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Vemlidy vs Baraclude
Introduction
For patients with chronic hepatitis B (HBV), certain antiviral drugs that inhibit the replication of HBV DNA in your body can help manage symptoms and prevent liver damage. Vemlidy and Baraclude are two such medications often prescribed for this purpose. Both impact how the virus multiplies but have different specificities and tolerability profiles. Vemlidy, also known as tenofovir alafenamide, is a prodrug designed to concentrate more in cells infected by HBV which reduces side effects on kidneys and bones compared to older forms of tenofovir. On the other hand, Baraclude, or entecavir, is an analogue of guanosine that inhibits all three steps in the reverse transcription of HBV: priming of the HBV polymerase, reverse transcription of negative strand from pregenomic messenger RNA, and synthesis of positive-strand HBV DNA. It's considered one of first-line therapies due to its potency against HBV replication and low risk for resistance when initiated among treatment-naive people.
Vemlidy vs Baraclude Side By Side
| Attribute | Vemlidy | Baraclude |
|---|---|---|
| Brand Name | Vemlidy | Baraclude |
| Contraindications | Should not be taken with drugs that significantly impact kidney function. Not approved for patients co-infected with HIV-1. | Should not be taken with drugs that significantly impact kidney function. |
| Cost | $1,600 for 30 tablets (approximately $53/day) | $840 for 30 tablets (approximately $28/day) |
| Generic Name | Tenofovir Alafenamide | Entecavir |
| Most Serious Side Effect | Lactic acidosis, liver problems, kidney issues, severe allergic reactions | Lactic acidosis, liver problems, kidney problems, allergic reactions |
| Severe Drug Interactions | Drugs that significantly impact kidney function | Not specifically mentioned, but caution advised with any drugs affecting kidney function |
| Typical Dose | 25mg/day | 0.5 mg/day for nucleoside-treatment-naive patients, 1 mg/day for lamivudine-refractory or decompensated liver disease patients |
What is Vemlidy?
Tenofovir alafenamide (the generic name for Vemlidy) is a new generation antiviral medication, marking a significant advancement over the older class of antivirals such as entecavir (Baraclude). It was first approved by the FDA in 2016. Vemlidy works by inhibiting the replication of hepatitis B virus cells, effectively reducing their presence in the body over time. It is prescribed for chronic hepatitis B treatment both in patients with compensated liver disease and those who have never been treated before. With its targeted mode of action, Vemlidy has less influence on kidney function and bone density compared to Baraclude, hence it presents fewer side effects related to these areas than other antiviral medications that may adversely affect them more severely.
What conditions is Vemlidy approved to treat?
Vemlidy is approved for the treatment of chronic hepatitis B infections:
- Treatment of adults with chronic hepatitis B virus (HBV) infection with compensated liver disease
- Vemlidy's approval does not extend to patients co-infected with HIV-1.
On the other hand, Baraclude has a broader range of applications:
- Treatment of chronic HBV infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
- This drug is useful for both patients who are HBeAg-positive and those who are HBe negative.
How does Vemlidy help with these illnesses?
Vemlidy is used to manage chronic hepatitis B infection by inhibiting the replication of the hepatitis B virus in the body. It does this by blocking a viral enzyme called reverse transcriptase, which is critical for the virus to multiply and infect new cells. This action reduces the amount of virus in your body, helping to keep liver disease such as cirrhosis and liver cancer at bay.
Like Vemlidy, Baraclude also works by inhibiting viral reverse transcriptase. However, while both drugs are effective at suppressing viral load and improving liver inflammation and fibrosis, some studies have indicated that Vemlidy may be associated with fewer adverse effects on kidney function and bone density compared to Baraclude.
It's important that individuals with hepatitis B discuss these factors with their healthcare provider when deciding between these two medications so they can choose one that best manages their condition while minimizing potential side effects.
What is Baraclude?
Baraclude, also known as entecavir, is an antiviral medication used in the treatment of hepatitis B virus (HBV) infection. It works by inhibiting the viral DNA polymerase, an enzyme that is necessary for the virus to replicate within human cells. Baraclude was first approved by the FDA in 2005 and has proven effective in reducing viral load and liver inflammation caused by HBV.
While it's not a cure for hepatitis B, it can help control your condition. Entecavir does not interfere with normal cell metabolism like some other anti-retroviral drugs do - meaning side effects may be less severe or frequent compared to other medications used for treating HBV. Its uncommon side effects include lactic acidosis and lipodystrophy.
It's particularly beneficial for patients who have experienced resistance to lamivudine-based therapy or those with decompensated liver disease where most typical anti-HBV drugs might be contraindicated due to toxicity concerns.
What conditions is Baraclude approved to treat?
Baraclude, also known as entecavir, has been endorsed by the FDA for treating:
- Chronic hepatitis B virus (HBV) infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
- This antiviral drug suppresses the replication of HBV by interfering with its DNA synthesis, helping to decrease liver damage caused by this chronic condition.
How does Baraclude help with these illnesses?
Baraclude, also known as entecavir, is a nucleoside analogue that acts against the hepatitis B virus. It inhibits the viral polymerase enzyme to prevent further replication of the virus in the body. This action reduces the amount of virus in your body and leads to a decrease in liver damage and an improvement in liver function. Like vemlidy, Baraclude is used for chronic Hepatitis B infection treatment but it's typically prescribed when patients have not shown significant progress with other antiviral medicines like Vemlidy or are unable to tolerate them due to side effects. Both medications work on similar principles but may be chosen based on individual patient needs and responses.
How effective are both Vemlidy and Baraclude?
Tenofovir alafenamide (Vemlidy) and entecavir (Baraclude) are both antiviral drugs used in the treatment of chronic hepatitis B infections. They were approved by the FDA at different times, with Baraclude gaining approval much earlier than Vemlidy. Despite this, they have shown similar effectiveness in controlling viral replication and improving liver inflammation.
A 2016 study compared Vemlidy to tenofovir disoproxil fumarate, a parent drug from which Vemlidy was derived. This trial showed that while both drugs had comparable efficacy in suppressing the hepatitis B virus, patients taking Vemlidy experienced fewer side effects related to kidney function and bone loss.
Entecavir has been available for longer than Vemlidy and its efficacy has been proven over time through numerous clinical trials. A 2006 meta-analysis confirmed that it is highly effective at reducing viral load in patients with chronic Hepatitis B virus infection when taken daily as recommended.
While both these antiviral medications display high efficacy rates, their use may be influenced by factors such as patient's renal function status or concurrent medication usage due to potential drug interactions. It’s important to remember that choosing between these two treatments should always involve a discussion between clinician and patient about individual health circumstances.
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At what dose is Vemlidy typically prescribed?
Oral dosages of Vemlidy are usually 25mg/day for treating chronic Hepatitis B in both adults and adolescents above 12 years. On the other hand, Baraclude is typically recommended at an oral dosage of 0.5 mg/day for nucleoside treatment-naive adults and adolescents with compensated liver disease or a higher dosage of up to 1 mg/day for patients who have lamivudine-resistant chronic hepatitis B or decompensated liver disease. In either population, close monitoring by your healthcare provider will be necessary to gauge the response to treatment. It's important that these prescribed dosages should not be exceeded without medical advice.
At what dose is Baraclude typically prescribed?
Baraclude treatment is typically initiated at a dosage of 0.5 mg/day for nucleoside-treatment-naive patients with chronic hepatitis B virus infection. For lamivudine-refractory or decompensated liver disease patients, the dose can be increased to 1 mg/day. This one-time daily dose should be taken on an empty stomach (at least two hours after a meal and two hours before the next meal). The maximum dose per day should not exceed 1mg. It's essential that this medication regimen is adhered to consistently, as irregular dosing can lead to resistance development in chronic hepatitis B treatments. If there is no adequate response to treatment at standard doses after several weeks, your healthcare provider may reassess your condition and adjust the therapy accordingly.
What are the most common side effects for Vemlidy?
Common side effects of Vemlidy may include:
- Headache
- Abdominal pain
- Fatigue (general weakness and tiredness)
- Nausea
- Diarrhea
- Coughing
- Back pain
- Rash
On the other hand, Baraclude can cause side effects such as:
- Headache
- Dizziness
- Tiredness
- Lactic acidosis (excess lactic acid in your blood) which includes symptoms like nausea, vomiting, unusual muscle pain and discomfort. -Liver problems: If you have liver disease or cirrhosis it might get worse. Symptoms to watch for are yellow eyes/skin, dark urine, persistent nausea/vomiting/loss of appetite.
Remember that these medications should be used under the guidance of a healthcare professional who will consider their potential benefits against possible side-effects.
Are there any potential serious side effects for Vemlidy?
Vemlidy, like any medication, can have potential side effects. While most people tolerate it well, some may experience adverse reactions such as:
- Severe allergic reactions: hives; difficulty breathing; swelling of your face, lips, tongue or throat
- Lactic acidosis (a serious metabolic condition): unusual muscle pain or weakness; trouble breathing; stomach discomfort; feeling cold especially in the arms and legs; dizziness or light-headedness;
- Liver problems: upper right abdominal pain or tenderness; dark urine coloration; yellowing of the skin and whites of eyes (jaundice); loss of appetite for several days accompanied by nausea
- Kidney issues: decrease in urination frequency or volume, blood in urine
- Changes in body fat distribution
- Symptoms suggestive of new infection
On the other hand Baraclude also has its own set of potential side effects which include:
- Allergic reaction symptoms like rash, itching/swelling especially on face/tongue/throat), severe dizziness and trouble breathing.
- Lactic Acidosis signs are similar to those described above for Vemlidy. -Liver problems with symptoms similar to those mentioned above but can also include easy bruising/bleeding. -Kidney issues are also a concern with signs including changes in amount/coloration of urine.
In either case if you notice these side-effects it is important that you contact a healthcare professional immediately.
What are the most common side effects for Baraclude?
Baraclude, an antiviral medication used in the treatment of hepatitis B, may cause some unwanted side effects. It's important to consult with your doctor if you experience any of these symptoms:
- Nausea or vomiting
- Stomach pain
- Headaches and dizziness
- Weakness and fatigue
- Sleep issues such as insomnia
- Soft stools or diarrhea
Remember that the benefits of taking Baraclude usually outweigh these minor discomforts. However, it is essential to monitor for more severe side effects like rapid heartbeat, confusion or agitation, unusual weight loss, skin rash or itching, muscle weakness or joint pain which warrant immediate medical attention.
Are there any potential serious side effects for Baraclude?
While Baraclude is a highly effective treatment for chronic hepatitis B, it's important to be aware of the potential serious side effects. These may include:
- Allergic reactions: Symptoms can range from hives, difficulty breathing, and swelling of your face or throat.
- Lactic acidosis (an imbalance in your body’s pH levels): This can result in symptoms like fatigue, irregular heartbeat, stomach pain or discomfort, feeling cold (especially in arms and legs), shortness of breath and unusual muscle pain.
- Liver problems: Look out for symptoms such as yellowing skin or eyes (jaundice), dark-colored urine, light-colored stools, loss of appetite for several days or longer.
- Kidney problems: Indicated by changes in the amount of urine produced or blood present in the urine.
Should you experience any of these signs while on Baraclude therapy; discontinue its use immediately and seek urgent medical attention.
Contraindications for Vemlidy and Baraclude?
Both Vemlidy and Baraclude, like many other antiviral medications, may cause serious side effects in some individuals. If you notice a worsening of symptoms such as nausea, vomiting, stomach pain or low fever while on these drugs, it is important to seek medical attention immediately.
Neither Vemlidy nor Baraclude should be taken if you are taking or have recently stopped using drugs that significantly impact kidney function. Always inform your doctor about any medications you are currently taking; these may require a period of time to clear from the system in order to prevent harmful interactions with Vemlidy and Baraclude.
It is also crucial to note that both medications could potentially cause lactic acidosis (an excess of lactic acid in your blood), which can lead to severe health complications. Be aware of symptoms including muscle pain or weakness, numbness or feeling cold in your arms and legs, trouble breathing, stomach discomfort and irregular heart rate.
These two antivirals work differently so they might not yield the same results for every patient. Always discuss treatment options thoroughly with your healthcare provider before making a decision.
How much do Vemlidy and Baraclude cost?
For the brand name versions of these drugs:
- The price of 30 tablets of Vemlidy (25 mg) averages around $1,600, which works out to approximately $53/day.
- The price of 30 tablets of Baraclude (0.5 mg) is about $840, working out to roughly $28/day.
Thus, if you are on a standard dose for both medications (i.e., one tablet per day), then brand-name Baraclude is less expensive on a per-day treatment basis. Please note that cost should not be the primary consideration in determining which antiviral drug is right for you as these treat serious conditions like Hepatitis B and your doctor's recommendation should be paramount.
As it stands now, there are no generic versions available for either Vemlidy or Baraclude in the United States due to patent laws protecting new drugs from competition for a certain period after they're launched.
Popularity of Vemlidy and Baraclude
Tenofovir Alafenamide, in generic form as well as brand names such as Vemlidy, was estimated to have been prescribed to about 150 thousand people in the US in 2020. Tenofovir Alafenamide accounted for just over 7% of antiviral prescriptions used for chronic Hepatitis B treatment in the US. Being a prodrug of Tenofovir, it is designed to be more targeted and therefore safer on the kidneys and bones compared with other broad class antivirals.
Entecavir, including brand versions such as Baraclude, was prescribed to approximately 250 thousand people in the USA in 2020. In the US, entecavir accounts for nearly 15% of total antiviral prescriptions specifically intended for chronic Hepatitis B treatment. The prevalence of Entecavir has remained steady over recent years despite being an older medication due its strong efficacy profile and lower risk of drug resistance development compared with some other medications.
Conclusion
Both Vemlidy (tenofovir alafenamide) and Baraclude (entecavir) are extensively prescribed antiviral drugs used in the treatment of chronic hepatitis B, with numerous clinical studies demonstrating their efficacy over placebo treatments. Occasionally, these drugs may be utilized together under careful physician supervision; however, this is rare due to potential drug interactions. Both function by inhibiting the viral DNA polymerase enzyme necessary for replication of the hepatitis B virus, although they bind at slightly different sites on this enzyme.
Vemlidy is a newer formulation designed to deliver more active drug to liver cells where it's needed while reducing levels elsewhere in the body which can lead to side effects. The main advantage being that Vemlidy has less impact on kidney function and bone density compared to its predecessor tenofovir disoproxil fumarate (TDF), making it a preferred option when these issues are a concern.
Baraclude offers once-daily dosing without regard for food and has been available as a generic since 2016 providing significant cost savings especially for those paying out-of-pocket.
While both drugs have relatively mild side-effect profiles, patients must closely monitor any changes in health status or symptoms such as fatigue, abdominal pain or jaundice during treatment initiation or ongoing therapy. Any concerning signs should trigger immediate contact with one's healthcare provider.
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Refrences
- Tang, L. S. Y., Covert, E., Wilson, E., & Kottilil, S. (2018, May 1). Chronic Hepatitis B Infection. Jama. American Medical Association (AMA).http://doi.org/10.1001/jama.2018.3795
- Robinson, D. M., Scott, L. J., & Plosker, G. L. (2006). Entecavir. Drugs. Springer Science and Business Media LLC.http://doi.org/10.2165/00003495-200666120-00009
- Ogawa, E., Furusyo, N., & Nguyen, M. H. (2017, November). Tenofovir alafenamide in the treatment of chronic hepatitis B: design, development, and place in therapy. Drug Design, Development and Therapy. Informa UK Limited.http://doi.org/10.2147/dddt.s126742