Antiretroviral Agents: Atripla = efavirenz + tenofovir + emtricitabine

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Atripla
efavirenz + emtricitabine + tenofovir

Detailed Prescribing Information

July 2006

Atripla A combination of emtricitabine + efavirenz + tenofovir Approved 7-12-2006
Forms Available	300 mg tenofovir / 200 mg emtricitabine / 600 mg efavirenz in tablet form
Dosing	1 tablet once a day without food Dosing at bedtime may improve tolerability to the efavirenz component.
	Renal dosing	Dosing interval Ccr 30-49 cc/min	Dosing interval Ccr < 30 cc/min
		Not recommended	Not recommended
	Hepatic dosing: no data available
Food dependence	Food increases efavirenz absorption and therefore may produce increased CNS side effects. Take Atripla on an empty stomach.
Adverse Effects	Same as tenofovir and emtricitabine and efavirenz (see above or click on the drug name) Efavirenz may cause CNS stimulation, restlessness, nightmares, depression, exacerbation of underlying mental health problems, rash or chemical hepatitis. Tenofovir may cause nephropathy, Fanconi-like syndrome, or loss of bone mineralization. Emtricitabine rarely causes discoloration of palms or soles.
Interactions	Same as tenofovir and emtricitabine and efavirenz (see above or click on the drug name) If Atripla is used with didanosine, reduce the dose of didanosine EC to 250 mg daily maximum. Atripla should be used cautiously if at all with atazanavir as the triple interaction of efavirenz, tenofovir, and atazanavir has not been well studied.
Suggested lab follow-up	Monthly CBC for 3 months, then every 3 months if stable Consider monthly creatinine measurements in lean individuals or those with renal insufficiency Monthly liver profile for 3 months, then every 3 months and as indicated if stable
Warning	Rare lactic acidosis and hepatic steatosis. Do not used fixed dose combination in persons with renal insufficiency. Severe acute exacerbations of chronic hepatitis B may be observed with sudden discontinuation of lamivudine, emtricitabine, Truvada, Trizivir, Epzicom, Atripla. Avoid use of efavirenz-containing medications in persons who require high levels of mental acuity or concentration in their work or lives, and in those with poor-controlled mental health issues such as schizophrenia or manic-depressive disorders.
Contraindication	None
Suggested Usage	In general Atripla should be used in persons who are naive to treatment as most persons who are treatment experienced may harbor resistance mutations to lamivudine/emtricitabine and/or NNRTIs. Resistance testing should be done prior to using Atripla. Do not use in combination with Sustiva, lamivudine, emtricitabine, Epzicom, Combivir, or Trizivir due to identical mechanism of action or duplication of efavirenz or emtricitabine dosing. Encourage exercise and calcium intake to minimize bone loss. Advise patient to avoid dehydration. Do not discontinue abruptly in patients with chronic hepatitis B without consideration of continuation of lamivudine or some other agent active against hepatitis B.
Complete prescribing information	Atripla Prescribing Info Also see http://www.atripla.com for further info as it becomes available. Patient handout for this drug HERE.

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Nucleoside & Nucleotide Reverse Transcriptase Inhibitors (NRTI)

AZT | ddC | ddI | d4T | 3TC | ABC | FTC | TDF | Combivir | Trizivir | Epzicom | Truvada | Atripla

Nonnucleoside Reverse Transcriptase Inhibitors (NNRTI)

efavirenz | nevirapine | delavirdine

Protease Inhibitors (PI) | Boosted Protease Inhibitors

Fusion Inhibitors

enfuvirtide

Quick Menu / Table of Contents
Introduction	Principles	Management	NRTI Info	NNRTI Info
PI Info	Fusion Inhibitors	Drug Summary	Investigational	Adherence
Lab Evaluation	Resistance Tests	PEP	Antiretroviral Tables	OI Prevention
Vaccinations	TB Therapy	Hepatitis Therapy	OI Diagnosis	OI Therapy
Bibliography		Links		Palliative Therapy

Updated 7.22.2006

1. Renal dosing information from: Ian R. McNicholl & Rudolph A. Rodriguez, MD, Dosing of Antiretroviral Drugs in Renal Insufficiency and Hemodialysis, May 2004
http://hivinsite.ucsf.edu/InSite?page=md-rr-18