Biktarvy 50/200/25mg Tablets
WARNING: Hepatitis B has gotten worse when this drug was stopped in some people with hepatitis B. Close follow-up for a few months is needed when therapy is stopped in people who have hepatitis B. Do not stop taking this drug without calling your doctor. @ COMMON USES: It is used to treat HIV infection.
Drug Class
Antiretroviral, complete regimen
Pharmacologic Class
Integrase Strand Transfer Inhibitor (INSTI) / Nucleoside Reverse Transcriptase Inhibitor (NRTI) combination
Pregnancy Category
Not assigned (data from Antiretroviral Pregnancy Registry suggests no increased risk of birth defects)
FDA Approved
Feb 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Biktarvy is a complete, once-daily medication used to treat HIV-1 infection. It combines three different antiviral medicines into one pill: bictegravir, emtricitabine, and tenofovir alafenamide. These medicines work together to reduce the amount of HIV in your body (viral load) and increase the number of CD4 cells, which helps your immune system fight off infections.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food.
It's crucial that you don't miss or skip a dose during treatment. If you're on dialysis, take your medication after your dialysis session on the day you receive dialysis. If you have any questions or concerns, be sure to discuss them with your doctor.
If needed, you can split the tablet into two parts and take them separately. However, make sure to swallow all parts of the tablet within 10 minutes.
Some products, such as antacids or vitamins, contain iron, aluminum, calcium, magnesium, or zinc. If you take these products, you may need to take them at a different time than your medication. Consult with your doctor or pharmacist to determine the best schedule.
Storing and Disposing of Your Medication
To maintain the quality and effectiveness of your medication, store it in its original container at room temperature in a dry place. Avoid storing it in a bathroom. If your medication comes in a bottle, keep the lid tightly closed. The bottle contains a desiccant packet and a polyester coil to keep the medication dry. Do not eat these, and be sure to keep the desiccant packet in the bottle.
Keep all medications in a safe place, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you're unsure about what to do if you miss a dose, contact your doctor for guidance.
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food.
It's crucial that you don't miss or skip a dose during treatment. If you're on dialysis, take your medication after your dialysis session on the day you receive dialysis. If you have any questions or concerns, be sure to discuss them with your doctor.
If needed, you can split the tablet into two parts and take them separately. However, make sure to swallow all parts of the tablet within 10 minutes.
Some products, such as antacids or vitamins, contain iron, aluminum, calcium, magnesium, or zinc. If you take these products, you may need to take them at a different time than your medication. Consult with your doctor or pharmacist to determine the best schedule.
Storing and Disposing of Your Medication
To maintain the quality and effectiveness of your medication, store it in its original container at room temperature in a dry place. Avoid storing it in a bathroom. If your medication comes in a bottle, keep the lid tightly closed. The bottle contains a desiccant packet and a polyester coil to keep the medication dry. Do not eat these, and be sure to keep the desiccant packet in the bottle.
Keep all medications in a safe place, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you're unsure about what to do if you miss a dose, contact your doctor for guidance.
Lifestyle & Tips
- Take Biktarvy exactly as prescribed, once daily, with or without food. Do not miss any doses.
- Biktarvy is not a cure for HIV. You must continue to take it every day to control your infection.
- Continue to practice safe sex to prevent HIV transmission to others.
- Inform your healthcare provider about all other medications, supplements, and herbal products you are taking, especially St. John's Wort, rifampin, or antacids/iron supplements.
- If you also have Hepatitis B (HBV), do not stop taking Biktarvy without talking to your doctor, as stopping it can cause your HBV to worsen suddenly.
- Attend all scheduled doctor appointments and laboratory tests to monitor your health and the effectiveness of the medication.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet (bictegravir 50 mg / emtricitabine 200 mg / tenofovir alafenamide 25 mg) orally once daily with or without food.
Dose Range:
50 - 25 mg
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
One tablet (bictegravir 50 mg / emtricitabine 200 mg / tenofovir alafenamide 25 mg) orally once daily for pediatric patients weighing at least 25 kg.
Adolescent:
One tablet (bictegravir 50 mg / emtricitabine 200 mg / tenofovir alafenamide 25 mg) orally once daily for pediatric patients weighing at least 25 kg.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment required for eGFR âĨ 30 mL/min.
Moderate:
No dose adjustment required for eGFR âĨ 30 mL/min.
Severe:
Not recommended for initiation in patients with eGFR < 30 mL/min (excluding patients on chronic hemodialysis).
Dialysis:
Not recommended for initiation in patients with eGFR < 15 mL/min who are not on chronic hemodialysis. For patients on chronic hemodialysis, Biktarvy can be initiated if eGFR is < 15 mL/min, but on dialysis days, administer after completion of dialysis treatment. Not recommended for patients with end-stage renal disease (eGFR < 15 mL/min) who are not on chronic hemodialysis.
Hepatic Impairment:
Mild:
No dose adjustment required (Child-Pugh A).
Moderate:
No dose adjustment required (Child-Pugh B).
Severe:
Not studied in patients with severe hepatic impairment (Child-Pugh C); therefore, not recommended.
Pharmacology
Mechanism of Action
Bictegravir is an integrase strand transfer inhibitor (INSTI) that inhibits HIV-1 integrase, an enzyme essential for viral replication, by blocking the strand transfer step of retroviral DNA integration. Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) that is phosphorylated to its active triphosphate form, which inhibits HIV-1 reverse transcriptase by competing with the natural substrate deoxycytidine-5'-triphosphate and by incorporation into viral DNA, leading to chain termination. Tenofovir alafenamide (TAF) is a prodrug of tenofovir, a nucleoside reverse transcriptase inhibitor (NRTI). TAF is converted intracellularly to tenofovir diphosphate, which inhibits HIV-1 reverse transcriptase by competing with the natural substrate deoxyadenosine-5'-triphosphate and by incorporation into viral DNA, leading to chain termination.
Pharmacokinetics
Absorption:
Bioavailability:
Bictegravir: ~60-80%; Emtricitabine: ~93%; Tenofovir Alafenamide: ~80%
Tmax:
Bictegravir: 2-4 hours; Emtricitabine: 1-3 hours; Tenofovir Alafenamide: 0.5-2 hours
FoodEffect:
Bictegravir: High-fat meal increases AUC by 24% and Cmax by 21%; light meal increases AUC by 26% and Cmax by 28%. Can be taken with or without food. Tenofovir Alafenamide: Food increases AUC by 35-40% (recommended to take with food in early studies, but now approved with or without food).
Distribution:
Vd:
Bictegravir: ~29 L; Emtricitabine: ~140 L; Tenofovir Alafenamide: ~24.4 L
ProteinBinding:
Bictegravir: >99%; Emtricitabine: <4%; Tenofovir Alafenamide: ~80%
CnssPenetration:
Limited for all components, but sufficient for therapeutic effect in CNS.
Elimination:
HalfLife:
Bictegravir: ~17.3 hours; Emtricitabine: ~10 hours; Tenofovir Alafenamide: ~0.51 hours (plasma), Tenofovir diphosphate (intracellular): ~150-180 hours
Clearance:
Bictegravir: ~37.4 L/hr; Emtricitabine: ~7 L/hr (renal); Tenofovir Alafenamide: Not directly reported for TAF, but tenofovir is renally cleared.
ExcretionRoute:
Bictegravir: Feces (60%), Urine (35%). Emtricitabine: Urine (70%), Feces (14%). Tenofovir Alafenamide: Urine (<1% as TAF, ~32% as tenofovir).
Unchanged:
Bictegravir: ~60% (feces), ~1% (urine); Emtricitabine: ~70% (urine); Tenofovir Alafenamide: <1% (urine)
Pharmacodynamics
OnsetOfAction:
Rapid (viral load reduction observed within days to weeks)
PeakEffect:
Sustained viral suppression typically achieved within 8-24 weeks
DurationOfAction:
24 hours (once daily dosing maintains therapeutic levels)
Safety & Warnings
BLACK BOX WARNING
Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF). Discontinuation of Biktarvy may result in severe acute exacerbations of hepatitis B in patients co-infected with HIV-1 and HBV. Monitor hepatic function closely in HIV-1/HBV co-infected patients who discontinue Biktarvy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of lactic acidosis (too much lactic acid in the blood), including:
+ Rapid breathing
+ Rapid heartbeat
+ Abnormal heartbeat
+ Severe upset stomach or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Extreme fatigue or weakness
+ Severe dizziness
+ Feeling cold
+ Muscle pain or cramps
New or worsening behavioral or mood changes, such as depression or suicidal thoughts
Changes in Your Immune System
When starting HIV treatment, your immune system may respond in unexpected ways. If you have an underlying infection, it may become apparent after taking this medication. Inform your doctor immediately if you experience any new symptoms, even if they occur several months after starting treatment. These symptoms may include:
Signs of infection, such as:
+ Fever
+ Sore throat
+ Weakness
+ Cough
+ Shortness of breath
Other Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Diarrhea
Upset stomach
* Headache
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of lactic acidosis (too much lactic acid in the blood), including:
+ Rapid breathing
+ Rapid heartbeat
+ Abnormal heartbeat
+ Severe upset stomach or vomiting
+ Excessive sleepiness
+ Shortness of breath
+ Extreme fatigue or weakness
+ Severe dizziness
+ Feeling cold
+ Muscle pain or cramps
New or worsening behavioral or mood changes, such as depression or suicidal thoughts
Changes in Your Immune System
When starting HIV treatment, your immune system may respond in unexpected ways. If you have an underlying infection, it may become apparent after taking this medication. Inform your doctor immediately if you experience any new symptoms, even if they occur several months after starting treatment. These symptoms may include:
Signs of infection, such as:
+ Fever
+ Sore throat
+ Weakness
+ Cough
+ Shortness of breath
Other Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Diarrhea
Upset stomach
* Headache
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of worsening Hepatitis B (if co-infected): severe tiredness, yellow skin or eyes, dark urine, light-colored stools, loss of appetite, nausea, stomach pain.
- Signs of kidney problems: decreased urination, swelling in your legs or feet, unusual tiredness.
- Signs of liver problems: yellowing of your skin or the whites of your eyes, dark urine, light-colored stools, nausea, vomiting, loss of appetite, pain in your upper right stomach area.
- Signs of lactic acidosis (a serious but rare side effect): feeling very weak or tired, unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, feeling cold, dizziness, fast or irregular heartbeat.
- Signs of immune reconstitution inflammatory syndrome (IRIS): new or worsening symptoms of an infection you had in the past (e.g., tuberculosis, herpes zoster, fungal infections).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Existing health conditions, such as kidney disease or liver disease.
Current medications, including:
+ Carbamazepine, dofetilide, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John's wort.
+ Other HIV treatments.
+ Medications that may increase the risk of kidney problems (your doctor or pharmacist can help you identify these).
Pregnancy, planned pregnancy, or breastfeeding. Discuss the benefits and risks of this medication with your doctor, as well as the best ways to prevent transmitting HIV to your baby.
Please note that this is not an exhaustive list of potential interactions. This medication can interact with numerous other drugs, which may increase the risk of severe, life-threatening, or fatal side effects.
To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems and medications with your doctor to confirm that it is safe to take this medication.
* Avoid starting, stopping, or changing the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Existing health conditions, such as kidney disease or liver disease.
Current medications, including:
+ Carbamazepine, dofetilide, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John's wort.
+ Other HIV treatments.
+ Medications that may increase the risk of kidney problems (your doctor or pharmacist can help you identify these).
Pregnancy, planned pregnancy, or breastfeeding. Discuss the benefits and risks of this medication with your doctor, as well as the best ways to prevent transmitting HIV to your baby.
Please note that this is not an exhaustive list of potential interactions. This medication can interact with numerous other drugs, which may increase the risk of severe, life-threatening, or fatal side effects.
To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems and medications with your doctor to confirm that it is safe to take this medication.
* Avoid starting, stopping, or changing the dose of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Your doctor will instruct you on when to undergo Hepatitis B testing, so be sure to follow their guidance and discuss any questions or concerns with them.
Regular blood work and laboratory tests are crucial while taking this drug. Adhere to the schedule recommended by your doctor to ensure your health is closely monitored.
It is crucial to understand that this medication is not a cure for HIV. Continue taking it exactly as prescribed by your doctor or healthcare provider, even if you feel well. Regular appointments with your doctor are necessary to maintain optimal care.
This drug helps reduce the amount of HIV in your blood. By lowering the viral load to undetectable levels, you can significantly reduce the risk of transmitting HIV to others. However, it is also important to practice other preventive measures, such as using condoms during sexual activity and avoiding the sharing of needles and other injection equipment. Consult with your doctor or healthcare provider to discuss the most effective ways to prevent the spread of HIV.
Be aware that kidney problems, including kidney failure, have been associated with this medication. If you have a history of kidney issues, inform your doctor promptly.
Although rare, this drug can cause severe side effects, including liver swelling and a buildup of acid in the blood, which can be life-threatening. The risk of these adverse effects may be higher in women, individuals who are overweight, and those who have taken similar medications for an extended period.
Your doctor will instruct you on when to undergo Hepatitis B testing, so be sure to follow their guidance and discuss any questions or concerns with them.
Regular blood work and laboratory tests are crucial while taking this drug. Adhere to the schedule recommended by your doctor to ensure your health is closely monitored.
It is crucial to understand that this medication is not a cure for HIV. Continue taking it exactly as prescribed by your doctor or healthcare provider, even if you feel well. Regular appointments with your doctor are necessary to maintain optimal care.
This drug helps reduce the amount of HIV in your blood. By lowering the viral load to undetectable levels, you can significantly reduce the risk of transmitting HIV to others. However, it is also important to practice other preventive measures, such as using condoms during sexual activity and avoiding the sharing of needles and other injection equipment. Consult with your doctor or healthcare provider to discuss the most effective ways to prevent the spread of HIV.
Be aware that kidney problems, including kidney failure, have been associated with this medication. If you have a history of kidney issues, inform your doctor promptly.
Although rare, this drug can cause severe side effects, including liver swelling and a buildup of acid in the blood, which can be life-threatening. The risk of these adverse effects may be higher in women, individuals who are overweight, and those who have taken similar medications for an extended period.
Overdose Information
Overdose Symptoms:
- Limited experience with overdose. Symptoms may include exaggeration of known adverse effects such as gastrointestinal disturbances, headache, or rash.
What to Do:
There is no specific antidote for Biktarvy overdose. Treatment should consist of general supportive measures, including monitoring of vital signs and observation of the patient's clinical status. Hemodialysis can remove emtricitabine and tenofovir, but bictegravir is highly protein-bound and unlikely to be removed by dialysis. Contact a poison control center (e.g., 1-800-222-1222) for specific guidance.
Drug Interactions
Contraindicated Interactions
- Dofetilide (due to increased dofetilide concentrations)
- Rifampin (strong CYP3A/UGT1A1 inducer, significantly decreases bictegravir concentrations)
Major Interactions
- Carbamazepine, Oxcarbazepine, Phenobarbital, Phenytoin (strong CYP3A/UGT1A1 inducers, may decrease bictegravir concentrations)
- St. John's Wort (strong CYP3A/UGT1A1 inducer, may decrease bictegravir concentrations)
- Rifabutin, Rifapentine (moderate CYP3A/UGT1A1 inducers, may decrease bictegravir concentrations - coadministration not recommended)
- Cation-containing antacids or oral iron supplements (separate administration by at least 2 hours before or 6 hours after Biktarvy, or take Biktarvy with food and at the same time as antacids/iron supplements)
- Metformin (TAF may increase metformin concentrations; monitor for metformin-related adverse reactions)
- Dabigatran (TAF is a P-gp substrate, dabigatran is a P-gp substrate; coadministration may increase dabigatran concentrations)
- Other antiretrovirals (e.g., adefovir dipivoxil, other tenofovir-containing products, lamivudine, other emtricitabine-containing products - avoid coadministration)
Moderate Interactions
- Oral polyvalent cations (e.g., calcium, magnesium, aluminum, iron supplements) - see major interaction for specific guidance.
- Certain proton pump inhibitors (PPIs) or H2-receptor antagonists (H2RAs) - generally no clinically significant interaction, but some older INSTIs had issues. Biktarvy can be taken with or without acid-reducing agents.
- Statins (e.g., atorvastatin, rosuvastatin) - generally no significant interaction, but monitor for potential changes in statin levels if co-administered with TAF.
Minor Interactions
- Most other commonly used medications, generally low interaction potential due to bictegravir's metabolism and TAF's prodrug nature.
Monitoring
Baseline Monitoring
HIV-1 RNA (viral load)
Rationale: To establish baseline viral burden and confirm HIV-1 infection.
Timing: Prior to initiation
CD4+ T-cell count
Rationale: To assess immune status and guide treatment decisions.
Timing: Prior to initiation
Hepatitis B virus (HBV) infection status (HBsAg, anti-HBc, anti-HBs)
Rationale: To identify co-infection, as Biktarvy contains components active against HBV, and discontinuation can lead to HBV exacerbation.
Timing: Prior to initiation
Renal function (eGFR, serum creatinine, urinalysis)
Rationale: To assess baseline kidney function, as components are renally eliminated and TAF can cause renal adverse effects.
Timing: Prior to initiation
Liver function tests (ALT, AST, total bilirubin)
Rationale: To assess baseline liver health.
Timing: Prior to initiation
Resistance testing (genotype)
Rationale: To identify pre-existing drug resistance mutations that may impact treatment efficacy.
Timing: Prior to initiation
Routine Monitoring
HIV-1 RNA (viral load)
Frequency: Every 4-8 weeks after initiation until undetectable, then every 3-6 months
Target: < 20-50 copies/mL (undetectable)
Action Threshold: Persistent detectable viral load or viral rebound; consider resistance testing and regimen change.
CD4+ T-cell count
Frequency: Every 3-6 months (or less frequently if stable and suppressed)
Target: Increasing towards normal range
Action Threshold: Significant decline or failure to increase; investigate opportunistic infections or treatment failure.
Renal function (eGFR, serum creatinine)
Frequency: Every 3-6 months (more frequently if risk factors for renal disease)
Target: Stable, within normal limits
Action Threshold: Significant decline in eGFR or increase in creatinine; investigate drug-related toxicity or other causes.
Liver function tests (ALT, AST, total bilirubin)
Frequency: Every 6-12 months (or more frequently if risk factors for liver disease)
Target: Within normal limits
Action Threshold: Significant elevation; investigate drug-related toxicity or other causes.
Lipid profile (total cholesterol, HDL, LDL, triglycerides)
Frequency: Annually (or more frequently if dyslipidemia present)
Target: Within target ranges for cardiovascular health
Action Threshold: Significant dyslipidemia; consider lifestyle modifications or lipid-lowering therapy.
Glucose (fasting or HbA1c)
Frequency: Annually (or more frequently if risk factors for diabetes)
Target: Within normal limits
Action Threshold: Elevated glucose; consider lifestyle modifications or antidiabetic therapy.
Symptom Monitoring
- Nausea
- Diarrhea
- Headache
- Fatigue
- Rash
- Signs of lactic acidosis (e.g., unexplained muscle pain, weakness, difficulty breathing, abdominal pain, nausea, vomiting)
- Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, light-colored stools, severe stomach pain, loss of appetite)
- Signs of kidney problems (e.g., decreased urination, swelling in legs/feet, unusual tiredness)
- Signs of immune reconstitution inflammatory syndrome (IRIS) (e.g., worsening of previous infections or new infections)
Special Patient Groups
Pregnancy
Biktarvy is a preferred regimen for HIV-1 treatment in pregnancy according to DHHS guidelines. Data from the Antiretroviral Pregnancy Registry (APR) and clinical trials indicate no increased risk of major birth defects with bictegravir, emtricitabine, or tenofovir alafenamide exposure during pregnancy. However, use should be based on individual risk-benefit assessment.
Trimester-Specific Risks:
First Trimester:
No increased risk of major birth defects observed based on available data.
Second Trimester:
Generally well-tolerated; continued use recommended for viral suppression.
Third Trimester:
Generally well-tolerated; continued use recommended for viral suppression and prevention of perinatal transmission.
Lactation
Breastfeeding is not recommended for mothers with HIV-1 infection in the U.S. to avoid postnatal transmission of HIV-1 to the infant. While components of Biktarvy are excreted in human milk, the primary concern is HIV transmission.
Infant Risk:
High (due to risk of HIV transmission from mother to infant, not primarily due to drug exposure)
Pediatric Use
Approved for pediatric patients weighing at least 25 kg. Dosing is one tablet once daily. Safety and efficacy have been established in this population. For patients weighing less than 25 kg, alternative formulations or regimens are needed.
Geriatric Use
No specific dose adjustment is required for elderly patients. However, older patients are more likely to have decreased renal function, and monitoring of renal function is important. Monitor for age-related comorbidities and polypharmacy that may increase the risk of adverse effects or drug interactions.
Clinical Information
Clinical Pearls
- Biktarvy is a complete, once-daily, single-tablet regimen for HIV-1, simplifying treatment and improving adherence.
- It can be taken with or without food, offering flexibility.
- Generally well-tolerated with a favorable drug interaction profile compared to some older regimens, but significant interactions with strong CYP3A/UGT1A1 inducers (e.g., rifampin, St. John's Wort) and polyvalent cations exist.
- Patients co-infected with HBV must be carefully monitored for HBV exacerbation if Biktarvy is discontinued.
- Renal function monitoring is crucial, especially in patients with pre-existing renal impairment or risk factors for kidney disease. Not recommended for initiation in severe renal impairment (eGFR < 30 mL/min, excluding chronic hemodialysis).
Alternative Therapies
- Other INSTI-based regimens (e.g., INSTI + 2 NRTIs)
- NNRTI-based regimens (e.g., NNRTI + 2 NRTIs)
- Protease Inhibitor (PI)-based regimens (e.g., PI + 2 NRTIs)
- Long-acting injectable regimens (e.g., cabotegravir/rilpivirine)
Cost & Coverage
Average Cost:
$3,000 - $4,000+ per 30 tablets
Insurance Coverage:
Tier 3 or 4 (Specialty Drug)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.