Atripla

Use with caution in individuals with depression or other psychiatric issues who are not receiving mental health care. A 2014 study reviewed four previously published AIDS Clinical Trials Group (ACTG) studies regarding efavirenz and suicidal ideation and re-emphasized an association between efavirenz and 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. The TDF in Atripla is associated with long-term decreases in bone mineral density (BMD). BMD monitoring should be considered in people who have a history of bone fracture due to disease or who are at risk for osteopenia or osteoporosis. While calcium and vitamin D levels can be checked to assess the need for these supplements, talk with your provider before starting on your own. 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 virus (HBV) infection. Severe exacerbations of hepatitis B have been reported in people co-infected with hepatitis B who have discontinued Atripla (due to elimination of the emtricitabine and TDF components, which also treat HBV). Monitor liver enzymes closely in people co-infected with hepatitis B and, if appropriate, initiation of anti-hepatitis B therapy may be warranted upon Atripla discontinuation. Call your health care provider right away if you develop any of the following signs or symptoms of hepatitis: yellowing of the skin or whites of the eyes; dark or tea-colored urine; pale-colored bowel movements; nausea or vomiting; loss of appetite; or pain, aching, or tenderness on the right side below the ribs. 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. See weight discussion in the onine version of this page.

Go to positivelyaware.com/articles/weighty-concerns and positivelyaware.com/articles/fatty-tissues. Weight gain is being more commonly recognized as a side effect. In the community, enlargement of the stomach and waist area can be distressing. According to the DHHS HIV treatment guidelines, “Weight gain has been associated with initiation of ART [antiretroviral therapy] and subsequent viral suppression. The increase appears to be greater with INSTIs than with other drug classes. Greater weight increase has also been reported with TAF than with TDF, and greater with DOR than EFV.” Other factors have been associated with weight gain in addition to medication used, including race, sex, and previous overweight status. There is no word yet on reversibility, but the race is on to find more answers.

Do not take with Cimduo or Temixys, Descovy, Emtriva, Epivir-HBV, Hepsera, Truvada, Vemlidy, or Viread, all used for the treatment of hepatitis B. Avoid taking with drugs that negatively affect the kidneys, including chronic use or high doses of anti-inflammatory drugs for pain like Advil or Motrin (ibuprofen) and Aleve (naproxen). 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 for torsades de pointes. For patients weighing at least 110 pounds (50 kg) and taking rifampin, it is recommended to give 200 mg of efavirenz in addition to Atripla (for a total efavirenz dose of 800 mg per day). May affect warfarin levels. Can decrease levels of buprenorphine and methadone—monitor for withdrawal. When taken with carbamazepine, phenobarbital, or phenytoin, periodic monitoring of anticonvulsant and efavirenz levels should be done or alternative anti-seizure drugs, such as levetiracetam, should be considered. Effectiveness of birth control pills may be decreased; consider using other contraceptive methods. Closer monitoring and dose adjustments may be required with posaconazole (avoid unless benefit outweighs potential risk) and itraconazole. Monitor effectiveness of clarithromycin or consider using azithromycin instead. Levels of immunosuppressants should be monitored when starting or stopping. Cardizem, Lipitor, Pravachol, and Zocor doses may need to be adjusted. Titrate dose of bupropion and sertraline based on clinical response. 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. Check with your provider or pharmacist first when stopping Atripla, so that you avoid the rapid development of HIV resistance to it. Many individuals switching from Atripla to a new regimen report never realizing what a fog they had been living under. For individuals with HIV-2, more commonly found outside the U.S., an NNRTI such as efavirenz would not be recommended as HIV-2 is inherently resistant to NNRTIs.

Dr. Melanie Thompson:

Atripla (efavirenz/TDF/FTC) was the first complete one pill STR and revolutionized therapy as much as it simplified it. Unfortunately, efavirenz causes a raft of side effects (see Sustiva), some serious (such as suicidality), and is no longer recommended as first-line therapy. There is some role for efavirenz in the treatment of tuberculosis when rifampin must be taken, but now we know that dolutegravir can be taken twice daily in this setting, making it less likely that Atripla would be used in this setting.

Activist Bridgette Picou:

Atripla is what I would call a “mixed bag” medication. It was the first STR and once a favorite for initial therapy. While effective, the drug had a host of neurotoxic side effects like vivid dreams, a sensation of being in a fog, fatigue, and depression. Despite this, many patients credit it with saving their life. I distinctly remember early on in my nursing career, patients were reluctant to switch from Atripla, even with the side effects, because it worked. If used, it should be taken on an empty stomach at bedtime.