What is Tivicay and Dolutegravir used for?
Tivicay is an antiviral medicine that contains the active substance dolutegravir . It is indicated in combination with other medicines to treat adults and adolescents over 12 years old with human immunodeficiency virus type 1 (HIV-1) infection, a virus that causes acquired immune deficiency syndrome (AIDS).
How is Tivicay used - Dolutegravir?
Tivicay can only be obtained with a prescription and must be prescribed by a doctor with experience in managing HIV infection. Tivicay is available as tablets (50 mg). The dose changes depending on whether the infection is resistant or supposed to be resistant to the drugs of the class to which Tivicay belongs (integrase inhibitors).
- In patients with infection without resistance to integrase inhibitors, the usual dose is one tablet a day; however, if Tivicay is given in combination with other medicines that decrease its effectiveness, the dose is increased to one tablet twice a day.
- The dose is one tablet twice a day in patients whose infection is resistant or is supposed to be resistant to integrase inhibitors; in these patients it is necessary to avoid the concomitant administration of Tivicay and other medicines that reduce its effectiveness.
Although Tivicay can usually be taken with or without food, patients with an infection resistant to this class of medicines should take Tivicay at meals, as food promotes the absorption of the medicine. For more information, see the package leaflet.
How does Tivicay - Dolutegravir work?
The active substance in Tivicay, 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. If given in combination with other medicines, Tivicay helps prevent the spread of HIV and keeps the amount of virus circulating in the blood low. Tivicay 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.
What benefit has Tivicay - Dolutegravir shown during the studies?
Tivicay has proven effective against HIV-1 in four main studies. The main measure of effectiveness in all studies was the response rate, ie the percentage of patients in whom a reduction in the amount of virus (viral load) in the blood was observed to less than 50 copies of HIV-1 RNA per ml. Two studies were conducted on patients who had not previously been treated for HIV:
- in the first of these studies, involving 822 patients, Tivicay taken once a day was compared to raltegravir (another integrase inhibitor), both administered in combination with two other HIV medicines belonging to a different class (so-called nucleoside reverse transcriptase inhibitors or NRTIs): 88% of patients (361 out of 411) treated with Tivicay and 85% of patients (351 out of 411) treated with raltegravir responded after 48 weeks of treatment .
- The second study was conducted on 833 patients who were given a combination of Tivicay and two NRTIs or a different combination of three drugs (Atripla) that did not include an integrase inhibitor. The 48-week response rate was 88% of patients (364 of 414) in the Tivicay group and 81% of patients (338 of 419) in the Atripla group.
Two other studies have investigated the effectiveness of Tivicay in subjects previously subjected to HIV therapy without a positive outcome:
- the first of these studies was conducted on 715 patients whose previous therapy did not include the use of an integrase inhibitor and in whom, therefore, the infection was supposed to be not resistant to this class of medicines. Patients were treated with a combination of HIV medicines that included Tivicay or raltegravir. The response rate at 48 weeks was 71% in patients treated with Tivicay-based therapy and 64% in subjects treated with raltegravir-based therapy.
- The second study conducted on subjects subjected to a therapy in the past was attended by 183 patients with infection resistant to a previous treatment based on an integrase inhibitor (their infection, therefore, showed resistance to various classes of medicines, including inhibitors of previously used integrases: adding a twice-daily dose of Tivicay to the other therapy resulted in a 69% response rate 24 weeks after starting treatment.
What is the risk associated with Tivicay - Dolutegravir?
The most common side effects of Tivicay (which may affect more than 1 in 10 people) are nausea, diarrhea and headache. The most serious adverse effects reported include an abnormal reaction of severe hypersensitivity (allergy), characterized by rash and possible effects on the liver. For the full list of all side effects reported with Tivicay, see the package leaflet. Tivicay should not be given concomitantly with dofetilide, a medicine used to treat cardiac arrhythmias, due to the appearance of potential serious side effects. Furthermore, it may be necessary to adjust the Tivicay dose in the event that other medicinal products are concomitantly administered. For the full list of limitations, see the package leaflet.
Why has Tivicay - Dolutegravir been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tivicay's benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee concluded that the efficacy of the medicine had been demonstrated both in patients not previously subjected to any therapy and in previously treated subjects, including subjects with infection resistant to integrase inhibitors. In general, the medicine was well tolerated, although the CHMP noted a possible risk of serious hypersensitivity reactions, albeit infrequent.
What measures are being taken to ensure the safe and effective use of Tivicay - Dolutegravir?
A risk management plan has been developed to ensure that Tivicay 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 Tivicay, including the appropriate precautions to be followed by healthcare professionals and patients.
More information on Tivicay - Dolutegravir
On 16 January 2014, the European Commission issued a marketing authorization for Tivicay, valid throughout the European Union. For more information on Tivicay therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 01-2014.
