Fda Warning: Worsening Of Hepatitis B
This drug has a boxed warning. This is the most serious Food and Drug Administration warning. A boxed warning alerts doctors and patients about drug effects that may be dangerous.
In people who have hepatitis B and HIV, stopping certain HIV drugs such as Biktarvy can make hepatitis B worse. This has been reported in people who stopped taking the drugs emtricitabine, tenofovir disoproxil fumarate, or both. Biktarvy contains emtricitabine and a different form of tenofovir called tenofovir alafenamide.
If you have hepatitis B and HIV and stop taking Biktarvy, your doctor will monitor your liver function for several months after you stop the drug. If your hepatitis B gets worse, you may need to take medication to treat it.
See the Biktarvy side effects section above for more information.
What Happens If I Delay Starting Hiv Treatment
In the past people could delay treatment if they werent ready to start. However, this isnt recommended now. If you have HIV, the sooner you start treatment, the better it is for your health.
The START trial found that there was a 53% reduction in the risk of death or serious illness if treatment was started when the CD4 count was still above 500.
Its common for people to feel apprehensive about taking treatment but all you need to remember is that:
- It will enable you to live a normal lifespan.
- When youâre on effective treatment you wonât be able to pass on HIV.
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I Have Too Much Going On
Life doesnât stop because you have been diagnosed with a disease â nor do your responsibilities. Whether itâs a chaotic work schedule, taking care of loved ones or juggling a job and school, the act of getting your medications refilled regularly and taking your meds consistently is difficult to maintain when so much is expected of you.
But balance is important, especially when it comes to your health. If you canât take care of yourself first, how are you going to be able to take care of your other responsibilities if you get really sick?
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Tips For Common Side Effects
Here is a list of symptoms, or side effects, that some people experience when they start taking HIV medications, along with some suggestions for what you can do at home to manage them. Because what seems like a side effect may actually be a sign of a more serious condition, such as a drug toxicity or an infection, be sure to discuss your symptoms with your medical provider.
Rash And Other Skin Side Effects
Biktarvy may cause a rash in some people. The rash may be mild or severe, and it may go away on its own or require immediate treatment. According to a clinical trial by GILEAD Sciences, the manufacturing company of Biktarvy, less than 2% of participants had experienced a skin rash by week 48 of treatment.
Two rash-like adverse effects of Biktarvy are Steven-Johnson Syndrome and toxic epidermal necrolysis. Both conditions are rare but require immediate medical attention.
Steven-Johnson Syndrome is when the top layer of skin dies and separates from the lower layers, causing painful sores or lesions on the body. Its often accompanied by flu-like symptoms such as fever, chills, fatigue, and muscle aches.
Toxic epidermal necrolysis is another serious condition in which the top layer of the skin dies and separates from the lower layers, causing large blisters and widespread peeling. It can also lead to extensive scarring, vision loss, and even death.
If you experience a rash while taking Biktarvy, seek medical attention right away.
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What Form Does This Medication Come In
Each purplish-brown, capsule-shaped, film-coated tablet, debossed with “GSI” on one side and “9883” on the other side, contains 50 mg of bictegravir , 200 mg of emtricitabine, and 25 mg of tenofovir alafenamide . Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate film-coating: iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
How Should Biktarvy Be Stored
- Store Biktarvy below 86°F .
- Keep Biktarvy in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent , do not remove it. The desiccant protects the medicine from moisture.
- Do not use Biktarvy if the original seal over the container opening is broken or missing.
- Throw away Biktarvy that is no longer needed or expired . Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep Biktarvy and all medicines out of reach of children.
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What To Do In Case You Take Too Much Biktarvy
Call your doctor if you think youve taken too much Biktarvy. You can also call 800-222-1222 to reach the American Association of Poison Control Centers or use their online resource. However, if you have severe symptoms, immediately call 911 or go to the nearest emergency room.
Biktarvy is a complete treatment for HIV, making it a convenient regimen because it can be taken alone. But there are also other treatment options available for HIV.
Talk with your doctor about all of your treatment choices based on your:
- medical and health history
- other medications you take
You may find complementary therapies helpful when used together with medications for HIV. These complementary therapies include activities such as mindfulness practice, meditation, or yoga. Take a look at these yoga apps.
Before taking Biktarvy, ask your doctor about what you can expect with treatment. Here are some possible questions to get you started:
- Can I take vitamins with Biktarvy?
- How will I know if Biktarvy is working for me?
- Will I gain weight with Biktarvy?
To learn more about HIV and new treatment options, you can sign up for Healthlines HIV newsletter.
- calcium carbonate
- calcium carbonate and magnesium hydroxide
But its important that the time you take antacids is spaced out from the time you take Biktarvy.
Aluminum, calcium, iron, and magnesium may lower your bodys absorption of bictegravir . This interaction can decrease your level of bictegravir, putting you at risk for viral resistance.
What Should I Discuss With My Healthcare Provider Before Taking Biktarvy
Some medicines can cause unwanted or dangerous effects when used with Biktarvy. Your doctor may need to change your treatment plan if you also use:
Tell your doctor if you have ever had:
- liver disease or
- kidney disease.
Tell your doctor if you are pregnant. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines to control your infection. Your name may be listed on a pregnancy registry to track the effects of Biktarvy on the baby.
Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.
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Taking Antiretroviral Treatment With Other Medicines
If you are taking other medications or drugs including: treatments for other health conditionscontraception hormonal therapies or use psychoactive drugs, its important that your doctor knows about this. Different drugs can interact, changing the way that they work. This may mean that a drug becomes too strong or that a drug becomes too weak, so that it can no longer control your HIV, prevent pregnancy or treat another health condition. Discuss the medication you take with your healthcare workers so they make sure that the combination is safe and will work well for you.
Can Biktarvy Be Crushed Split Or Chewed
Biktarvys manufacturer hasnt reported whether Biktarvy tablets can be crushed, split, or chewed for adults and children weighing at least 25 kilograms .
The tablet can be split for children weighing 14 kilograms to less than 25 kilograms who arent able to swallow a whole tablet of Biktarvy. However, all tablet pieces must be taken within 10 minutes.
Ideally, Biktarvy should be swallowed whole, if possible. If you have trouble swallowing the pill, talk with your doctor.
Biktarvy is used to treat HIV in certain situations.
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What If Your Treatment Isnt Working
Sometimes the HIV medications donât work. This may occur because the drugs donât completely stop the virus from reproducing. As the virus makes copies of itself, changes sometimes occur. These changes may result in a new strain of the virus that is resistant to the action of the drugs. If your providers think this has happened, they will do a blood test that can help show which drugs the virus has become resistant to. This can help identify other drugs that might still work against your virus.
If a person has a strain of HIV that is resistant to most or all available drugs, that person may want to consider joining a clinical trial that is testing new drugs that have not yet been approved by the U.S. Food and Drug Administration . See Clinical Trials.
Take Biktarvy At The Same Time Each Day
While Biktarvy can be taken at any time of day, you should aim to take it at the same time every day. This will help you avoid missed doses. Missing doses can lead to the HIV virus developing resistance to Biktarvy. Dont change your dosing schedule without consulting with your healthcare provider first.
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Safety Laboratory Monitoring In Persons Taking Antiretroviral Therapy
All persons with HIV who initiate antiretroviral therapy should have laboratory studies performed at the initial visit, before initiating or changing a regimen, and as regular monitoring for long-term safety once a regimen is initiated. If abacavir or any abacavir fixed-dose combination is used in the regimen, baseline HLA-B*5701 testing should be performed. The following summarizes key baseline and safety laboratory studies recommended for individuals taking antiretroviral therapy .
Biktarvys Side Effects Explained
Below, you can find detailed information about some of Biktarvys side effects. To learn more about other side effects of this medication, talk with your doctor.
Worsened hepatitis B after stopping Biktarvy
Stopping Biktarvy may lead to worsened hepatitis B in people who have both HIV and the hepatitis B virus .
In fact, Biktarvy has a boxed warning for this risk. A boxed warning is the most serious warning from the Food and Drug Administration . It alerts doctors and patients about drug effects that may be dangerous.
It isnt known how many people who stopped taking Biktarvy in clinical studies may have had worsened hepatitis B.
Worsened hepatitis B can lead to other liver problems, including liver failure. For symptoms and other details about liver problems with Biktarvy, see Liver problems directly below.
Due to this risk, your doctor will likely test you for HBV before you start taking Biktarvy. Its also important that you talk with your doctor before you stop taking Biktarvy.
If you have HBV and your doctor feels its safe to stop taking Biktarvy, theyll likely monitor you with tests. These tests, called liver function tests, check how well your liver is working. Your doctor may give you these tests for several months after stopping treatment.
If you have worsened hepatitis B after stopping Biktarvy, your doctor may prescribe you treatment for the condition. If youre concerned about worsening hepatitis B after stopping Biktarvy, talk with your doctor.
Depression
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Biktarvy 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 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 .
Do not take Biktarvy if you also take a medicine that contains:
Could My Treatment Stop Working
For many people, the treatment they start taking will continue to work for as long as they take it.
If your viral load is not being kept under control by the treatment you are taking, your healthcare professional will want to find out why. It may be that you are having problems taking the drugs correctly, that they do not interact well with other drugs that you are taking or that your virus has become resistant to them.
Your healthcare professional may be able to help you resolve the problem and stay on the same treatment. However, if your treatment has stopped working, perhaps because of drug resistance, then you will be advised to change treatment. There are a number of HIV drugs, so your healthcare provider should be able to find a combination of drugs that is effective for you.
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What Side Effects Can Biktarvy Cause
Biktarvy may cause side effects. Some side effects of Biktarvy can be serious, as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.Other possible side effects of Biktarvy include:
- Changes in your immune system . IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
- Diarrhea and headache.
Tell your health care provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Biktarvy. To learn more about possible side effects of Biktarvy, read the drug label or package insert or talk to your health care provider or pharmacist.
You can report side effects to FDA at 1-800-FDA-1088 or online.
What Are The Side Effects Of Dovato
This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.
As with all medications, Dovato can cause side effects. Tell your healthcare provider about any side effects you experience while taking this medication.
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Before Taking This Medicine
You should not use Biktarvy if you are allergic to antiviral medicines that contain emtricitabine or tenofovir .
Some medicines can cause unwanted or dangerous effects when used with Biktarvy. Your doctor may need to change your treatment plan if you also use:
-
kidney disease.
Tell your doctor if you are pregnant. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines to control your infection. Your name may be listed on a pregnancy registry to track the effects of Biktarvy on the baby.
Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.
Nucleoside Reverse Transcriptase Inhibitors
Several of the older nucleoside reverse transcriptase inhibitors didanosine, stavudine, and zidovudinecan cause mitochondrial and metabolic adverse effects these effects rarely occur with abacavir, emtricitabine, lamivudine, tenofovir alafenamide, or tenofovir DF. Any impact of the NRTIs on human mitochondria is important, since mitochondria play an essential role in producing energy for the cell in the form of adenosine triphosphate . Mitochondrial toxicity caused by the NRTIs can result in a wide range of adverse effects, including lactic acidosis, hepatic steatosis, myopathy, cardiomyopathy, peripheral neuropathy, pancreatitis, and possibly lipodystrophy syndrome. The mechanism of NRTI-induced mitochondrial toxicity occurs through inhibition of gamma-DNA polymerase-gamma, the key enzyme responsible for mitochondrial DNA replication this inhibition can decrease cellular oxidative phosphorylation, increase intracellular lipids, and cause accumulation of lactic acid . If NRTI-related peripheral neuropathy and/or lipoatrophy develops, it only partially reverses, or does not reverse at all, with discontinuation of the offending medication.
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How Should I Take My Antiretroviral Treatment
When and how you take your ART will vary depending on the specific antiretroviral drugs you take. Most antiretroviral drugs are taken once a day, with or without food. However, some drugs are taken twice a day. If this might be something you find difficult, talk to your doctor about your options.
Once you start ART its very important that you take it properly and dont miss or skip doses, as this can lead to something called HIV drug resistance, and may mean that your drugs dont work as well for you in the future. If youre finding it hard to take your treatment at the right times and in the right way, speak to your healthcare worker. They can offer you support and give you advice on how to make taking your treatment easier.
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