Lactic Acidosis/severe Hepatomegaly With Steatosis
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including emtricitabine, a component of Biktarvy, and tenofovir DF, another prodrug of tenofovir, alone or in combination with other antiretrovirals. Treatment with Biktarvy should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity .
Risk For Hepatitis B Virus Reactivation
Due to shared modes of transmission, HIV/HCV-coinfected patients are at risk for hepatitis B virus infection. HBV reactivation has been reported in patients starting DAA HCV therapy who are not on active HBV agents. Consistent with general recommendations for the assessment of both HIV- and HCV-infected patients, all patients initiating HCV DAA therapy should be assessed for HBV coinfection with HBsAg, anti-HBs, and anti-HBc testing. HIV-infected patients with evidence of HBV infection should be on antiretroviral agents with activity against HBV, preferably tenofovir disoproxil fumarate or tenofovir alafenamide. For patients who are only anti-HBc positive and not on tenofovir-based ART, subsequent monitoring for HBV reactivation should be conducted as detailed in the Monitoring section.
What Are The Long
Biktarvy may cause some long-term side effects. These arent common, but they can occur.
Potential long-term side effects of Biktarvy can include:
- new or worsening kidney problems, such as kidney failure
If you notice symptoms of long-term side effects while taking Biktarvy, call your doctor. Your doctor can help determine how to handle any side effects you have. This may include trying an HIV medication other than Biktarvy.
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Before Taking This Medicine
You should not take Vemlidy if you are allergic to tenofovir.
Do not take Vemlidy together with adefovir , or with combination medicines that contain tenofovir .
To make sure Vemlidy is safe for you, tell your doctor if you have ever had:
kidney disease or
low bone mineral density.
You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Ask your doctor about your risk.
Tell your doctor if you are pregnant, and use your medications properly to control your infection.
It may not be safe to breastfeed while using Vemlidy. Ask your doctor about any risk.
Biktarvy Breakthrough: New Data Proves It’s Effective For Those With Hep B & Hiv
Gilead Sciences recently released new research data reinforcing and further proving that Biktarvy is a highly effective treatment option for a broad range of people living with HIV, including those also dealing with a hepatitis B diagnosis .
Interim data from the Alliance trial showed that Biktarvy did a better job than an alternative treatment of suppressing hepatitis B virus in people who are living with both HIV and HBV.
Additional data from two Phase 3 trials further demonstrated Biktarvys sustained efficacy, safety, and high barrier to resistance in adults with HIV who are just starting treatment. The findings were presented in July at the 24th International AIDS Conference.
A press release detailing the new data noted that HIV/HBV coinfection is a major global public health threat that increases the morbidity and mortality beyond either infection alone. HBV impacts approximately 8 percent of people with HIV globally, and HIV/HBV coinfection rates can reach 25 percent in areas where both viruses are endemic, such as Asia.
Additionally, pooled data showed that 99 percent of participants who initiated treatment with Biktarvy and remained in the study for all 240 weeks achieved and maintained an undetectable viral load through five years of follow-up. The data supports showed long-term use of Biktarvy caused no significant changes to metabolic, bone, and renal markers.
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Prospects For The Future
As of 2017, Gilead’s challenge is to develop or acquire new blockbuster drugs before its current revenue-producers wane or their patent protection expires. Gilead benefited from the expansion of Medicaid in the ACA Leerink analyst Geoffrey Porges wrote that Gilead’s HIV drugs could face funding pressure under reform proposals. Gilead has $32 billion in cash, but $27.4 billion is outside the U.S. and is unavailable for acquisitions unless Gilead pays U.S. tax on it, though it could borrow against it. Gilead would benefit from proposals to let companies repatriate offshore capital with minimal further taxation.
What Should I Know About Storage And Disposal Of This Medication
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture .
It is important to keep all medication out of sight and reach of children as many containers are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location â one that is up and away and out of their sight and reach.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website for more information if you do not have access to a take-back program.
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Recommendations For Patients Requiring Hepatitis B Virus And Hiv Treatment
In patients with HIV and HBV coinfection, HBV infection should be treated only in conjunction with HIV infection. Treatment of HBV infection alone without addressing the HIV infection will lead to emergence of HIV strains that are resistant to nucleoside reverse-transcriptase inhibitors .
Only tenofovir is fully active for treatment in patients with known or suspected lamivudine-resistant HBV infection. Tenofovir is considered a first-line agent in patients with chronic HBV infection because the virologic efficacy is high and the risk for HBV resistance is low. Tenofovir is available in 2 preparations, tenofovir disoproxil fumarate and tenofovir alafenamide . TDF can lead to renal impairment and bone loss. The TAF formulation is associated with less renal toxicity and less effect on bone density.
In treatment-naive patients with HIV/HBV coinfection, a regimen containing TDF plus FTC or TDF plus 3TC should be used as the backbone of HIV therapy.
If TDF cannot be used, entecavir may be used to treat HBV infection however, owing to its weak activity against HIV, this is not considered an active component of the antiretroviral regimen. Lamivudine-resistant strains of HBV may rapidly develop resistance therefore, a higher dose is recommended with more frequent HBV viral load monitoring.
If the HIV therapy requires modification , the HBV-active antiretroviral must be continued and new antiretrovirals added to achieve HIV viral suppression.
Medications For Hepatitis B
Several drugs are currently available for treatment of hepatitis B. Most of these are antiviral drugs that directly stop hepatitis B from reproducing. Hepatitis B treatment may also include pegylated interferon, which stimulates the body’s immune response against the virus.
Most hepatitis B drugs are nucleoside or nucleotide analogues, similar to one class of drugs used to treat HIV. In fact, some commonly used anti-HIV drugs are also active against hepatitis B. This can make treatment of both viruses easier, since it requires fewer drugs, but it must be done carefully to avoid either virus becoming resistant. These are:
- emtricitabine .
- tenofovir disoproxil or TDF .
- tenofovir alafenamide or TAF .
Other antiviral drugs are used to treat hepatitis B but not HIV:
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How Should This Medicine Be Used
The combination of bictegravir, emtricitabine, and tenofovir comes as a tablet to take by mouth. It is usually taken once daily with or without food. Take bictegravir, emtricitabine, and tenofovir at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take bictegravir, emtricitabine, and tenofovir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Continue to take bictegravir, emtricitabine, and tenofovir even if you feel well. Do not stop taking bictegravir, emtricitabine, and tenofovir without talking to your doctor. If you stop taking bictegravir, emtricitabine, and tenofovir even for a short time, or skip doses, the virus may become resistant to medications and may be harder to treat.
Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.
What If I Miss A Dose
If you miss a dose of Biktarvy, take it as soon as you remember. However, its important that you dont miss doses.
If you miss a dose of Biktarvy, the level of medication in your blood can fall to a point where it no longer controls the virus. This can allow the virus to develop resistance to the medication.
Viral resistance involves the virus developing small changes that make it less sensitive to a particular drug. If this happens with Biktarvy, the medication may become less effective or stop working to control your HIV.
Try using a medication reminder to help ensure you dont miss a dose. This can include setting a daily alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too.
Make sure you dont run out of Biktarvy. Be sure to refill your prescription when your supplies start to run low.
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Treatment Of Hepatitis C Virus With Coexisting Hiv Infection
Increased rates of cirrhosis in patients with hepatitis C virus are attributable to various factors, including older age, alcoholism, male sex, and HIV infection higher rates of progression to cirrhosis are seen in patients with HCV/HIV.
HCV infection in patients with HIV infection can have significant consequences, including liver disease progression, liver fibrosis, cirrhosis, increased rates of end-stage liver disease, and shortened lifespan after hepatic decompensation.
Genotype 1 accounts for approximately 75% of hepatitis C infections in the United States.
What Is Biktarvy Used For
If youre considering HIV treatments, your doctor may recommend that you take Biktarvy. Its used to treat HIV-1 in adults and children weighing at least 14 kilograms .
HIV-1 is the most common type of HIV. HIV weakens your immune system, making your body more susceptible to certain conditions such as infections and cancers.
Biktarvy is prescribed for people who:
- have never taken antiretroviral medications in the past.
- are changing their current HIV treatment, in certain situations. For this use, Biktarvy can be prescribed for people when:
- their HIV isnt resistant to any of the ingredients of Biktarvy.
- they have an undetectable viral load .
- they havent had an HIV treatment that didnt work for them in the past.
Biktarvy contains three active drugs that work together to stop HIV from making copies of itself in your body. This lowers the level of HIV of your body and helps treat the condition.
HIV isnt cured with Biktarvy. But if the drug is taken as prescribed, it can keep the level of HIV low in your body so that its not detectable.
Find answers below to some commonly asked questions about Biktarvy.
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Clinical Trial Results In Pediatric Subjects With Hiv
In Trial 1474, an open-label, single arm trial the efficacy, safety, and pharmacokinetics of Biktarvy in HIV-1 infected pediatric subjects were evaluated in virologically-suppressed adolescents between the ages of 12 to less than 18 years weighing at least 35 kg , in virologically-suppressed children between the ages of 6 to less than 12 years weighing at least 25 kg , and in virologically-suppressed children at least 2 years of age and weighing at least 14 to less than 25 kg .
Cohort 1: Virologically-suppressed adolescents
Subjects in cohort 1 treated with Biktarvy once daily had a mean age of 14 years and a mean baseline weight of 51.7 kg , 64% were female, 27% were Asian and 65% were black. At baseline, median CD4+ cell count was 750 cells per mm3 , and median CD4+% was 33% .
After switching to Biktarvy, 98% of subjects in cohort 1 remained suppressed at Week 48. The mean change from baseline in CD4+ cell count at Week 48 was -22 cells per mm3.
Cohort 2: Virologically-suppressed children
Subjects in cohort 2 treated with Biktarvy once daily had a mean age of 10 years and a mean baseline weight of 31.9 kg , 54% were female, 22% were Asian and 72% were black. At baseline, median CD4+ cell count was 898 cells per mm3 and median CD4+% was 37% .
After switching to Biktarvy , 100% of subjects in cohort 2 remained suppressed at Week 24. The mean change from baseline in CD4+ cell count at Week 24 was -24 cells per mm3.
Cohort 3: Virologically-suppressed children
Alcohol Use With Biktarvy
There isnt a known interaction between drinking alcohol and taking Biktarvy. However, both Biktarvy and alcohol can cause liver problems, including liver damage. And alcohol could make certain side effects of Biktarvy worse. These include nausea, vomiting, and diarrhea.
If you drink alcohol, talk with your doctor about how much, if any, is safe for you to have while taking Biktarvy.
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Drug Forms And Strengths
Biktarvy comes as tablets that you take by mouth. Each tablet contains three active drugs.
Its available in two strengths:
- 50 milligrams of bictegravir/200 mg of emtricitabine/25 mg of tenofovir alafenamide, which is prescribed for adults and children weighing at least 25 kilograms .
- 30 mg of bictegravir/120 mg of emtricitabine/15 mg of tenofovir alafenamide, prescribed for children weighing at least 14 kilograms to less than 25 kilograms.
What Does Biktarvy Cost
Costs of prescription drugs can vary depending on many factors. These factors include what your insurance plan covers and which pharmacy you use.
If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. You can also visit the Biktarvy manufacturers website to see if they have support options.
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Does Biktarvy Cause Hair Loss
No, hair loss wasnt a side effect of Biktarvy in clinical trials.
However, Biktarvy contains active drugs from a class of medications* called nucleoside reverse transcriptase inhibitors, and an active drug from a class of medications called integrase inhibitors. And drugs in these classes have been reported to cause hair loss.
If you notice hair loss while taking Biktarvy, contact your doctor. Theyll be able to help you decide how to manage this side effect.
* A class of medications is a group of drugs that work in a similar way. Biktarvy contains the active drugs emtricitabine and tenofovir alafenamide, which are nucleoside reverse transcriptase inhibitors. It also contains the active drug bictegravir sodium, which is an integrase inhibitor.
Does Biktarvy Have Interactions
Taking medications, vaccines, foods, and other things with a certain drug can affect how the drug works. These effects are called interactions.
Before taking Biktarvy, be sure to tell your doctor about all the medications you take . Also describe any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about any interactions these items may cause with Biktarvy.
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Data Collection And Analysis
We will follow the available guidelines provided in the Cochrane Handbook for Systematic Reviews of Interventions . We will use RevMan Web 2019 and Trial Sequential Analysis software to perform the analyses .
Selection of studies
Following retrieval of potentially eligible publications for inclusion in this Cochrane Review, EOU and GUE will independently select the studies fulfilling the inclusion criteria detailed in the current protocol. We will include trials, regardless of their reporting on outcomes of interest to our review. EOU and GUE will contact study authors if trial reports selected for our review do not provide sufficient or clear information. Review authors will look for reports of harms in quasirandomised and other studies obtained during the searches for randomised clinical trials only. EOU, GUE, and AOU will resolve disagreements by discussion.
Data extraction and management
Two review authors will independently complete a pilottested data extraction form for all included trials. We will retrieve the following data.
We will also record whether the included trials had prepublished protocols, and we will add the protocol publications to the references to included studies.
Assessment of risk of bias in included studies
Allocation sequence generation
Blinding of participants and personnel
Blinded outcome assessment
Incomplete outcome data
Selective outcome reporting
Overall bias assessment
Measures of treatment effect
Questions About Taking Biktarvy
Questions for your doctor
You may have questions about Biktarvy and your treatment plan. Its important to discuss all your concerns with your doctor.
Here are a few tips that might help guide your discussion:
- Before your appointment, write down questions like:
- How will Biktarvy affect my body, mood, or lifestyle?
Bring someone with you to your appointment if doing so will help you feel more comfortable. If you dont understand something related to your condition or treatment, ask your doctor to explain it to you.
Remember, your doctor and other healthcare professionals are available to help you. And they want you to get the best care possible. So dont be afraid to ask questions or offer feedback on your treatment.
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How Are Biktarvy And Genvoya Alike And Different
Biktarvy and Genvoya have quite a few similarities and some slight differences. They have some of the same active drugs and side effects. And they have the same uses.
Both Biktarvy and Genvoya are complete treatments for HIV in certain situations. As complete treatments, they dont need to be taken with other HIV drugs. For more information about how Biktarvy is used, see the What is Biktarvy used for? section just above.
Biktarvy and Genvoya have slightly different active ingredients:
- Biktarvy contains emtricitabine, tenofovir alafenamide, and bictegravir.
- Genvoya contains emtricitabine, tenofovir alafenamide, elvitegravir, and cobicistat.
Both medications come as tablets you swallow once per day. Biktarvy can be taken with or without food, but Genvoya needs to be taken with food.
To learn about side effects of these drugs, see the What are Biktarvys side effects? section above. And view Genvoyas patient information.
If youd like to know more about the differences and similarities of these drugs, talk with your doctor.