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- What is Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) and how is it used?
- What are the most important side effects and other facts about Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)?
- Other side effects of Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)
- What is the dosage for Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)?
- Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) Contraindications, Pregnancy Safety and Drug Interactions
What is Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) and how is it used?
Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) is a prescription medicine that is used without other anti-HIV-1 medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in adults and children who weigh at least 55 pounds (25 kg):
- who have not received anti-HIV-1 medicines in the past, or
- to replace their current anti-HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements.
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
Biktarvy contains the medicines bictegravir, emtricitabine, and tenofovir alafenamide.
Some medicines may interact with Biktarvy. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
You can ask your healthcare provider or pharmacist for a list of medicines that interact with Biktarvy.
Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Biktarvy with other medicines.
What are the most important side effects and other facts about Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)?
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.
Biktarvy can cause serious side effects, including:
- Worsening of Hepatitis B virus infection. If you have hepatitis B virus (HBV) infection and take Biktarvy, your HBV may get worse (flare-up) if you stop taking Biktarvy. A “flare-up” is when your HBV infectionsuddenly returns in a worse way than before.
- Do not run out of Biktarvy. Refill your prescription or talk to your healthcare provider before your Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)is all gone.
- Do not stop taking Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)without first talking to your healthcare provider. If you stop taking Biktarvy, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking Biktarvy.
Other side effects of Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)
Biktarvy may cause serious side effects, including:
- Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.
- New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys when starting and during treatment with Biktarvy. Your healthcare provider may tell you to stop taking Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)if you develop new or worse kidney problems.
- Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
- Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.
What is the dosage for Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)?
- Take Biktarvy exactly as your healthcare provider tells you to take it. Biktarvy is taken by itself (not with other HIV-1 medicines) to treat HIV-1 infection.
- Take Biktarvy 1 time each day with or without food.
- Do not change your dose or stop taking Biktarvy without first talking with your healthcare provider. Stay under a healthcare provider’s care during treatment with Biktarvy.
- If you take antacids that contain aluminum or magnesium, take Biktarvy at least 2 hours before or 6 hours after you take these antacids.
- If you take supplements or antacids that contain iron or calcium, take Biktarvy with food at the same time that you take these supplements or antacids.
- Do not miss a dose of Biktarvy.
- If you take too much Biktarvy, call your healthcare provider or go to the nearest hospital emergency room right away.
- When your Biktarvy 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 Biktarvy and become harder to treat.
Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) Contraindications, Pregnancy Safety and Drug Interactions
Before taking Biktarvy, tell your healthcare provider about all your medical conditions, including if you:
- have liver problems, including hepatitis B virus infection
- have kidney problems
- are pregnant or plan to become pregnant. It is not known if Biktarvy can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with Biktarvy.
- are breastfeeding or plan to breastfeed. Do not breastfeed if you take Biktarvy.
Pregnancy Registry: There is a pregnancy registry for women who take Biktarvy during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.
You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
At least one of the medicines in Biktarvy can pass to your baby in your breast milk. It is not known if the other medicines in Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)can pass into your breast milk.
Talk with your healthcare provider about the best way to feed your baby.
It is not known if Biktarvy is safe and effective in children who weigh less than 55 pounds (25 kg).
Do not take Biktarvy if you also take a medicine that contains:
Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) is a prescription medicine that is used without other anti-HIV-1 medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in adults and children who weigh at least 55 pounds (25 kg). 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. Do not take Biktarvy if pregnant or breastfeeding.
Related Disease Conditions
HIV Early Signs and Stages
Human immunodeficiency virus or HIV, destroys important cells that fight disease and infection, which weakens a person's immune system. Some people with HIV don’t have any signs or symptoms. Early signs and symptoms of HIV infection include mononucleosis-like or flu-like symptoms, which include body aches, fever, and headache. Signs and symptoms begin around seven or eight years after HIV infection, which include weight loss, loss of energy and appetite, and swollen lymph nodes. There are 3 stages of HIV.
HIV and AIDS
Second Source article from WebMD
Human Immunodeficiency Virus (HIV)
HIV (human immunodeficiency virus) infection left untreated causes AIDS (acquired immunodeficiency syndrome). Still incurable, AIDS describes immune system collapse that opens the way for opportunistic infections and cancers to kill the patient. Early symptoms and signs of HIV infection include flu-like symptoms and fungal infections, but some people may not show any symptoms for years. Highly active antiretroviral therapy (ART) is the standard treatment for HIV infection. These combination drug regimens have made HIV much less deadly, but a cure or vaccine for the pandemic remains out of reach. HIV is usually transmitted through sexual contact or sharing IV drug needles, but can also infect someone through contact with infected blood. Sexual abstinence, safe sex practices, quitting IV drugs (or at least using clean needles), and proper safety equipment by clinicians and first responders can drastically reduce transmission rates for HIV/AIDS.
HIV vs. AIDS
Human immunodeficiency virus causes HIV infection. Acquired immunodeficiency syndrome (AIDS) is a condition that results after HIV has extensively damaged a person's immune system. Risk factors for HIV and AIDS include use of contaminated needles or syringes, unprotected sex, STDs, receiving a blood transfusion prior to 1985 in the United States, having many sex partners, and transmission from a mother to her child.
HIV/AIDS Testing: Diagnosis and Monitoring
HIV/AIDS diagnosis and monitoring have come a long way from the days when a diagnosis was a death sentence. Crucial parts of the effective treatment regimens developed in the last 40 years are consistent monitoring of the viral load (the amount of virus in the blood), and the immune cell count, which function as biological markers of the disease’s progression. Doctors also must test for drug resistance.
HIV/AIDS Facts: What Is HIV?
HIV (human immunodeficiency virus) is the precursor infection to AIDS (acquired immunodeficiency syndrome). HIV is transmitted through blood and genital secretions; most people get it through sexual contact or sharing needles for illegal IV drug use. HIV can be controlled by a strict drug regimen, but left unchecked, it leads to AIDS. In AIDS, the immune system collapses and the body falls prey to secondary, opportunistic infections and cancers that typically kill the person.
HIV/AIDS Infection Transmission and Prevention
HIV (human immunodeficiency virus) is spread through contact with genital fluids or blood of an infected person. The spread of HIV can occur when these secretions come in contact with tissues such as those lining the vagina, anal area, mouth, eyes (the mucus membranes), or with a break in the skin, such as from a cut or puncture by a needle.
HIV Medications List and Drug Charts
The ultimate goal of HIV treatment is getting the viral load down below detectable levels. As long as those viral load and antibody levels are below a proscribed range, people with HIV can stave off AIDS and other serious symptoms. Antiviral treatment options usually include combinations of two NRTIs, often referred to as "nucs," and a third drug, typically being a boosted protease inhibitor, a NNRTI, often called "non-nucs," and integrase strand transfer inhibitors.
When should you start HIV medication?
Nearly everyone who is infected with HIV (human immunodeficiency virus) should start antiviral medication therapy as soon as they are diagnosed. Older guidelines recommended delaying treatment to help reduce the potential for drug side effects and viral resistance to treatment. Current thinking theorizes that early treatment may preserve more of the body's immune function.
What Are the Side Effects of HIV Medications?
It’s important to know the potential side effects of all the drugs you take to control your HIV infection, as well as potential drug interactions. All of the NNRTIs (nonnucleoside analogue reverse transcriptase inhibitors), for example, are associated with important drug-drug interactions so they must be used with caution in patients on other medications. Learn more about the side effects of the drugs in standard treatment regimens.
Treatment & Diagnosis
- HIV Treatment, Medications, and Prevention
- HIV: Two Patients Face The Diagnosis
- HIV Treatment - To Interrupt or Not
- Unprotected Sex Between HIV-Infected Partners: What's the Harm?
- HIV Transmission and Progression to AIDS Continues
- Physical and Biochemical Changes in HIV Disease
- Babies On The Breast Of HIV Moms
- HIV Urine Test Approved
- HIV / AIDS Conference Update 2005 - Index
- Does Circumcision Prevent HIV and AIDS?
- Can HIV Cause Kaposi's Sarcoma?
- Do You Need Antiretroviral Therapy for HIV with No Symptoms?
- Does HIV Cause Colorectal Cancer?
- Does Anti-Retroviral Therapy for HIV Cause Diabetes?
- How Long Should You Wait to Get an HIV Test?
- What Liver Problems Does HIV Cause?
- HIV Infection Facts, History, Causes, and Risk Factors
- HIV Tests, Symptoms, Signs, and Stages of Infection
- Baby "Cured" of HIV Infection
- HIV/AIDS Conference Highlights July 27 2005
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Medications & Supplements
- What Are NRTIs in Antiretroviral Therapy For HIV Infection?
- Symtuza (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide)
- Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate)
- What Are the Single-Tablet ART Regimens for HIV Infection?
- Temixys (lamivudine and tenofovir disoproxil fumarate)
- Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide)
- Complera (emtricitabine, rilpivirine, tenofovir disoproxil fumarate)
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.