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Active Substance: elvitegravir
Common Name: elvitegravir
ATC Code: J05AX11
Marketing Authorisation Holder: Gilead Sciences International Ltd
Active Substance: elvitegravir
Status: Authorised
Authorisation Date: 2013-11-13
Therapeutic Area: HIV Infections
Pharmacotherapeutic Group: Antivirals for systemic use

Therapeutic Indication

Vitekta co-administered with a ritonavir-boosted protease inhibitor and with other antiretroviral agents, is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults who are infected with HIV-1 without known mutations associated with resistance to elvitegravir.

What is Vitekta and what is it used for?

Vitekta is an antiviral medicine that contains the active substance elvitegravir. It is used to treat adults with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS). It is used in combination with ‘protease inhibitors’ medicines taken together with ritonavir, and with other anti-HIV medicines in patients whose disease is not expected to be resistant to elvitegravir.

How is Vitekta used?

Vitekta can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infections. Vitekta is available as tablets (85 and 150 mg); the recommended dose is one tablet a day, taken with food. The choice of dose of Vitekta depends on which other medicines it is given with. Vitekta is taken either at the same time as a once-daily protease inhibitor, or with the first dose of a twice-daily protease inhibitor. For further information, see the package leaflet.

How does Vitekta work?

The active substance in Vitekta, elvitegravir, is a type of antiviral agent called an ‘integrase inhibitor’. It blocks an enzyme called integrase, which is involved in a step in the reproduction of HIV. When the enzyme is blocked, the virus cannot reproduce normally, slowing down the spread of infection.

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 benefits of Vitekta have been shown in studies?

Vitekta has been investigated in one main study involving 712 patients with HIV-1 who had not been treated before with an integrase inhibitor. The main measure of effectiveness was based on the reduction in the levels of HIV in the blood (viral load). Patients who attained a viral load of less than 50 copies/ml after 48 weeks of treatment were considered to have responded to treatment.

In this study, Vitekta was at least as effective as raltegravir (another integrase inhibitor) when taken in combination with other anti-HIV medicines. After 48 weeks, around 59% of patients treated with Vitekta (207 out of 351) responded to treatment compared with around 58% of patients treated with raltegravir (203 out of 351).

What are the risks associated with Vitekta?

The most common side effects with Vitekta (which may affect up to 1 in 10 people) are headache, abdominal pain (stomach ache), diarrhoea, vomiting, nausea (feeling sick), rash, fatigue (tiredness). For the full list of all side effects reported with Vitekta, see the package leaflet.

Vitekta must not be used with certain other medicines that may reduce its effectiveness or increase the risks of resistance. For the full list of restrictions, see the package leaflet.

Why is Vitekta 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 the levels of HIV in the blood had been clearly shown in studies. Regarding the safety profile of the medicine, this was not considered of concern, with side effects comparable to other similar medicines. The Committee also noted that there is a significant potential for interactions with other medicines, and this has been reflected in the product information.

What measures are being taken to ensure the safe and effective use of Vitekta?

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 about Vitekta

The European Commission granted a marketing authorisation valid throughout the European Union for Vitekta on 13 November 2013.

For more information about treatment with Vitekta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.