What is Triumeq - dolutegravir, abacavir, lamivudine and what is it used for?
Triumeq is an antiviral medicine indicated for the treatment of patients with human immunodeficiency virus (HIV) infection, the virus that causes acquired immune deficiency syndrome (AIDS). It is used in patients over 12 years of age and with a body weight of at least 40 kg. Triumeq contains three active substances: dolutegravir, abacavir and lamivudine .
How is Triumeq - dolutegravir, abacavir, lamivudine used?
Triumeq can only be obtained with a prescription and treatment must be prescribed by a doctor with experience in managing HIV infections. Before starting therapy with Triumeq, all patients must undergo a test to check for the presence of a gene called "HLA-B (type 5701)". Patients with this gene are at high risk of developing an allergic reaction to abacavir and therefore should not take Triumeq. Triumeq is available as tablets (50 mg of dolutegravir / 600 mg of abacavir / 300 mg of lamivudine); the recommended dose is one tablet a day, to be taken with or without food.
How does Triumeq - dolutegravir, abacavir, lamivudine work?
One of the active ingredients of Triumeq, dolutegravir, is an integrase inhibitor. It is an antiviral medicine that blocks an enzyme, called integrase, which the HIV virus needs to make new copies of itself in the body. The other two active substances, abacavir and lamivudine, are nucleoside reverse transcriptase inhibitors (NRTIs). They both act in a similar way, blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows the virus to infect cells and reproduce. Triumeq reduces the amount of HIV in the blood, keeping it at a low level. Triumeq does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS. All three active ingredients of Triumeq are already available in the European Union (EU) as single-component medicines: abacavir has been authorized since 1999 under the name Ziagen, lamivudine since 1996 under the name Epivir and dolutegravir since January 2014 under the name Tivicay . The combination of abacavir and lamivudine is authorized under the name Kivexa since 2004.
What benefit has Triumeq - dolutegravir, abacavir, lamivudine shown during the studies?
The combination of dolutegravir, abacavir and lamivudine (present in Triumeq) was evaluated in a main study involving 833 patients not undergoing previous therapies. The data collected as part of this study had already been used for the Tivicay authorization application. Patients were treated with the combination of Triumeq or a different combination of three drugs (Atripla), not containing an integrase inhibitor. The main measure of effectiveness was the response rate, ie the percentage of patients in whom there was a reduction in the level of virus (viral load) in the blood to less than 50 copies of HIV RNA per ml. After 48 weeks, 88% of patients treated with the Triumeq combination (364 out of 414) responded to treatment compared to 81% of patients treated with Atripla (338 out of 419). The data collected up to week 96 in this study showed that this effect was maintained over time. The company also examined the way in which Triumeq was absorbed into the body compared to two distinct tablets (dolutegravir and abacavir / lamivudine) containing the three active ingredients that make up the medicine. The results of this study showed that Triumeq was absorbed by the body in the same way as distinct medicines.
What is the risk associated with Triumeq - dolutegravir, abacavir, lamivudine?
The most common side effects with Triumeq (which may affect more than 1 in 10 people) are insomnia, headache, nausea, diarrhea and fatigue. Some serious side effects have been observed in patients taking some of the ingredients of Triumeq including hypersensitivity (allergy). For the full list of all side effects reported with Triumeq, see the package leaflet. Triumeq should not be used in combination with dofetilide, a medicine used to control cardiac arrhythmia (irregular heartbeat). For the full list of limitations, see the package leaflet.
Why has Triumeq - dolutegravir, abacavir, lamivudine been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Triumeq's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that the medicine has proved its efficacy in previously untreated patients and that similar benefits are expected in patients already undergoing therapy. The CHMP also noted that administration of the combination of dolutegravir, abacavir and lamivudine in a single tablet represents an additional therapeutic option for HIV-infected subjects who do not have the HLA-B gene (type 5701). The administration of the combination instead of the medicines individually reduces the number of tablets that patients must take, facilitating adherence to the therapeutic regimen. Furthermore, the CHMP considers as an additional advantage compared to other similar medicines that Triumeq should be taken strictly with or without food. As for the safety profile of Triumeq, it is expected to be similar to the safety profile of individual ingredients and comparable to that of other medicines used to treat HIV infections.
What measures are being taken to ensure the safe and effective use of Triumeq - dolutegravir, abacavir, lamivudine?
A risk management plan has been developed to ensure that Triumeq 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 Triumeq, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Triumeq will provide healthcare professionals who should prescribe the medicine educational material that mentions the risk of hypersensitivity associated with abacavir. Further information is available in the summary of the risk management plan.
Other information on Triumeq - dolutegravir, abacavir, lamivudine
On 1 September 2014, the European Commission issued a marketing authorization for Triumeq, valid throughout the European Union. For more information on Triumeq therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 08-2014.
