Question 1

What is Bictegravir?

Accepted Answer

Bictegravir is an antiretroviral medication used in the treatment of human immunodeficiency virus (HIV). It belongs to a class of drugs called integrase strand transfer inhibitors, which work by interfering with the enzymes the virus needs to multiply.

By preventing the virus from replicating, the medication helps to reduce the amount of HIV in the body. It is typically used as one component of a multi-drug treatment plan to support immune system health.

Question 2

What is Bictegravir used for?

Accepted Answer

Bictegravir is used to treat HIV-1 infection .

Question 3

How does Bictegravir work?

Accepted Answer

Mechanism of Action

Bictegravir belongs to a group of medicines called integrase strand transfer inhibitors (INSTIs). It works by targeting a specific enzyme that the human immunodeficiency virus (HIV) needs to reproduce.

The medication works through the following process:

Blocking the integrase enzyme: HIV uses an enzyme called integrase to insert its own genetic material into the DNA of healthy human immune cells.

Preventing replication: By blocking this enzyme, bictegravir prevents the virus from completing its life cycle. This stops the virus from making new copies of itself.

Reducing viral load: As the virus is unable to multiply, the total amount of HIV in the blood (known as the viral load) decreases.

By keeping the viral load low, the medication helps the immune system stay stronger and reduces the risk of HIV-related illnesses. However, bictegravir does not cure HIV; it is used as part of a long-term treatment plan to manage the condition.

Question 4

What are the brand names for Bictegravir?

Accepted Answer

Bictegravir is sold under the brand name Biktarvy .

Question 5

What are the active ingredients in Bictegravir?

Accepted Answer

The active ingredient in Bictegravir is bictegravir .

Question 6

What are the side effects of Bictegravir?

Accepted Answer

Common side effects of Bictegravir may include:

diarrhea

nausea

headache

and others

Always consult with a healthcare professional about potential side effects.

Question 7

What drug class is Bictegravir?

Accepted Answer

Bictegravir belongs to the HIV integrase strand transfer inhibitor drug class.

Question 8

What is the dosage of Bictegravir and how do I take it?

Accepted Answer

How to Take This Medication

This medication is a tablet taken by mouth, usually once every day. It is important to take it at the same time each day to maintain a consistent level of medicine in the body. The tablet should be swallowed whole; do not chew, crush, or split the tablet unless specifically instructed by a healthcare provider.

Taking with Food and Other Products

You may take this medication with or without food. However, certain minerals and antacids can interfere with how the body absorbs the medicine. If you take antacids containing magnesium or aluminum, or supplements containing iron or calcium, you may need to adjust your schedule. Generally, these products should be taken at a different time than this medication, or taken together with a full meal as directed by a healthcare professional.

Missed Doses

If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time to make up for a missed one. It is vital not to skip doses, as missing doses can make the virus harder to treat and may lead to drug resistance.

Question 9

Is Bictegravir safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

There is limited data on the use of bictegravir in pregnant individuals. While animal studies have not shown evidence of harm to the fetus at high doses, human clinical data is not yet sufficient to confirm safety. Decisions regarding the use of this medication during pregnancy should be made in consultation with a healthcare provider to balance the importance of maintaining viral suppression with potential risks.

A pregnancy exposure registry exists to monitor the health outcomes of individuals and their infants who are exposed to antiretroviral medications during pregnancy. Healthcare providers can provide information on how to enroll in this registry to help improve the understanding of the drug's effects.

Breastfeeding

Health experts generally recommend that individuals with HIV avoid breastfeeding to prevent the transmission of the virus to the infant through breast milk. Additionally, it is not known if bictegravir passes into human breast milk or what effects it might have on a nursing baby. In regions where safe water and infant formula are available, these are the preferred methods for feeding to ensure the infant's safety.

Question 10

What forms and strengths does Bictegravir come in?

Accepted Answer

Available Forms

Bictegravir is not available as a standalone medication. It is only available as a component of a fixed-dose combination tablet intended for oral administration. This combination therapy includes bictegravir along with other antiretroviral drugs.

Administration

The medication is taken by mouth as a tablet.

Different tablet sizes are available to accommodate both adult and pediatric patients based on weight.

Question 11

What is the FDA approval status of Bictegravir?

Accepted Answer

FDA Approval Status

Bictegravir was first approved by the U.S. Food and Drug Administration (FDA) in February 2018. It is approved for use as a component of a complete, fixed-dose combination tablet for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Approved Indications

The medication is indicated for the treatment of HIV-1 infection in the following populations:

Adults and pediatric patients weighing at least 14 kilograms who have no history of antiretroviral treatment.

Adults and pediatric patients weighing at least 14 kilograms to replace their current stable antiretroviral regimen, provided they meet specific clinical criteria regarding viral suppression and have no known resistance to the individual components of the therapy.

Boxed Warning

The FDA-approved labeling for the combination product containing bictegravir includes a boxed warning regarding the risk of post-treatment acute exacerbation of hepatitis B (HBV). Patients co-infected with HIV-1 and HBV may experience severe, acute worsening of their hepatitis B condition if they stop taking this medication. Healthcare providers are advised to monitor liver function closely in these patients for several months after treatment is discontinued.

Other Regulatory Information

Bictegravir is available only by prescription. It is not a controlled substance. While it carries a boxed warning, there is no specific Risk Evaluation and Mitigation Strategy (REMS) program required beyond the standard requirement for a patient medication guide to be provided with each prescription.

Question 12

What should I know about Bictegravir and fda?

Accepted Answer

FDA Approval History

The FDA approved bictegravir on February 7, 2018, as part of a three-drug fixed-dose combination tablet. It was developed as an integrase strand transfer inhibitor (INSTI) to provide a complete treatment regimen in a single pill.

Approved Indications

Bictegravir is FDA-approved for the treatment of HIV-1 infection in the following populations:

Adults and pediatric patients weighing at least 25 kg who have no history of antiretroviral treatment.

Adults and pediatric patients weighing at least 25 kg to replace their current antiretroviral regimen if they are virologically suppressed on a stable regimen, have no history of treatment failure, and have no known resistance to the medication's components.

Pediatric patients weighing at least 14 kg to less than 25 kg for specific low-dose formulations.

FDA Boxed Warning

The FDA-approved labeling for the combination product containing bictegravir includes a boxed warning regarding the risk of post-treatment acute exacerbation of hepatitis B (HBV). Patients co-infected with HIV-1 and HBV may experience severe liver problems if they discontinue the medication. Healthcare providers are required to test patients for HBV infection before initiating treatment.

Regulatory Status

Bictegravir is available only by prescription. It is not approved for use as a standalone medication and must be used as part of the specific combination therapy approved by the FDA.

Bictegravir

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