Biktarvy

Biktarvy (bictegravir-emtricitabine-tenofovir)

What is Biktarvy?

Containing bictegravir, emtricitabine, and tenofovir alafenamide, Biktarvy is a medicine available by prescription to treat Human Immunodeficiency Virus-1 (HIV-1). HIV-1 is the virus that leads to Acquired Immune Deficiency Syndrome (AIDS).

Biktarvy is prescribed for adults and children and is not used with any other anti-HIV-1 medicines. It is an antiviral that stops HIV from spreading in the body. Biktarvy is not a cure for HIV or AIDS. Also, Biktarvy does not prevent the patient using it from passing HIV on to another person. Biktarvy may be supplied in different forms and under different brand names.

Specifically, it is for adults and children who:

• weigh at least 55 pounds (25 kg)
• have not previously been treated with anti-HIV-1 medicines, or
• need alternatives to their current anti-HIV-1 medicines to meet healthcare provider requirements.

How does Biktarvy work?

Biktarvy is made up of bictegravir, emtricitabine, and tenofovir alafenamide. Bictegravir is an INSTI (integrase strand transfer inhibitor). HIV needs integrase to reproduce. Integrase is an enzyme that is blocked by INSTIs, so Bictegravir stops HIV from reproducing.

Emtricitabine and tenofovir are antiretrovirals that belong to a group called nucleoside analog reverse transcriptase inhibitors (NRTIs). Another enzyme that HIV needs to spread and infect cells is reverse transcriptase. Emtricitabine and tenofovir stop reverse transcriptase from working as it normally does.

By reducing the effectiveness of the enzymes HIV needs to spread, antiretroviral medicines decrease the level of HIV in the blood. They may also increase the amount of CD4 (T) cells in the body, helping the immune system.

Dosage

Biktarvy is taken no more than once daily, by mouth, with or without food. However, if your doctor has prescribed a dose that is different to this, you should not change your prescribed dose without speaking with your doctor as there are many factors that can impact the dose they have recommended. Your weight, other medical conditions and medications you are taking may have led your doctor to prescribe a different dose.

Biktarvy is a complete treatment for HIV, which means that you should not need any other HIV treatments to complement it.

Overdose

Do not take more Biktarvy than has been prescribed by your doctor, otherwise, the side effects may be serious. If you think you, or someone else, has used too much and have severe side effects, you should contact the emergency services immediately.

Side Effects

Common Side Effects

Some Biktarvy side effects are more common than others. Side effects can last a few weeks, some days, or be temporary. If any side effects last longer or make you feel significantly uncomfortable, you should discuss them with your doctor or a pharmacist.

Here are some of the side effects most commonly reported by patients using Biktarvy.

• diarrhea
• fatigue
• headache
• nausea
• unsettled sleep with unusual dreams or insomnia
• dizziness

Milder Side Effects

The mild side effects of using Biktarvy may include:

• abdominal pain
• diarrhea
• dizziness
• fatigue
• flatulence
• headache
• nausea and vomiting
• dyspepsia (upset stomach or indigestion)
• unsettled sleep with unusual dreams or insomnia
• rash

If these side effects last longer than a few weeks or make you feel uncomfortable, or become severe, you should consult your doctor.

Serious Side Effects

Taking Biktarvy can result in more serious side effects, as listed below. However, this list may not include all the possible side effects. If whilst taking Biktarvy you experience any of these serious side effects, you should contact your doctor immediately. If you think the side effects you are experiencing are life-threatening or that it’s a medical emergency, you should contact the emergency services.

The more serious Biktarvy side effects may include:

• Lactic acidosis caused by the body having too much lactic acid. The symptoms may include:
  • abdominal pain
  • cold hands or feet, they may turn blue
  • dizziness
  • fatigue
  • increased heart rate
  • muscle pain
  • nausea and vomiting
• Liver damage. The symptoms may include:
  • abdominal pain
  • decreased or loss of appetite
  • jaundice
  • nausea
  • pale stool
  • unusually dark urine
• New or worsening kidney problems. The symptoms may include:
  • confusion
  • nausea and vomiting
  • producing less urine or needing to urinate less than usual
  • swollen ankles and feet
• Immune reconstitution syndrome.
• Depression, suicidal thoughts or actions.
• After stopping treatment with Biktarvy, existing hepatitis B may worsen.

Warnings & Precautions

Before starting treatment with Biktarvy, let your doctor know of any allergies or medical issues you have. Make sure they are aware of all the other medication you are taking. Let them know if you are pregnant, or breastfeeding, or if there are any other health-related issues your doctor needs to know about, as these may have an impact on how you should take Biktarvy.

Cholesterol

During treatment for HIV, blood cholesterol levels may go up. If you are already at risk before beginning Biktarvy treatment for HIV, your doctor should have a conversation with you about how it may affect your health. It may have an impact on the dosage they recommended for you, you may also require special monitoring.

Diabetes

Biktarvy can increase your blood sugar levels by affecting blood glucose control and changing your tolerance to glucose. Patients who have diabetes before commencing treatment with Biktarvy may need to monitor their blood sugar levels more assiduously while using Biktarvy.

If you are at higher risk of developing diabetes, you should talk with your doctor about how Biktarvy may impact your health. It may affect the dose your doctor recommends and your condition may require special monitoring.

Hepatitis B

Hepatitis B patients will need a thorough discussion of their HIV treatment with their doctor before taking Biktarvy. For patients with hepatitis B, the safety and effectiveness of taking Biktarvy have not yet been established. However, patients taking emtricitabine or tenofovir have reported a recurrence of hepatitis B once the treatment with those medications has stopped.

Immune reconstitution inflammatory syndrome

Biktarvy may cause immune reconstitution inflammatory syndrome. The symptoms may begin soon after the anti-HIV treatment begins and they may vary. It is believed that it occurs due to the improvement of the immune system and its ability to deal with infections that had previously lain dormant without showing any symptoms. Such infections include pneumonia, herpes, and tuberculosis. Due to immune reconstitution inflammatory syndrome, autoimmune disorders have been found to develop, potentially affecting the thyroid, digestive system, muscles or joints. You should immediately consult your doctor if you notice any new symptoms.

Kidneys

Biktarvy may change your kidney function. Patients with reduced kidney function or kidney disease should discuss treatment with Biktarvy with their doctor as it may impact the dosage or necessitate special monitoring.

Lactic acidosis and enlarged liver

In addition to an enlarged and fatty liver, Biktarvy can cause lactic acidosis, a build-up of lactic acid. Laboratory tests and frequent monitoring to check on your liver will be required. However, if you experience any symptoms of immune reconstitution inflammatory syndrome, you should immediately seek medical help. The symptoms include:

• nausea
• vomiting
• stomach pain
• weakness
• tiredness
• feeling cold
• dizziness
• lightheadedness
• irregular heartbeat

Liver issues

You should discuss any liver problems with your doctor prior to starting treatment with Biktarvy. It may necessitate special monitoring and your doctor may also need to adjust your dosage. Also, your liver issues may affect how effective Biktarvy will be for you. You should consult your doctor if you experience any of the following symptoms of liver problems while taking Biktarvy.

• fatigue
• feeling unwell
• loss of appetite
• nausea
• jaundice
• dark urine
• pale stools
• abdominal pain or swelling
• itchy skin

Stopping Biktarvy

You will risk your HIV infection getting worse if you stop using Biktarvy. You should take it as your doctor has prescribed and should not stop using it before discussing it with your doctor.

Biktarvy and children

Biktarvy has not yet been established as safe for use by children weighing under 25kg.

Pregnancy and breastfeeding

It is not yet known whether Biktarvy is safe for use whilst pregnant. You should not use Biktarvy during pregnancy unless you have discussed it with your doctor and have determined that the benefits of taking Biktarvy outweigh the risks. If you are already taking Biktarvy when you become pregnant, you should discuss it immediately with your doctor. If you have HIV and are pregnant or planning to become pregnant, you should discuss HIV treatment options with your doctor.

While it is unknown whether bictegravir or tenofovir alafenamide can pass from  a mother to child in breast milk, emtricitabine can pass through breast milk, affecting the baby with side effects. Women with HIV are cautioned against breastfeeding as the virus can be passed to an uninfected baby. Patients who have HIV should discuss alternative baby-feeding options with their doctor.

Drug interactions

Biktarvy may interact with other medications and over-the-counter products, affecting its effectiveness and potentially increasing Biktarvy side effects. The list below does not necessarily include all the drugs that interact with Biktarvy, see your doctor or pharmacist for more information.

• anticonvulsant medications, such as:
  • carbamazepine
  • phenobarbital
  • phenytoin
  • oxcarbazepine
• certain antibiotics, such as:
  • rifampin (Rifadin)
  • rifabutin (Mycobutin)
  • rifapentine (Priftin)
• the atrial fibrillation medication dofetilide (Tikosyn)
• the type 2 diabetes medication metformin

Patients on Biktarvy should avoid taking certain antacids, such as:

• aluminum hydroxide, magnesium hydroxide, and simethicone (Mylanta maximum strength liquid antacid/anti-gas)
• aluminum hydroxide and magnesium trisilicate (Gaviscon)
• calcium carbonate (Tums)
• calcium carbonate and magnesium hydroxide (Rolaids)

If you are taking Biktarvy, your doctor or pharmacist will be able to advise you on indigestion medication that is safe to take. Meanwhile, consider taking smaller meals and avoiding foods that could upset your stomach.

Frequently Asked Questions