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Has a generic version of Atripla been approved?

No. There is currently no therapeutically equivalent version of Atripla available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Atripla. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.
Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug’s development and may include a wide range of claims.

Benzoxazinones as inhibitors of HIV reverse transcriptase
Patent 5,519,021
Issued: May 21, 1996
Inventor(s): Young; Steven D. & Britcher; Susan F. & Payne; Linda S. & Tran; Lekhanh O. & Lumma, Jr.; William C.
Assignee(s): Merck & Co., Inc.
Certain benzoxazinones are useful in the inhibition of HIV reverse transcriptase (including its resistant varieties), the prevention or treatment of infection by HIV and the treatment of AIDS, either as compounds, pharmaceutically acceptable salts, pharmaceutical composition ingredients, whether or not in combination with other antivirals, immunomodulators, antibiotics or vaccines. Methods of treating AIDS and methods of preventing or treating infection by HIV are also described.
Patent expiration dates:
November 21, 2013
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Pediatric exclusivity
Benzoxazinones as inhibitors of HIV reverse transcriptase
Patent 5,663,169
Issued: September 2, 1997
Inventor(s): Young; Steven D. & Payne; Linda S. & Britcher; Susan F. & Tran; Lekhanh O. & Lumma, Jr.; William C.
Assignee(s): Merck & Co., Inc.
Certain benzoxazinones are useful in the inhibition of HIV reverse transcriptase (including its resistant varieties), the prevention or treatment of infection by HIV and the treatment of AIDS, either as compounds, pharmaceutically acceptable saks, pharmaceutical composition ingredients, whether or not in combination with other antivirals, immunomodulators, antibiotics or vaccines. Methods of treating AIDS and methods of preventing or treating infection by HIV are also described.
Patent expiration dates:
September 2, 2014
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Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
September 2, 2014
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Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS
March 2, 2015
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Pediatric exclusivity
Method for the synthesis, compositions and use of 2′-deoxy-5-fluoro-3′-thiacytidine and related compounds
Patent 5,814,639
Issued: September 29, 1998
Inventor(s): Liotta; Dennis C. & Schinazi; Raymond F. & Choi; Woo-Baeg
Assignee(s): Emory University
The present invention relates to a method of preparing the antiviral compounds 2′-deoxy-5-fluoro-3’thiacytidine (FTC) and various prodrug analogues of FTC from inexpensive precursors with the option of introducing functionality as needed; methods of using these compounds, particularly in the prevention and treatment of AIDS; and the compounds themselves. This synthetic route allows the stereoselective preparation of the biologically active isomer of these compounds and related compounds.
Patent expiration dates:
September 29, 2015
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March 29, 2016
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Pediatric exclusivity
Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Patent 5,914,331
Issued: June 22, 1999
Inventor(s): Liotta; Dennis C. & Schinazi; Raymond F. & Choi; Woo-Baeg
Assignee(s): Emory University
A method and composition for the treatment of HIV and HBV infections in humans is disclosed that includes administering an effective amount of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane, a pharmaceutically acceptable derivative thereof, including a 5′ or N.sup.4 alkylated or acylated derivative, or a pharmaceutically acceptable salt thereof, in a pharmaceutically acceptable carrier. A process for the resolution of a racemic mixture of nucleoside enantiomers is also disclosed that includes the step of exposing the racemic mixture to an enzyme that preferentially catalyzes a reaction in one of the enantiomers.
Patent expiration dates:
July 2, 2017
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Drug substance
January 2, 2018
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Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability
Patent 5,922,695
Issued: July 13, 1999
Inventor(s): Arimilli; Murty N. & Cundy; Kenneth C. & Dougherty; Joseph P. & Kim; Choung U. & Oliyai; Reza & Stella; Valentino J.
Assignee(s): Gilead Sciences, Inc.
Novel compounds are provided that comprise esters of antiviral phosphonomethoxy nucleotide analogs with carbonates and/or carbamates having the structure –OC(R.sup.2).sub.2 OC(O)X(R).sub.a, wherein R.sup.2 independently is H, C.sub.1 -C.sub.12 alkyl, aryl, alkenyl, alkynyl, alkyenylaryl, alkynylaryl, alkaryl, arylalkynyl, arylalkenyl or arylalkyl which is unsubstituted or is substituted with halo, azido, nitro or OR.sup.3 in which R.sup.3 is C.sub.1 -C12 alkyl; X is N or O; R is independently H, C.sub.1 -C.sub.12 alkyl, aryl, alkenyl, alkynyl, alkyenylaryl, alkynylaryl, alkaryl, arylalkynyl, arylalkenyl or arylalkyl which is unsubstituted or is substituted with halo, azido, nitro, –O–, –N.dbd., –NR.sup.4 –, –N(R.sup.4).sub.2 — or OR.sup.3, R.sup.4 independently is –H or C.sub.1 -C.sub.8 alkyl, provided that at least one R is not H; and a is 1 or 2, with the proviso that when a is 2 and X is N, (a) two R groups can be taken together to form a carbocycle or oxygen-containing heterocycle, or (b) one R additionally can be OR.sup.3. The compounds are useful as intermediates for the preparation of antiviral compounds or oligonucleotides, or are useful for administration directly to patients for antiviral therapy or prophylaxis. Embodiments are particularly useful when administered orally.
Patent expiration dates:
July 25, 2017
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Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
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July 25, 2017
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Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS
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January 25, 2018
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Pediatric exclusivity
Nucleotide analog composition and synthesis method
Patent 5,935,946
Issued: August 10, 1999
Inventor(s): Munger, Jr.; John D. & Rohloff; John C. & Schultze; Lisa M.
Assignee(s): Gilead Sciences, Inc.
The invention provides a composition comprising bis(POC)PMPA and fumaric acid (1:1). The composition is useful as an intermediate for the preparation of antiviral compounds, or is useful for administration to patients for antiviral therapy or prophylaxis. The composition is particularly useful when administered orally. The invention also provides methods to make PMPA and intermediates in PMPA synthesis. Embodiments include lithium t-butoxide, 9-(2-hydroxypropyl) adenine and diethyl p-toluenesulfonylmethoxyphosphonate in an organic solvent such as DMF. The reaction results in diethyl PMPA preparations containing an improved by-product profile compared to diethyl PMPA made by prior methods.
Patent expiration dates:
July 25, 2017
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Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
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July 25, 2017
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Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS
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January 25, 2018
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Pediatric exclusivity
Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
Patent 5,977,089
Issued: November 2, 1999
Inventor(s): Arimilli; Murty N. & Cundy; Kenneth C. & Dougherty; Joseph P. & Kim; Choung U. & Oliyai; Reza & Stella; Valentino J.
Assignee(s): Gilead Sciences, Inc.
Compounds are provided that comprise esters of antiviral phosphonomethoxy nucleotide analogs with carbonates and/or carbamates having the structure –OC(R.sup.2).sub.2 OC(O)X(R).sub.a, wherein R.sup.2 independently is H, C.sub.1 -C.sub.12 alkyl, aryl, alkenyl, alkynyl, alkyenylaryl, alkynylaryl, alkaryl, arylalkynyl, arylalkenyl or arylalkyl which is unsubstituted or is substituted with halo, azido, nitro or OR.sup.3 in which R.sup.3 is C.sub.1 -C.sub.12 alkyl; X is N or O; R is independently H, C.sub.1 -C.sub.12 alkyl, aryl, alkenyl, alkynyl, alkyenylaryl, alkynylaryl, alkaryl, arylalkynyl, arylalkenyl or arylalkyl which is unsubstituted or is substituted with halo, azido, nitro, –O–, –N.dbd., –NR.sup.4 –, –N(R.sup.4).sub.2 — or OR.sup.3, R.sup.4 independently is –H or C.sub.1 -C.sub.8 alkyl, provided that at least one R is not H; and a is 1 or 2, with the proviso that when a is 2 and X is N, (a) two R groups can be taken together to form a carbocycle or oxygen-containing heterocycle, or (b) one R additionally can be OR.sup.3. The compounds are useful as intermediates for the preparation of antiviral compounds or oligonucleotides, or are useful for administration directly to patients for antiviral therapy or prophylaxis. Embodiments are particularly useful when administered orally.
Patent expiration dates:
July 25, 2017
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Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
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July 25, 2017
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Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS
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January 25, 2018
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Pediatric exclusivity
Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
Patent 6,043,230
Issued: March 28, 2000
Inventor(s): Arimilli; Murty N. & Cundy; Kenneth C. & Dougherty; Joseph P. & Kim; Choung U. & Oliyai; Reza & Stella; Valentino J.
Assignee(s): Gilead Sciences, Inc.
Novel compounds are provided that comprise esters of antiviral phosphonomethoxy nucleotide analogs with carbonates and/or carbamates having the structure -OC(R.sup.2).sub.2 OC(O) X(R).sub.a, wherein R.sup.2 independently is H, C.sub.1 -C.sub.12 alkyl, aryl, alkenyl, alkynyl, alkyenylaryl, alkynylaryl, alkaryl, arylalkynyl, arylalkenyl or arylalkyl which is unsubstituted or is substituted with halo, azido, nitro or OR.sup.3 in which R.sup.3 is C.sub.1 -C12 alkyl; X is N or O; R is independently H, C.sub.1 -C.sub.12 alkyl, aryl, alkenyl, alkynyl, alkyenylaryl, alkynylaryl, alkaryl, arylalkynyl, arylalkenyl or arylalkyl which is unsubstituted or is substituted with halo, axido, nitro, –O–, –N.dbd., –NR.sup.4 –, –N(R.sup.4).sub.2 — or OR.sup.3, R.sup.4 independently is –H or C.sub.1 -C.sub.8 alkyl, provided that at least one R is not H; and a is 1 or 2, with the proviso that when a is 2 and X is N, (a) two R groups can be taken together to form a carbocycle or oxygen-containing heterocycle, or (b) one R additionally can be OR.sup.3. The compounds are useful as intermediates for the preparation of antiviral compounds or oligonucleotides, or are useful for administration directly to patients for antiviral therapy or prophylaxis. Embodiments are particularly useful when administered orally.
Patent expiration dates:
July 25, 2017
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Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
July 25, 2017
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Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS
January 25, 2018
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Pediatric exclusivity
Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one
Patent 6,639,071
Issued: October 28, 2003
Inventor(s): Louis S.; Crocker & Joseph L.; Kukura, II & Andrew S.; Thompson & Christine; Stelmach & Steven D.; Young
Assignee(s): Merck & Co., Inc.
The instant invention describes a method for crystallizing (−)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one from a solvent and anti-solvent system and producing the crystalline product. The desired final crystal form, Form I, can be produced when using methanol or ethanol. Form II is isolated from 2-propanol and can be converted to the desired crystal form at low drying temperatures, such as between about a temperature of 40° C. and 50° C.
Patent expiration dates:
February 14, 2018
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August 14, 2018
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Pediatric exclusivity
Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane
Patent 6,642,245
Issued: November 4, 2003
Inventor(s): Dennis C.; Liotta & Raymond F.; Schinazi & Woo-Baeg; Choi
Assignee(s): Emory University
A method and composition for the treatment of HIV and HBV infections in humans is disclosed that includes administering an effective amount of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane, a pharmaceutically acceptable derivative thereof, including a 5′ or N4 alkylated or acylated derivative, or a pharmaceutically acceptable salt thereof, in a pharmaceutically acceptable carrier. A process for the resolution of a racemic mixture of nucleoside enantiomers is also disclosed that includes the step of exposing the racemic mixture to an enzyme that preferentially catalyzes a reaction in one of the enantiomers.
Patent expiration dates:
November 4, 2020
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Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
November 4, 2020
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Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS
May 4, 2021
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Pediatric exclusivity
Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
Patent 6,703,396
Issued: March 9, 2004
Inventor(s): Dennis C.; Liotta & Raymond F.; Schinazi & Woo-Baeg; Choi
Assignee(s): Emory University
A process for the resolution of a racemic mixture of nucleoside enantiomers that includes the step of exposing the racemic mixture to an enzyme that preferentially catalyzes a reaction in one of the enantiomers. The nucleoside enantiomer (−)-2-hydroxymethyl-5-(5-flurocytosin-1-yl)-1,3-oxathiolane is an effective antiviral agent against HIV, HBV, and other viruses replicating in a similar manner.
Patent expiration dates:
March 9, 2021
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September 9, 2021
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Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one
Patent 6,939,964
Issued: September 6, 2005
Inventor(s): Crocker; Louis S. & Kukura, II; Joseph L. & Thompson; Andrew S. & Stelmach; Christine & Young; Steven D.
Assignee(s): Merck & Co., Inc.
The instant invention describes a method for crystallizing (−)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one from a solvent and anti-solvent solvent system and producing the crystalline product. The desired final crystal form, Form I, can be produced when using methanol or ethanol. Form II is isolated from 2-propanol and can be converted to the desired crystal form at low drying temperatures, such as between about a temperature of 40° C. and 50° C.
Patent expiration dates:
January 20, 2018
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July 20, 2018
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Pediatric exclusivity
Compositions and methods for combination antiviral therapy
Patent 8,592,397
Issued: November 26, 2013
Assignee(s): Gilead Sciences, Inc.
The present invention relates to therapeutic combinations of [2-(6-amino-purin-9-yl)-1-methyl-ethoxymethyl]-phosphonic acid diisopropoxycarbonyloxymethyl ester (tenofovir disoproxil fumarate, Viread®) and (2R, 5S, cis)-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one(emtricitabine, Emtriva™, (-)-cis FTC) and their physiologically functional derivatives. The combinations may be useful in the treatment of HIV infections, including infections with HIV mutants bearing resistance to nucleoside and/or non-nucleoside inhibitors. The present invention is also concerned with pharmaceutical compositions and formulations of said combinations of tenofovir disoproxil fumarate and emtricitabine, and their physiologically functional derivatives, as well as therapeutic methods of use of those compositions and formulations.
Patent expiration dates:
January 13, 2024
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Patent use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
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January 13, 2024
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Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS
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Unitary pharmaceutical dosage form
Patent 8,598,185
Issued: December 3, 2013
Assignee(s): Bristol-Myers Squibb & Gilead Sciences, Inc.
In accordance with this invention a novel pharmaceutical product containing efavirenz, emtricitabine and tenofovir DF are provided as a multicomponent unitary oral dosage form, component 1 comprising tenofovir DF (and, optionally, emtricitabine) and component 2 comprising efavirenz, wherein components 1 and 2 are in a stabilizing configuration. In preferred embodiments component 1 is made by dry granulation.
Patent expiration dates:
May 1, 2028
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Drug product

What is Atripla?

Atripla (efavirenz, emtricitabine, and tenofovir) is an antiviral medication that prevents human immunodeficiency virus (HIV) from reproducing in your body.

Atripla treats HIV in adults and children who are at least 12 years old. HIV causes acquired immunodeficiency syndrome (AIDS). This medication is not a cure for HIV or AIDS.

Atripla may also be used for purposes not listed in this medication guide.
Important information

Do not take Atripla together with adefovir (Hepsera), or with medications that contain emtricitabine, lamivudine, or tenofovir (Combivir, Complera, Emtriva, Epivir, Epzicom, Stribild, Trizivir, Truvada, Viread).

Some other medicines can cause unwanted or dangerous effects when used with Atripla. Your doctor may need to change your treatment plan if you also use: midazolam, pimozide, St. John’s wort, triazolam, voriconazole, or an ergot medicine (dihydroergotamine, ergonovine, ergotamine, methylergonovine).
Slideshow: Flashback: FDA Drug Approvals 2013
Flashback: FDA Drug Approvals 2013

Atripla may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Atripla can also cause severe or fatal liver problems. Call your doctor at once if you have symptoms such as nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Before taking this medicine

You should not take Atripla if you are allergic to efavirenz (Sustiva), emtricitabine (Emtriva), or tenofovir (Viread).

Do not take Atripla together with adefovir (Hepsera), or with medications that contain emtricitabine, lamivudine, or tenofovir (Combivir, Complera, Emtriva, Epivir, Epzicom, Stribild, Trizivir, Truvada, Viread).

Some medicines can cause unwanted or dangerous effects when used with Atripla. Your doctor may need to change your treatment plan if you are taking any of the following drugs:

midazolam or triazolam;

pimozide;

St. John’s wort;

voriconazole; or

an ergot medicine–dihydroergotamine, ergonovine, ergotamine, methylergonovine.

This medication should not be used in children weighing less than 88 pounds.

To make sure Atripla is safe for you, tell your doctor if you have:

liver or kidney disease;

a history of mental illness, use of antipsychotic medication, or injection drug use;

epilepsy or other seizure disorder;

low bone mineral density; or

hepatitis B or C infection.

Some people taking Atripla develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your risk.

FDA pregnancy category D. Do not use Atripla if you are pregnant. It could harm the unborn baby. Use two forms of birth control, including a barrier form (such as a condom or diaphragm with spermicide) while you are using this medication and for at least 12 weeks after your treatment ends.

See also: Pregnancy and breastfeeding warnings (in more detail)

HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.
How should I take Atripla?

Take Atripla exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take Atripla in larger or smaller amounts or for longer than recommended.

Take this medication on an empty stomach at bedtime.

While using Atripla, you may need frequent blood tests. Your liver function may also need to be tested.

This medication can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking Atripla.

Use Atripla regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store Atripla in the original container at room temperature, away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using Atripla.
What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Taking this medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.
Atripla side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Stop using Atripla and call your doctor at once if you have:

kidney problems–increased thirst and urination, loss of appetite, constipation, little or no urinating; or

sore throat, flu symptoms, easy bruising or unusual bleeding;

liver problems–nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

unusual thoughts or behavior, anger, severe depression, thoughts of hurting yourself or others, hallucinations, seizure (convulsions); or

severe skin reaction — fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Atripla may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with Atripla. Tell your doctor if you have:

signs of a new infection–fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

cold sores, sores on your genital or anal area;

rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or

swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include

mild nausea;

mild depression;;

headache, dizziness, tired feeling, strange dreams; or

changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)
What other drugs will affect Atripla?

Atripla can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Many drugs can interact with Atripla. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Atripla, especially:

a blood thinner–clopidogrel; any other HIV medicines–especially atazanavir, didanosine, efavirenz, lopinavir with ritonavir, or tenofovir.

This list is not complete and many other drugs can interact with Atripla. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Efavirenz / emtricitabine / tenofovir Pregnancy and Breastfeeding Warnings

Efavirenz / emtricitabine / tenofovir is also known as: Atripla

Overview
Side Effects
Dosage
Interactions
Pregnancy
More

Efavirenz / emtricitabine / tenofovir Pregnancy Warnings

Animal studies have revealed evidence of fetal harm with efavirenz. Efavirenz crosses the placenta in animals and produces fetal blood levels similar to maternal blood levels. Efavirenz may cause fetal harm when used during the first trimester. There are no controlled data in human pregnancy. To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry (APR) has been established. Healthcare providers are encouraged to prospectively register patients. Information is available at www.apregistry.com. As of July 2010, the APR had received reports of 792 pregnancies exposed to efavirenz-containing regimens, 718 of which were first trimester exposures. Birth defects were observed in 17 of 604 live births with first trimester exposure and 2 of 69 live births with second or third trimester exposure. One of these prospective reports with first trimester exposure was a neural tube defect. Also, a single case of anophthalmia has been prospectively reported with first trimester efavirenz exposure; however, this case included severe oblique facial clefts and amniotic banding, a known association with anophthalmia. There have been 6 cases of findings consistent with neural tube defects (including meningomyelocele) retrospectively reported in infants of mothers with first trimester efavirenz exposure. Multiple defects (Dandy-Walker syndrome) in a fetus from a spontaneous abortion and neural tube defects in a fetus from a pregnancy terminated during the second trimester have also been reported. Both mothers had first trimester exposure to efavirenz-containing regimens. Causality could not be clearly established in any of these cases. The manufacturer recommends avoiding pregnancy during efavirenz/emtricitabine/tenofovir therapy. Barrier contraception must always be used in combination with other methods of contraception (e.g., hormonal) during use of this drug. Use of adequate contraception for 12 weeks after discontinuing the drug is recommended. Women of childbearing age should undergo pregnancy testing before starting efavirenz/emtricitabine/tenofovir and should be advised to notify their physician if they become pregnant during therapy. Patients should be advised of the potential harm to the fetus if they become pregnant while taking efavirenz/emtricitabine/tenofovir or if it is used during the first trimester. FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

FDA pregnancy category: D Efavirenz/emtricitabine/tenofovir should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus. Comments: Effective contraception is recommended during therapy and for 12 weeks after the drug is stopped.
Efavirenz / emtricitabine / tenofovir Breastfeeding Warnings

Breast milk samples from 5 HIV-1 infected women showed emtricitabine is secreted in human milk. Infants breastfed by mothers treated with emtricitabine may be at risk for developing viral resistance to emtricitabine. Other emtricitabine-associated risks in such infants are unknown. Breast milk samples from 5 HIV-1 infected mothers showed tenofovir is secreted in human milk. The impact of this exposure in infants breastfed by mothers treated with tenofovir is unknown. Since the risks of infant exposure to emtricitabine and tenofovir are unknown and due to the potential for HIV-1 transmission, the manufacturer states that mothers should not breastfeed if they are taking efavirenz/emtricitabine/tenofovir.

Breastfeeding is not recommended during use of efavirenz/emtricitabine/tenofovir. Excreted into human milk: Unknown (efavirenz); Yes (emtricitabine and tenofovir) Excreted into animal milk: Yes (efavirenz and tenofovir); Unknown (emtricitabine) The effects in the nursing infant are unknown. The US Centers for Disease Control and Prevention and the American Academy of Pediatrics advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected.

Atripla Side Effects

Generic Name: efavirenz / emtricitabine / tenofovir

Overview
Side Effects
Dosage
Interactions
For Professionals
More

Note: This page contains information about the side effects of efavirenz / emtricitabine / tenofovir. Some of the dosage forms included on this document may not apply to the brand name Atripla.

Not all side effects for Atripla may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer

Applies to efavirenz / emtricitabine / tenofovir: oral tablet

Along with its needed effects, efavirenz / emtricitabine / tenofovir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking efavirenz / emtricitabine / tenofovir:
Less common

Abdominal or stomach pain or tenderness
blistering, peeling, or loosening of the skin
body aches or pain
clay-colored stools
cough
dark urine
ear congestion
fever or chills
headache
itching
loss of voice
muscle aches
nausea and vomiting
severe skin rash
sore throat
swelling of the feet or lower legs
tightness of the chest
trouble concentrating
yellow eyes or skin

Some side effects of efavirenz / emtricitabine / tenofovir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common

Diarrhea
dizziness
unusual tiredness or weakness

decreased appetite
discouragement
feeling sad or empty
irritability
loss of appetite
loss of interest or pleasure
mild rash
pain or tenderness around the eyes and cheekbones
sleepiness
trouble sleeping
unusual drowsiness

Atripla Prices, Coupons & Patient Assistance Programs

www.drugs.com/price-guide/atripla

Atripla Prices, Coupons & Patient Assistance Programs – Drugs.com Atripla Prices, Coupons and Patient Assistance Programs Atripla (efavirenz / emtricitabine / tenofovir) is a member of the antiviral combinations drug class and is commonly used for HIV Infection. Atripla Prices This Atripla price guide…
Atripla Drug Interactions

Drug Interactions (Cerner Multum)

Atripla Drug Interactions – Drugs.com Atripla (efavirenz / emtricitabine / tenofovir) Drug Interactions Overview Side Effects Dosage Interactions For Professionals More Pregnancy Warnings User Reviews Drug Images Support Group Q & A Pricing & Coupons Drug Interactions (754) Alcohol / Food…
Atripla

www.drugs.com/uk/atripla.html

Atripla | Drugs.com Atripla Active Substance: efavirenz / emtricitabine / tenofovir disoproxil fumarate Common Name: efavirenz / emtricitabine / tenofovir disoproxil ATC Code: J05AR06 Marketing Authorisation Holder: Bristol-Myers Squibb and Gilead Sciences Ltd. Active Substance: efavirenz / …
Atripla Reviews & Ratings

User Reviews (Drugs.com)

Atripla Reviews & Ratings at Drugs.com User Reviews for Atripla The following information is NOT intended to endorse drugs or recommend therapy. While these reviews might be helpful, they are not a substitute for the expertise, skill, knowledge and judgement of healthcare practitioners in patient…

GILEAD 701 (Truvada 200 mg / 300 mg)

Generic Name: emtricitabine/tenofovir

Pill imprint GILEAD 701 has been identified as Truvada 200 mg / 300 mg.

Truvada is used in the treatment of pre-exposure prophylaxis; hiv infection; nonoccupational exposure and belongs to the drug class antiviral combinations. There is no proven risk in humans during pregnancy. Truvada 200 mg / 300 mg is not subject to the Controlled Substances Act.

Truvada Side Effects

Generic Name: emtricitabine / tenofovir

Overview
Side Effects
Dosage
Interactions
For Professionals
More

Note: This document contains side effect information about emtricitabine / tenofovir. Some of the dosage forms listed on this page may not apply to the brand name Truvada.

Some side effects of Truvada may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer

Applies to emtricitabine / tenofovir: oral tablet

Along with its needed effects, emtricitabine / tenofovir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking emtricitabine / tenofovir:
Less common

Blisters under the skin
rash with flat lesions or small raised lesions on the skin
redness of the skin
skin rash, itching skin, hives or welts
spots on your skin resembling a blister or pimple

Rare

Blindness or vision changes
burning of the face or mouth
burning, crawling, itching, numbness, painful, prickling, “pins and needles”, or tingling feelings in the hands, arms, feet, or legs
chest pain
clumsiness or unsteadiness
sensation of pins and needles
sneezing
sore throat
stabbing pain
weakness in the hands or feet

Incidence not known

Abdominal or stomach discomfort
agitation
bloating
bloody or cloudy urine
bone pain
chills
coma
confusion
constipation
convulsions or seizures
cough
darkened urine
decreased appetite
decreased frequency or amount of urine
depression
diarrhea
difficult or labored breathing
difficult or painful urination
difficulty with swallowing
dizziness
fast heartbeat
fast, shallow breathing
fever
general feeling of discomfort
headache
hostility
increase in the amount of urine
increased blood pressure
increased thirst
indigestion
irritability
lethargy
loss of appetite
lower back or side pain
muscle pain or cramping
muscle twitching
nausea
pains in the stomach, side, or abdomen, possibly radiating to the back
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid weight gain
sleepiness
stupor
sudden decrease in the amount of urine
swelling of the face, fingers, hands, lower legs, or ankles
tightness in the chest
trouble breathing
unusual tiredness or weakness
vomiting
weight gain
yellow eyes or skin

Some side effects of emtricitabine / tenofovir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common

Lack or loss of strength
passing of gas
weight loss

Rare

Acid or sour stomach
back pain
belching
difficulty with moving
discouragement
feeling sad or empty
heartburn
increased cough
joint pain
loss of interest or pleasure
muscle aching or cramping
muscle pain or stiffness
pain
runny nose
stomach upset
stuffy nose
sweating
swollen joints
tiredness
trouble concentrating
trouble sleeping

For Healthcare Professionals

Applies to emtricitabine / tenofovir: oral kit, oral tablet
General

Side effects have been reported for emtricitabine and/or tenofovir when taken in combination with other antiretroviral agents. The most common side effects (10% or more; any severity) reported in HIV-1-infected patients during a clinical study of efavirenz, emtricitabine, and tenofovir included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.

In HIV-1-uninfected individuals in preexposure prophylaxis trials, the most common side effects (greater than 2%) reported were headache, abdominal pain, and decreased weight.
Gastrointestinal

Common (1% to 10%): Diarrhea (Grades 2 to 4: up to 9%; all Grades: up to 7%), nausea (Grades 2 to 4: up to 9%), abdominal pain (all Grades: up to 4%), vomiting (Grades 2 to 4: up to 2%)
Frequency not reported: Flatulence

Emtricitabine or tenofovir:
Common (1% to 10%): Dyspepsia (at least 5%)

Tenofovir:
Postmarketing reports: Pancreatitis, abdominal pain, increased amylase
Metabolic

Hypokalemia and hypophosphatemia may occur as a result of proximal renal tubulopathy.

Very common (10% or more): Increased fasting cholesterol (greater than 240 mg/dL: up to 22%)
Common (1% to 10%): Decreased phosphorus (2.5 to less than lower limit of normal: up to 7%; less than 2 mg/dL: up to 10%), increased creatine kinase (greater than 990 units/L in males and 845 units/L in females: up to 9%), increased serum amylase (greater than 175 units/L: up to 8%), increased fasting triglycerides (greater than 750 mg/dL: 4%), increased pancreatic amylase (greater than 2 times upper limit of normal [ULN]: up to 3%), increased serum lipase (greater than 2 times ULN: up to 3%), altered serum glucose (less than 40 mg/dL or greater than 250 mg/dL: up to 3%), weight loss (up to 3%), hyperglycemia (greater than 250 mg/dL: up to 2%), increased alkaline phosphatase (greater than 550 units/L: 1%)
Frequency not reported: Redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, “cushingoid appearance”)

Tenofovir:
Postmarketing reports: Hypokalemia, lactic acidosis, hypophosphatemia
Hepatic

Very common (10% or more): Elevated AST (1.25 to less than 2.5 times ULN: up to 14%), elevated ALT (1.25 to less than 2.5 times ULN: up to 14%)
Common (1% to 10%): Elevated AST (greater than 180 units/L in males and 170 units/L in females: 3%; greater than 2.6 times ULN: up to 5%), elevated ALT (greater than 215 units/L in males and 170 units/L in females: 2%; greater than 2.6 times ULN: up to 7%), bilirubin (greater than 2.5 times ULN: up to 3%)
Frequency not reported: Severe acute exacerbations of hepatitis B

Emtricitabine:
Frequency not reported: Liver failure, liver decompensation

Tenofovir:
Frequency not reported: Lactic acidosis/severe hepatomegaly with steatosis
Postmarketing reports: Hepatic steatosis, hepatitis, increased liver enzymes (primarily AST, ALT, gamma glutamyltransferase)

Severe acute exacerbations of hepatitis have been reported in patients with hepatitis B after discontinuation of emtricitabine-tenofovir and were associated with liver failure and liver decompensation in some emtricitabine-treated patients.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs, including tenofovir, in combination with other antiretroviral agents.
Hematologic

Very common (10% or more): Decreased neutrophils (1000 to 1300/mm3: up to 13%)
Common (1% to 10%): Decreased neutrophils (less than 750/mm3: up to 5%), hemoglobin (8.5 to 10 mg/dL: 4%; less than 9.4 mg/dL: up to 2%)
Respiratory

Very common (10% or more): Pharyngitis (all Grades: up to 13%)
Common (1% to 10%): Sinusitis (Grades 2 to 4: up to 8%), upper respiratory tract infections (Grades 2 to 4: up to 8%), nasopharyngitis (Grades 2 to 4: up to 5%)

Emtricitabine or tenofovir:
Common (1% to 10%): Increased cough (at least 5%), pneumonia (at least 5%), rhinitis (at least 5%)

Tenofovir:
Postmarketing reports: Dyspnea
Psychiatric

Common (1% to 10%): Depression (Grades 2 to 4: up to 9%; all Grades: up to 6%), insomnia (Grades 2 to 4: up to 5%), anxiety (all Grades: up to 3%)
Frequency not reported: Abnormal dreams

Emtricitabine or tenofovir:
Common (1% to 10%): Anxiety (at least 5%)
Nervous system

Common (1% to 10%): Dizziness (Grades 2 to 4: 8%), headache (Grades 2 to 4: up to 6%; all Grades: up to 7%)
Frequency not reported: Somnolence

Emtricitabine or tenofovir:
Common (1% to 10%): Peripheral neuropathy (including neuropathy and peripheral neuritis; at least 5%), paresthesia (at least 5%)
Other

Common (1% to 10%): Fatigue (Grades 2 to 4: up to 9%)

Emtricitabine or tenofovir:
Common (1% to 10%): Asthenia (at least 5%), pain (at least 5%), abdominal pain (at least 5%), back pain (at least 5%), fever (at least 5%)

Tenofovir:
Frequency not reported: Higher 1,25 vitamin D levels
Postmarketing reports: Asthenia
Dermatologic

Common (1% to 10%): Rash event (including rash, maculopapular rash, exfoliative rash, generalized rash, macular rash, pruritic rash, vesicular rash; Grades 2 to 4: up to 7%)

Emtricitabine:
Frequency not reported: Skin discoloration (palmar-plantar hyperpigmentation)

Tenofovir:
Frequency not reported: Sweating
Postmarketing reports: Rash
Musculoskeletal

Rhabdomyolysis, osteomalacia, muscular weakness, and myopathy may occur as a result of proximal renal tubulopathy.

Common (1% to 10%): Bone fractures (1.7%)
Frequency not reported: Decreased bone mineral density

Emtricitabine or tenofovir:
Common (1% to 10%): Myalgia (at least 5%), arthralgia (at least 5%), back pain (all Grades: up to 5%)

Tenofovir:
Frequency not reported: Decreased bone mineral density, increased biochemical markers of bone metabolism
Postmarketing reports: Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathy
Renal

Rhabdomyolysis, osteomalacia, hypokalemia, muscular weakness, myopathy, and hypophosphatemia may occur as a result of proximal renal tubulopathy.

Common (1% to 10%): Increased creatinine (1.1 to 1.3 times ULN: up to 2%)
Uncommon (0.1% to 1%): Increased creatinine (greater than 1.4 times ULN: less than 1%)

Tenofovir:
Frequency not reported: New onset or worsening renal impairment
Postmarketing reports: Renal insufficiency, renal failure, acute renal failure, Fanconi syndrome, proximal renal tubulopathy, increased creatinine, nephrogenic diabetes insipidus, acute tubular necrosis, interstitial nephritis (including acute cases)
Genitourinary

Common (1% to 10%): Proteinuria (Grade 1: up to 6%), syphilis (all Grades: up to 6%), secondary syphilis (all Grades: up to 6%), urethritis (all Grades: up to 5%), urinary tract infection (all Grades: up to 5%), hematuria (greater than 75 RBC/HPF: up to 3%), genital ulceration (all Grades: 2%), anogenital warts (all Grades: up to 2%)
Uncommon (0.1% to 1%): Proteinuria (Grade 2 to 3: less than 1%), glycosuria (3 plus or greater: less than 1%)

Tenofovir:
Postmarketing reports: Proteinuria, polyuria
Immunologic

Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves’ disease, polymyositis, Guillain-Barre syndrome)
Hypersensitivity

Tenofovir:
Postmarketing reports: Allergic reaction (including angioedema)
Endocrine

Tenofovir:
Frequency not reported: Higher serum parathyroid hormone levels