Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir
Elvitegravir, cobicistat, emtricitabine, and tenofovir is a four-drug combination used as a complete treatment regimen for HIV-1 infection in adults and eligible pediatric patients.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
If you also have hepatitis B (HBV) and you stop taking Genvoya, your hepatitis B can come back suddenly and severely. This rebound — called an acute exacerbation — can cause serious liver damage or even liver failure. It has been reported in people who stopped taking medications containing emtricitabine or tenofovir, both of which are in Genvoya. If you have HIV and hepatitis B and need to stop Genvoya for any reason, your doctor must monitor your liver closely — with blood tests and checkups — for at least several months after stopping. In some cases, hepatitis B treatment may need to be started to protect your liver.
📖 Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir: Patient Information Guide
A plain-language walkthrough of Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
This four-drug combination is used as a complete treatment regimen for HIV-1 infection — no additional HIV medications are needed alongside it.
- Genvoya is approved for adults and pediatric patients weighing at least 25 kg who have never been treated for HIV, or who are switching from a stable HIV regimen where their virus is already well-controlled (HIV-1 RNA below 50 copies/mL for at least 6 months with no treatment failures or relevant resistance)
- Stribild is approved for adults and pediatric patients 12 years and older weighing at least 35 kg, under the same treatment-naïve or virologically-suppressed switch criteria
⚙️How it works▾
This combination targets HIV using two distinct mechanisms. Elvitegravir is an integrase inhibitor — it blocks the viral enzyme that inserts HIV's DNA into your own cell's DNA, stopping the virus from establishing a permanent foothold. Emtricitabine and the tenofovir component are reverse transcriptase inhibitors — they mimic the building blocks HIV needs to copy its genetic material, and once incorporated, they halt the copying process entirely. Cobicistat is not an antiviral; it is a pharmacokinetic booster that inhibits the liver enzyme (CYP3A) responsible for breaking down elvitegravir, keeping elvitegravir levels high enough to work effectively.
Because Genvoya and Stribild contain different forms of tenofovir — tenofovir alafenamide (TAF) in Genvoya and tenofovir disoproxil fumarate (TDF) in Stribild — they have different pharmacological profiles, particularly regarding kidney and bone effects. The prescribing requirements for each product reflect these differences.
💊How it's taken▾
Both Genvoya and Stribild are taken as one tablet once daily by mouth, and both must be taken with food to ensure adequate absorption.
- Genvoya: Suitable for patients weighing at least 25 kg with creatinine clearance ≥30 mL/min, or adults on chronic hemodialysis (taken after the dialysis session on those days). Not recommended in severe liver impairment or during pregnancy.
- Stribild: Suitable for patients 12 years and older weighing at least 35 kg with creatinine clearance ≥70 mL/min at the start of treatment. Should be stopped if creatinine clearance drops below 50 mL/min. Not recommended in severe liver impairment or during pregnancy.
Always follow your prescriber's exact instructions. If you miss a dose, take it as soon as you remember — unless it is almost time for your next dose. Do not double up.
🤒Side effects — in detail▾
The most common side effects are generally mild, but there are a few serious ones to know about right away.
- Nausea (most common, reported in about 1 in 10 patients on Genvoya)
- Diarrhea
- Headache
- Fatigue
- Increases in blood cholesterol and triglycerides (fats in the blood), more pronounced with Genvoya than Stribild
- A modest rise in serum creatinine — a kidney marker — caused by cobicistat blocking its secretion; this does not always mean the kidneys are actually damaged, but it needs monitoring
- Decreased bone mineral density (bone thinning) over time, particularly with tenofovir-containing regimens
Seek medical help right away if you notice signs of lactic acidosis (muscle pain, trouble breathing, unusual tiredness, stomach pain), liver problems (yellowing skin or eyes, dark urine), or worsening kidney function (swelling, decreased urination, bone or muscle pain).
⚠️Warnings & precautions▾
- Hepatitis B flare on stopping: In people coinfected with HIV and hepatitis B, abruptly stopping these medications can trigger a sudden, severe worsening of hepatitis B that may lead to liver failure. Close monitoring for months after stopping is essential.
- Kidney injury: Both products can impair kidney function. Stribild, which contains TDF, carries a higher risk of Fanconi syndrome (kidney tubule damage). Regular kidney tests are required before and during treatment.
- Lactic acidosis and liver enlargement: Rare but potentially fatal buildup of lactic acid and liver swelling have been reported with the nucleoside components. Stop treatment and contact a doctor immediately if symptoms appear.
- Drug interactions: Because cobicistat strongly inhibits liver enzymes, it raises blood levels of many other drugs to potentially dangerous levels. A thorough medication review is essential before starting.
- Bone density loss: Long-term use — especially with TDF in Stribild — has been associated with decreased bone mineral density. Patients with osteoporosis risk factors should be monitored.
- Immune reconstitution syndrome: When the immune system starts recovering after starting HIV treatment, it can overreact to hidden infections, causing new inflammation that may require treatment.
🔀What it interacts with▾
Because cobicistat is a potent inhibitor of the CYP3A liver enzyme system, this combination interacts with a very wide range of medications — always review your full drug list with your pharmacist or doctor.
- Rifampin, carbamazepine, phenobarbital, phenytoin, St. John's wort: Contraindicated — these inducers dramatically lower levels of elvitegravir and cobicistat, risking treatment failure and resistance
- Lovastatin, simvastatin, lomitapide: Contraindicated — cobicistat raises their levels to dangerous concentrations
- Lurasidone, pimozide, alfuzosin: Contraindicated — risk of serious or life-threatening reactions
- Sildenafil (Revatio, for pulmonary arterial hypertension): Contraindicated; standard sildenafil for erectile dysfunction requires separate dose guidance
- Triazolam and oral midazolam (sedatives): Contraindicated due to risk of extreme sedation
- Blood thinners (apixaban, rivaroxaban, warfarin, dabigatran): Levels may increase significantly — dosing adjustments and monitoring are needed
- Antiarrhythmics (amiodarone, digoxin, others): Require careful monitoring of drug levels
- High-dose or frequent NSAIDs (ibuprofen, naproxen): Can worsen kidney function when combined with tenofovir — alternatives are preferred in at-risk patients
- Other HIV antiretrovirals: Should not be added to this regimen — it is already a complete treatment
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Tell your doctor if you have hepatitis B — testing is required before starting, and stopping the medication without medical supervision can be dangerous
- Tell your doctor if you have kidney disease — Genvoya requires creatinine clearance ≥30 mL/min for most patients; Stribild requires ≥70 mL/min to start
- Tell your doctor if you have severe liver disease — neither Genvoya nor Stribild is recommended for patients with severe hepatic impairment
- Pregnancy: Genvoya and Stribild are not recommended during pregnancy; blood levels of cobicistat and elvitegravir fall substantially in the second and third trimesters, risking treatment failure. Neither should be started in pregnancy; an alternative regimen is recommended if you become pregnant while taking either
- Breastfeeding: Not recommended, due to the risk of HIV transmission to the infant through breast milk
- Children: Genvoya is not recommended for patients weighing less than 25 kg; Stribild is not recommended for patients under 12 years old or weighing less than 35 kg
- Share your complete medication list — including supplements and herbal products — before starting, as cobicistat interacts with dozens of drugs
🚑If you take too much▾
There is limited experience with overdose of these medications. In studies using higher-than-therapeutic doses of the individual components in healthy volunteers, no severe reactions were reported, but the effects of a large overdose in patients are not fully known. If an overdose is suspected, seek medical attention immediately — treatment focuses on monitoring vital signs and supportive care. Emtricitabine can be partially removed by hemodialysis, and tenofovir is efficiently removed by hemodialysis; elvitegravir and cobicistat are highly protein-bound and are unlikely to be significantly cleared by dialysis.
📡Pharmacodynamics — effects in the body▾
Cobicistat, one of the four components, can cause a measurable decrease in estimated kidney clearance (creatinine clearance) — not because it damages the kidneys, but because it blocks the kidney's active secretion of creatinine, a waste product. This effect is reversible when cobicistat is stopped and does not reflect actual loss of kidney function. Studies also show that elvitegravir, cobicistat, and the tenofovir alafenamide component in Genvoya do not significantly affect the heart's electrical rhythm (QT interval), and clinically meaningful changes to the PR interval are unlikely at the doses used in these combination products.
🔬Pharmacokinetics — how your body processes it▾
All four components are taken orally once daily and are well absorbed. Food significantly increases the absorption of elvitegravir in particular, which is why these tablets must be taken with a meal. Elvitegravir and cobicistat are very highly bound to proteins in the blood (around 98–99%) and are broken down primarily by the CYP3A enzyme system in the liver. The tenofovir alafenamide in Genvoya is rapidly converted inside cells to its active form, tenofovir diphosphate, which has a very long intracellular half-life of 150–180 hours — meaning it stays active inside immune cells for days even after the plasma level drops. Emtricitabine is largely excreted unchanged by the kidneys (about 70% in urine), which is why kidney function is a key factor in dosing decisions for both products.
📦How to store it▾
Store at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °F) (see USP Controlled Room Temperature).
📄 Written from Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly do Genvoya and Stribild do — will they cure my HIV? ▾
Do I really need to take it with food every single time? ▾
What side effects are most likely, and which ones should make me call my doctor? ▾
I've heard these medications can interact with a lot of other drugs — what should I watch out for? ▾
What happens if I miss a dose or decide to stop taking it? ▾
Can I take Genvoya or Stribild if I'm pregnant or trying to get pregnant? ▾
Is Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir available over the counter? ▾
When was Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir first available? ▾
Who makes Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir? ▾
💬 Answers drafted from Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir comes
Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Genvoya is used to treat HIV-1 infection in adults and pediatric patients weighing at least 25 kg, either as a first HIV regimen or as a switch for patients who are already virologically suppressed on a stable regimen
- Stribild is used to treat HIV-1 infection in adults and pediatric patients 12 years and older weighing at least 35 kg, either as a first HIV regimen or as a switch for virologically suppressed patients on a stable regimen
- Genvoya: take one tablet by mouth once daily with food; on hemodialysis days, take Genvoya after the dialysis session is complete
- Stribild: take one tablet by mouth once daily with food
- Genvoya is not recommended if creatinine clearance is between 15 and 30 mL/min, or below 15 mL/min unless receiving chronic hemodialysis
- Stribild should not be started if creatinine clearance is below 70 mL/min and should be stopped if it falls below 50 mL/min during treatment
📊 Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir across the U.S. market
How Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir is used
A general measure of how commonly Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir prescribed? Of the 1,597 medications we measure, Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir ranks #572 by Medicaid prescriptions — more than 64% of them.
Utilization by Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
cobicistat 150 MG / elvitegravir 150 MG / emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1306292
Other Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 3 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 6 listed Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir NDCs with Medicaid activity.
🔍 Compare Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir products
A representative set of FDA-listed product records for Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| ELVITEGRAVIR 150 mg/1; COBICISTAT 150 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 10 mg | Oral | Gilead Sciences, Inc. | NDA | View NDC → |
| ELVITEGRAVIR 150 mg/1; COBICISTAT 150 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg | Oral | Gilead Sciences, Inc. | NDA | View NDC → |
| 150; 150; 200; 10 mg/1; mg/1; mg/1; mg | Oral | Gilead Sciences, Inc. | NDA | View NDC → |
| 150; 150; 200; 300 mg/1; mg/1; mg/1; mg | Oral | Gilead Sciences, Inc. | NDA | View NDC → |
| ELVITEGRAVIR 150 mg/1; COBICISTAT 150 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR ALAFENAMIDE FUMARATE 10 mg | — | Patheon Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| ELVITEGRAVIR 150 mg/1; COBICISTAT 150 mg/1; EMTRICITABINE 200 mg/1; TENOFOVIR DISOPROXIL FUMARATE 300 mg | — | Patheon Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir belongs to the Cytochrome P450 3A Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Gilead Sciences, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.