Bictegravir, Emtricitabine, and Tenofovir Alafenamide

Biktarvy

Biktarvy tablets are used in the treatment of HIV-1. It provides patients with an effective and convenient therapy to manage their condition. The medication works by reducing the HIV virus and improving the quality of life for people living with this virus. People can take the medication orally as directed by their doctors. It can be taken with or without food. The dosage can vary from children to adults based on the patient’s medical condition and treatment response. The medication can have several side effects and drug interactions if not consumed properly. Therefore, it is advised to take medical guidance while taking it.

Product Overview

Biktarvy is a combination antiretroviral medication used for treating HIV-1 infection in adults. It contains three main active ingredients: emtricitabine, bictegravir, and tenofovir alafenamide. Bictegravir is an integrase strand-transfer inhibitor (INSTI) that prevents viral DNA from merging into the genetic material of human cells. This process effectively stops the virus from replicating. Emtricitabine and tenofovir alafenamide are reverse transcriptase inhibitors that block the activity of reverse transcriptase (an enzyme), which the virus uses to copy itself.

This medication has two strengths: 50/200/25 mg and 30/120/15 mg. It is administered orally as a single tablet taken once daily, with or without food. Biktarvy is suitable for both adults and children. The medication helps in reducing the amount of HIV virus in the body, making the immune system work better. This process lowers the chances of HIV complications like infections or cancer and improves body health. 

Its common side effects are nausea, diarrhea, and headache. Patients should be advised to monitor for these symptoms and report to their healthcare provider immediately. Important precautions include avoiding combination with other drugs that may interact negatively and regular monitoring of kidney and liver function. In cases of missed doses, patients should take the medication as soon as they remember. Overdosing should be avoided, and in the event it occurs, seek immediate medical attention. Biktarvy should be stored at room temperature, away from excessive heat and moisture. Patients are advised to stick to their healthcare provider’s guidance closely for the best outcomes in their treatment regimen.

Uses of Biktarvy

These tablets are prescribed for:

• Preventing HIV (Human Immunodeficiency Virus) infection in adults and adolescents. 
• Reducing the amount of HIV in the body.
• Helping control the infection.
• Improving the immune system’s function.

How to Use Biktarvy?

Dosage

It only comes in the form of tablets with two strengths:

• 50/200/25 mg of bictegravir, emtricitabine and tenofovir alafenamide respectively.
• 30/120/15 mg of bictegravir, emtricitabine and tenofovir alafenamide respectively.

Recommended Dosage for Different Patients

For Adults and Pediatric Patients (25 Kg or More)

• Adults and pediatric patients using 50/200/25 mg tablets who have a 30 mL/min creatinine clearance or higher.
• Virologically-suppressed adults with creatinine clearance under 15 mL/min undergoing chronic hemodialysis.

For Pediatric Patients (14 Kg and Less Than 25 Kg)

• Patients using 50/200/25 mg tablets with creatinine clearance of 30 mL per min or higher. 

For Renal Impairment Patients

• Not recommended to patients with estimated creatinine clearance of 15 to under 30 mL/min.
• Not recommended to patients with end-stage renal disease (ESRD) with a creatinine clearance below 15 mL/min unless undergoing chronic hemodialysis.

For Hepatic Impairment Patients

• Not recommended

[Note: Remember these recommendations may vary depending on person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

How to Take It?

It is advised to take Biktarvy 50mg/200mg/25mg as prescribed by a medical expert. Adhere to your prescription label and read all the instructions. For proper usage:

• Take your medication once a day, either with food or without food. 
• If you face difficulty swallowing the tablet as a whole, split it in half and consume each part within 10 minutes.
• Talk to your doctor if you want to stop or change your medication dosage.
• Stay under the guidance of a medical professional during this treatment.
• If you are taking any iron or calcium supplements, take your medicine with food at the same time you take your supplements.
• If you are taking supplements that contain aluminum or magnesium, take your medication at least 2 hours prior or 6 hours post your supplements.  
• Dialysis patients can take their daily dose after their dialysis treatment.
• Do not go low on your medicine supply as it can increase the virus amount in your body. 
• Do not miss a dose.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Biktarvy Work?

Bictegravir (BIC), one of the components of Biktarvy, serves as an INSTI. This component targets the HIV integrase enzyme, which is essential for the viral replication process. By suppressing this enzyme, bictegravir prevents the combination of viral DNA into the DNA of the patient’s cell, effectively interfering with the virus replication. This disruption is crucial because it prevents the virus from multiplying into new cells, thereby helping to control the infection and reduce the viral amount in the patient’s body.

Additionally, Biktarvy contains two other active substances, emtricitabine (FTC) and tenofovir alafenamide (TAF), which are both NRTIs. These components mimic the natural building blocks of DNA. When the virus attempts to replicate its genetic material, it mistakenly includes these compounds in its DNA chain. This incorporation leads to premature termination of the DNA chain, thus further breaking down the replication of the virus. Together, these three drugs provide a powerful combination therapy that not only prevents the progression of HIV but also helps maintain the immune system.

Important Safety Information

Side Effects

Common side effects of Biktarvy may include:

• Diarrhea
• Skin rash
• Dizziness
• Fatigue
• Nausea
• Headache
• Sleeping troubles

Serious side effects of Biktarvy may include:

• Kidney problems, along with kidney failures
• Liver problems
• Increased level of lactic acid 
• Immune reconstitution syndrome
• Depression

[Note: This list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

Warnings

• Adverse Reactions to Drug Interactions: Combining Biktarvy with several other drugs can result in significant drug interactions. These effects can reduce the effectiveness of HIV medication, leading to drug resistance. In addition, the patient might experience serious side effects due to the increased level of the concurrent medications. Therefore, always assess the risk of drug interactions before and during your HIV treatment.
• Immune Reconstitution Inflammatory Syndrome: There have been reports of IRIS in patients taking combination antiretroviral therapy. During the starting stage of this treatment, people with responsive immune systems may develop an inflammatory reaction to opportunistic infections (Mycobacterium avium infections, cytomegalovirus, Pneumocystis jirovecii pneumonia, or tuberculosis). This may require additional diagnostic and therapeutic treatments. 
• Risk of Renal Impairment: Post-marketing reports have indicated renal impairment cases, including acute renal failure and proximal renal tubulopathy, associated with products containing tenofovir alafenamide (TAF). Although these reports often involve other contributing factors, these conditions could also expose patients to adverse effects related to tenofovir. Biktarvy is not advised for patients with severe renal impairment, those not on chronic hemodialysis, or those without a history of antiretroviral treatment and on chronic hemodialysis. Discontinue Biktarvy if significant renal dysfunction or Fanconi syndrome develops.
• Lactic Acidosis and Severe Hepatomegaly with Steatosis: Instances of lactic acidosis and serious hepatomegaly with steatosis, consisting of fatal events, have been observed with the use of nucleoside analogs, including emtricitabine and tenofovir DF, components of Biktarvy, both alone and in combination. Discontinue this medication if a patient develops clinical or laboratory signs indicative of lactic acidosis or severe hepatotoxicity, which may include enlarged liver and fat accumulation even without significant liver enzyme elevation.

Boxed Warnings 

• Severe acute worsening symptoms of hepatitis B have been noticed in patients coinfected with HIV-1 and HBV who stopped the medications containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF).
• Frequently check hepatic function through both physical assessments and laboratory tests for several months for patients coinfected with HIV-1 and HBV and those who discontinued Biktarvy.
• If required, initiate therapy for anti-hepatitis B, especially for people suffering from advanced liver disease. 

Precautions

• If you have allergic reactions to Biktarvy 50mg/200mg/25mg tablets or if you have other allergies, tell your medical professional or pharmacist. This medication contains certain inactive ingredients that can lead to allergies. 
• Before taking this medication, consult with a healthcare provider about your medical history if you are a patient who has liver problems (hepatitis B, hepatitis C, cirrhosis), kidney or alcohol issues.
• If you are undergoing any medical surgery or procedure, tell your dentist or doctor about every drug you are taking (prescription, non-prescription, or herbal products).
• If you are pregnant, take the prescribed medication only when needed, as the treatment lowers the risk of transmitting the virus to the infants. 
• Remember to discuss every risk and benefit with your medical professional.
• For lactating women, take medical guidance as the drugs can pass into the breast milk, which may transmit HIV infection to the baby. So, seek medical assistance before breastfeeding.

Contraindications

• Dofetilide: Avoid co-administration with Biktarvy. Dofetilide levels may increase when taken with this medication, potentially causing serious or life-threatening events.
• Rifampin: It can reduce bictegravir levels, leading to decreased effectiveness of BIKTARVY and possible resistance development.
• St. John’s Wort: It reduces the effectiveness of bictegravir, leading to the increased risk of therapeutic failure and resistance development.

Missed Dose

• If you forget to take a dose of Biktarvy, take the skipped dose whenever you remember it. 
• At the time of your next dose, follow your dosage schedule as usual.
• Do not take more than one dose simultaneously to cover the missed dose.

[Note: If you have missed a medication dose and are unsure when to take the next one, immediately consult your doctor or pharmacist.]

Overdose

There has been no data on an overdose of Biktarvy in patients. In case someone took their medication in exceeding amounts, monitor them for any signs of toxicity. Additionally, hemodialysis treatments also remove the FTC dose within 3 hours of dialysis duration.  

[Note: If you consumed more than the recommended dose, get medical help right away or call the Poison Help line at 1-800-222-1222.]

Storage

• Ensure that the tablet bottles are tightly closed with a child-resistant closure. 
• Do not try to remove the desiccant packet. 
• Always store the bottle below 30 °C (86 °F).
• If it is a blister pack, check if the pack is sealed with a child-resistant laminated foil.
• Keep the pack at 25 °C (77 °F). 
• Temperature can go a bit higher or lower, but it should stay between 15°C and 30°C.
• Store the medicine in its original packing, not in any other containers.
• Check the packaging or take medical guidance for detailed information.
• Discard the medication when it is past its usage period.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

Biktarvy Interactions

• Antiretroviral Medications: Using Biktarvy with the same class of medications is not advised as it is a full treatment regimen. Detailed data on drug-drug interactions with other antiretroviral drugs are not extensively available as the safety and efficacy of such combined treatments remain uncertain.
• Effects on Other Drugs: BIC, one of the active components of Biktarvy, slows down the organic cation transporter 2 (OCT2) and the multidrug and toxin extrusion transporter 1 (MATE1) in laboratory settings. When these drugs are taken with Biktarvy, it results in increased plasma concentrations.
• Effects of Other Drugs on Biktarvy Components: BIC is metabolized by both CYP3A and UGT1A1 enzymes. Drugs that strongly induce these enzymes can significantly reduce BIC’s plasma levels, potentially decreasing the medications’ effectiveness and developing resistance. 
• Drugs Affecting Renal Function: Since FTC and tenofovir are excreted through the kidneys via glomerular filtration and active tubular secretion, combining HIV medication with drugs that lower renal function may increase the concentrations of FTC, tenofovir, and other drugs cleared by the kidneys heightening the risk of adverse effects.

[Note: This isn’t a complete list, and there could be other drugs that interact with Biktarvy. Tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re taking.]

Biktarvy Alternatives

• Triumeq
• Dovato
• Genvoya
• Stribild
• Cabenuva
• Aptivus 
• Edurant 
• Emtriva 
• Epivir 
• Fuzeon 
• Intelence 
• Isentress 
• Pifeltro 
• Cimduo
• Complera
• Delstrigo 
• Descovy 
• Evotaz 
• Kaletra

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.] 

Frequently Asked Questions

Can Biktarvy cause sleep disturbances?

While not a serious complication, the medication can cause sleep disturbances like insomnia or changes in sleep patterns after starting treatment with Biktarvy. If the situation worsens, patients are advised to communicate with their healthcare providers, as good sleep is crucial for overall health. 

Is Biktarvy effective for all patients?

The medication is highly effective for many patients suffering from HIV-1. However, its effectiveness depends on various factors. These include the presence of pre-existing drug resistance, other health conditions, and adherence to the medication regimen. However, there are patients with certain genetic mutations who are not advised of this medication due to their resistance to the drug components. Patients need to work closely with their doctors to monitor their treatment response and make any necessary adjustments.

Can I use Biktarvy for PrEP?

No, you can not use Biktarvy as PrEP (pre-exposure prophylaxis). PrEP usually involves a combination of two anti-HIV components, namely tenofovir disoproxil fumarate, and emtricitabine, used for the prevention of HIV. On the other hand, Biktarvy is a combination of three ingredients, bictegravir, emtricitabine, and tenofovir alafenamide, that is strictly for HIV treatment.

For how long can one miss out on their Biktarvy dose?

If you have missed a dose for less than 18 hours from your usual dosing time, take the skipped dose as soon as possible. However, do not take the missed dose if the duration has been more than 18 hours. Instead, wait until your next scheduled dose. It’s important to follow this guidance to maintain the effectiveness of your treatment regimen. If you have any concerns about missed doses, it’s best to ask your healthcare provider for personalized advice.

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