Atripla

Dual-Class Fixed Dose Combination

Combo Drug

Common Name: efavirenz, emtricitabine, and tenofovir DF

Brand Name: Atripla

Class: Dual-class fixed dose combination; single dose regimen -- nucleoside analogs (also called nucleoside reverse transcriptase inhibitors, NRTI 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, but do not double up on your next dose.

AWP: $1,727.76 / month

Manufacturer contact: Bristol-Myers Squibb,
www.atripla.com, 1 (800) 321-1335 and Gilead Sciences,
www.gilead.com, 1 (800) GILEAD5 (445-3235)

AIDSInfo:
1 (800) HIV-0440 (448-0440), www.aidsinfo.nih.gov

Potential side effects and toxicity: See the drugs contained in Atripla -- Sustiva, Emtriva, and Viread. Nausea, diarrhea, and rash. Dose cannot be adjusted for people with kidney problems.

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. Immune Reconstitution Inflammatory Syndrome (IRIS) may occur as the immune system regains strength; report symptoms of illness, such as shingles and TB, to health care provider.

Tips: Where to begin to sing the praises of Atripla? Atripla is a complete HIV treatment by itself -- no other pills needed. And this is only one pill, once a day. It's a first in HIV. A great benefit: the single med cuts the number of insurance co-pays. Atripla is probably the most commonly prescribed medication for people taking HIV medicine for the first time. The medicines in Atripla can be very tolerable, or not, depending on the person taking them. It is well tolerated in most people. Atripla, however, is not for everyone. 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. The separate components of Atripla have their various considerations: 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. Please see package insert for more complete potential side effects and interactions. See the drugs contained in Atripla: Sustiva, Emtriva, and Viread.

Doctor

Atripla (tenofovir/emtricitabine/efavirenz) was approved for once-daily dosing for HIV infection in 2006. This was the first dual-class complete HAART regimen in one pill formulation and dosed once daily. When this fixed dose combination became available, the "old timers" (those of us who have been treating HIV from the beginning) shouted, "It's finally here!" While our treatment of HIV has progressed greatly, we can all remember the early years when often 40 pills per day was the norm. The early drugs made a profound impact on HIV infection, but it was a full-time job for the patient to take them (especially when you consider that antiretrovirals were only part of their total treatment regimen). Many of those individuals who braved all the sickness, excessive number of pills, and side effects are now gone. They are true heroes. Interestingly, some patients in our clinic will stay on Truvada/Sustiva rather than switching to Atripla due to fear of change. It is important that you and your health care provider remember that Atripla cannot be stopped abruptly. Because efavirenz (Sustiva) remains in the bloodstream a long time after stopping the drug (and the other components of Atripla don't), you could be receiving monotherapy with Sustiva. This can lead to Sustiva resistance. If Atripla is to be stopped, you should be given Truvada alone for at least a week to protect Sustiva. One must also remember that the pregnancy warning with Sustiva applies also to this fixed dose combination. In developing countries (especially Africa), Atripla has marginal use at best. On the other hand, the dual class fixed dose combination Triomune (3TC/d4T/nevirapine), dosed twice daily, has been around for some time and is the primary drug used in HAART therapy. Knowing the number of patients infected in developing countries, there is little doubt that Triomune, in a global perspective, is used more than any other antiretroviral. -- Frank M. Graziano, M.D., Ph.D.

Activist

In case you haven't heard: Atripla is a complete, effective HIV regimen in a one-pill, once-a-day treatment option, combining three drugs from two ARV classes. It contains the DHHS on Antiretroviral Guidelines "preferred" drugs from both classes: the NRTI Truvada (Emtriva/Viread) and the NNRTI Sustiva. Atripla is the only dual-class fixed dose combination drug on the market; and of historic note, it is the first single product of two competing pharmaceutical companies. (See what can happen when we all play nice?) The lesson learned from Combivir, HIV's first co-formulated drug, bears repeating here: Know what you're taking -- the whole is only as good as the sum of its parts. And again, because of its Viread component, it may cause gas. -- Morris Jackson

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