What is Dutrebis - Lamivudine and Raltegravir used for?
Dutrebis is a medicine indicated for the treatment of patients with human immunodeficiency virus type 1 (HIV-1) infection, which causes acquired immune deficiency syndrome (AIDS). It is used in combination with other HIV medicines and can be used in patients from 6 years of age and weighing not less than 30 kg. Dutrebis contains the active substances lamivudine and raltegravir and can only be used in patients whose infection is not resistant to these medicines or to certain related antiviral medicines.
How is Dutrebis used - Lamivudine and Raltegravir?
Dutrebis can only be obtained with a prescription and treatment should be prescribed by a doctor with experience in managing HIV infections. Dutrebis is available as tablets containing 150 mg of lamivudine and 300 mg of raltegravir; the recommended dose is one tablet twice a day. Dutrebis should be used in combination with other anti-HIV medicines. For more information, see the package leaflet.
How does Dutrebis work - Lamivudine and Raltegravir?
The two active ingredients in Dutrebis work by blocking different stages of the HIV virus replication process in the body. An active substance, lamivudine, is a "nucleoside reverse transcriptase inhibitor" (NRTI). It works by blocking the activity of reverse transcriptase, an enzyme necessary for HIV to produce genetic instructions for the creation of other viruses once the cell is infected. The other active ingredient, raltegravir, is an "integrase inhibitor". Blocks an enzyme called integrase, necessary for the subsequent replication phase of the virus. Dutrebis reduces the amount of HIV present in the blood, keeping it at a low level. While not treating HIV infection or AIDS, it can delay the damage to the immune system and the development of infections and diseases associated with AIDS. The active ingredients of Dutrebis are already available in the European Union (EU) as single-ingredient medicines: lamivudine as Epivir since 1996 and raltegravir as Isentress since 2007.
What benefit has Dutrebis - Lamivudine and Raltegravir shown during the studies?
Since lamivudine and raltegravir have already been individually approved for the treatment of HIV infection, the company presented data from studies used to authorize these medicines, including a study of 160 patients treated with raltegravir associated with lamivudine (in addition to a another anti-HIV medicine, tenofovir) for a total of 240 weeks. The main measure of effectiveness was the percentage of patients in whom there was a reduction in the concentration of virus (viral load) in the blood to less than 50 copies of HIV RNA per ml (68.8%). The company also examined how Dutrebis was absorbed into the body compared to two separate tablets containing lamivudine and raltegravir. The results of the studies showed that Dutrebis produces lamivudine levels in the body similar to lamivudine administered separately; although raltegravir levels are slightly different, Dutrebis has been shown to produce raltegravir concentrations equally effective in controlling the virus.
What is the risk associated with Dutrebis - Lamivudine and Raltegravir?
The most common side effects with lamivudine or raltegravir (which may affect up to 1 in 10 people) are headache and nausea. Other common side effects of lamivudine are malaise, fatigue, nasal signs and symptoms, diarrhea and cough. For the full list of all side effects and restrictions with Dutrebis, see the package leaflet.
Why has Dutrebis - Lamivudine and Raltegravir been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Dutrebis's benefits are greater than its risks and recommended that it be approved for use in the EU. The committee noted that the two active ingredients of Dutrebis are often administered together in clinical practice. Dutrebis allows these active ingredients to be taken in a single tablet, even if the latter has to be taken twice a day and in combination with other medicines to treat HIV infection. It is believed that the efficacy and safety are the same individually observed with the two active ingredients, which are well characterized and do not cause particular concern.
What measures are being taken to ensure the safe and effective use of Dutrebis - Lamivudine and Raltegravir?
A risk management plan has been developed to ensure that Dutrebis is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Dutrebis, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
Other information on Dutrebis - Lamivudine and Raltegravir
On 26 March 2015, the European Commission issued a marketing authorization for Dutrebis, valid throughout the European Union. For more information about treatment with Dutrebis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 03-2015
