Atripla

Brand name: Atripla

Generic name: efavirenz/emtricitabine/tenofovir, or EFV/FTC/TDF

Class: NNRTI and NRTI -- single-tablet regimen (STR)

Manufacturer: Bristol-Myers Squibb, www.bms.com, (800) 321-1335, and Gilead Sciences, www.gilead.com, (800) GILEAD-5 (445-3235), www.atripla.com

AWP: $2,080.97/month

Standard Dose: One tablet (600 mg efavirenz/200 mg emtricitabine/300 mg tenofovir), once a day, preferably at bedtime, on an empty stomach or with a light, low-fat snack. 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. 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.

Potential side effects and toxicity: See the individual drugs contained in Atripla -- Sustiva, Emtriva, and Viread (efavirenz, emtricitabine, and tenofovir). Atripla is well tolerated in most, but not all, individuals. Use with caution in individuals with depression or other psychiatric issues. Diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. Kidney function should be assessed before initiating treatment and throughout therapy as determined by a provider. Women should not become pregnant on Atripla or for 12 weeks after discontinuation, and should not breast-feed while on it, because of the risk of birth defects. Dose cannot be adjusted for people with kidney problems. See chart for potential drug class side effects.

Potential drug interactions: See the individual drugs contained in Atripla: Sustiva, Emtriva, and Viread. Do not take Atripla with Combivir, Complera, Emtriva, Epivir, Epivir-HBV, Epzicom, Sustiva, Trizivir, Truvada, or Viread, since these medications are already in Atripla or they have equivalent medications. Atripla should not be taken with Vascor, Propulsid, Versed, Orap, Halcion, Vfend, Hepsera, or St. John's wort. Tell your provider or pharmacist about all medications, herbs, and supplements you are taking or thinking of taking, prescribed or not.

More information: Atripla was the first complete HIV treatment regimen in one pill, taken once daily, but now has head-to-head competition from Complera, approved in 2011, and there are more single-tablet regimens on the way (see the "Quad" page). Atripla is on the list of preferred regimens for treatment-naïve patients in the DHHS HIV treatment guidelines. Atripla is one of the most commonly prescribed medications for those taking HIV medicine for the first time due to the ease of taking one pill, once a day. Another benefit: the single tablet cuts the number of insurance co-pays. Complera's approval, however, makes Atripla's side effect profile harder to overlook. Efavirenz should not be taken during pregnancy. According to one meta-analysis, if women get pregnant while on Sustiva (efavirenz) or Atripla, however, the risk of birth defects is minimal. The efavirenz in Atripla can cause a false positive for marijuana on certain drug tests. A more specific confirmatory test can be done. Atripla should not be used in patients under 18 years of age. Most treatment-experienced people (those who've already been on HIV therapy) may not be able to use Atripla due to having developed drug resistance (when their medications may no longer work against the virus), and Complera is not an option for people resistant to Atripla. Drug resistance most commonly occurs when people don't take their HIV medicine as prescribed, but some may also be infected with a drug-resistant virus against which some of the medications in Atripla will not work. Because it is one dose once a day, it is important not to miss a dose. Be careful when stopping Atripla, so that you avoid the rapid development of HIV resistance to it -- check with your doctor or pharmacist first. Use of tenofovir must be monitored in people with underlying kidney problems. In this combination product, the tenofovir dose cannot be adjusted. Therefore, Atripla should not be used in people with severe kidney problems. Tenofovir and emtricitabine are also both used to treat hepatitis B. If you are co-infected with hepatitis B, when you stop Atripla your hepatitis B may be reactivated. If your HIV develops resistance to tenofovir and/or emtricitabine, it does not mean that your hepatitis B is also resistant to them. Gilead and BMS are forever to be commended for collaborating to bring Atripla to market. See package insert for more complete information on potential side effects and interactions.

Doctor's Comments

Atripla was the first single-tablet, once-daily regimen. It's a preferred regimen in all treatment guidelines based on its outstanding efficacy, safety, tolerability, and convenience. The main disadvantages include the potential for kidney toxicity with tenofovir (see Viread) and the early side effects of efavirenz (see Sustiva). Atripla is not a good choice for people who aren't fully committed to staying on therapy without interruption. The long half-lives of the three drugs mean that an occasional missed dose or two won't matter, but interrupting therapy altogether can cause drug resistance, especially to efavirenz.

-- Joel Gallant, M.D., M.P.H.

Activist's Comments

The gold standard for realistic regimens we can take indefinitely, Atripla still has the benefits of simplicity: a once-daily pill with everything you need in it. The downside is the compound has the same drawbacks as Sustiva (efavirenz), which is one of its three ingredients, the other two being the Emtriva (emtricitabine) and Viread (tenofovir) found in Truvada. It can cause vivid dreams, nightmares, depression, out of range lipids, or bone density problems (for some people, not all). It has the easiest by far co-pay programs, as well as patient assistance programs (PAPs). This breakthrough product showed us that pharmaceutical companies can get along and work together (Gilead and Bristol-Myers Squibb). Still by far one of the most prescribed regimens in the ADAP world, we were very glad to see the companies work out a deal for price freezes and easy access patient assistance programs; helping to save Florida's ADAP from getting deeper into fiscal debt.

-- Joey Wynn