What is Atripla?
Atripla is a medicine containing three active substances: efavirenz (600 mg), emtricitabine (200 mg) and tenofovir disoproxil (245 mg). It is available as pink, capsule-shaped tablets.
What is Atripla used for?
Atripla is an antiviral drug used to treat adults with human immunodeficiency virus type 1 (HIV-1) infection, a virus that causes acquired immune deficiency syndrome (AIDS). Atripla is used only for those patients with HIV levels in the blood (viral load) less than 50 copies / ml for more than three months with the combination anti-HIV therapy in progress. Atripla should not be used in patients whose previous combined anti-HIV treatment has failed or ceased to be effective. It is necessary to exclude that HIV infection contracted by patients before starting the first combined anti-HIV treatment is likely to present little possibility of response even to only one of the three active ingredients contained in Atripla.
The medicine can only be obtained with a prescription.
How is Atripla used?
Treatment with Atripla should be started by a doctor who has experience in the management of HIV infection. The recommended dose is one tablet once a day, to be swallowed whole with water. It is recommended to take Atripla on an empty stomach, preferably at bedtime. The medicine should be taken regularly without skipping any dose.
Atripla should be used with caution in elderly patients; its use is not recommended in patients with moderate to severe kidney problems. Patients with liver problems should be carefully observed to detect any side effects. If the patient has to stop taking efavirenz, emtricitabine or tenofovir disoproxil or if the doses have to change, medicines containing efavirenz, emtricitabine or tenofovir disoproxil should be taken separately. Atripla should not be taken with other medicinal products containing efavirenz, emtricitabine, tenofovir disoproxil or lamivudine (another antiviral medicine). For more information, see the summary of product characteristics (also included in the EPAR).
How does Atripla work?
Atripla contains three active ingredients: efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI); emtricitabine, a nucleoside inhibitor of reverse transcriptase; and tenofovir disoproxil, a prodrug of tenofovir or that is converted into the active ingredient tenofovir once in the body. Tenofovir is a nucleotide inhibitor of reverse transcriptase. Both nucleoside and nucleotide reverse transcriptase inhibitors are commonly known as NRTIs. All three of these active ingredients block the activity of reverse transcriptase, an enzyme produced by HIV that allows the virus to infect cells and reproduce. Atripla keeps the level of HIV in the blood low; it does not cure HIV infection or AIDS, but it can delay the damage to the immune system and the development of infections and diseases associated with AIDS.
All three active ingredients are already available in the European Union (EU): efavirenz was approved in 1999 with the designations Sustiva and Stocrin, emtricitabine was approved in 2003 with the name Emtriva and tenofovir disoproxil was approved in 2002 under the Viread name. The combination of tenofovir disoproxil and emtricitabine was approved in 2005 under the name Truvada.
How has Atripla been studied?
The main study conducted on Atripla involved 300 HIV-infected patients already successfully treated with various combinations of antiviral drugs. The study compared the effectiveness of switching to Atripla tablets, taken on an empty stomach, compared to continuing the combined anti-HIV treatment. The main measure of effectiveness was the proportion of patients with viral loads below 200 copies / ml after 48 weeks.
The company has also observed how the combination of tablets is absorbed in the body compared to taking the drugs separately.
What benefit has Atripla shown during the studies?
In the main study, switching to Atripla was as effective as maintaining the previous combined treatment. After 48 weeks, in 89% of patients taking Atripla (181 out of 203) and in 88% of patients continuing with the previous treatment (85 out of 97) the viral load was less than 200 copies / ml.
The combination tablet was absorbed by the body in the same way as the medicines taken separately, always with intake far from meals.
What is the risk associated with Atripla?
The most common side effect associated with Atripla (ie seen in more than 1 patient in 10) is vertigo. For the full list of all side effects reported with Atripla, see the Package Leaflet.
Atripla should not be used in patients who may be hypersensitive (allergic) to efavirenz, emtricitabine, tenofovir disoproxil or any of the other ingredients. Atripla should not be used in patients with severe liver disease or taking any of the following drugs:
- terfenadine, astemizole (commonly used for the treatment of allergic symptoms; these are medicines that may also be available without a prescription);
- cisapride (for the treatment of certain stomach disorders);
- midazolam, triazolam (for the treatment of anxiety or sleep disorders);
- pimozide (for the treatment of mental illnesses);
- bepridil (for the treatment of angina);
- ergot alkaloids such as e.g. ergotamine, dihydroergotamine, ergonovine and methylergonovine (for the treatment of migraine);
- St. John's wort (herbal preparation against depression);
- voriconazole (for the treatment of fungal infections).
The possible administration of Atripla in conjunction with other medicinal products should be performed with caution. For more details, see the package leaflet.
As with other anti-HIV drugs, patients treated with Atripla may be exposed to an increased risk of lipodystrophy (changes in body fat distribution), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by recovery of the immune system). Patients with liver problems (including hepatitis B or C infection)
may be exposed to a greater risk of liver damage if treated with Atripla. Like other NRTI-containing medicines, Atripla can also induce lactic acidosis (accumulation of lactic acid in the body).
Why has Atripla been approved?
The Committee for Medicinal Products for Human Use (CHMP) noted that Atripla should be taken on an empty stomach to avoid some side effects, but that this could cause low levels of tenofovir in the blood. Therefore the committee concluded that Atripla could constitute an adequate treatment based on a single daily tablet when used to keep viral load levels low in patients already on anti-HIV treatment, but that however the information available is not sufficient to establish with certainty the effects in previously untreated patients. The Committee therefore decided that the benefits of Atripla outweigh the risks in the treatment of HIV-1 virus infection in adult patients with virological suppression at HIV-1 ribonucleic acid (RNA) levels below 50 copies / ml for more than three months with combination antiretroviral therapy in progress.
The committee noted that the demonstration of the benefits of Atripla is mainly based on data referring to a 48-week period of a study conducted on patients with stable suppression of HIV undergoing combined anti-HIV treatment and subsequently switched to Atripla. No data are available on the effects of the medicine on patients previously untreated or treated in the past with several different HIV medications. Information on the use of Atripla with other anti-HIV drugs is also not available.
The committee recommended the granting of the marketing authorization for Atripla.
What measures are being taken to ensure the safe use of Atripla?
The company that makes Atripla undertakes to ensure that the medicine is used safely, bearing in mind the considerations relating to the possible effects of tenofovir disoproxil on the kidneys.
More information on Atripla
On 13 December 2007, the European Commission granted a marketing authorization valid for the entire European Union for Atripla to Bristol-Myers Squibb And Gilead Sciences Limited.
For the full version of the Atripla evaluation (EPAR) click here.
Last update of this summary: 01-2009.
