What is Rezolsta - darunavir, cobicistat and what is it used for?
Rezolsta is an antiviral medicine used in combination with other medicines to treat adult patients infected with human immunodeficiency virus type 1 (HIV-1), which causes acquired immune deficiency syndrome (AIDS). Rezolsta contains the active ingredients darunavir and cobicistat . The medicine is intended for use only in patients who have not been treated for HIV in the past or in those who have been treated previously, when it is expected that the infection is not resistant to darunavir therapy and patients are in good health conditions with HIV levels below a certain threshold.
How is Rezolsta - darunavir, cobicistat used?
Rezolsta can only be obtained with a prescription and treatment should only be started by a doctor who is experienced in managing HIV infection. Rezolsta is available as tablets containing 800 mg of darunavir and 150 mg of cobicistat. The recommended dose is one tablet once a day, taken with food. For more information, see the package leaflet.
How does Rezolsta - darunavir, cobicistat work?
Rezolsta contains two active ingredients. Darunavir is a protease inhibitor, which means that it blocks an enzyme called protease that the HIV virus needs to make new copies of itself. When the enzyme is blocked, the virus does not reproduce normally and its growth and spread slow down. Cobicistat acts as an "enhancer" to strengthen the effects of darunavir, prolonging its duration of action in the body. Rezolsta, taken in combination with other anti-HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level. Rezolsta does not cure HIV infection or AIDS, but it may delay or reverse the damage to the immune system and the development of infections and diseases associated with AIDS. Darunavir is currently authorized under the name Prezista and cobicistat under the name Tybost.
What benefit has Rezolsta - darunavir, cobicistat shown during the studies?
Since the efficacy of darunavir and cobicistat has been demonstrated previously and the two active substances are authorized for use in the treatment of HIV infection, studies have mostly been conducted to show that Rezolsta produces effects and levels of darunavir in the blood similar to those observed with the two active substances administered separately and with darunavir administered with ritonavir, another medicine that acts as a "potentiator" (a consolidated combination). Furthermore, a main study was conducted to examine the safety and efficacy of darunavir and cobicistat given with two other anti-HIV medicines in 313 HIV-infected adult patients who had never been treated before or who had been treated and in which the infection was not expected to be resistant to darunavir. Efficacy was measured by a reduction in the viral load (the amount of HIV-1 virus in the blood) to less than 50 copies / ml. Overall, 258 patients (82%) showed such a response after 24 weeks of treatment and 253 patients (81%) after 48 weeks; these data are similar to the results previously observed with darunavir and ritonavir.
What is the risk associated with Rezolsta - darunavir, cobicistat?
The most common side effects with Rezolsta (which may affect more than 1 in 10 people) are diarrhea, nausea and a rash. The most serious side effects are rash, diabetes, hypersensitivity (allergic) reactions, vomiting and "inflammatory immune reconstitution syndrome". Immune reconstitution inflammatory syndrome occurs when the patient's immune system begins to function again and to fight ongoing infections, causing inflammation at the site of infection. For the full list of all side effects reported with Rezolsta, see the package leaflet. Rezolsta should not be given to patients with severe impairment of liver function. Furthermore, it must not be used together with certain other medicines with which it could interact, reducing the effectiveness of the therapy or increasing the risk of side effects. For the full list of limitations, see the package leaflet.
Why has Rezolsta - darunavir, cobicistat been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Rezolsta's benefits are greater than its risks and recommended that it be approved for use in the EU. Both active ingredients have already been shown to be effective and it was considered more practical for the patient that they were combined in a single tablet than the separate intake, as it reduces the risk of errors. Moreover, there is no evidence of unexpected problems in terms of security.
What measures are being taken to ensure the safe and effective use of Rezolsta - darunavir, cobicistat?
A risk management plan has been developed to ensure that Rezolsta 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 Rezolsta, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Rezolsta - darunavir, cobicistat
On 19 November 2014, the European Commission issued a marketing authorization for Rezolsta, valid throughout the European Union. For more information about treatment with Rezolsta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 11-2014.
