Question 1

What is Genvoya?

Accepted Answer

Genvoya is a combination antiretroviral therapy consisting of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide. It combines an integrase inhibitor, a pharmacokinetic enhancer, and two nucleoside reverse transcriptase inhibitors into one treatment.

The medication works by interfering with the viral replication cycle. By inhibiting enzymes the virus needs to copy itself, the therapy helps to lower the viral presence in the body and supports immune system health.

Question 2

What is Genvoya used for?

Accepted Answer

Genvoya is used to treat HIV-1 infection .

Question 3

How does Genvoya work?

Accepted Answer

Mechanism of Action

Genvoya is a complete regimen for treating HIV-1 infection. It combines four different drugs that interfere with the virus's ability to copy itself and infect new cells.

Elvitegravir is an integrase strand transfer inhibitor (INSTI). It prevents the virus from inserting its genetic code into the DNA of human immune cells.

Cobicistat is a pharmacokinetic enhancer. It does not have antiviral activity on its own but works by blocking an enzyme in the liver that breaks down elvitegravir. This boosts the level of elvitegravir in the blood so it can work effectively.

Emtricitabine and Tenofovir Alafenamide are nucleoside reverse transcriptase inhibitors (NRTIs). These drugs act as faulty building blocks that stop the virus from completing the process of copying its genetic material.

By using these different methods simultaneously, Genvoya reduces the amount of HIV in the body, also known as the viral load. Lowering the viral load helps the immune system recover and increases the number of CD4+ cells, which are essential for fighting off other infections. While Genvoya helps control HIV, it does not cure the virus.

Question 4

What are the active ingredients in Genvoya?

Accepted Answer

The active ingredients in Genvoya are cobicistat , elvitegravir , tenofovir alafenamide , and others.

Question 5

What are the side effects of Genvoya?

Accepted Answer

Common side effects of Genvoya may include:

Nausea

Diarrhea

Headache

Others

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Genvoya?

Accepted Answer

Genvoya belongs to the antiretroviral combination drug class.

Question 7

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

Accepted Answer

Genvoya is a complete treatment regimen for HIV-1 infection and should be taken exactly as prescribed by a healthcare provider. It is typically taken as one tablet once per day.

General Instructions

Take with food: This medication must be taken with a meal. Taking Genvoya with food ensures the medicine is absorbed correctly by the body.

Daily schedule: It is best to take the tablet at the same time every day to maintain a steady level of the medication in the blood.

Swallow whole: The tablet should be swallowed whole rather than crushed or chewed.

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 timing. Do not take two doses at the same time to make up for a missed one.

Importance of Adherence

It is important not to skip doses or stop taking the medication without consulting a healthcare provider. Consistent use helps prevent the virus from multiplying and reduces the risk of the virus developing resistance to the treatment.

Question 8

Is Genvoya safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

Genvoya is typically not recommended for use during pregnancy. Clinical data suggests that the levels of certain components in the medication, specifically elvitegravir and cobicistat, can drop significantly during the second and third trimesters. When drug levels are too low, there is an increased risk that the medication will not effectively suppress the virus, which could lead to treatment failure or the transmission of HIV to the fetus.

If a person becomes pregnant while taking Genvoya, healthcare providers usually discuss switching to an alternative HIV treatment regimen that is more effective during pregnancy. There is an antiretroviral pregnancy registry that monitors health outcomes for people who take these medications while pregnant to better understand their safety and impact.

Breastfeeding

Health authorities generally recommend that individuals with HIV avoid breastfeeding. This is primarily to prevent the risk of transmitting the virus to the infant through breast milk. Furthermore, it is not fully known if all the active ingredients in Genvoya pass into human breast milk or what effects they might have on a nursing infant. Discussing safe infant feeding alternatives with a healthcare professional is recommended.

Question 9

What forms and strengths does Genvoya come in?

Accepted Answer

Available Forms

Genvoya is provided as a film-coated tablet intended for oral administration. This medication is a fixed-dose combination, meaning multiple active ingredients are contained within a tablet to provide a complete treatment regimen.

Oral tablet

Question 10

What is the FDA approval status of Genvoya?

Accepted Answer

FDA Approval and Indications

Genvoya is approved by the U.S. Food and Drug Administration (FDA) as a complete treatment regimen for HIV-1 infection. It is intended for use in adults and pediatric patients weighing at least 25 kg (approximately 55 pounds). It may be prescribed for individuals who have not previously taken HIV medications or as a replacement for a stable regimen in patients who are virologically suppressed and have no history of treatment failure.

Boxed Warning

The medication carries a boxed warning, which is the FDA's most serious warning, regarding the risk of post-treatment acute exacerbation of hepatitis B. Patients co-infected with HIV-1 and hepatitis B virus (HBV) may experience severe flare-ups of their hepatitis B infection if they stop taking Genvoya. Healthcare providers typically monitor liver function closely in these patients for several months after treatment is discontinued.

Additional Regulatory Information

Genvoya is a combination of four active ingredients: elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide. While it helps manage HIV-1 infection, the FDA notes that it is not a cure for HIV or AIDS. Regulatory authorities continue to monitor the drug's safety profile through postmarketing surveillance, including specific reviews of its effects on pediatric patients to ensure ongoing safety and effectiveness.

Question 11

What should I know about Genvoya and cost?

Accepted Answer

Insurance and Out-of-Pocket Costs

The price of Genvoya can vary based on your specific health insurance plan. Most insurance providers, including Medicare and Medicaid, provide coverage for this medication, but your copay or coinsurance amount will depend on your plan's formulary. Some insurance companies may require prior authorization before covering the drug.

Generic Availability

Genvoya is a brand-name medication. Currently, there is no generic version of Genvoya available in the United States. Generic drugs typically cost less than brand-name versions, so the lack of a generic option may contribute to a higher out-of-pocket cost.

Financial Assistance Programs

The manufacturer of Genvoya may offer patient assistance programs or copay coupons to help lower the cost for those who qualify. Additionally, various non-profit organizations and state-funded programs, such as the AIDS Drug Assistance Program (ADAP), may provide financial support to help patients afford their HIV medications.

Genvoya

📋Overview

What It's Used For

How It Works

Side Effects

Warnings & Precautions

Dosage & How to Take

Pregnancy & Breastfeeding

Forms & Strengths

FDA / Regulatory Status

Price Information

FAQ

Additional Resources

Support & Help Resources

📚References

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