Genvoya (Cobicistat/Elvitegravir/Emtricitabine/Tenofovir)
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Fact Table
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| Formula | C23H23ClFNO5 (elvitegravir); C40H53N7O5S2 (cobicistat); C8H10FN3O3S (emtricitabine); C21H29O5N6P·½(C4H4O4) (tenofovir alafenamide fumarate) |
| License | FDA approved (NDA 207561; 2015); EMA authorised in the EU on 19 November 2015 |
| Bioavailability | Absolute bioavailability not stated for the fixed-dose combination; must be taken with food, which increases elvitegravir exposure |
| Legal status | Prescription only (Rx-only) |
| Chemical Name | Fixed-dose combination of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide fumarate |
| Elimination half-life | Elvitegravir 12.9 h; cobicistat 3.5 h; emtricitabine 10 h; tenofovir alafenamide 0.51 h; intracellular tenofovir diphosphate 150–180 h |
| Dosage (Strength) | 150 mg elvitegravir / 150 mg cobicistat / 200 mg emtricitabine / 10 mg tenofovir alafenamide tablet; one tablet orally once daily with food |
| Pregnancy | Not recommended during pregnancy; should not be initiated in pregnant individuals and an alternative regimen is recommended if pregnancy occurs |
| Brands | Genvoya (Gilead Sciences) |
| Protein binding | Elvitegravir ~99%; cobicistat ~98%; emtricitabine <4%; tenofovir alafenamide ~80% |
| PubChem CID | 5277135 (elvitegravir); 25151504 (cobicistat); 60877 (emtricitabine); 9574768 (tenofovir alafenamide); 71492247 (tenofovir alafenamide fumarate) |
| MedlinePlus | a625076 |
| ChEBI | 72289 (elvitegravir); 72291 (cobicistat); 31536 (emtricitabine); 90926 (tenofovir alafenamide) |
| ATC code | J05AR18 |
| DrugBank | DB09101 (elvitegravir); DB09065 (cobicistat); DB00879 (emtricitabine); DB09299 (tenofovir alafenamide) |
| KEGG | D10755 (combination); D06677 (elvitegravir); D09881 (cobicistat); D01199 (emtricitabine); D10605 (tenofovir alafenamide fumarate); D10428 (tenofovir alafenamide) |
| Routes of administration | By mouth (oral film-coated tablet) |
Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) is a prescription tablet used to treat HIV-1 infection in adults and children weighing at least 25 kg (55 lbs). It combines four medications into a single daily pill that work together to block HIV from copying itself and keep the virus under control. While it is not a cure for HIV, it helps support the health of the immune system. It is taken once daily with food and is available by prescription.
Directions
Take one Genvoya tablet by mouth once daily with food. Swallow the tablet whole. Do not break, crush, or chew it. Try to take it at the same time every day. If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and resume your regular schedule. Do not take two doses at once. Kidney function will need to be checked before starting treatment.
Ingredients
The active ingredients in Genvoya are elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide. Inactive ingredients include croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, and sodium lauryl sulfate. The film-coating may contain FD and C Blue No. 2, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
Cautions
Before using this medication, you may want to consult a healthcare provider about the following:
- Any existing health conditions
- Any allergies
- A list of all medications currently being taken
Severe and potentially life-threatening flare-ups of hepatitis B have been reported in patients co-infected with HIV and hepatitis B after stopping Genvoya. Liver function should be monitored closely if the medication is discontinued.
Genvoya may worsen existing kidney disease or cause new kidney damage, including a rare condition called Fanconi syndrome. Kidney function should be checked before and during treatment.
Some patients taking antiretroviral medications like Genvoya have experienced decreases in bone mineral density.
A rare but serious condition involving a buildup of lactic acid in the blood has been reported with similar medications, particularly in women, people with obesity, or those who have taken nucleoside analogues for a long time.
Genvoya interacts with many other medications through liver enzymes. Tell your healthcare provider about all medications, vitamins, and supplements being taken.
Contraindications
Avoid taking or using this medication if any of the following apply:
- Currently taking alfuzosin
- Currently taking carbamazepine, phenobarbital, or phenytoin
- Currently taking rifampin
- Currently taking St. John’s wort
- Currently taking ergot derivatives, such as dihydroergotamine, ergotamine, ergonovine, or methylergonovine
- Currently taking lomitapide, lovastatin, or simvastatin
- Currently taking lurasidone or pimozide
- Currently taking sildenafil for pulmonary arterial hypertension
- Currently taking triazolam or oral midazolam
Side Effects
Common side effects of Genvoya include:
- Nausea
- Diarrhea
- Headache
- Fatigue
Serious side effects may occur with Genvoya. Kidney problems, including acute kidney failure and a condition called proximal renal tubulopathy that affects how the kidneys filter the blood, have been reported.
Patients co-infected with hepatitis B may experience severe liver flares if Genvoya is stopped.
Some patients experience lactic acidosis, a dangerous buildup of lactic acid in the blood that can be life-threatening.
A condition called immune reconstitution syndrome may also occur when the immune system starts to recover, sometimes causing inflammation in response to hidden infections.
If any unusual or severe symptoms develop, contact a healthcare provider immediately.
Frequently Asked Questions about Genvoya
What is Genvoya used for?
Genvoya is a prescription tablet used as a complete regimen to treat HIV-1 infection in adults and in pediatric patients who weigh at least 25 kg. It may be used in people who have not taken HIV treatment before, or to replace a stable HIV regimen in certain people whose virus is already suppressed.
What is in Genvoya?
Genvoya combines four medicines in one tablet: elvitegravir, an integrase inhibitor; cobicistat, a booster that raises elvitegravir levels; and emtricitabine plus tenofovir alafenamide, which are nucleoside reverse transcriptase inhibitors. The “tenofovir” in Genvoya is specifically tenofovir alafenamide, often shortened to TAF.
Is Genvoya taken with other HIV medicines?
No. Genvoya is meant to be used by itself as a complete HIV treatment regimen, so it should generally not be taken with other antiretroviral medicines for HIV-1 unless a clinician specifically directs otherwise.
How do you take Genvoya?
The usual dose is one tablet by mouth once daily with food. For adults on chronic hemodialysis, the dose is taken after dialysis on dialysis days.
Who should not use Genvoya or may need extra caution?
Genvoya is not recommended for patients weighing under 25 kg, for people with severe hepatic impairment, or for people with severe renal impairment with estimated creatinine clearance 15 to below 30 mL/min. It can be used in adults with end-stage kidney disease on chronic hemodialysis, but not in those with estimated creatinine clearance below 15 mL/min who are not on chronic hemodialysis.
What are the most common side effects?
The most common side effect is nausea. In clinical studies, diarrhea, headache, and fatigue were also reported.
What is the most important safety warning?
Genvoya carries a boxed warning about severe worsening of hepatitis B after stopping treatment in people who have both HIV-1 and hepatitis B. Patients should be tested for hepatitis B before or when starting treatment, and if Genvoya is stopped, liver function may need close monitoring for several months.
What other serious side effects can happen?
Serious risks include drug interactions, immune reconstitution syndrome, new or worsening kidney problems, lactic acidosis, and severe liver problems. Kidney tests are recommended before and during treatment.
Are there important drug interactions?
Yes. Genvoya interacts with many medicines and herbal products. It is contraindicated with certain drugs such as rifampin, carbamazepine, phenytoin, phenobarbital, St. John’s wort, lovastatin, and simvastatin, among others. Antacids containing aluminum, magnesium, or calcium should be taken at least 2 hours before or after Genvoya.
What should patients know about pregnancy, breastfeeding, storage, and missed doses?
Genvoya is not recommended during pregnancy and should not be started in pregnant individuals because elvitegravir and cobicistat levels can be lower during pregnancy; a different regimen is usually recommended if pregnancy occurs during treatment. Breastfeeding is not recommended. The patient information stresses not to miss doses and not to run out of medicine, because even a short interruption can raise viral levels and promote resistance. Store the tablets below 30°C (86°F) in the original tightly closed container.
