Your skin or the white part of your eyes turns yellow (jaundice).
Your urine turns dark.
Your bowel movements (stools) turn light in color.
You don't feel like eating food for several days or longer.
You feel sick to your stomach (nausea).
You have lower stomach area (abdominal) pain.
You may be more likely to get lactic acidosis or liver problems if you are female, very overweight (obese), or have been taking nucleoside analog-containing medicines, like ATRIPLA, for a long time.
If you also have hepatitis B virus (HBV) infection and you stop taking ATRIPLA, you may get a "flare-up" of your hepatitis. A "flare-up" is when the disease suddenly returns in a worse way than before. Patients with HBV who stop taking ATRIPLA need close medical follow-up for several months, including medical exams and blood tests to check for hepatitis that could be getting worse. ATRIPLA is not approved for the treatment of HBV, so you must discuss your HBV therapy with your healthcare provider.
What is ATRIPLA?
ATRIPLA contains 3 medicines, SUSTIVA® (efavirenz), EMTRIVA® (emtricitabine) and VIREAD® (tenofovir disoproxil fumarate also called tenofovir DF) combined in one pill. EMTRIVA and VIREAD are HIV-1 (human immunodeficiency virus) nucleoside analog reverse transcriptase inhibitors (NRTIs) and SUSTIVA is an HIV-1 non-nucleoside analog reverse transcriptase inhibitor (NNRTI). VIREAD and EMTRIVA are the components of TRUVADA®. ATRIPLA can be used alone as a complete regimen, or in combination with other anti-HIV-1 medicines to treat people with HIV-1 infection. ATRIPLA is for adults and children 12 years of age and older who weigh at least 40 kg (at least 88 lbs). ATRIPLA is not recommended for children younger than 12 years of age. ATRIPLA has not been studied in adults over 65 years of age.
HIV infection destroys CD4+ T cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops.
ATRIPLA helps block HIV-1 reverse transcriptase, a viral chemical in your body (enzyme) that is needed for HIV-1 to multiply. ATRIPLA lowers the amount of HIV-1 in the blood (viral load). ATRIPLA may also help to increase the number of T cells (CD4+ cells), allowing your immune system to improve. Lowering the amount of HIV-1 in the blood lowers the chance of death or infections that happen when your immune system is weak (opportunistic infections).
Does ATRIPLA cure HIV-1 or AIDS?
ATRIPLA does not cure HIV-1 infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using ATRIPLA.
Who should not take ATRIPLA?
Together with your healthcare provider, you need to decide whether ATRIPLA is right for you.
Do not take ATRIPLA if you are allergic to ATRIPLA or any of its ingredients. The active ingredients of ATRIPLA are efavirenz, emtricitabine, and tenofovir DF. See the end of this leaflet for a complete list of ingredients.
What should I tell my healthcare provider before taking ATRIPLA?
Tell your healthcare provider if you:
Are pregnant or planning to become pregnant (see "What should I avoid while taking ATRIPLA?").
Are breastfeeding (see "What should I avoid while taking ATRIPLA?").
Have kidney problems or are undergoing kidney dialysis treatment.
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