What is it and what is it used for?
Kivexa is a medicine that contains two active substances, abacavir (600 mg) and lamivudine (300 mg). It is available as tablets.
Kivexa is used in combination with at least one other antiviral medicine to treat adults and children weighing at least 25 kg who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
The medicine can only be obtained with a prescription.
How Kivexa is used
Kivexa should be prescribed by a doctor who has experience in the management of HIV infection.
Before starting treatment with abacavir, all patients should have a test to find out if they have a gene called ‘HLA-B (type 5701)’. Patients with this gene are at an increased risk of having an allergic reaction to abacavir, so they should not take Kivexa.
Kivexa is taken as one tablet once a day. It should only be given to patients who weigh at least 25 kg. Patients who need to adjust the dose of abacavir or lamivudine should take the medicines separately.
How Kivexa works
Both active substances in Kivexa, abacavir and lamivudine, are nucleoside reverse transcriptase inhibitors (NRTIs). They both work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses. Kivexa, taken in combination with at least one other HIV 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 can delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Both active substances have been available in the European Union (EU) since the late 1990s: abacavir has been authorised as Ziagen since 1999, and lamivudine has been authorised as Epivir since 1996.
What are the benefits?
The CHMP decided that Kivexa’s benefits are greater than its risks and recommended that it be given marketing authorisation.
What are main side effects?
The most common side effects with Kivexa (seen in between 1 and 10 patients in 100) are hypersensitivity (allergic reactions), rash, nausea (feeling sick), vomiting, diarrhoea, abdominal pain (stomach ache), headache, arthralgia (joint pain), muscle disorders, cough, nasal symptoms (nose problems, such as irritation and runny nose), fever, lethargy (lack of energy), tiredness, insomnia (difficulty sleeping), malaise (feeling unwell), loss of appetite and alopecia (hair loss). For the full list of all side effects reported with Kivexa, see the package leaflet.
Hypersensitivity reactions occur in patients taking Kivexa, usually within the first six weeks of treatment, and can be life-threatening. The risk of hypersensitivity is higher in patients who have the HLA‑B (type 5701) gene. Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal pain, dyspnoea (difficulty breathing), cough, lethargy, malaise, headache, signs of liver damage in the blood and myalgia (muscle pain). Treatment with Kivexa should be stopped promptly if the patient has a hypersensitivity reaction. For more information and the full list of restrictions, see the package leaflet.
What studies have been done?
Both doses of abacavir, taken in combination with lamivudine and other antiviral medicines, were equally effective in reducing viral loads. In the first study, 66% (253 out of 384) of the patients taking abacavir once a day had viral loads below 50 copies/ml after 48 weeks of treatment, compared with 68% (261 out of 386) of the patients taking it twice a day. The combination tablet taken once a day was also as effective as the medicines taken separately twice a day in reducing viral loads over 24 weeks of treatment.
Kivexa was first approved for use in the EU in 2004. It is manufactured by ViiV Healthcare UK Limited.
European Medicines Agency website page Kivexa (accessed 24/07/18)
Links available in External Resources