Atripla
Encyclopedia
Emtricitabine/tenofovir/efavirenz (INNs
, trade name Atripla) is a fixed-dose combination drug for the treatment of HIV
infection. It combines Gilead Sciences
's tenofovir and emtricitabine
(already available in the anti-HIV combination Truvada
) with Bristol-Myers Squibb
's efavirenz
into a fixed-dose pill. Combining the three drugs into a single, once-daily pill reduces pill burden and simplifies dosing schedules, and therefore has the potential to increase adherence to antiretroviral therapy.
Atripla is the first multi-class antiretroviral drug available in the United States and represents the first collaboration between two U.S. pharmaceutical companies to combine their patented anti-HIV drugs into one product. The drug retails in the United States for for a one-month supply. As of 2007, annual cost in India is US$1,344, and US$528 in Africa. It was approved by the U.S. FDA
on July 12, 2006. In the UK, the drug cost to the NHS is 620 per month.
Atripla is a fixed dose combination of 600 mg efavirenz
, 300 mg tenofovir, and 200 mg emtricitabine
. In adults, it is taken once daily on an empty stomach. Dosing at bedtime is recommended to improve tolerability of nervous system symptoms. Atripla is not recommended for patients under 18 years of age.
Atripla is a pink, capsule-shaped tablet with "123" impressed on one side.
In North America and Europe, Atripla is marketed jointly by Gilead Sciences
and Bristol-Myers Squibb
, but in much of the developing world, marketing and distribution is handled by Merck & Co.
Cipla
released its own version of Atripla in India, called Viraday. In Argentina
, Atripla is marketed by Laboratorios Gador.
Antiviral activity
In combination studies there were synergistic antiviral effects observed between emtricitabine and efavirenz, efavirenz and tenofovir, and emtricitabine and tenofovir.
International Nonproprietary Name
An International Nonproprietary Name is the official nonproprietary or generic name given to a pharmaceutical substance, as designated by the World Health Organization...
, trade name Atripla) is a fixed-dose combination drug for the treatment of HIV
HIV
Human immunodeficiency virus is a lentivirus that causes acquired immunodeficiency syndrome , a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive...
infection. It combines Gilead Sciences
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics. For many years since the company was founded, the company concentrated primarily on antiviral drugs to treat patients infected with HIV, hepatitis B or influenza. In 2006, Gilead acquired two...
's tenofovir and emtricitabine
Emtricitabine
Emtricitabine , with trade name Emtriva , is a nucleoside reverse transcriptase inhibitor for the treatment of HIV infection in adults and children....
(already available in the anti-HIV combination Truvada
Truvada
Tenofovir/emtricitabine, trademark Truvada, is a fixed-dose combination of two antiretroviral drugs used for the treatment of HIV. It consists of 300 milligrams of tenofovir and 200 milligrams of emtricitabine. By combining the two agents into one tablet, it reduces the pill burden and increases...
) with Bristol-Myers Squibb
Bristol-Myers Squibb
Bristol-Myers Squibb , often referred to as BMS, is a pharmaceutical company, headquartered in New York City. The company was formed in 1989, following the merger of its predecessors Bristol-Myers and the Squibb Corporation...
's efavirenz
Efavirenz
Efavirenz is a non-nucleoside reverse transcriptase inhibitor and is used as part of highly active antiretroviral therapy for the treatment of a human immunodeficiency virus type 1....
into a fixed-dose pill. Combining the three drugs into a single, once-daily pill reduces pill burden and simplifies dosing schedules, and therefore has the potential to increase adherence to antiretroviral therapy.
Atripla is the first multi-class antiretroviral drug available in the United States and represents the first collaboration between two U.S. pharmaceutical companies to combine their patented anti-HIV drugs into one product. The drug retails in the United States for for a one-month supply. As of 2007, annual cost in India is US$1,344, and US$528 in Africa. It was approved by the U.S. FDA
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
on July 12, 2006. In the UK, the drug cost to the NHS is 620 per month.
Atripla is a fixed dose combination of 600 mg efavirenz
Efavirenz
Efavirenz is a non-nucleoside reverse transcriptase inhibitor and is used as part of highly active antiretroviral therapy for the treatment of a human immunodeficiency virus type 1....
, 300 mg tenofovir, and 200 mg emtricitabine
Emtricitabine
Emtricitabine , with trade name Emtriva , is a nucleoside reverse transcriptase inhibitor for the treatment of HIV infection in adults and children....
. In adults, it is taken once daily on an empty stomach. Dosing at bedtime is recommended to improve tolerability of nervous system symptoms. Atripla is not recommended for patients under 18 years of age.
Atripla is a pink, capsule-shaped tablet with "123" impressed on one side.
In North America and Europe, Atripla is marketed jointly by Gilead Sciences
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics. For many years since the company was founded, the company concentrated primarily on antiviral drugs to treat patients infected with HIV, hepatitis B or influenza. In 2006, Gilead acquired two...
and Bristol-Myers Squibb
Bristol-Myers Squibb
Bristol-Myers Squibb , often referred to as BMS, is a pharmaceutical company, headquartered in New York City. The company was formed in 1989, following the merger of its predecessors Bristol-Myers and the Squibb Corporation...
, but in much of the developing world, marketing and distribution is handled by Merck & Co.
Merck & Co.
Merck & Co., Inc. , also known as Merck Sharp & Dohme or MSD outside the United States and Canada, is one of the largest pharmaceutical companies in the world. The Merck headquarters is located in Whitehouse Station, New Jersey, an unincorporated area in Readington Township...
Cipla
Cipla
Cipla Limited is a prominent Indian pharmaceutical company, best-known outside its home country for manufacturing low-cost anti-AIDS drugs for HIV-positive patients in developing countries...
released its own version of Atripla in India, called Viraday. In Argentina
Argentina
Argentina , officially the Argentine Republic , is the second largest country in South America by land area, after Brazil. It is constituted as a federation of 23 provinces and an autonomous city, Buenos Aires...
, Atripla is marketed by Laboratorios Gador.
Background
Atripla was approved as a once daily tablet to treat HIV in 2006. The main advantage of the new drug Atripla was that could be taken once daily and reduces the overall stress in an antiretroviral regimen. There is currently no generic version of Atripla available in the United States, but countries like Brazil and India are involved with compulsory licensing. The main advantage for these countries in producing a generic Atripla (Viraday) is they can sell it domestically at a radically lower cost than the price of the United States version. India is currently a signatory to TRIPS and consequently there will be a drop in the amount of generic HIV medicines available.Mechanism of Action
Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRT) of HIV-1. Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) of HIV-1.Tenofovir is a nucleotide reverse transcriptase inhibitor of HIV-1, but it can be classified as a NRTI. These three drugs work in combination to target HIV at different point in its life cycle and it reduces the virus’s capacity to mutate.Antiviral activity
In combination studies there were synergistic antiviral effects observed between emtricitabine and efavirenz, efavirenz and tenofovir, and emtricitabine and tenofovir.
Side effects
Common side effects of Atripla are tiredness, dizziness, stomach and intestinal upset, and skin discoloration. More severe side effects are hallucinations, sleeplessness and depression.Interactions
Medications that should not be taken with Atripla are "Hismanal (astemizole), Vascor (bepridil), Propulsid (cisapride), Versed (midazolam), Orap (pimozide), Halcion (triazolam), or ergot derivatives (for example, Wigraine and Cafergot)." Discuss any other HIV or hepatitis medications you are taking with your doctor to avoid complications. Additionally, St. John's wort is known to reduce the effectiveness of Atripla, resulting in increased viral load and possible resistance to Atripla.Contraindications
Patients who have shown strong hypersensitivity to efavirenz, a constituent of Atripla, should not take Atripla. Drugs that are contraindicated in the intake of Atripla are: voriconazole, ergot derivative drugs, benzodiazepines midazolam and triazolam, calcium channel blocker bepridil, cisapride, pimozide and St. John’s wort (Hypericum perforatum) Breastfeeding is also contraindicated.[6]External links
- Atripla.com managed by Gilead SciencesGilead SciencesGilead Sciences is a biopharmaceutical company that discovers, develops and commercializes therapeutics. For many years since the company was founded, the company concentrated primarily on antiviral drugs to treat patients infected with HIV, hepatitis B or influenza. In 2006, Gilead acquired two...
and Bristol-Myers SquibbBristol-Myers SquibbBristol-Myers Squibb , often referred to as BMS, is a pharmaceutical company, headquartered in New York City. The company was formed in 1989, following the merger of its predecessors Bristol-Myers and the Squibb Corporation... - Atripla article on The Body, an HIV reference site