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, side effects). 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.
See package insert for more complete information on potential side effects and interactions.
Gilead Sciences, Inc.
(800) GILEAD-5 (445–3235)
Potential Side Effects and Toxicity
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 emtricitabine 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 component in Atripla can cause a false positive result 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 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. Many individuals switching from Atripla to a new regimen report never realizing what a fog they had been living under.
Dr. Ross Slotten says:
Poor Atripla, the drug that once was king! The first STR approved in 2006 (although its components, efavirenz—brand name Sustiva—and FTC/TDF, were approved a few years earlier), Atripla has fallen from Olympus. Gilead, its manufacturer, is anxious to make way for a new generation of HIV medications (especially since generic versions are appearing). No sighs or sobs for Atripla’s demise. Efavirenz often causes vivid dreams and other so-called neuropsychiatric abnormalities (fatigue, depression), but many people taking it have no complaints. TDF can adversely affect kidney function and increase the risk for osteoporosis. These adverse effects were not discovered in early studies; they emerged later. Yet the drug fails to fade. I admit that I still have a good number of people on Atripla. Dr. David Hardy’s statement in last year’s Drug Guide that “Atripla is now rarely, if ever, used in the U.S.” isn’t true in my experience. When people have no side effects from a medication, they’re reluctant to change to something else. “If it ain’t broke, don’t fix it,” they’ll say. Let’s not forget that Atripla has saved many lives because of its potency and ease of administration. If taken at night and on an empty stomach, most people aren’t bothered by the neuropsychiatric side effects. We have 20 years of experience with Atripla and the vast majority of people on it are totally fine. We have only a few years of experience with INSTIs and TAF. Let’s not be so quick to bury Atripla or its generic replacements. Who knows what unknown long-term complications, if any, might arise from newer agents?
Activist Bridgette Picou says:
Once considered a staple and frontline treatment for HIV, Atripla is an older medicine that is still prescribed today. It has been known to have neurotoxic effects, things like fatigue, vivid dreams, and depression. Even though these side effects are known, the drug is effective and works well to control HIV when taken properly. Take it on an empty stomach and do not skip doses. Keep regular appointments with your healthcare provider to monitor liver, kidney, and central nervous system effects.