AIDS and HIV Information
Genvoya is an FDA-approved fixed dose tablet containing a combination of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide. It is indicated for the treatment of Human Immunodeficiency Virus (HIV-1) in adults and children 12 years of age and older. Your doctor may prescribe this four-drug combination if you have not been previously treated with antiretroviral therapy (ART) or if you need to replace your current treatment regimen provided you:
- Have been on a stable ART regimen for the last 6 months;
- Have a viral load of less than 50 copies/ml;
- And have no previous history of treatment failure or resistance to any component of this drug.
The drug is available as a green, capsule-shaped, film-coated tablet, debossed with GSI on one side and 510 on the other side. Each dose contains 150mg of elvitegravir, 150mg of cobicistat, 200mg of emtricitabine, and 10mg of tenofovir alafenamide.
Elvitegravir – is an integrase strand transfer inhibitor (INSTI)
Cobicistat – is a booster that enhances the effects of the other drugs in this regimen
Emtricitabine – a nucleoside reverse transcriptase inhibitor (NRTI)
Tenofovir alafenamide – another NRTI that reduces the presence of HIV in the blood
Before taking Genvoya
Your doctor will test you for hepatitis B virus infection because this medication is not recommended for HBV-infected patients.
Your doctor may ask for additional tests, such as serum creatinine, estimated creatinine clearance, urine protein, urine glucose, and serum phosphorus if you have chronic kidney disease.
You should not take Genvoya if you are using other anti-HIV drugs, unless advised by your doctor.
Inform your doctor if you have an existing medical condition or a history of the following:
- Hypersensitivity or allergic reaction to Genvoya or any of its components;
- Kidney problems;
- Liver problems;
- Hepatitis B infection;
- Bone problems.
Recommended dose and method of administration
The recommended dosage for Genvoya is one tablet once daily with food in patients 12 years and older, weighing at least 35kg and a creatinine clearance of greater than or equal to 30 ml/minute.
- For adults and children
Regardless of age, you should not take this drug if your weight is below 35 kilograms.
- For the elderly
No dose adjustment is required for older healthy patients.
- For patients with kidney problems
No dose adjustment is required as long as the estimated creatinine clearance (CrCl) is ≥ 30 ml/min. You should discontinue the treatment if your CrCl declines below 30ml per minute.
- For patients with liver problems
No dose adjustment is required in patients with mild and moderate liver impairment. Genvoya is contraindicated in patients with severe liver damage.
Missed doses and overdosage
It is strongly advised not to miss a dose of Genvoya. Should you miss a dose within 18 hours of the scheduled dose, take Genvoya with food as soon as possible. If you miss a dose for more than 18 hours since your last dose, do not take the missed dose and take the next dose at the regular time. If you take two or more doses of Genvoya at the same time, seek medical help immediately or call your local poison control center.
How Genvoya works against HIV
This antiretroviral regimen contains four active ingredients that all work together to reduce the amount of HIV in the blood and keep it at low level. Elvitegravir blocks the enzyme integrase and the two NRTIs emtricitabine and tenofovir block reverse trancriptase. By blocking these enzymes, the drugs also stops the integration of the virus’ genetic materials into the immune cells, thereby preventing their replication. Simply put, Genvoya prevents HIV from multiplying and attacking the immune cells. While it does not cure HIV, it helps slow down the spread of infection and delay the damage to the immune system.
The advantage of Genvoya over other single-tablet regimens is the addition of the newer prodrug tenofovir alafenamide (TAF). Old versions of tenofovir are associated with kidney toxicity and decreased bone density. It has been found that tenofovir alafenamide is less toxic to the kidneys and bones. In clinical trials, Genvoya has a high efficacy rating; when given to previously untreated patients, 97% of 959 participants have their viral load reduced into undetectable levels (viral load of less than 50 copies per ml). Among those who have switched to Genvoya, 93% have responded to treatment.