Atripla

The active ingredients in Atripla are efavirenz, emtricitabine, and tenofovir disoproxil fumarate.

Each ingredient belongs to a different medication class:

Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI).

Emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) are nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs).

All three slow down HIV infection by blocking the action of reverse transcriptase, an enzyme the human immunodeficiency virus relies on to multiply inside the body. By reducing viral activity, Atripla lowers viral load, reduces the risk of HIV mutation, and supports a healthier immune system.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Atripla. However, the following is a synopsis of the general guidelines for the use of Atripla:

• Take Atripla once daily on an empty stomach, preferably before bedtime, to reduce certain side effects such as dizziness or drowsiness.
• Swallow the tablet whole with water.
• Do not change your dose or stop the medication unless your healthcare provider instructs you to.
• If you miss a dose, take it as soon as you remember unless it is close to your next dose. Do not double up.
• Keep taking Atripla exactly as prescribed, even if you feel well.
• Your healthcare provider may perform regular bloodwork to monitor kidney function, liver enzymes, and viral load.
• Atripla is always used as part of antiretroviral therapy and should never be taken alone without professional medical oversight.

Some mild or common side effects of Atripla seen in clinical trials as compared to placebo include:

• Dizziness or lightheadedness.
• Trouble sleeping or abnormal dreams.
• Tiredness or sleepiness.
• Headache.
• Stomach pain, nausea, or diarrhea.
• Rash.
• Drowsiness.
• Difficulty concentrating.
• Increased cholesterol levels.
• Body fat changes.
• Mild muscle or joint pain.

Some individuals may experience serious side effects while using Atripla. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Lactic acidosis (symptoms: muscle pain, trouble breathing, cold skin, severe fatigue).
• Liver problems or hepatitis B flare-ups.
• Kidney problems such as Fanconi syndrome.
• Severe rash or allergic reactions, including hives or swelling.
• Mental health effects such as depression, hallucinations, or suicidal thoughts.
• Bone pain or fractures are linked to reduced bone density.
• Severe abdominal pain or signs of pancreatitis.
• Fast or irregular heartbeat.
• Worsening hepatitis C or liver inflammation.

These are not all of the possible side effects of Atripla. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Atripla, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Kidney problems or a history of kidney disease.
• Liver disease, including hepatitis B virus (HBV) or hepatitis C.
• Mental health conditions.
• Seizure disorders.
• High cholesterol.
• Bone problems.
• Trouble sleeping.
• Heart problems.
• A history of substance use.
• Allergies to efavirenz, emtricitabine, or tenofovir.
• If you have hepatitis B, stopping Atripla suddenly may cause severe flare-ups. Your healthcare provider will monitor liver function accordingly.
• Avoid high-fat meals before taking Atripla, as they can increase side effects.

Boxed Warning

According to the FDA Prescribing Information, Atripla does not carry a boxed warning specific to the combination product. However, components of Atripla have important warnings your healthcare provider will review with you, including the risk of lactic acidosis and severe liver problems.

Atripla should not be used in individuals who:

• Are allergic to efavirenz, emtricitabine, tenofovir, or any tablet ingredient.
• Have severe liver impairment.
• Your healthcare professional will review all contraindications before starting therapy.

Most patients see improvements in viral load within 2 to 8 weeks, with continued decreases over time. The immune system (measured by CD4 cell count) may also improve gradually.

When Atripla is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Other antiretrovirals (lamivudine, atazanavir, ritonavir).
• Antifungals such as voriconazole.
• St. John’s Wort.
• Anticonvulsants (phenytoin, phenobarbital).
• Hepatitis C medications.
• Certain antidepressants.
• Cholesterol medications.
• Birth control pills (Atripla may reduce effectiveness).
• Immunosuppressants.
• Supplements affecting the liver or kidneys.

Atripla is available as a single fixed-dose tablet containing:

• Efavirenz 600 mg
• Emtricitabine 200 mg
• Tenofovir disoproxil fumarate 300 mg

It is taken once per day. Pediatric dosing varies and should be determined only by an HIV specialist.

If you miss a dose, take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Store at room temperature and keep out of reach of children.

Atripla is manufactured through a partnership between Bristol-Myers Squibb and Gilead Sciences.

Yes. Several generic versions containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate are available.

Do not stop taking Atripla without talking to your healthcare provider. Stopping treatment can cause the HIV viral load to rise quickly.

If you have hepatitis B, stopping can cause a serious flare-up, so your healthcare provider will monitor you closely if Atripla needs to be discontinued.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. Atripla is not recommended during pregnancy unless the potential benefit outweighs the risk, particularly due to concerns with efavirenz during early pregnancy. Females who can become pregnant should use 2 effective forms of birth control (contraception) during treatment.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. Women with HIV are generally advised not to breastfeed because HIV can be passed to the baby through breast milk, regardless of medication.