efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF)
Standard DoseOne tablet once daily on an empty stomach, preferably at bedtime (food increases the risk of central nervous system, or CNS, toxicities). Tablet contains 600 mg of the NNRTI efavirenz plus 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate (TDF).
For adults and children 12 years of age and older weighing at least 88 pounds (40 kg).
Take missed dose as soon as possible, unless it is closer to the time of your next dose. Do not double up on your next dose. Do not split or crush the tablet. Dose cannot be adjusted for people with kidney problems and Atripla should not be used in people with moderate or severe kidney or liver impairment.
A similar, but not exact, off-patent medication is available (see pages for Symfi and Symfi Lo, EFV/3TC/TDF).
Gilead Sciences, Inc.
(800) GILEAD-5 (445–3235)
Potential Side Effects and Toxicity
• See the individual drugs contained in Atripla: Sustiva and Truvada (co-formulation of Emtriva and Viread).
• See package insert for more complete information on potential side effects and interactions.
Use with caution in individuals with depression or other psychiatric issues who are not receiving mental health care. A 2014 study (reference online) reviewed four previously published AIDS Clinical Trials Group (ACTG) studies regarding efavirenz and suicidal ideation and re-emphasized the fact that efavirenz has an association with suicidality (reported suicidal ideation or attempted or completed suicide), and should be used with caution in patients with severe or uncontrolled depression and/or a history of suicidality. It is recommended for anyone on a regimen containing efavirenz to be screened for depression and suicidality. Common side effects may include dizziness, drowsiness, abnormal or vivid dreams, difficulty concentrating, rash, diarrhea, nausea, fatigue, headache, and insomnia. These side effects may go away after a few weeks. Kidney function should be assessed before initiating treatment and throughout therapy as determined by a provider. Prior to initiation, people should be tested for hepatitis B (HBV) infection. Severe exacerbations of hepatitis B have been reported in people who are co-infected with hepatitis B and have discontinued the emtri-citabine and/or tenofovir components. Monitor liver enzymes closely in people co-infected with hepatitis B and, if appropriate, initiation of anti-hepatitis B therapy may be warranted. The efavirenz component of Atripla has been associated with central nervous system (CNS) birth defects in non-human primates, and cases of neural tube defects have been reported after first trimester exposure in humans. A link between efavirenz and birth defects in humans has not been supported in meta-analyses. The recommendation is that women in their first trimester continue taking efavirenz as long as their viral load remains undetectable; however, efavirenz should only be used if the potential benefit outweighs the potential risk (as when other treatment options are not available). Because of the association with suicidality and neuropsychiatric effects, it is also recommended to screen for antenatal and postpartum depression in women with HIV who are taking a regimen containing efavirenz. The efavirenz in Atripla can cause a false positive for marijuana on certain drug tests. A more specific confirmatory test can be done.
Potential Drug Interactions
Do not take with Epivir-HBV, Hepsera, or Vemlidy (TAF), all three used for the treatment of hepatitis B. Atripla should not be taken with voriconazole, ergot derivatives, midazolam, pimozide, triazolam, bepridil, or St. John’s wort. Atripla should also not be taken with other medications that prolong QTc interval (a heart problem) or medications with a known risk of torsades de pointes. No dose adjustment of Atripla needed with Sovaldi. Use caution when administering Atripla with Harvoni and monitor renal function closely due to possible increased tenofovir levels. Increase dose of Daklinza to 90 mg when used with Atripla. Atripla should not be taken with Epclusa, Olysio, Viekira Pak, or Zepatier. Not intended to be taken with other HIV medications, unless prescribed that way. Tell your provider or pharmacist about all medications, herbals, and supplements you are taking or thinking of taking, prescribed or not, as there are other drug interactions which are not listed here.
Atripla is listed as a “Recommended Regimen in Certain Clinical Situations” in the DHHS guidelines based on a high rate of central nervous system side effects and a possible association with suicidality. Be careful when stopping Atripla, so that you avoid the rapid development of HIV resistance to it—check with your provider or pharmacist first.
Dr. David Hardy says:
Atripla was the first STR to be approved, in 2006. It was a popular, heavily recommended regimen for many years, until better STRs were approved. Due to its at times persistent neuropsychiatric side effects (grogginess, vivid dreams, worsening of mental health conditions) and elevated cholesterol, along with a requirement to be taken without food and at bedtime, this STR fell out of the recommended guidelines several years ago. Clinical trials of Atripla versus integrase inhibitor-containing ART regimens have shown that the integrase inhibitor ART regimens were superior to Atripla. Atripla is now rarely, if ever, used in the U.S.; however, it remains a commonly used ART regimen in other parts of the world (Africa, India, South America) although its use is decreasing. Of note, two quasi-generic, nearly-identical versions of Atripla were approved in 2018, but their uptake has not been strong.
Activist Moisés Agosto-Rosario says:
Atripla is a once-a-day single-tablet regimen that has been used to treat HIV infection for quite some time. It was the favorite for initial therapy due to its potency and relative safety. The medicines contained in Atripla are efavirenz, emtricitabine, and tenofovir disoproxil. Efavirenz is known for its neurotoxicity. Individuals taking it have reported vivid dreams, depression, fatigue, and insomnia. For some time people believed these side effects would go away while others believe that you just get used to them. Watch out for any liver, kidney, bone, or mental problems while taking this regimen. Make sure your doctor monitors you closely.