occur in approximately 5% of patients taking Kivexa, usually in the first six weeks of treatment. Some of these cases can be fatal. Symptoms almost always include fever or rash but nausea, vomiting, diarrhea, abdominal pain (stomach ache), dyspnoea (difficulty breathing), cough, lethargy, malaise, headache, signs of liver damage in the blood and myalgia (muscle pain). Patients receiving treatment with Kivexa receive a card detailing these symptoms so that they are aware of it and should contact their doctor immediately if a reaction occurs. For more information, see the package leaflet.
Kivexa should not be used in patients with severe liver disease or patients who may be hypersensitive (allergic) to lamivudine, abacavir or any of the other ingredients.
As with other anti-HIV drugs, patients taking Kivexa 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 reactivation of immune system). Patients with liver disease (including hepatitis B or C infection) may be at an increased risk of developing liver damage if treated with Kivexa.
As with all other NRTIs, Kivexa can also cause lactic acidosis (excess lactic acid in the body) and, in children of mothers who have taken Kivexa during pregnancy, mitochondrial dysfunction (damage to energy-producing components in cells that can cause problems in the blood).
Why has Kivexa been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Kivexa's benefits are greater than its risks in combination antiretroviral therapy for the treatment of adults and adolescents aged 12 years and older with HIV infection. The committee took into account that the demonstration of Kivexa's benefits was mainly based on a single study in adults, most of whom had not received previous treatment for HIV infection and had no symptoms of HIV infection. The Committee recommended that Kivexa be given marketing authorization.
More information on Kivexa:
On 17 December 2004, the European Commission issued a marketing authorization valid for Kivexa, valid throughout the European Union, to Glaxo Group Ltd.
The full EPAR for Kivexa can be found here.
Last update of this summary: 10-2007.
