What is Vitekta - elvitegravir and what is it used for?
Vitekta is an antiviral medicine that contains the active substance elvitegravir . It is indicated for the treatment of adult patients infected with human immunodeficiency virus type 1 (HIV-1), which causes acquired immune deficiency syndrome (AIDS). It is used in combination with "protease inhibitor" medicines taken with ritonavir and other medicines used to treat HIV, in patients in whom resistance to elvitegravir is not suspected.
How is Vitekta - elvitegravir used?
Vitekta can only be obtained with a prescription and treatment should be started by a doctor with experience in managing HIV infections. Vitekta is available as tablets (85 and 150 mg); the recommended dose is one tablet a day, to be taken with food. The choice of dose depends on which other medicines are administered in addition to Vitekta. Vitekta should be taken at the same time as a protease inhibitor given once a day, at the same time, or with the first dose of a protease inhibitor given twice a day. For more information, see the package leaflet.
How does Vitekta - elvitegravir work?
The active substance in Vitekta, elvitegravir, is a type of antiviral agent called an "integrase inhibitor". Elvitegravir blocks an enzyme, called integrase, which takes part in a phase of HIV reproduction. If the enzyme is blocked, the virus is unable to reproduce normally and the spread of the infection is slowed down. Vitekta does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
What benefit has Vitekta - elvitegravir shown during the studies?
Vitekta was studied in one main study involving 712 patients with HIV-1 who had never previously been treated with an integrase inhibitor. The main measure of effectiveness was the reduction of HIV levels (viral load) in the blood. Patients with a viral load below 50 copies / ml were considered to have responded to treatment after 48 weeks of treatment. In this study, Vitekta was at least as effective as raltegravir (another integrase inhibitor) when taken in combination with other medicines used to treat HIV infection. After 48 weeks, approximately 59% of patients treated with Vitekta (207 out of 351) responded to treatment compared with approximately 58% of patients treated with raltegravir (203 out of 351).
What is the risk associated with Vitekta - elvitegravir?
The most common side effects with Vitekta (which may affect up to 1 in 10 people) are headache, abdominal pain (stomach ache), diarrhea, vomiting, nausea, rash and exhaustion (fatigue). For the full list of all side effects reported with Vitekta, see the package leaflet. Vitekta should not be used with certain other medicines which may reduce its effectiveness or increase the risk of resistance. For the full list of limitations, see the package leaflet.
Why has Vitekta - elvitegravir been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vitekta's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that the benefits of Vitekta in reducing blood HIV levels had been clearly demonstrated in the studies. The safety profile of the medicine has not been considered a problem, since the side effects are comparable to those of other medicines. The Committee also noted that there is a significant potential for interactions with other medicinal products, which are included in the package leaflet.
What information is still awaited for Vitekta - elvitegravir?
A risk management plan has been developed to ensure that Vitekta 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 Vitekta, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information on Vitekta - elvitegravir
On 13 November 2013, the European Commission issued a marketing authorization for Vitekta, valid throughout the European Union. For more information on Vitekta therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 11/2013.
