Biktarvy is a complete HIV-1 treatment in a once-a-day single tablet that contains the three antiviral medicines bictegravir, emtricitabine, and tenofovir alafenamide.  Biktarvy works by preventing HIV from multiplying in your body, lowering HIV blood levels, and decreasing your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses, such as cancer or severe infections. 

Biktarvy is a complete treatment and should not be used with any other HIV medicines. Human immunodeficiency virus type 1 (HIV-1) is the virus that can cause acquired immune deficiency syndrome (AIDS).

There is no Biktarvy generic available.

Who can take Biktarvy?

Biktarvy is used to treat HIV-1 infection in adults and pediatric patients who weigh at least 14 kg who:

• have not taken HIV-1 medicine in the past OR
• to replace their current HIV-1 medicine if they are virologically suppressed (HIV-1 RNA less than 50 copies per mL), on a stable antiretroviral regimen with no history of treatment failure and with no known substitutions associated with resistance to bictegravir or tenofovir.
• have taken antiretroviral treatment in the past and are not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir.

Biktarvy’s FDA approval was first received on February 7, 2018, by Gilead Sciences, Inc. The latest expansion of FDA approval on July 30, 2025, makes Biktarvy a treatment option for patients with HIV who need to restart treatment and are not virologically suppressed.

Biktarvy is also recommended by the CDC as one of the preferred agents for PEP (post-exposure prophylaxis of HIV-1), despite it not being FDA-approved for this purpose. 

How does Biktarvy work?

Biktarvy contains three antiviral active ingredients that prevent HIV replication, which decreases viral load. 

Biktarvy’s mechanism of action is as an integrase strand transfer inhibitor (INSTI) for the active ingredient bictegravir, and as nucleoside reverse transcriptase inhibitors (NRTIs) for the active ingredients emtricitabine and tenofovir alafenamide. 

Biktarvy Side Effects

Common Biktarvy side effects

The most common Biktarvy side effects include: 

• Diarrhea (6%)
• Nausea (6%) 
• Headache (5%) 
• Tiredness (3%) 
• Abnormal dreams (3%) 
• dizziness (2%) 
• Sleep problems (2%) 
• Bloating abdomen (2%) 

These common side effects occurred in 2% or more of Biktarvy patients in clinical trial 1489. 

Biktarvy’s other side effects, of abdominal pain, gas (flatulence), indigestion (dyspepsia), and vomiting, occurred in less than 2% of patients in clinical trials 1489 and 1490.

Biktarvy side effects may also include laboratory abnormalities.

Serious Biktarvy side effects

If you are allergic to Biktarvy, get emergency medical help if you have signs of an allergic reaction, including rash, hives, shortness of breath, or swelling of your face, lips, tongue, or throat.

Biktarvy may cause other serious side effects. Call your doctor at once if you have:

• Kidney problems – little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
• Lactic acidosis – muscle pain or weakness, numbness or cold feeling, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, or feeling very weak or tired; or
• Liver problems – swelling around your midsection, upper stomach pain, unusual tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Biktarvy affects your immune system, which may cause certain side effects (even weeks or months after you’ve taken this medicine). Tell your doctor if you have:

• Signs of a new infection – fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• Trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
• Swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

This is not a complete list of side effects, and others may occur. Talk to your doctor, pharmacist, or healthcare provider for medical advice about side effects.

Warnings

Biktarvy has a boxed warning for worsening of hepatitis B virus (HBV) infection after stopping treatment with Biktarvy.  If you’ve ever had hepatitis B, it may become active or get worse after you stop using this medicine. You should have liver function tests with both clinical and laboratory follow-up before treatment and for several months after treatment to determine if you need to be prescribed medicine to treat hepatitis B. Always tell your prescriber about any new or unusual symptoms you may have after you stop taking this medicine.

Biktarvy is not recommended in patients with severe renal impairment, patients with end-stage renal disease who are not receiving chronic hemodialysis, or patients with no antiretroviral treatment history and end-stage renal disease (ESRD) who are receiving chronic hemodialysis

Do not run out of these tablets. Before your tablets are finished, you should refill your prescription or talk to your healthcare provider.

You should not stop taking these tablets without first talking to your doctor.

Before taking this medicine

You should not use this medicine if you are allergic to antiviral medicines bictegravir, emtricitabine, or tenofovir contained in medicines such as Atripla, Complera, Emtriva, Descovy, Genvoya, Odefsey, Stribild, or Truvada.

Some medicines can cause unwanted or dangerous effects when used with Biktarvy, and your doctor may need to change your treatment plan. Do not take Biktarvy if you also take a medicine that contains: 

• dofetilide; or
• rifampin.

Tell your doctor if you have or ever had:

• liver disease (especially cirrhosis) 
• hepatitis B virus (HBV)
• kidney disease

Before starting treatment with this medicine, you will be tested for hepatitis B virus infection.

Before starting treatment and during treatment, your serum creatinine, estimated creatinine clearance, urine glucose, and urine protein will be monitored as clinically appropriate. In patients with chronic kidney disease, serum phosphorus will also be assessed. 

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant during treatment with this medicine. There is a pregnancy registry for women who take this medicine during pregnancy. The purpose of this registry is to collect information about your and your baby’s health. Talk with your healthcare provider about how you can take part in this registry by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258- 4263.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or planning to breastfeed. This medicine passes to your baby in your breast milk. Talk to your healthcare provider about the following risks to your baby from breastfeeding during treatment with this medicine: 

• The HIV-1 virus may pass to your baby if your baby does not have HIV-1 infection. 
• The HIV-1 virus may become harder to treat if your baby has HIV-1 infection. 
• Your baby may get side effects from these tablets. 

Talk with your healthcare provider about the best way to feed your baby.

How should I take Biktarvy?

• Take one tablet once a day; it can be taken with or without food.
• Children who have difficulty swallowing a whole tablet can have the tablet split in half and then swallow each part separately, as long as all parts are swallowed within about 10 minutes.
• You should not change your dose or stop taking this medicine without first talking with your healthcare provider. Stay under a healthcare provider’s care during treatment with this medicine.
• If you take other medicines, such as antacids or supplements, see the drug interaction section for specific advice.
• For patients who are on dialysis, you should take your tablet following dialysis.
• Do NOT let your tablets run out. When your medicine supply starts to run low, get more from your healthcare provider or pharmacy before you run out. If the medicine is stopped for even a short time, the amount of virus in your blood may increase, and the virus may develop resistance to this medicine and become harder to treat.
• You will need frequent medical tests.
• Do not miss a dose of Biktarvy.

Take Biktarvy exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Biktarvy is a complete HIV-1 treatment regimen. You should not take it with other HIV-1 medicines.

Biktarvy Dosage Information

Usual Biktarvy dose in adults and pediatric patients weighing at least 25 kg, or virologically-suppressed adults with estimated creatinine clearance below 15 mL/min receiving chronic hemodialysis:

• Biktarvy (Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) one tablet once a day, with or without food.

Recommended Biktarvy dosage in pregnant individuals who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known substitutions associated with resistance to the individual components of Biktarvy: 

• Biktarvy (Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) one tablet once a day, with or without food.

Usual Biktarvy dose pediatric (weighing 14 kg to less than 25 kg):

• Biktarvy (Bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15mg) one tablet once a day, with or without food.

Renal impairment: Biktarvy is not recommended in patients with an estimated creatinine clearance of 15 to below 30 mL/min, or below 15 mL/min who are not receiving chronic hemodialysis, or below 15 mL/min who have no antiretroviral treatment history. 

Hepatic impairment: This medicine is not recommended in patients with severe hepatic impairment. 

Comments:

For children who are at least 14 kg to less than 25 kg and are unable to swallow a whole tablet, the tablet can be split, and each part can be taken separately as long as all parts are ingested within about 10 minutes.

Biktarvy tablets are available in two different strengths:

• 30 mg bictegravir, 120 mg emtricitabine, 15 mg tenofovir alafenamide
• 50 mg bictegravir, 200 mg emtricitabine, 25 mg tenofovir alafenamide

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

When your tablets 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 this medicine and become harder to treat.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What other drugs will affect Biktarvy?

Sometimes, it is not safe to use certain medications at the same time as taking Biktarvy. Drugs can affect the blood levels of other drugs you take, which may increase side effects or make the medications less effective.

You should not take Biktarvy with

• dofetilide; or
• Rifampin.

It is not recommended to take Biktarvy with:

• Rifabutin
• Rifapentine
• St. John’s wort

When taking Biktarvy, alternative anticonvulsants should be considered instead of:

• carbamazepine
• oxcarbazepine
• phenobarbital
• phenytoin.

Avoid taking these tablets with other medications that may also harm the kidneys. Serious side effects, such as acute renal failure, have been reported in postmarketing studies.

Antacids containing aluminium/magnesium:

• Biktarvy can be taken at least 2 hours before or 6 hours after taking antacids containing aluminium/magnesium.

Supplements or Antacids containing Calcium or Iron:

• Biktarvy and supplements or antacids containing calcium or iron can be taken together with food.

In pregnant individuals:

Antacids containing Al/Mg:

• Biktarvy can be taken at least 2 hours before or 6 hours after antacids containing aluminium/magnesium regardless of food intake.

Supplements or Antacids containing Calcium or Iron:

• Biktarvy and supplements or antacids containing calcium or iron can be taken together with food.
• When Biktarvy is taken on an empty stomach it should be taken at least 2 hours before or 6 hours after supplements or antacids containing calcium or iron.

General interaction information

Many drugs can interact with Biktarvy. This includes prescription, over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using. 

Biktarvy Package Insert 

HCPs and patients often use the Biktarvy Package Insert (PI) for more detailed information about this medicine. The Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called the Biktarvy Prescribing Information (PI) or FDA label.

Storage

• Store tablets in the original bottle below 86°F (30 °C).
• Keep the bottle tightly closed.
• This medicine contains a desiccant packet to help keep your medicine dry (protect it from moisture). Keep the desiccant packet in the bottle. Do not eat the desiccant packet.
• Store the tablets blister pack at room temperature between 68 °F to 77 °F (20 °C to 25 °C).
• Keep tablets in their original bottle or blister pack.
• Biktarvy comes in a child-resistant package.

Bactrim and Bactrim DS are antibiotics used to treat ear infections, urinary tract infections, bronchitis, traveler’s diarrhea, shigellosis, and Pneumocystis jiroveci pneumonia. Bactrim and Bactrim DS contain a combination of two antibiotics, sulfamethoxazole and trimethoprim, that treat different types of infection caused by bacteria. Bactrim DS (double strength) tablets are twice as strong as Bactrim tablets.

Sulfamethoxazole is a sulfonamide antibiotic that prevents the growth of susceptible bacteria by interfering with their ability to make folic acid. Trimethoprim is an antifolate antibiotic that works by inhibiting an enzyme, resulting in bacteria’s inability to make DNA and survive. Sulfamethoxazole and trimethoprim are combined because they are complementary and have a greater effect when used together.

To help reduce the development of drug-resistant bacteria and maintain sulfamethoxazole-trimethoprim effectiveness, this medicine should be used only to treat infections proven or strongly suspected to be caused by susceptible bacteria.

Bactrim side effects

Common Bactrim side effects

Common Bactrim DS and Bactrim side effects are nausea, vomiting, loss of appetite, and skin rash.

Serious Bactrim and Bactrim DS side effects

Get emergency medical help if you have signs of an allergic reaction to this medicine (hives, cough, chest pain, shortness of breath, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, joint pain, muscle aches, severe weakness, pale skin, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
• any skin rash, no matter how mild;
• yellowing of your skin or eyes;
• a seizure;
• new or unusual joint pain;
• increased or decreased urination;
• swelling, bruising, or irritation around the IV needle;
• increased thirst, dry mouth, fruity breath odor;
• new or worsening cough, fever, trouble breathing;
• high blood potassium – nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
• low blood sodium – headache, confusion, problems with thinking or memory, weakness, feeling unsteady; or
• low blood cell counts – fever, chills, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Also, see the Warnings section.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

You should not use this medicine if you have severe liver disease, kidney disease that is not being monitored, anemia caused by folic acid deficiency, if you take dofetilide, or if you have had low platelets caused by using trimethoprim or a sulfa drug.

You should not take this medicine if you are pregnant or breastfeeding.

Use this medicine only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

You should not use this medicine if you are allergic to sulfamethoxazole or trimethoprim, or if you have:

• severe liver disease;
• kidney disease that is not being treated or monitored;
• anemia (low red blood cells) caused by folic acid deficiency;
• a history of low blood platelets after taking trimethoprim or any sulfa drug; or
• if you take dofetilide.

Sulfamethoxazole and trimethoprim may cause birth defects. Do not use Bactrim if you are pregnant. Tell your doctor if you become pregnant.

Do not breastfeed.

This medicine should not be given to a child younger than 2 months old.

To make sure you can safely take this medicine, tell your doctor if you have ever had:

• kidney or liver disease;
• a folate (folic acid) deficiency;
• asthma or severe allergies;
• HIV or AIDS;
• a thyroid disorder;
• malnourishment;
• alcoholism;
• an electrolyte imbalance (such as low blood sodium or high potassium);
• porphyria, or glucose-6-phosphate dehydrogenase (G6PD) deficiency; or
• if you use a blood thinner (such as warfarin) and you have routine “INR” or prothrombin time tests.

How should I use Bactrim?

Take Bactrim exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Drink plenty of fluids to prevent kidney stones.

Antibiotic medicines can cause diarrhea. Tell your doctor if you have diarrhea that is watery or bloody.

Keep using this medicine even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication. This antibiotic will not treat a viral infection (flu or a common cold).

You may need blood and urine tests, and this medicine may be stopped based on the results.

Store tablets at room temperature away from moisture, heat, and light. Do not refrigerate.

Bactrim Dosing Information

Bactrim is contraindicated in pediatric patients less than 2 months of age.

Bactrim tablets are available as

• Bactrim DS (double strength) tablets: 800 mg sulfamethoxazole and 160 mg trimethoprim
• Bactrim tablets: 400 mg sulfamethoxazole and 80 mg trimethoprim

Usual Bactrim dose for Urinary Tract Infections

Adults dose for UTI

• Bactrim DS tablets (800mg/160mg): one tablet every 12 hours for 10 to 14 days
• Bactrim tablets (400mg/80mg): two tablets every 12 hours for 10 to 14 days

Children (2 months and older) dose for UTI

• Dose is based on weight: 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days.
• Use: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiellaspecies, Enterobacterspecies, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.

Usual Bactrim dose Acute Otitis Media Children (2 months and older)

• Dose is based on weight: 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days.
• Use: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when sulfamethoxazole and trimethoprim offer some advantage over the use of other antimicrobial agents, in the judgment of the physician.

Usual Adult Bactrim Dose for Bronchitis

• Bactrim DS tablets (800mg/160mg): one tablet every 12 hours 14 days
• Bactrim tablets (400mg/80mg): two tablets every 12 hours 14 days
• Use: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when the physician deems that this drug could offer some advantage over the use of a single antimicrobial agent.

Usual Adult Bactrim Dose for Traveler’s Diarrhea

• Bactrim DS tablets (800mg/160mg): one tablet every 12 hours 5 days
• Bactrim tablets (400mg/80mg): two tablets every 12 hours for 5 days
• Use: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E coli.

For Patients with Impaired Renal Function

• When renal function is impaired, a reduced dosage should be employed.
• This is not all the dosing information available. For more detailed dosing information, click on the link below.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include loss of appetite, vomiting, fever, blood in your urine, yellowing of your skin or eyes, confusion, or loss of consciousness.

What should I avoid while using Bactrim?

This medicine could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect Bactrim?

You may need more frequent check-ups or medical tests if you also use medicine to treat depression, diabetes, seizures, or HIV.

Tell your doctor about all your current medicines. Many drugs can interact with sulfamethoxazole and trimethoprim, especially:

• amantadine, digoxin, cyclosporine, indomethacin, leucovorin, methotrexate, procainamide, pyrimethamine;
• an “ACE inhibitor” heart or blood presure medication (benazepril, enalapril, lisinopril, quinapril, ramipril, and others); or
• a diuretic or “water pill”.