Atripla

Treatment of HIV-1 Infection

Atripla is a prescription medication indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1). It combines three antiretroviral drugs—efavirenz, emtricitabine, and tenofovir disoproxil fumarate—into a single tablet. It is used for:

• Adults with HIV-1.
• Pediatric patients weighing at least 40 kg (88 lbs).

This medication can be used as a complete standalone treatment or in combination with other antiretroviral drugs as determined by a healthcare provider.

Goals of Therapy

The main purpose of Atripla is to manage the progression of HIV by:

• Reducing the viral load (the amount of HIV in the blood).
• Increasing the number of CD4 cells, which are white blood cells that help the body fight infections.

By controlling the virus, the medication helps reduce the risk of complications and improves the overall function of the immune system.

Limitations of Use

It is important to note that Atripla is not a cure for HIV or AIDS. Patients must continue to take the medication as prescribed to keep the virus suppressed. Additionally, taking this medication does not eliminate the risk of transmitting HIV to others through sexual contact or blood exposure.

Mechanism of Action

Atripla is a combination of three antiretroviral medications: efavirenz, emtricitabine, and tenofovir disoproxil fumarate. These medications work together to prevent HIV from multiplying in the body.

The virus requires a specific enzyme called reverse transcriptase to create copies of itself. Atripla targets this enzyme to stop the viral replication process. The three components work in the following ways:

• Efavirenz: This is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It binds directly to the enzyme to prevent it from functioning properly.
• Emtricitabine and Tenofovir: These are nucleoside reverse transcriptase inhibitors (NRTIs). They act as faulty building blocks that the virus tries to use to create its DNA. When the virus incorporates these instead of normal building blocks, the DNA chain is broken, and the virus cannot finish copying itself.

By lowering the amount of HIV in the blood, Atripla helps the immune system function better. This increases the body's ability to fight off other infections and reduces the risk of complications related to HIV. While Atripla helps manage the condition, it does not cure HIV or AIDS and must be taken consistently to remain effective.

Common Side Effects

Many people experience side effects that are often mild and may improve as the body adjusts to the medication. These include:

• Dizziness, drowsiness, or trouble concentrating
• Difficulty sleeping or vivid, unusual dreams
• Headache
• Nausea, vomiting, or diarrhea
• Gas
• Mild skin rash
• Changes in the shape or location of body fat
• Discoloration of the skin, such as small spots or freckles

Serious Side Effects

Some side effects can be severe and require immediate medical attention. Contact a healthcare provider right away if you experience:

• Mental health changes: Severe depression, anxiety, aggressive behavior, hallucinations, or thoughts of suicide.
• Liver problems: Yellowing of the skin or eyes, dark-colored urine, or pain in the upper right side of the stomach area.
• Lactic acidosis: Extreme tiredness, unusual muscle pain, trouble breathing, stomach pain with nausea, or feeling cold and dizzy.
• Kidney issues: Changes in how much you urinate or swelling in the feet and ankles.
• Severe skin reactions: A rash that occurs with a fever, blisters, or peeling skin.
• Bone problems: Persistent bone pain or thinning bones that may lead to fractures.
• Immune system changes: Signs of a new or past infection that may appear as the immune system becomes more active.

Boxed Warnings

Atripla has several boxed warnings, which are the most serious warnings issued by the FDA:

• Lactic Acidosis and Liver Enlargement: A dangerous buildup of lactic acid in the blood (lactic acidosis) and severe liver enlargement with fatty deposits (steatosis) can occur. These conditions can be life-threatening.
• Hepatitis B Exacerbation: For individuals co-infected with HIV and hepatitis B virus (HBV), stopping Atripla may cause a severe, acute worsening of the hepatitis B infection. Liver function must be monitored closely for several months if the medication is discontinued.

Psychiatric and Neurological Symptoms

Serious psychiatric adverse experiences have been reported in patients using the efavirenz component of Atripla. These may include severe depression, suicidal thoughts or attempts, aggressive behavior, and psychosis. Patients should contact a healthcare provider immediately if they experience these symptoms.

Nervous system symptoms are also common, including dizziness, insomnia, impaired concentration, somnolence, and abnormal dreams. These typically occur during the first few days of treatment and often improve after two to four weeks.

Kidney Impairment

New or worsening kidney impairment, including cases of acute kidney failure and Fanconi syndrome, has been associated with the use of tenofovir. Healthcare providers typically assess kidney function before starting treatment and monitor it regularly during therapy.

Bone Effects

Decreases in bone mineral density (BMD) have been observed in patients taking the components of Atripla. There is also a risk of osteomalacia (softening of the bones) associated with kidney problems caused by the medication.

Liver Toxicity

Monitoring of liver enzymes is recommended for all patients, particularly those with a history of hepatitis B or C. There is an increased risk of liver-related complications in patients with pre-existing liver disease.

Skin Reactions

Severe rash, including Stevens-Johnson syndrome, has been reported. Treatment should be discontinued if a severe rash develops, especially if it is accompanied by fever, blistering, or muscle aches.

Pregnancy and Fetal Risk

Atripla may cause fetal harm, including neural tube defects, if taken during the first trimester of pregnancy. Effective contraception is recommended for individuals of childbearing potential while using this medication and for 12 weeks after stopping it.

Pregnancy

The use of Atripla during pregnancy involves several considerations. One of its components, efavirenz, has been associated with a risk of birth defects when used during the first trimester. Because of this, healthcare providers often recommend using effective contraception while taking this medication and for several weeks after stopping it.

If you become pregnant while taking Atripla, it is important to contact a healthcare provider immediately. They will help determine if the medication should be continued or if a different treatment plan is necessary. Maintaining control of the HIV infection is vital for the health of the parent and to reduce the risk of transmitting the virus to the baby.

Breastfeeding

In general, health authorities recommend that people with HIV do not breastfeed their infants. This recommendation is intended to prevent the transmission of HIV to the baby through breast milk. Furthermore, the medications in Atripla can pass into breast milk, and their safety for nursing infants has not been fully established.

Dosage Forms

Atripla is supplied as a film-coated tablet. This medication is a combination product intended for oral use.

• Tablet

FDA Approval Status

The U.S. Food and Drug Administration (FDA) approved Atripla in July 2006. It was the first once-daily medication to combine three different antiretroviral drugs into a single tablet for the treatment of HIV-1 infection. It is approved for use in adults and pediatric patients weighing at least 40 kg.

Boxed Warnings

Atripla carries a boxed warning, which is the most serious warning required by the FDA. These warnings include:

• Lactic Acidosis and Liver Toxicity: There is a risk of lactic acidosis (a buildup of acid in the blood) and severe liver enlargement with fatty deposits (hepatomegaly with steatosis). These conditions can be life-threatening.
• Hepatitis B Virus (HBV) Exacerbation: Atripla is not approved to treat chronic HBV infection. Patients with both HIV-1 and HBV may experience a severe worsening of their hepatitis B if they stop taking Atripla. The FDA recommends that these patients have their liver function monitored closely for several months after stopping the drug.

Prescription and Safety Information

Atripla is available only by prescription. The FDA requires that a Medication Guide be provided to patients with each prescription to explain the risks and proper use of the medication. It does not currently require a Risk Evaluation and Mitigation Strategy (REMS) program.

Factors Influencing Cost

The price of Atripla can vary significantly based on several factors. Generic versions of the combination of efavirenz, emtricitabine, and tenofovir disoproxil fumarate are available and are generally more affordable than the brand-name drug.

Other factors that affect the cost include:

• Insurance coverage: Most commercial insurance plans, Medicare, and Medicaid cover this medication, though out-of-pocket costs like copays and deductibles will vary by plan.
• Pharmacy selection: Costs may differ between local retail pharmacies and mail-order pharmacy services.

Financial Assistance

Financial support may be available for those who have difficulty affording the medication:

• Patient Assistance Programs: Manufacturers often offer programs to provide medications at low or no cost to individuals who meet certain income and eligibility criteria.
• Co-pay Cards: Some patients with private insurance may qualify for savings cards that reduce their monthly out-of-pocket expenses.
• Government Programs: The AIDS Drug Assistance Program (ADAP) is a state-run program that helps eligible individuals access HIV treatments.