Complera/Eviplera (Rilpivirine + Emtricitabine + Tenofovir)

What Is Complera?

Complera is a tablet that contains three antiretroviral drugs (ARVs) used to fight HIV: rilpivirine (Edurant), emtricitabine (Emtriva), and tenofovir (Viread). Complera is manufactured by Gilead and Janssen. In Europe it is called Eviplera. It is the second tablet that includes a complete antiretroviral regimen (after Atripla, see Fact Sheet 439).

The drugs in Complera are a non-nucleoside reverse transcriptase inhibitor (rilpivirine) and two nucleoside analog reverse transcriptase inhibitors, or nukes (emtricitabine and tenofovir). These drugs block the reverse transcriptase enzyme. This enzyme changes HIV's genetic material (RNA) into the form of DNA. This has to occur before HIV's genetic code gets inserted into an infected cell's own genetic codes.

Who Should Take Complera?

Complera was approved in 2011 as an antiretroviral treatment for adults with HIV infection who have not already taken antiviral drugs. In 2012, its approval was restricted to patients whose viral load (see Fact Sheet 125) is below 100,000.

There are no absolute rules about when to start antiretroviral therapy (ART). You and your health care provider should consider your CD4 cell count, your viral load, any symptoms you are having, and your attitude about taking ART. Fact Sheet 404 has more information about guidelines for the use of ART.

If you take Complera, you can reduce your viral load to extremely low levels, and increase your CD4 cell counts. This should mean staying healthier longer.

Complera provides three drugs in one pill. It can be more convenient to use Complera than some other combinations of drugs. This could mean fewer missed doses and better control of HIV. Complera can be an effective regimen of ARVs in one pill.

Who Should Not Take Complera?

Complera should not be used by people who have already used any other anti-HIV medications. Also, it is not recommended for patients less than 18 years of age. Complera has not been studied in people age 65 and over.

Complera is a fixed-dose combination. Dosages of the individual components cannot be adjusted. Patients who have moderate or severe kidney disease, or severe liver disease, should not use Complera.

What About Drug Resistance?

Many new copies of HIV are mutations. They are slightly different from the original virus. Some mutations can keep multiplying even when you are taking an ARV. When this happens, the drug will stop working. This is called "developing resistance" to the drug. See Fact Sheet 126 for more information on resistance.

Sometimes, if your virus develops resistance to one drug, it will also have resistance to other ARVs. This is called "cross-resistance."

Resistance can develop quickly. It is very important to take ARVs according to instructions, on schedule, and not to skip or reduce doses.

How Is Complera Taken?

Complera is taken by mouth as a tablet. The normal adult dose is one tablet, once a day. Each tablet includes 25 milligrams (mg) of rilpivirine, 200 mg of emtricitabine, and 300 mg of tenofovir.

Complera should be taken with a meal. If you miss your dose, you can take Complera up to 12 hours late. Otherwise, take your next dose at the regular time.

What Are the Side Effects?

When you start any ART, you may have temporary side effects such as headaches, high blood pressure, or a general sense of feeling ill. These side effects usually get better or disappear over time.

The most common side effects of Complera are the same as with the drugs it contains: rilpivirine (see Fact Sheet 435), emtricitabine (see Fact Sheet 420), and tenofovir (see Fact Sheet 419). They include depression, headache, diarrhea, nausea, vomiting, anxiety, rash, dizziness, insomnia, and loss of appetite.

If you have had hepatitis B or C, your liver function tests may increase significantly. These should be monitored carefully. Some people taking Complera who have previously taken emtricitabine or tenofovir have had their hepatitis B worsen significantly.

How Does Complera React With Other Drugs?

Complera can interact with other drugs or supplements you are taking. These interactions can change the amount of each drug in your bloodstream and cause an under- or overdose. New interactions are constantly being identified. Make sure that your health care provider knows about ALL drugs and supplements you are taking.

Drugs to avoid include some antacids. Drugs to watch out for include other ARVs, drugs to treat tuberculosis (see Fact Sheet 518), for erectile dysfunction (such as Viagra), and for heart rhythm (antiarrhythmics). Interactions are also possible with several antihistamines (allergy medications), sedatives, drugs to lower cholesterol, and anti-fungal drugs.

The herb St. John's Wort (See Fact Sheet 729) lowers the blood levels of some non-nucleoside reverse transcriptase inhibitors. Do not take it with Complera.