Prescription medicine
Bictegravir and emtricitabine and tenofovir alafenamide Brand names: Biktarvy
Bictegravir and emtricitabine and tenofovir alafenamide (Biktarvy) is a prescription medicine with an FDA approval on record since 2018. No generic is listed; pharmacies paid $136.73 per Biktarvy 50-200-25 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the bictegravir and emtricitabine and tenofovir alafenamide FDA label on DailyMed (effective April 30, 2024, A-S Medication Solutions); the NDA 210251 record on Drugs@FDA; every bictegravir and emtricitabine and tenofovir alafenamide label on DailyMed.
Highlights of the record
FDA label of April 30, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B.
Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ]. WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function in these patients. If appropriate, anti-hepatitis B therapy may be warranted.
Used for
From the label: indications and usageBIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 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 with no known or suspected substi
Forms and strengths
- 30 mg / 120 mg / 15 mg
- 50 mg / 200 mg / 25 mg
Tablet.
On the market
- Earliest approval on file
- February 7, 2018 Biktarvy, Gilead Sciences Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- November 8, 2036 Biktarvy tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $136.73 per tablet Biktarvy 50-200-25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
What is bictegravir and emtricitabine and tenofovir alafenamide used for?
From the label: indications and usageBIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 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 with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. […]
Conditions named in the indications of bictegravir and emtricitabine and tenofovir alafenamide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor and Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (Biktarvy), NDA210251 (Gilead Sciences Inc), as published by A-S Medication Solutions, effective April 30, 2024 (SPL set 0476d7eb-1024-4821-bbe7-abaacfda32a2), via openFDA; the full label on DailyMed
Is there a generic for bictegravir and emtricitabine and tenofovir alafenamide (Biktarvy)?
No generic bictegravir and emtricitabine and tenofovir alafenamide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 9 patents for Biktarvy tablets: the compound patent runs to June 19, 2035, and the last listed entry to November 8, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for bictegravir and emtricitabine and tenofovir alafenamide (Biktarvy)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $136.73 per Biktarvy 50-200-25 mg tablet, about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Biktarvy 30-120-15 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Biktarvy 30-120-15 mg tablet | Brand | $136.66 per tablet | $4,099.65 | +0.1% |
| Biktarvy 50-200-25 mg tablet | Brand | $136.73 per tablet | $4,101.85 | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the bictegravir and emtricitabine and tenofovir alafenamide label say about other medicines?
The bictegravir and emtricitabine and tenofovir alafenamide label names 22 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Acyclovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.4) ]. |
| Carbamazepine | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine Drug-drug interaction study was conducted with either BIKTARVY or its components as individual agents. oxcarbazepine phenobarbital phenytoin; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↓ BIC ↓ TAF; … |
| Cidofovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.4) ]. |
| Dofetilide | contraindications | CONTRAINDICATIONS BIKTARVY is contraindicated to be co-administered with: dofetilide due to the potential for increased dofetilide plasma concentrations and associated serious and/or life-threatening events [see Drug Interactions (7.5) ]. … |
| Ganciclovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.4) ]. |
| Gentamicin | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.4) ]. |
| Ledipasvir and sofosbuvir | drug interactions | Drugs without Clinically Significant Interactions with BIKTARVY Based on drug interaction studies conducted with BIKTARVY or the components of BIKTARVY, no clinically significant drug interactions have been observed when BIKTARVY is combined with the following drugs: ethinyl estradiol, ledipasvir/sofosbuvir … |
| Metformin | drug interactions | Concomitant Drug Class/Drug Name: Metformin; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↑ Metformin; Clinical Comment: Refer to the prescribing information of metformin for assessing the benefit and risk of concomitant use of BIKTARVY and metformin. |
| Midazolam | drug interactions | … been observed when BIKTARVY is combined with the following drugs: ethinyl estradiol, ledipasvir/sofosbuvir, midazolam, norgestimate, sertraline, sofosbuvir, sofosbuvir/velpatasvir, and sofosbuvir/velpatasvir/voxilaprevir. |
| Oxcarbazepine | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine Drug-drug interaction study was conducted with either BIKTARVY or its components as individual agents. oxcarbazepine phenobarbital phenytoin; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↓ BIC ↓ TAF; … |
| Phenobarbital | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine Drug-drug interaction study was conducted with either BIKTARVY or its components as individual agents. oxcarbazepine phenobarbital phenytoin; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↓ BIC ↓ TAF; … |
| Phenytoin | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine Drug-drug interaction study was conducted with either BIKTARVY or its components as individual agents. oxcarbazepine phenobarbital phenytoin; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↓ BIC ↓ TAF; … |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials: rifabutin rifampin, Strong inducer of CYP3Aand P-gp, and inducer of UGT1A1. rifapentine; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↓ BIC ↓ TAF; … |
| Rifampin | contraindications | CONTRAINDICATIONS BIKTARVY is contraindicated to be co-administered with: dofetilide due to the potential for increased dofetilide plasma concentrations and associated serious and/or life-threatening events [see Drug Interactions (7.5) ]. … |
Every other medicine the bictegravir and emtricitabine and tenofovir alafenamide label names
| Medicine named | Section | What the label says |
|---|---|---|
| Rifapentine | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials: rifabutin rifampin, Strong inducer of CYP3Aand P-gp, and inducer of UGT1A1. rifapentine; … |
| Sertraline | drug interactions | … ethinyl estradiol, ledipasvir/sofosbuvir, midazolam, norgestimate, sertraline, sofosbuvir, sofosbuvir/velpatasvir, and sofosbuvir/velpatasvir/voxilaprevir. |
| Sofosbuvir | drug interactions | … is combined with the following drugs: ethinyl estradiol, ledipasvir/sofosbuvir, midazolam, norgestimate, sertraline, sofosbuvir, sofosbuvir/velpatasvir, and sofosbuvir/velpatasvir/voxilaprevir. |
| Sofosbuvir and velpatasvir | drug interactions | Drugs without Clinically Significant Interactions with BIKTARVY Based on drug interaction studies conducted with BIKTARVY or the components of BIKTARVY, no clinically significant drug interactions … |
| Sofosbuvir and velpatasvir and voxilaprevir | drug interactions | Drugs without Clinically Significant Interactions with BIKTARVY Based on drug interaction studies conducted with BIKTARVY or the components of BIKTARVY, no clinically significant drug interactions … |
| Sucralfate | drug interactions | … Calcium or iron supplements Cation-containing antacids or laxatives Sucralfate Buffered medications; Effect on Concentration ↑ = Increase, ↓ = Decrease.: ↓ BIC; … |
| Valacyclovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g. … |
| Valganciclovir | drug interactions | … are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.4) ]. |
Check bictegravir and emtricitabine and tenofovir alafenamide against other medicines
Source: FDA drug label (Biktarvy), NDA210251 (Gilead Sciences Inc), as published by A-S Medication Solutions, effective April 30, 2024 (SPL set 0476d7eb-1024-4821-bbe7-abaacfda32a2), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as bictegravir and emtricitabine and tenofovir alafenamide?
34 other medicines are given the same way (oral) and in the same FDA class as bictegravir and emtricitabine and tenofovir alafenamide or labeled mainly for the same use (HIV), the same class first. HIV lists all 47 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lamivudine | HIV | 14 labelers | $0.489 per tablet 150 mg tablet | No current entry |
| Tenofovir disoproxil | HIV | 15 labelers | $0.294 per tablet 300 mg tablet | No current entry |
| Abacavir | HIV | 12 labelers | $0.546 per tablet 300 mg tablet | No current entry |
| Lamivudine and zidovudine | HIV | 7 labelers | $0.771 per tablet Lamivudine-zidovudine tablet | No current entry |
| Zidovudine | HIV | 3 labelers | $0.464 per tablet 300 mg tablet | No current entry |
| Abacavir and lamivudine | HIV | 6 labelers | $1.48 per unit 600-300 mg | No current entry |
| Efavirenz and lamivudine and tenofovir disoproxil | HIV | 1 labeler | n/a | No current entry |
| Abacavir and dolutegravir and lamivudine | HIV | none listed | $130.01 per tablet 600-50-300 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does bictegravir and emtricitabine and tenofovir alafenamide compare with medicines for the same use?
1 side-by-side page set bictegravir and emtricitabine and tenofovir alafenamide beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to bictegravir and emtricitabine and tenofovir alafenamide
- 34 medicines for the same use
- Other hepatitis b virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other