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Odefsey vs Complera
Introduction
For patients with human immunodeficiency virus (HIV), certain antiretroviral drugs that inhibit the virus's replication can help in controlling viral load and maintaining immune system health. Odefsey and Complera are two such drugs that are prescribed for HIV treatment. Both medication regimens consist of a combination of antiretrovirals, but they each contain different components. Odefsey contains emtricitabine, rilpivirine, and tenofovir alafenamide while Complera contains emtricitabine, rilpivirine, and tenofovir disoproxil fumarate. The key difference lies in the form of Tenofovir used: Tenofovir alafenamide in Odefsey is considered less harmful to the kidneys and bones compared to Tenofovir disoproxil fumarate found in Complera.
Odefsey vs Complera Side By Side
| Attribute | Odefsey | Complera |
|---|---|---|
| Brand Name | Odefsey | Complera |
| Contraindications | Should not be taken with nephrotoxic agents. Risk of new or worsening kidney problems, lactic acidosis, and severe liver problems. | Should not be taken with nephrotoxic agents. Risk of new or worsening kidney problems, lactic acidosis, and severe liver problems. |
| Cost | $3,300 for a 30-tablet supply | $2,700 for a 30-day supply |
| Generic Name | Emtricitabine, Rilpivirine, Tenofovir Alafenamide | Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate |
| Most Serious Side Effect | Mood changes or depressive symptoms such as thoughts of suicide, signs of an allergic reaction, irregular heartbeats, shortness of breath, signs of lactic acidosis, liver problems | Severe allergic reactions, unusual changes in mood or behavior including depression and suicidal thoughts, liver problems, kidney problems, lactic acidosis, bone density loss |
| Severe Drug Interactions | Not specified in the provided text, but typically involves interactions with nephrotoxic agents and drugs that may exacerbate side effects or reduce efficacy. | Not specified in the provided text, but typically involves interactions with nephrotoxic agents and drugs that may exacerbate side effects or reduce efficacy. |
| Typical Dose | One tablet per day, taken orally with a meal | One tablet per day, taken orally with a meal |
What is Odefsey?
Odefsey and Complera are both antiretroviral medications designed for the treatment of HIV-1 in certain patients. Odefsey, approved by the FDA in 2016, is a second-generation medication that combines emtricitabine, rilpivirine, and tenofovir alafenamide (TAF). On the other hand, Complera combines these same drugs but uses tenofovir disoproxil fumarate (TDF) instead of TAF. The key difference lies in their usage of TAF or TDF - while they achieve similar levels of virus suppression, studies suggest that TAF has less impact on bone density and kidney function compared to TDF. This makes Odefsey potentially a safer option long-term with fewer side effects than Complera. Both these medications should be taken as part of a complete treatment plan under medical supervision.
What conditions is Odefsey approved to treat?
Odefsey is approved for the treatment of HIV-1 infection in specific scenarios:
- In adults and children who weigh at least 35kg and have not previously received antiretroviral therapy
- As a replacement regimen in those already stably suppressed (HIV RNA<50 copies/mL) on a similar regimen, with no known or suspected resistance to any component of Odefsey.
Complera serves as an option for the following conditions:
- For use as a complete regimen or in combination with other antiretroviral agents for treating adult patients infected with HIV type 1 who have never taken anti-HIV medicines before, and who have no more than 100,000 copies/mL of virus in their blood.
How does Odefsey help with these illnesses?
Odefsey and Complera are two antiretroviral medications used to manage HIV by inhibiting specific enzymes that the virus needs to replicate within the body. Both of these drugs contain emtricitabine and tenofovir alafenamide, which work together to block the reverse transcriptase enzyme, preventing HIV from replicating its genetic material and thus slowing down its progression.
However, Odefsey includes an additional active ingredient known as rilpivirine. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that further increases this blocking effect for better efficacy. Compared with Complera, which contains ritonavir-boosted elvitegravir instead of rilpivirine, Odefsey has been found in some studies to have lower risks of certain side effects such as kidney damage or loss of bone mineral density.
Therefore, while both medications can effectively manage HIV infection when taken consistently as prescribed alongside other preventive measures, individuals may choose Odefsey over Complera based on potential side-effect profiles tailored to their specific health conditions and lifestyle factors.
What is Complera?
Complera is a brand name for the combination of emtricitabine, rilpivirine, and tenofovir disoproxil fumarate. It acts as an antiretroviral medication used primarily in the treatment of HIV. The three active substances work together to inhibit specific enzymes vital to the replication of HIV cells: reverse transcriptase inhibitors (emtricitabine and tenofovir) block an enzyme needed by HIV-1 to reproduce while rilpivirine inhibits another enzyme called non-nucleoside reverse transcriptase. Complera was first approved by the FDA in 2011.
As Complera does not have an effect on serotonin reuptake, it has a different side-effect profile compared to SSRIs like Prozac. In particular, it is less likely to cause weight gain or sexual dysfunction which are common side effects seen with SSRI medications. The combined action on crucial viral enzymes makes it effective for those living with HIV who might not respond well to other types of antiretroviral treatments.
What conditions is Complera approved to treat?
Complera is an FDA-approved medication used in the treatment of the following condition:
- Human Immunodeficiency Virus (HIV) infection
It's important to note that while Complera helps manage HIV, it doesn't cure it. It works by reducing the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications such as new infections or cancer and improves your quality of life.
How does Complera help with these illnesses?
Complera is an antiretroviral medication that combines three drugs into one pill to suppress the HIV virus and prevent it from progressing to AIDS. It works in several ways; by blocking a specific enzyme needed for the virus replication, inhibiting the conversion of viral RNA into DNA (a necessary step for HIV multiplication), and preventing HIV-infected cells from producing new viruses. Similar to Odefsey, Complera also contains emtricitabine and tenofovir disoproxil fumarate. However, instead of rilpivirine used in Odefsey, Complera contains efavirenz which may cause more central nervous system side effects but less cardiovascular complications compared to rilpivirine. Therefore, healthcare providers might choose Complera over Odefsey depending on a patient’s individual health profile and their potential risk factors.
How effective are both Odefsey and Complera?
Both Odefsey and Complera are well-established antiretroviral medications used in the management of HIV. They were approved by the FDA within a few years of each other, with Complera receiving approval in 2011 and Odefsey in 2016. These two medications are combination drugs, meaning they contain multiple active ingredients that work together to suppress the virus. The effectiveness of both Odefsey and Complera was directly studied through rigorous clinical trials where they exhibited similar efficacy in managing symptoms of HIV infection as well as promising safety profiles.
A review on studies involving these drugs shows that both combinations successfully reduce viral load (the amount of HIV present in the blood) and increase CD4 cell count (a type of white blood cell that is targeted by HIV). Both have been found generally well-tolerated among patients across various populations.
However, an important distinction lies within their components: While both include emtricitabine (FTC) and tenofovir alafenamide fumarate (TAF), Odefsey uses rilpivirine whereas Complera contains efavirenz for its third component. Rilpivirine has shown fewer side effects related to mental health issues such as depression or suicidal ideation compared to efavirenz; hence, it could be a better choice for individuals who already struggle with these conditions.
Furthermore, while data confirming their efficacy is robust when taken correctly, it's worth noting that rilpivirine-containing regimens like Odefsey require being taken with a meal to enhance absorption—a factor which may affect compliance for some patients.
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At what dose is Odefsey typically prescribed?
Dosages of Odefsey and Complera, both used to treat HIV-1 infection in adults and children weighing at least 35 kg, are typically one tablet taken orally once daily. In contrast to the dose flexibility seen with Prozac, these antiretroviral therapies have set doses that should not be altered unless under medical guidance. For both medications, it's crucial to maintain consistent dosing without missing doses as this can lead to viral resistance. It is also important that they are taken with a meal for optimal absorption into the body. The maximum dosage for either medication should never exceed one tablet per day.
At what dose is Complera typically prescribed?
Complera treatment is typically initiated at one tablet per day, taken orally. Each tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine hydrochloride, and 300 mg of tenofovir disoproxil fumarate. It's recommended to take Complera with a meal for optimal absorption. The dosage remains consistent and does not require increasing over time unless specifically instructed by your healthcare provider. However, if there's no improvement in the patient's condition after a period of consistent usage or if side effects become unmanageable, consult your doctor immediately to discuss potential adjustments to the treatment plan.
What are the most common side effects for Odefsey?
Common side effects that may occur when taking Odefsey include:
- Nausea
- Diarrhea
- Headache
- Dizziness
- Abnormal dreams
- Rash, itching or skin discoloration
- Insomnia (trouble sleeping)
- Fatigue (general weakness and tiredness)
- Depression, mood changes, anxiety
-Dyspepsia (burning sensation or discomfort in the upper abdomen or lower chest) -Muscle pain and stiffness
It's important to note that not everyone experiences these side effects. If any of them do occur and persist, it is crucial to seek medical attention promptly.
Are there any potential serious side effects for Odefsey?
Odefsey, like Complera, is used to treat HIV infection. Although these medications can be quite effective in managing the disease, they may also cause some potentially serious side effects in rare cases. These include:
- Mood changes or depressive symptoms such as thoughts of suicide
- Signs of an allergic reaction: rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; chest tightness
- eye problems (including blurry vision and light sensitivity)
- irregular heartbeats
- shortness of breath or difficulty breathing
- signs of lactic acidosis - severe nausea, vomiting and unusual muscle pain
- liver problems - dark urine coloration and yellowing eyes/skin
In addition to these side effects that are specific for Odefsey medication therapy, it's essential to monitor for any alarming neurologic presentations such as tremors or convulsions. If you experience any of these symptoms while taking Odefsey medicine treatment regimen consult your healthcare provider promptly.
What are the most common side effects for Complera?
Complera, an antiviral medication used to treat HIV, can come with its own set of side effects. These may include:
- Nausea and vomiting
- Diarrhea or constipation
- Changes in body shape or fat distribution
- Insomnia and other sleep disruptions
- Mild rash
- Dizziness and headaches It's also important to note that Complera may cause a new or worsening immune system condition (immune reconstitution syndrome). Patients might experience mood changes such as depression while on this medication; it is crucial for them to report any symptoms promptly to their healthcare provider.
Are there any potential serious side effects for Complera?
While taking Complera, some rare but serious side effects may occur. If you experience any of these symptoms, seek medical attention immediately:
- Signs of a severe allergic reaction such as hives; difficulty breathing; swelling in your face, lips, tongue or throat
- Unusual changes in mood or behavior including depression and suicidal thoughts
- Liver problems: yellowing eyes/skin (jaundice), dark urine, persistent nausea/vomiting
- Kidney problems: increased thirst/urination
- Lactic acidosis: unusual muscle pain and weakness, trouble breathing, feeling cold especially in your arms and legs, dizziness or light-headedness, fast or irregular heartbeats
- Bone density loss can also be a concern with long-term usage – symptoms include bone pain and fractures.
Keep in mind that this isn't an exhaustive list of potential side effects. Always consult with your healthcare provider if you notice any new or worrisome symptoms while on medication.
Contraindications for Odefsey and Complera?
Both Odefsey and Complera, along with most other antiretroviral medications, may lead to new or worsening kidney problems. If you notice any changes in urine color, volume, pain during urination or swelling in your legs and feet while taking these drugs, consult with your healthcare provider immediately.
Neither Odefsey nor Complera should be taken if you are using or have recently used nephrotoxic agents (drugs that can damage the kidneys). Always inform your physician about all the medications you are currently taking as some of them might require a certain period to clear from the system to avoid harmful interactions with Odefsey and Complera.
Additionally, note that both drugs can potentially cause lactic acidosis (a serious metabolic disorder), severe liver problems which may sometimes become life-threatening. It is essential for patients starting on these medications to monitor their health condition closely under medical supervision.
How much do Odefsey and Complera cost?
For the brand name versions of these drugs:
- The price of a 30-tablet supply of Odefsey (200 mg/25 mg/25 mg) averages around $3,300, which works out to about $110/day.
- The price for a 30-day supply of Complera (200mg/25mg/300mg) is approximately $2,700, resulting in an average daily cost of about $90.
Thus, if you are considering either Odefsey or Complera for your treatment plan, the latter may be less expensive on a per-day treatment basis. However, it's crucial to remember that cost should not be the main factor in determining which medication is best suited for you.
As far as generic versions go:
Unfortunately at this time there are no available generic versions for either Odefsey or Complera due to patent protections. Therefore costs remain high and can only be offset by insurance coverage or patient assistance programs where available.
Popularity of Odefsey and Complera
Odefsey and Complera are both brand names for antiretroviral therapy (ART) combinations used in the treatment of HIV. These medications contain different active ingredients, but they work in similar ways to control HIV infection.
In 2020, it was estimated that Odefsey was prescribed to about 60,000 people in the United States. This accounted for roughly 10% of all single-tablet regimen prescriptions for treating HIV-1 infection. The use of Odefsey has been generally increasing since its approval by the FDA in 2016 due to its improved renal and bone safety profile compared with other treatments.
On the other hand, Complera was prescribed to an estimated number of around 40,000 patients across the US during the same year. In terms of overall single-tablet regimen prescriptions for managing HIV-1 infection, Complera represented about 7%. Its usage has remained relatively steady over recent years despite being available a few years prior than Odefsey.
Conclusion
Both Odefsey and Complera have long-standing records of usage in patients with HIV, and are backed by numerous clinical studies indicating that they are more effective than placebo treatments. In some cases, the drugs may be combined but this is subject to careful consideration by a physician as they can also interact negatively with one another. Due to their different components, with Odefsey containing emtricitabine, rilpivirine and tenofovir alafenamide; and Complera having emtricitabine, rilpivirine and tenofovir disoproxil fumarate; they tend to be prescribed under different circumstances.
Odefsey is often considered when there's an intention to minimize potential kidney or bone density side effects due to its component of tenofovir alafenamide being less harmful than the tenofovir disoproxil fumarate found in Complera.
Both drugs require consistent adherence for optimal benefit; it's crucial not only because the effect might not be noticeable right away but also because inconsistent use can lead to drug resistance.
The side effect profile is similar between the two drugs - including nausea, depression or mood changes – both being generally well-tolerated. However, Odefsey has been associated less frequently with certain side effects such as kidney problems compared to Complera. For both drugs, patients should closely monitor any new symptoms after beginning treatment or changes in existing symptoms and seek medical help immediately if these occur.
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Refrences
- Chai, P. R., Pereira, L. M., Jambaulikar, G. D., Carrico, A. W., O'Cleirigh, C., Mayer, K. H., & Boyer, E. W. (2019, April). Short Communication: Bioequivalence of Tenofovir Component of Tenofovir/Rilpivirine/Emtricitabine in Digital Pills. AIDS Research and Human Retroviruses. Mary Ann Liebert Inc.http://doi.org/10.1089/aid.2018.0073
- De Clercq, E. (2012, August). Where rilpivirine meets with tenofovir, the start of a new anti-HIV drug combination era. Biochemical Pharmacology. Elsevier BV.http://doi.org/10.1016/j.bcp.2012.03.024
- Kabbara, W. K., & Ramadan, W. H. (2015, September). Emtricitabine/rilpivirine/tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults. Journal of Infection and Public Health. Elsevier BV.http://doi.org/10.1016/j.jiph.2015.04.020
- DeJesus, E., Ramgopal, M., Crofoot, G., Ruane, P., LaMarca, A., Mills, A., … Cao, H. (2017, May). Switching from efavirenz, emtricitabine, and tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. The Lancet HIV. Elsevier BV.http://doi.org/10.1016/s2352-3018(17)30032-2
- Wainberg, M. (2013, February). Combination therapies, effectiveness, and adherence in patients with HIV infection: clinical utility of a single tablet of emtricitabine, rilpivirine, and tenofovir. HIV/AIDS - Research and Palliative Care. Informa UK Limited.http://doi.org/10.2147/hiv.s32377