Genvoya

Primary Indications

Genvoya is used to treat HIV-1 infection. It is a combination of four different medications that work together as a complete treatment regimen. It is approved for use in:

• Adults
• Children who weigh at least 25 kilograms (about 55 pounds)

Usage Scenarios

Healthcare providers may prescribe Genvoya in two primary situations:

• New Treatment: For individuals who have never received antiretroviral therapy to treat HIV-1.
• Treatment Switch: To replace a current stable HIV-1 medication regimen in people who meet specific criteria.

Criteria for Switching

For those switching from another HIV-1 regimen, Genvoya is typically used when:

• The person has been on a stable antiretroviral regimen for at least six months.
• The virus is currently suppressed (HIV-1 RNA levels are less than 50 copies per mL).
• There is no history of treatment failure.
• There are no known genetic mutations or resistance associated with the individual drugs contained in Genvoya.

While Genvoya helps manage the amount of HIV in the body, it is not a cure for HIV infection or AIDS.

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.

Common Side Effects

The most frequently reported side effect of Genvoya is nausea. Other common side effects may include:

• Diarrhea
• Headache
• Fatigue or unusual tiredness
• Stomach pain
• Dizziness
• Trouble sleeping or abnormal dreams

Serious Side Effects

Genvoya can cause serious side effects that may require immediate medical attention. These include:

• Kidney problems: This medication can cause new or worsening kidney impairment, including kidney failure.
• Lactic acidosis: A rare but serious condition where too much lactic acid builds up in the blood. Symptoms can include unusual muscle pain, stomach pain with nausea and vomiting, cold arms and legs, or feeling very weak.
• Liver problems: Serious liver issues may occur. Signs include yellowing of the skin or eyes, dark urine, or pain in the upper right stomach area.
• Immune system changes: As the immune system recovers, it may react to older, hidden infections (immune reconstitution syndrome).
• Bone density loss: Some patients may experience thinning of the bones or bone pain, which can increase the risk of fractures.
• Changes in body fat: Fat may shift to different parts of the body, such as the back, neck, or trunk.

Boxed Warning: Hepatitis B Virus

Individuals with both HIV-1 and hepatitis B virus (HBV) may experience a severe worsening of their hepatitis B infection if they stop taking Genvoya. Liver function should be closely monitored for several months in people who discontinue this medication, and anti-hepatitis B therapy may be necessary.

Liver and Kidney Health

Genvoya may cause serious liver problems, including a condition called lactic acidosis, where lactic acid builds up in the blood. This is a medical emergency that requires immediate attention. Symptoms can include unusual tiredness, stomach pain, shortness of breath, or feeling cold. It may also cause severe hepatomegaly (enlarged liver) with steatosis (fatty liver).

New or worsening kidney impairment, including kidney failure, can occur. Healthcare providers typically monitor kidney function through blood and urine tests before starting treatment and regularly during therapy. Genvoya is generally not recommended for individuals with severe kidney disease.

Drug Interactions

Genvoya contains cobicistat, which significantly affects how the body processes many other medications. Taking Genvoya with certain drugs can lead to dangerous levels of those medications in the body or make Genvoya less effective. It is important to review all current medications, including herbal supplements like St. John's Wort and over-the-counter products, with a healthcare provider to avoid serious interactions.

Other Precautions

• Bone Health: Some people may experience a decrease in bone mineral density while taking medications containing tenofovir. Healthcare providers may monitor bone health, especially in those with a history of bone fractures or osteoporosis.
• Immune Reconstitution Syndrome: As the immune system strengthens during treatment, it may react strongly to previously hidden or old infections, such as pneumonia or tuberculosis.
• Fat Redistribution: Changes in body fat distribution, sometimes called lipodystrophy, may occur in individuals receiving antiretroviral therapy.

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.

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

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.

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.