Biktarvy

Primary Indications

Biktarvy is used as a complete treatment regimen for HIV-1 infection. It combines three different medicines into a single pill, so it is generally not used with other antiretroviral drugs. It is prescribed for two main types of patients:

• New Treatment: People who have never taken HIV-1 medications before.
• Treatment Switch: People who are currently on a stable HIV treatment plan, have a suppressed viral load (the amount of virus in the blood is very low), and have no history of treatment failure or resistance to the components of Biktarvy.

Patient Population

This medication is approved for use in adults and pediatric patients who weigh at least 14 kilograms (approximately 31 pounds). Healthcare providers determine if a patient is a candidate for switching to Biktarvy based on their medical history and previous response to other HIV therapies.

Important Considerations

While Biktarvy helps decrease the amount of HIV in the body and supports the immune system, it is not a cure for HIV infection or AIDS. It must be taken consistently as prescribed to remain effective in managing the virus.

How Biktarvy Works

Biktarvy contains three active ingredients: bictegravir, emtricitabine, and tenofovir alafenamide. These drugs belong to two different classes of antiretroviral medications that target the human immunodeficiency virus (HIV) at different stages of its life cycle.

Blocking Viral Replication

The components of Biktarvy work by interfering with specific enzymes that the virus uses to make copies of itself:

• Bictegravir: This is an integrase strand transfer inhibitor (INSTI). It blocks an enzyme called integrase, which HIV uses to insert its own genetic material into the DNA of healthy human cells.
• Emtricitabine and Tenofovir Alafenamide: These are nucleoside reverse transcriptase inhibitors (NRTIs). They block an enzyme called reverse transcriptase, which the virus needs to convert its genetic material into a form that can be integrated into human cells.

Effects on the Body

By preventing the virus from multiplying, Biktarvy helps to:

• Reduce the amount of HIV in the blood, often referred to as the viral load.
• Increase the number of CD4 cells (T-cells), which are white blood cells that help the immune system fight infections.

While Biktarvy helps control the infection and can make the viral load undetectable, it is not a cure for HIV or AIDS. It must be taken consistently to keep the virus from replicating and to prevent the immune system from becoming weaker.

Common Side Effects

The most frequently reported side effects of Biktarvy include:

• Diarrhea
• Nausea
• Headache
• Fatigue
• Dizziness
• Trouble sleeping or vivid dreams

Serious Side Effects

Biktarvy may cause serious health issues that require medical intervention. Seek medical help if you experience:

• Kidney issues: New or worsening kidney impairment, including kidney failure.
• Liver problems: Signs include yellowing of the skin or eyes, dark-colored urine, or loss of appetite.
• Lactic acidosis: A rare but serious condition where lactic acid builds up in the blood, causing weakness, unusual muscle pain, or a cold feeling in the arms and legs.
• Immune system changes: The immune system may become overactive and attack old or hidden infections (immune reconstitution syndrome).
• Bone problems: Bone pain or thinning bones may occur in some patients.

Severe allergic reactions are rare but require immediate emergency care if you develop a rash, hives, swelling of the face or throat, or difficulty breathing.

Boxed Warning: Hepatitis B Virus Reactivation

Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued medications containing emtricitabine or tenofovir. Liver function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are co-infected with HIV-1 and HBV and stop taking Biktarvy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Contraindications

Biktarvy should not be used at the same time as certain other medications because of the potential for serious or life-threatening drug interactions. These include:

• Dofetilide: Taking these together can increase the levels of dofetilide in the blood, which may lead to serious heart rhythm problems.
• Rifampin: This medication can significantly decrease the levels of Biktarvy in the body, which may lead to a loss of virologic response and possible resistance.

Kidney Health

New onset or worsening renal impairment, including cases of acute renal failure, has been reported with the use of tenofovir prodrugs. Healthcare providers typically assess kidney function (estimated glomerular filtration rate) before starting treatment and monitor it periodically during therapy. Biktarvy is generally not recommended for patients with severe renal impairment unless they are already receiving chronic hemodialysis.

Lactic Acidosis and Liver Issues

Lactic acidosis and severe liver enlargement with fatty deposits (steatosis), including fatal cases, have been reported with the use of nucleoside analogs. Treatment may need to be suspended if clinical or laboratory findings suggest the development of these conditions.

Immune Reconstitution Syndrome

As the immune system strengthens during treatment, it may develop an inflammatory response to previously hidden or inactive infections, such as tuberculosis, cytomegalovirus, or certain types of pneumonia. This is known as immune reconstitution syndrome. Autoimmune disorders, such as Graves' disease or polymyositis, may also occur months after starting treatment.

Pregnancy

Data regarding the safety of Biktarvy during pregnancy is limited. While studies in animals have not shown a clear risk of harm to the fetus, there is not enough information from human studies to determine if the medication is safe for use during pregnancy. Healthcare providers may encourage pregnant individuals taking Biktarvy to enroll in the Antiretroviral Pregnancy Registry to help monitor the health of both the parent and the baby.

It is important to maintain effective HIV treatment during pregnancy to protect the health of the parent and to lower the risk of passing the virus to the child. Decisions about using Biktarvy during pregnancy should be made in consultation with a healthcare professional.

Breastfeeding

The Centers for Disease Control and Prevention (CDC) and other health organizations recommend that people with HIV-1 do not breastfeed their infants. This recommendation is intended to prevent the transmission of HIV to the baby through breast milk. Furthermore, it is known that some ingredients in Biktarvy can pass into breast milk, and the potential for serious adverse reactions in a nursing infant is unknown.

Dosage Forms

Biktarvy is supplied as a film-coated tablet for oral administration. It is a fixed-dose combination medication that contains multiple active ingredients in a single pill.

The tablets are produced in different sizes to accommodate use in adults and pediatric patients based on body weight. The tablets are typically capsule-shaped or round, depending on the specific formulation prescribed by a healthcare provider.

FDA Approval and Indications

Biktarvy is approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV-1 infection. It is a complete regimen, meaning it is not intended to be taken with other antiretroviral drugs. The medication is indicated for adults and pediatric patients weighing at least 14 kilograms. It may be used in patients who have not previously received HIV treatment or as a replacement for a current stable regimen in patients who are virologically suppressed and have no history of treatment failure.

Boxed Warning

The FDA requires a boxed warning for Biktarvy because it contains emtricitabine and tenofovir alafenamide, which can cause a severe acute exacerbation of hepatitis B (HBV) in patients co-infected with HIV-1 and HBV who stop taking the medication. Healthcare providers are advised to test all patients for HBV infection before starting Biktarvy. If the medication is discontinued, liver function must be monitored closely through both clinical and laboratory follow-up for at least several months.

Other Regulatory Information

Biktarvy is a prescription-only medication. It is not indicated for the treatment of chronic HBV infection. While it is used to manage HIV-1, it is not a cure for HIV or AIDS.

Insurance Coverage

The out-of-pocket cost for Biktarvy is primarily determined by your health insurance plan. Most private insurance, Medicare, and Medicaid plans cover Biktarvy, but the specific copayment or coinsurance amount varies by plan. Since Biktarvy is a brand-name medication and does not currently have a generic version, costs may be higher than for some other treatments.

Savings and Support Options

Several programs may be available to help manage the cost of Biktarvy:

• Manufacturer Copay Cards: Eligible patients with commercial insurance may use copay savings cards to reduce their monthly out-of-pocket costs.
• Patient Assistance Programs: For those who are uninsured or have limited insurance coverage, the manufacturer may offer programs that provide the medication at no cost or a significantly reduced price based on income eligibility.
• State Assistance: Programs like the AIDS Drug Assistance Program (ADAP) can help eligible individuals obtain HIV medications.

Patients should consult their pharmacist or insurance provider for specific pricing information and to explore available financial support.