Atripla
Combo Drug
Common Name: efavirenz, emtricitabine, and tenofovir disoproxil fumarate
Brand Name: Atripla
Class: Dual-class fixed dose combination; single dose regimen—nucleoside analogs (also called nucleoside reverse transcriptase inhibitors, NRTIs, or nukes) and non-nucleoside analog (also called non-nucleoside reverse transcriptase inhibitor, NNRTI, or non-nuke)
Standard dose: One tablet (Sustiva [600 mg] and Truvada [200 mg Emtriva and 300 mg Viread]), once a day, on an empty stomach or with a light, low-fat snack. Take missed dose as soon as possible, unless it is almost time for your next dose. Do not double up on your next dose.
AWP: $1,755.50 / month
Manufacturer contact: Bristol-Myers Squibb, www.bms.com, 1 (800) 321–1335 and Gilead Sciences, www.gilead.com, 1 (800) GILEAD5 (445–3235), or www.atripla.com
Potential side effects and toxicity: See the drugs contained in Atripla—Sustiva, Emtriva, and Viread. Diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. Dose cannot be adjusted for people with kidney problems. Immune Reconstitution Inflammatory Syndrome (IRIS) may occur as the immune system regains strength; signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is initiated. Report symptoms of illness, such as shingles and TB, to a health care provider.
Potential drug interactions: See the drugs contained in Atripla: Sustiva, Emtriva, and Viread. Do not take Sustiva, Emtriva, Truvada, Viread, Epivir, Epivir-HBV, Epzicom, Combivir, or Trizivir, while taking Atripla, since these medications are already in Atripla or have equivalent medications.
Tips: Where to begin to sing the praises of Atripla? Atripla is a complete HIV treatment regimen in one pill, taken once daily. It’s a first in HIV. It is on the current list of preferred regimens for treatment-naïve patients in the U.S. DHHS HIV treatment guidelines. Atripla is one of the most commonly prescribed medications for those taking HIV medicine for the first time due to ease of taking one pill, once a day. A great benefit: the single tablet cuts the number of insurance co-pays. Atripla is well tolerated in most, but not all individuals. Use with caution in individuals with depression or other psychiatric issues. Most treatment-experienced people, those who’ve already been on HIV therapy, may not be able to use it due to their having developed drug resistance, when medications may no longer work against the virus. Drug resistance most commonly occurs when people don’t take their HIV medicine as prescribed, but you 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. Remember, Atripla is a combination of three drugs so see the pages for its components, Sustiva, Emtriva, and Viread. Sustiva cannot be taken during pregnancy, and use of Viread must be monitored in people with underlying kidney problems. In this combination product, the Viread dose cannot be adjusted. Therefore, Atripla should not be used in people with severe kidney problems. Atripla can cause a false positive for marijuana on certain drug tests. A more specific confirmatory test can be done. There’s another triple regimen in one pill in the works; see Intelence. Please see package insert for more complete potential side effects and interactions.
Doctor
Atripla (tenofovir/emtricitabine/efavirenz) was approved for once-daily dosing for HIV infection in 2006. This was the first two-class, three-drug, complete HAART regimen in one pill and dosed once daily. Since this fixed dose combination became available, there has been great enthusiasm for these three drugs due to the combination of simplicity as a single tablet, plus the effectiveness that has never been “beat” in any randomized comparative drug study. One reason why this combination may be as effective as it is could be due to the long “half-lives” of all three drugs—meaning that while this drug is taken once daily, the drug levels last longer than 24 hours and there is a “cushion” in case someone is late in taking a dose. The relevance of this observation was demonstrated in a study called FOTO—Five days On, and Two days Off. This study included only people who had long-term virologic suppression while taking Atripla. After a year of taking this combination just five days per week with weekends off, the viral load remained suppressed in all of them. As these studies are small, this approach is not recommended outside of a clinical study, but it demonstrates one of the potential benefits of taking antivirals that last a long time in the cells. While this is a very successful combination, there are some limitations and considerations with the use of this drug and the sections on tenofovir and Sustiva highlight these concerns in detail. —Cal Cohen, MD
Activist
The ultimate convenience—this three-in-one pill taken once a day has made HIV treatment easy and tolerable for huge numbers of patients, not to mention cut co-pays from three to one for those who have to pay them. Doctors love to prescribe this combination because of its simplicity and the assumption that it will solve all adherence problems. The downside, of course, comes from the Sustiva in it—with its potential for sleep disturbances and lipid problems. Once again, the sum is no greater than its parts. It is notable in that this is the first time two different companies collaborated to create a single-pill combo drug—setting an important precedent for other companies now following suit with other fixed dose combos in the pipeline. —Jeff Taylor
