What is Emtriva?
Emtriva is a medicine containing the active substance emtricitabine. It is available in white and blue capsules (200 mg) and in an oral solution (10 mg / ml).
What is Emtriva used for?
Emtriva is an antiviral drug, indicated in combination with other antiviral medicines to treat adults and children infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
In the case of patients who have previously taken other drugs for the treatment of HIV infection and have not responded to therapy, doctors must prescribe Emtriva only after carefully examining the patient's previous antiviral treatments and evaluating the possibility that the virus responds to any new prescribed therapies.
The medicine can only be obtained with a prescription.
How is Emtriva used?
Treatment with Emtriva should be started by a doctor experienced in treating HIV infection. The recommended dose of Emtriva for patients weighing at least 33 kg is one capsule once a day. The oral solution should be used in patients weighing less than 33 kg and in subjects who are unable to swallow the capsules. The recommended dose of oral solution is 6 mg per kilogram of body weight up to a maximum of 240 mg (24 ml) once a day. In patients with kidney problems it is necessary to adjust the dose. Emtriva can be taken with or without food. Due to the limited information available on the safety and efficacy of the medicine in children under four months of age, the use of Emtriva on this group of patients is not recommended. For more information, see the package leaflet.
How does Emtriva work?
The active substance in Emtriva, emtricitabine, is a nucleoside reverse transcriptase inhibitor (NRTI). It blocks the activity of reverse transcriptase, an enzyme produced by the HIV virus that allows it to infect cells and reproduce. Emtriva, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Emtriva 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.
How has Emtriva been studied?
Emtriva has been studied in three main studies involving more than 1, 498 HIV infected adults. The first study compared Emtriva with stavudine (another antiviral drug) in 571 treatment-naïve adults, ie never previously treated for treatment of HIV infection. Both drugs were taken in combination with didanosine and efavirenz (other antiviral drugs). In the second study, Emtriva was compared with lamivudine (another antiviral drug) in 468 treatment-naïve adults, in combination with stavudine and efavirenz or nevirapine (other antiviral drugs). The third study involved 459 patients who took three antiviral drugs (including lamivudine) for at least 12 weeks and with low levels of HIV in the blood. The study compared the effects of lamivudine replacement with Emtriva compared to maintaining the combination of ongoing antiviral drugs. In all three studies the main measure of effectiveness was the number of patients with very low levels of HIV in the blood (viral load).
The efficacy of Emtriva in combination with other antiviral drugs was also evaluated in two studies involving 120 HIV-infected patients aged between four months and 18 years.
What benefit has Emtriva shown during the studies?
Emtriva, in combination with other antiviral drugs, reduced the viral load in HIV-infected patients. In the first study of naïve treatment adults, the number of patients with a viral load less than 50 copies / ml after 24 weeks was higher in the Emtriva-treated group than in the stavudine-treated group (81% and 70%, respectively). This difference remained so after 48 weeks of treatment (73% and 56%). In the second study, Emtriva was as effective as lamivudine: after 48 weeks, about two thirds of patients had viral loads below 400 copies / ml, while a slightly lower number of subjects showed a viral load of less than 50 copies / ml. In patients already treated the number of individuals, among whom lamivudine was replaced with Emtriva, who showed a viral load of less than 400 copies / ml was similar, after 48 weeks, to the number of subjects who continued to take lamivudine (73% and 82% respectively).
Similar results were observed in two studies in children and adolescents treated with Emtriva in combination with other antiviral drugs.
What is the risk associated with Emtriva?
The most common side effects that may occur when taking Emtriva (seen in more than 1 patient in 10) are headache, diarrhea, nausea and an increase in creatine kinase levels in the blood (an enzyme found in muscles). Cases of alterations in skin coloring are also very common in children. For the full list of all side effects reported with Emtriva, see the Package Leaflet.
Emtriva must not be used in people who are hypersensitive (allergic) to emtricitabine or any of the other substances.
As with other anti-HIV drugs, patients receiving Emtriva may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (inflammatory signs and symptoms caused by system reactivation). immune). Patients with liver problems (including hepatitis B or C) may be at an increased risk of developing liver damage if treated with Emtriva. Like all other NRTIs, Emtriva can also cause a condition called lactic acidosis (accumulation of lactic acid in the body) and, in children of mothers treated during pregnancy, mitochondrial dysfunction (injuries to the cellular constituents that produce energy, which can cause problems with the blood).
Why has Emtriva been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Emtriva's benefits are greater than its risks for the treatment of HIV-1 infection in adults and children in combination with other antiretroviral drugs. The committee noted that this indication is based on studies conducted on patients who had never been treated for HIV infection previously or whose virus was already adequately controlled by antiviral drugs. There was no experience regarding the use of Emtriva in patients in whom previous treatments for HIV were ineffective. The Committee therefore recommended that Emtriva be given marketing authorization.
Other information on Emtriva:
The European Commission granted a marketing authorization valid throughout the European Union for Emtriva to Gilead Sciences International Limited on 24 October 2003. The marketing authorization was renewed on 24 October 2008.
The full EPAR for Emtriva can be found here.
Last update of this summary: 10-2008
