Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide

What is Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide?

Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (GENVOYA) are the antiviral drugs used in combination for the treatment of HIV-1 infection, also called the Quad pill.

What are the uses of this medicine?

It is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of GENVOYA.

How does this medicine work?

GENVOYA is a fixed-dose combination tablet containing Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide for oral administration.

• Elvitegravir is an HIV-1 integrase strand transfer inhibitor.
• Cobicistat is a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family.
• Emtricitabine, a synthetic nucleoside analog of cytidine, is an HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI).
• Tenofovir alafenamide, an HIV NRTI, is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate.

Who Should Not Use this medicine?

• It is not recommended in patients with severe renal impairment (estimated creatinine clearance of 15 to below 30 mL per minute), end stage renal disease (ESRD; estimated creatinine clearance below 15 mL per minute) who are not receiving chronic hemodialysis.
• It is not recommended in patients with severe hepatic impairment.
• It is not recommended for use during pregnancy.

Is this medicine FDA approved?

It is approved by US FDA by November 5, 2015.

What are the brand names and dosage forms of this medicine?

• Brand name: GENVOYA
• Dosage form: Oral tablet; Each GENVOYA tablet contains 150 mg of Elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide (TAF) (equivalent to 11.2 mg of tenofovir alafenamide fumarate).

How should this medicine be used?

• Take GENVOYA exactly as your healthcare provider tells you to take it. GENVOYA is taken by itself (not with other HIV-1 medicines) to treat HIV-1 infection.
• Take GENVOYA 1 time each day with food.
• If you are on dialysis, take your daily dose of GENVOYA following dialysis.
• Do not change your dose or stop taking GENVOYA without first talking with your healthcare provider. Stay under a healthcare provider's care during treatment with GENVOYA.
• If you need to take a medicine for indigestion (antacid) that contains aluminum hydroxide, magnesium hydroxide, or calcium carbonate during treatment with GENVOYA, take it at least 2 hours before or after you take GENVOYA.
• Do not miss a dose of GENVOYA.
• When your GENVOYA supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to GENVOYA and become harder to treat.
• If you take too much GENVOYA, call your healthcare provider or go to the nearest hospital emergency room right away.

What side effects can this medication cause?

The following are the possible side effects:

• Severe Acute Exacerbations of Hepatitis B.
• Immune Reconstitution Syndrome.
• New Onset or Worsening Renal Impairment.
• Lactic Acidosis/Severe Hepatomegaly with Steatosis.

What to do in case of emergency/overdose?

No data are available on overdose of GENVOYA in patients. If overdose occurs, monitor the patient for evidence of toxicity. Treatment of overdose with GENVOYA consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

It is not recommended during pregnancy.

Can this medicine be used in children?

The safety and effectiveness of GENVOYA for the treatment of HIV-1 infection was established in pediatric patients with body weight greater than or equal to 25 kg. Use of GENVOYA in pediatric patients between the ages of 12 to less than 18 years and weighing at least 35 kg is supported by studies in adults and by a study in antiretroviral treatment-naïve HIV-1 infected pediatric subjects ages 12 to less than 18 years and weighing at least 35 kg (cohort 1 of Study 106, N=50). The safety and efficacy of GENVOYA in these pediatric subjects was similar to that in adults.

What should I know about storage and disposal of this medication?

• Store below 30 °C (86 °F).
• Keep container tightly closed.
• Dispense only in original container.

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