WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT EXACERBATION OF HEPATITIS B
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of ATRIPLA, in combination with other antiretrovirals
[See Warnings and Precautions].
ATRIPLA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of ATRIPLA have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued EMTRIVA or VIREAD, which are components of ATRIPLA. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue ATRIPLA. If appropriate, initiation of anti-hepatitis B therapy may be warranted
[See Warnings and Precautions]
ATRIPLA is a fixed-dose combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate (tenofovir DF). SUSTIVA is the brand name for efavirenz, a non-nucleoside reverse transcriptase inhibitor. EMTRIVA is the brand name for emtricitabine, a synthetic nucleoside analog of cytidine. VIREAD is the brand name for tenofovir DF, which is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. VIREAD and EMTRIVA are the components of TRUVADA.
ATRIPLA tablets are for oral administration. Each tablet contains 600 mg of efavirenz, 200 mg of emtricitabine, and 300 mg of tenofovir DF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients. The tablets include the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablets are film-coated with a coating material containing black iron oxide, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, and titanium dioxide.
ATRIPLA® is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.
Media Articles Related to Atripla (Efavirenz / Emtricitabine / Tenofovir)
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Published Studies Related to Atripla (Efavirenz / Emtricitabine / Tenofovir)
A randomized double-blind comparison of coformulated
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus
efavirenz/emtricitabine/tenofovir disoproxil fumarate for initial treatment of
HIV-1 infection: analysis of week 96 results. 
We report week 96 results from a phase 3 trial of
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
(EVG/COBI/FTC/TDF, n = 348) vs efavirenz/emtricitabine/tenofovir disoproxil
fumarate (EFV/FTC/TDF, n = 352). At week 48, EVG/COBI/FTC/TDF was noninferior to
EFV/FTC/TDF (88% vs 84%, difference +3.6%, 95% confidence interval: -1.6% to
Randomized, phase 2 evaluation of two single-tablet regimens elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for the initial treatment of HIV infection. [2011.03.27]
OBJECTIVE: To assess the safety and efficacy of two, single-tablet regimens for the initial treatment of HIV infection. DESIGN: Phase 2, randomized, double-blind, double-dummy, multicenter, active-controlled study... CONCLUSION: Once-daily EVG/COBI/FTC/TDF achieved and maintained a high rate of virologic suppression with fewer central nervous system and psychiatric adverse events compared to a current standard-of-care regimen of EFV/FTC/TDF.
Patient-reported outcomes in virologically suppressed, HIV-1-Infected subjects after switching to a simplified, single-tablet regimen of efavirenz, emtricitabine, and tenofovir DF. [2010.02]
A randomized, open-label, multicenter study was conducted to evaluate the therapeutic switch to a single-tablet formulation of efavirenz/emtricitabine/tenofovir DF (EFV/FTC/TDF) among virologically suppressed, HIV-1-infected subjects. Eligible subjects on stable antiretroviral therapy (ART) with HIV-1 RNA less than 200 copies per milliliter for 3 months or more were stratified by prior protease inhibitor (PI)- or non-nucleoside reverse transcriptase inhibitor (NNRTI)-based therapy and randomized (2:1) to EFV/FTC/TDF or to stay on their baseline regimen (SBR)...
Simplification of antiretroviral therapy to a single-tablet regimen consisting of efavirenz, emtricitabine, and tenofovir disoproxil fumarate versus unmodified antiretroviral therapy in virologically suppressed HIV-1-infected patients. [2009.06.01]
OBJECTIVE: To evaluate a simplification strategy for HIV-1-infected patients virologically suppressed on antiretroviral therapy (ART) by switching to a single-tablet regimen consisting of efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF). DESIGN:: Prospective, randomized, controlled, open-label, multicenter study... CONCLUSION: Simplification to EFV/FTC/TDF maintained high and comparable rates of virologic suppression vs. SBR through 48 weeks.
Efavirenz/emtricitabine/tenofovir disoproxil fumarate single-tablet regimen (Atripla(R)): a review of its use in the management of HIV infection. [2010.12.03]
The non-nucleoside reverse transcriptase inhibitor, efavirenz, and the two nucleoside reverse transcriptase inhibitors, emtricitabine and tenofovir disoproxil fumarate (tenofovir DF) are now available as a single-tablet regimen (efavirenz/emtricitabine/tenofovir DF 600 mg/200 mg/300 mg; Atripla(R))...
Reports of Suspected Atripla (Efavirenz / Emtricitabine / Tenofovir) Side Effects
Chest Pain (21),
Aplasia Pure RED Cell (21),
Cardiac Failure (20),
Megakaryocytes Increased (19),
Histiocytosis Haematophagic (19),
RED Blood Cell Abnormality (18),
Bone Marrow Disorder (18), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 1 ratings/reviews, Atripla has an overall score of 10. The effectiveness score is 10 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst.
Atripla review by 37 year old male patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || HIV|
|Dosage & duration:|| || 600mg taken every night at 9pm for the period of been on it for one year|
|Other conditions:|| || none|
|Other drugs taken:|| || none|
|Benefits:|| || increased CD4 count,and lower viral load. |
|Side effects:|| || flushed face, sleepiness, equilibrium out of balance|
|Comments:|| || one pill everynight at 9pm for as long as the treatment works, can be very long term.|
Page last updated: 2015-08-26