Atripla is a three-in-one combination pill containing Emtriva (emtricitabine), Viread (tenofovir DF), and Sustiva (efavirenz).

Atripla is the first one-pill, once-daily complete regimen containing different types of HIV medications. Putting more than one drug in a single tablet means you can take fewer pills each day and may have lower insurance co-payments.

Atripla is made up of two HIV drugs (Emtriva and Viread) from a class called nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), also known as “nukes.” Emtriva is one of many approved nucleoside reverse transcriptase inhibitors. Viread is the only approved nucleotide reverse transcriptase inhibitor.

Sustiva, the third drug in Atripla, is a non-nucleoside reverse transcriptase inhibitor (NNRTI), also known as a “non-nuke.”

The three drugs in Atripla block reverse transcriptase, a protein that HIV needs to make more copies of itself. This may slow down HIV disease.

The Food and Drug Administration (FDA) has approved Atripla for use alone or in combination with other HIV drugs for the treatment of HIV infection in adults. Atripla is not currently approved for children.

Atripla is a tablet that contains:

• 200 milligrams (mg) of Emtriva
• 300 mg of Viread
• 600 mg of Sustiva

The dose is one tablet, once daily.

Atripla may be used alone, or may be used in combination with other medications to treat HIV.

Atripla should be taken on an empty stomach. Taking it with food increases the chances of side effects. Taking Atripla at bedtime can help reduce some side effects.

Women who are pregnant or trying to get pregnant should not take Atripla.

Speak with your doctor if you have kidney, liver, pancreas or bone problems; mental health issues (such as depression); or are using street drugs or alcohol.

It can take two to three weeks for Sustiva, one of the drugs in Atripa, to be eliminated from your body after you stop taking it. If you stop taking Atripla, Sustiva stays in your body longer than the other 2 drugs, which can cause drug resistance. Careful planning with your doctor is necessary if you want to stop taking Atripla.

Atripla is one of the easiest HIV drugs to take—you take one pill, once a day. This convenience may help you achieve good adherence.

As with all HIV drugs, it is important to take Atripla as prescribed. Missing or skipping doses can cause your blood levels of the drugs in Atripla to fall too low and resistance can develop. This may cause the drugs in Atripla and any other HIV drugs you may be taking to stop working.

If you miss your dose, you can take Atripla up to 12 hours late. Otherwise, take your next dose at the regular time. Do not take two Atripla tablets at once.

Atripla can be used if you’re just starting HIV treatment.

Atripla can also be used if you’ve been on HIV treatment before. But it may not work as well for people who are already resistant to Emtriva, Viread, Sustiva, Epivir (lamivudine or 3TC), or the other NNRTIs Rescriptor (delavirdine) and Viramune (nevirapine).

You and your health care provider should use resistance testing and your treatment history to help guide the use of Atripla and to determine which drugs will work best for you.

If your virus develops resistance to the drugs in Atripla, then it may stop working or may not work as well for you. You also may not get as much benefit from other NRTIs or NNRTIs.

Sometimes taking more than one medication together can cause drug interactions. This can lead to the drugs not working as well or an increased risk of side effects.

Atripla can interact with other medications used to treat HIV, HIV-related complications, and other diseases. Taking Atripla with these drugs can change the amount of each drug in your blood. Your health care provider may need to either adjust the doses of your drugs to avoid under- or overdosing or to change the drugs you currently take.

Atripla should not be combined with:

• Emtriva, Viread, or Sustiva (which are already included in the Atripla pill)
• Truvada (which contains Emtriva and Viread)
• Epivir (a drug that is similar to Emtriva)
• Combivir, Trizivir, or Epzicom (combination pills that contain Epivir)
• Reyataz (atazanavir)
• Priftin (rifapentine)
• Vfend (voriconazole)
• Hismanal (astemizole)
• Orap (pimozide)
• Propulsid (cisapride)
• Vascor (bepridil)
• Versed (midazolam)
• Halcion (triazolam)
• Wigraine and Cafergot (ergot medications)
• Products containing the herb St. John’s Wort

Atripla may decrease the effectiveness of birth control pills, so alternative birth control methods (such as condoms) should be used for women who are taking Atripla.

Atripla may also interact with Invirase (saquinavir), Kaletra (lopinavir/ritonavir), Crixivan (indinavir), Videx (didanosine, ddI), methadone, cholesterol-lowering medications and drugs to treat TB, MAC, bacterial and fungal infections, seizures, heart problems, high blood pressure, and erectile dysfunction.

This is not a complete list of medications. Because there are many possible drug interactions with Atripla, it is very important to go over all your medications with your health care provider. Be sure your health care provider knows about all the medications you are taking (including over-the-counter, prescription, street drugs, and herbs), even if you only use them occasionally.

For more information and additional resources to check interactions between the particular drugs you are taking, see our info sheet on drug interactions or go to:

http://www.hiv-druginteractions.org/
OR
http://hivinsite.ucsf.edu/insite?page=ar-00-02

Atripla is associated with the same side effects as the drugs it contains. These side effects are likely to be temporary and go away as your body adjusts to the medication (usually within the first two to four weeks). But in some cases, side effects may last longer than a month.

• Nausea
• Vomiting
• Diarrhea
• Headaches
• Fatigue (unusual tiredness)
• Skin rash
• Skin discoloration
• Muscle pain
• Central nervous system (CNS) symptoms including dizziness, insomnia (trouble sleeping), drowsiness, poor concentration, vivid dreams, mood changes, and depression

Some people find that they can handle the CNS side effects better if they take Atripla at bedtime. Your health care provider may have other strategies for helping to manage side effects.

If you are experiencing side effects that do not go away or are difficult to tolerate, call your health care provider for advice. Don’t just stop taking your medication.

More serious but uncommon side effects:

• An increase of lactic acid in the blood ( lactic acidosis), an enlarged and fatty liver, and liver failure have been reported in people using NRTIs. Lactic acidosis is a rare but potentially fatal side effect. Symptoms may include nausea, vomiting, or stomach pain; feeling very weak and tired; and shortness of breath.
• A life-threatening hypersensitivity reaction called Stevens-Johnson syndrome. Symptoms may include a severe rash, blisters, mouth sores, swelling, fever, and weakness.
• Liver toxicity: this may be indicated by abnormal liver blood tests or yellowing of the skin and eyes (jaundice). People with existing liver disease (including hepatitis B or C co-infection) are at higher risk and should have their liver blood tests monitored regularly.
• Kidney problems: have your creatinine (blood test for the kidneys) levels monitored regularly; high levels can indicate kidney damage. People with existing kidney problems should not take Atripla.
• Bone problems such as brittle bones or softening or thinning of the bones.
• Serious psychiatric symptoms including severe depression, paranoia, aggression, or thoughts of suicide. People who have had psychiatric problems in the past seem to be at higher risk.
• Lipodystrophy, which may include elevated blood sugar (glucose), elevated lipid levels ( cholesterol and triglycerides), and fat gain or loss in certain areas. The exact causes of lipodystrophy are not known, but may include HIV and/or HIV drugs. It is unclear if the drugs in Atripla will cause or impact symptoms of lipodystrophy. For more information on lipodystrophy, see our info sheet.

If you are experiencing persistent, unusual, or serious side effects, call your doctor right away.

The drugs in Atripla (Emtriva, Viread, and Sustiva) have been studied in both men and women (see the fact sheets on these separate drugs for more information). Studies of pharmacokinetics (how drugs are processed by the body) showed that the three drugs behave similarly in the bodies of women and men. Sustiva may reach higher blood levels in women, but the drug manufacturer does not recommend any dose adjustments based on sex.

Study 934 showed the effectiveness of the combination of drugs in Atripla. The study included 517 participants being treated for the first time, of whom 14 percent (or about 71) were women.

This study compared a once-daily treatment with Atripla  against the twice-daily regimen of Combivir (Retrovir [zidovudine or AZT/ZDV] plus Epivir) plus Sustiva.  After 144 weeks, the drugs in Atripla appeared to work better than Combivir plus Sustiva. People taking Atripla  were more likely to have undetectable HIV viral load (71% vs 58%) and larger CD4 cell  increases than those taking Combivir plus Sustiva. In addition, adverse side effects were less common in the group that took Atripla instead of Combivir plus Sustiva, and fewer people stopped treatment with Atripla. Atripla still continued to work better with fewer side effects after 144 weeks.

Studies have also shown that the Atripla combination pill works as well as the separate medications used together (known as bioequivalence). In the COMET study, people who switched from Combivir to the Truvada combination pill (Emtriva plus Viread) while continuing to take Sustiva were more likely to have undetectable HIV viral loads after 24 weeks than they were before the switch. This study enrolled a total of 411 participants, of whom 14 percent (or about 58) were women.

In terms of side effects, some research suggests that women are more likely than men to develop liver problems and the rare but very serious side effect, lactic acidosis, while taking NRTI drugs. The Viread in Atripla may reduce bone mineral density. Since HIV+ women are already at higher risk for bone problems, it is important to get enough calcium and vitamin D and to ask your health care provider about a bone mineral density test.

Studies of Sustiva did not seem to show that women experience more or different side effects than men. But we know that in general, depression and mood disorders are more common in women, so more research is needed on nervous system side effects in women taking this medication.

Studies have shown that pregnant women who use HIV drugs can greatly reduce the risk of passing HIV on to their babies. There have been no formal studies on the use of Atripla during pregnancy. However, the Sustiva in Atripla has been linked to birth defects in animal studies and in humans. The FDA recommends that Sustiva not be used during pregnancy.

Because of this, women who are pregnant or trying to get pregnant should not use Atripla, and women who are taking Atripla should use effective birth control. Since Sustiva can decrease the effectiveness of birth control pills, alternative or additional birth control methods (such as condoms) should be used.

An Antiretroviral Pregnancy Registry has been established to collect information on pregnant women who take HIV drugs, including Atripla. If you are pregnant and taking Atripla or other HIV drugs, your health care provider can register you by calling 1-800-258-4263 or going to www.apregistry.com.

It is not known whether Atripla passes into breast milk. HIV+ women should not breast-feed because their babies could be infected with HIV through the breast milk.

Check with your health care provider about the best treatment options for you and your baby if you are thinking of getting pregnant.

Click this link for more information about pregnancy.

The Emtriva and Viread in Atripla both work against the hepatitis B virus (HBV). If you are co-infected with HIV and HBV and are taking Atripla for HIV treatment, stopping the drug may result in a worsening of hepatitis. If you are co-infected, speak with your health care provider about treatment options.

People who are starting HIV treatment for the first time may develop Immune Reconstitution Syndrome or IRS (also called Immune Reconstitution Inflammatory Syndrome or IRIS). IRS can happen as a result of the immune system getting stronger and responding to an HIV-related infection such as Mycobacterium avium infection (MAC), cytomegalovirus (CMV), Pneumocystis jiroveci pneumonia (PCP), or tuberculosis (TB). People may have been treated for these infections in the past or not even know they have them. If you notice any unusual symptoms soon after starting HIV drugs for the first time, let your doctor know right away so you can be evaluated and, if necessary, treated.