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Real ATRIPLA patient.
The POWER to
help you go from
For your HIV viral load,
INDICATION and IMPORTANT SAFETY INFORMATION for
ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate [DF])
What is ATRIPLA?
ATRIPLA is a prescription medication used alone as a complete regimen, or with other
anti-HIV-1 medicines, to treat HIV-1 infection in adults and children at least 12 years
old who weigh at least 40 kg (88 lbs).
ATRIPLA does not cure HIV-1 infection or AIDS and you may continue to experience illnesses
associated with HIV-1 infection, including opportunistic infections.
See your healthcare provider regularly while taking ATRIPLA.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ATRIPLA?
ATRIPLA can cause serious side effects:
• Some people who have taken medicine like ATRIPLA (which contains nucleoside analogs) have
developed lactic acidosis (build up of an acid in the blood). Lactic acidosis can be a serious medical
emergency that can lead to death.
Call your healthcare provider right away if you get the following signs
or symptoms of lactic acidosis:
- feel very weak or tired
- have unusual (not normal)
- have trouble breathing
- have stomach pain with nausea
• Some people who have taken medicines like ATRIPLA (efavirenz/emtricitabine/tenofovir
disoproxil fumarate) have developed serious liver problems (hepatotoxicity), with liver
enlargement (hepatomegaly) and fat in the liver (steatosis). In some cases, these
liver problems can lead to death.
Call your healthcare provider right away if you get the following signs or symptoms
of liver problems:
- skin or the white part of your eyes turns yellow (jaundice)
- urine turns dark
- bowel movements (stools) turn light in color
- don't feel like eating food for several days or longer
- feel sick to your stomach (nausea)
- 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 to check for hepatitis that could be getting worse. ATRIPLA is not approved for the
treatment of HBV, so you need to discuss your HBV therapy with your healthcare provider.
Who should not take ATRIPLA?
You and your healthcare provider should decide if ATRIPLA is right for you.
Do not take ATRIPLA if you are allergic to ATRIPLA or any of its ingredients.
What should I tell my healthcare provider before taking ATRIPLA?
Tell your healthcare provider if you:
• Are pregnant or planning to become pregnant: Women should not become pregnant while
taking ATRIPLA and for 12 weeks after stopping ATRIPLA.
- feel cold, especially in your
arms and legs
- feel dizzy or lightheaded
- have a fast or irregular
*Undetectable was defined as a viral load of fewer than 400 copies/mL.
†In this study, 511 adult patients new to therapy received either the meds in ATRIPLA each taken once
daily or Combivir® (lamivudine/zidovudine) twice daily + SUSTIVA® (efavirenz) once daily.
‡Symphony Health Solutions, Source® PHAST Prescription Monthly, equivalized counts, July 2006--July 4, 2014.
• ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) has been proven TO LOWER VIRAL LOAD
to undetectable* in approximately 8 out of 10 adult patients new to therapy through 48 weeks compared
to approximately 7 out of 10 adult patients in the comparator group
• ATRIPLA has been proven TO LOWER VIRAL LOAD to undetectable* in approximately 7 out of every 10 adult
patients new to therapy through 3 years compared to approximately 6 out of 10 in the comparator group†
• The most common (at least 5%) moderate to severe side effects in patients on ATRIPLA were diarrhea,
nausea, tiredness, depression, dizziness, sinusitis, upper respiratory tract infections, rash, headache,
trouble sleeping, anxiety, and common cold. Each of these was reported in less than 10% of patients
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