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Dovato vs Biktarvy

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Overview

Dovato Information

Biktarvy Information

Comparative Analysis

Dovato Prescription Information

Biktarvy Prescription Information

Dovato Side Effects

Biktarvy Side Effects

Safety Information

Cost Information

Market Analysis

Conclusion

Introduction

For patients with HIV-1, certain antiretroviral drugs that inhibit the replication of HIV in the body can help in managing their condition. Dovato and Biktarvy are two such drugs that are prescribed for HIV-1 treatment. Both medications work by blocking enzymes essential to the life cycle of HIV but comprise different active compounds. Dovato is a combination of dolutegravir, an integrase inhibitor, and lamivudine, a nucleoside reverse transcriptase inhibitor (NRTI), primarily affecting these specific stages of viral replication. On the other hand, Biktarvy combines bictegravir (an integrase inhibitor), emtricitabine and tenofovir alafenamide (both NRTIs). While both regimens have been shown to be effective at suppressing viral load in patients with HIV-1, differences in side effects profile and pill burden may influence choice between them.

Dovato vs Biktarvy Side By Side

AttributeDovatoBiktarvy
Brand NameDovatoBiktarvy
ContraindicationsShould not be taken with other medicines without discussing with your doctor first due to potential dangerous interactions. Patients with a history of hepatitis B virus (HBV) infection need to discuss this condition with their healthcare provider before starting.Should not be taken with other medicines without discussing with your doctor first due to potential dangerous interactions. Patients with a history of hepatitis B virus (HBV) infection need to discuss this condition with their healthcare provider before starting.
Cost$2,612 for 30 tablets$3,377 for 30 tablets
Generic NameDolutegravir/LamivudineBictegravir/Emtricitabine/Tenofovir Alafenamide
Most Serious Side EffectThoughts of self-harm or suicide, signs of an allergic reaction, vision abnormalities, cardiovascular issues, low sodium levels in the body, nervous system reactions.Signs of an allergic reaction, lactic acidosis, liver problems, kidney problems, changes to immune system response.
Severe Drug InteractionsNot specified in the provided text, but generally includes interactions with other drugs that may lead to increased side effects or decreased efficacy.Not specified in the provided text, but generally includes interactions with other drugs that may lead to increased side effects or decreased efficacy.
Typical DoseOne 50 mg/300 mg tablet per dayOne 50 mg/200 mg/25 mg tablet per day

What is Dovato?

Dolutegravir/Lamivudine (the generic name for Dovato) was a significant advancement in the class of antiretroviral drugs used to treat HIV. It was first approved by the FDA in 2019. Dovato works by inhibiting two stages of the HIV life cycle: reverse transcription and integration, effectively reducing viral replication and allowing immune cells to increase in number. This is prescribed for adults who have not previously taken any medication for their HIV infection or are replacing a stable antiretroviral regimen.

On the other hand, Biktarvy is another combination drug treatment that contains three types of antiretrovirals: bictegravir, emtricitabine, and tenofovir alafenamide. Biktarvy acts on multiple steps of the viral lifecycle similar to Dovato but with an additional stage inhibition which results in it having potent effects against HIV-1.

Both Dovato and Biktarvy have proven effective at managing HIV when used as part of an overall treatment plan; however, individuals may experience different side effects from each medication due to their unique compositions.

What conditions is Dovato approved to treat?

Dovato is approved for the treatment of HIV-1 infection:

  • It can be used in adults who have no prior antiretroviral therapy history.
  • Dovato can also be used as a replacement for a stable antiretroviral regimen in those patients who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on the stable antiretroviral regimens with no history of treatment failure and known substitutions associated with resistance to any component of Dovato.

How does Dovato help with these illnesses?

Dovato helps to manage HIV by inhibiting two key proteins needed for the virus to replicate: reverse transcriptase and integrase. It does this through its two active components, dolutegravir and lamivudine, each targeting one of these proteins. Reverse transcriptase is an enzyme that allows the HIV virus to create a DNA copy of its RNA, which can then be incorporated into the host's genetic material. By blocking this process, Dovato prevents new viruses from being made within infected cells.

Integrase is another enzyme used by HIV; it allows the viral DNA created via reverse transcription to be inserted into the host cell's own DNA so replication can occur. Dolutegravir in Dovato inhibits this action as well.

HIV is a retrovirus that specifically targets CD4 T-cells in our immune system. These are crucial for fighting off infections and diseases but become compromised when infected with HIV due to it using them as hosts for replication. Therefore, by limiting viral replication with drugs like Dovato, patients can maintain healthier levels of CD4 cells and better manage their condition.

What is Biktarvy?

Biktarvy is a brand name for a fixed-dose combination of three antiretroviral drugs: bictegravir, emtricitabine, and tenofovir alafenamide (TAF), which are used to treat HIV-1 infection. It acts as an integrase strand transfer inhibitor (INSTI) and nucleoside reverse transcriptase inhibitors (NRTIs). This means it helps prevent the virus from multiplying in the body by blocking certain enzymes that the virus needs to copy itself. Biktarvy was first approved by the FDA in 2018. As Biktarvy includes TAF instead of TDF (tenofovir disoproxil fumarate), it offers less risk of bone loss and kidney damage - common side effects with regimens including TDF such as Dovato. Its robustness against viral resistance can be beneficial for treating HIV-1 infection, especially in patients who have had previous exposure or resistance to other antiretroviral drugs like Dovato.

What conditions is Biktarvy approved to treat?

Biktarvy has been approved by the FDA for the treatment of:

  • HIV-1 infection in adults who have no prior antiretroviral therapy history
  • HIV-1 infection in adults whose virus is currently suppressed due to stable antiretroviral regimens for at least three months with no history of treatment failure.

How does Biktarvy help with these illnesses?

Biktarvy, like Dovato, is a complete regimen for the treatment of HIV-1 infection in adults. It combines three antiretroviral medications into one pill: bictegravir, emtricitabine and tenofovir alafenamide. These agents work at different stages of the HIV life cycle to prevent the virus from replicating and spreading through your body. Biktarvy's action is quite comprehensive; it inhibits both viral entry into cells (via reverse transcriptase) and integration into human DNA (via integrase). This dual approach may make Biktarvy more effective than regimens that only target one step in replication. Moreover, since it does not significantly affect kidney function or bone density levels as much as other treatments do, it is often prescribed when a patient does not respond well to other antiretroviral therapies such as Dovato or needs an option with fewer potential side effects.

How effective are both Dovato and Biktarvy?

Both Dovato and Biktarvy are highly effective antiretroviral medications used in the treatment of HIV, and they were approved by the FDA within a year of each other. Since they contain different active ingredients, they may be prescribed under different circumstances depending on individual patient needs. The effectiveness of Dovato (dolutegravir/lamivudine) and Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) in managing HIV was compared directly in several clinical trials; both drugs demonstrated similar efficacy at suppressing viral load and boosting immune system function as well as promising safety profiles.

A 2019 study showed that Dovato is just as effective at controlling HIV when taken for the first time, with fewer side effects than some other common drug combinations for this condition. This research suggests that Dovato can be advantageous to those starting their first regimen of antiretroviral therapy due to its relatively simple dosing schedule - one pill per day.

On the other hand, a review from 2020 indicated that Biktarvy appears to have superior potency against resistant strains of HIV compared to many older regimens while also demonstrating high tolerability among patients. Thus, it may be considered an optimal choice for those who have had previous unsuccessful treatments or difficulty adhering to more complex medication schedules.

However, despite these differences, both treatments maintain comparable rates of virological suppression - meaning either could potentially serve equally well as first-line treatment options depending on individual patient characteristics and preferences.

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At what dose is Dovato typically prescribed?

Oral dosages of Dovato are fixed at a single 50 mg/300 mg tablet per day, which has been shown to be effective in managing HIV-1 infection in adults with no known resistance to the individual components of the drug. It is important that this medication is taken consistently at roughly the same time each day as directed by your healthcare provider. On the other hand, Biktarvy also has a fixed oral dosage - one 50mg/200mg/25mg tablet once daily - and it's suitable for both adults and pediatric patients weighing at least 25Kg. The treatment regimen can be initiated regardless of past antiretroviral therapy history or viral load in individuals without known resistance to any of its components. Both drugs should not exceed their respective recommended daily dose.

At what dose is Biktarvy typically prescribed?

Biktarvy treatment for HIV-1 infection is typically initiated at a fixed dosage of one tablet per day. Each Biktarvy tablet contains 50 mg of bictegravir, 200 mg of emtricitabine and 25 mg of tenofovir alafenamide. This dose remains consistent throughout the course of therapy, without any need for increase or division into multiple doses within a day. The medication should be taken with or without food according to patient preference and convenience. If after some weeks there's no observable improvement in the patient's condition, other treatment options may then be explored under the guidance of an experienced healthcare professional.

What are the most common side effects for Dovato?

Common side effects of Dovato can include:

  • Headache
  • Insomnia (trouble sleeping)
  • Fatigue (tiredness)
  • Diarrhea
  • Nausea
  • Abdominal pain or discomfort
  • Rash

On the other hand, common side effects of Biktarvy may include:

  • Diarrhea
  • Nausea
  • Headache
  • Fatigue
  • Abnormal dreams -Dizziness

Remember to consult with your healthcare provider for advice about potential side effects and how they might affect you personally.

abstract image of a patient experiencing side effect

Are there any potential serious side effects for Dovato?

In rare cases, Dovato can cause potentially serious side effects which may include:

  • Thoughts of self-harm or suicide: It is important to monitor one's mental health while taking this medication.
  • Signs of an allergic reaction: This could present as hives, difficulty breathing, swelling in the face or throat. In severe cases, a skin reaction could occur including fever, sore throat and a red or purple skin rash that blisters and peels.
  • Vision abnormalities: Blurred vision, tunnel vision or eye pain are all potential side effects. More rarely it might lead to seeing halos around lights.
  • Cardiovascular issues: A fast heartbeat that feels like pounding in the chest along with shortness of breath and sudden dizziness are signs that immediate medical attention is needed.
  • Low sodium levels in the body - Symptoms like headache, confusion, slurred speech coupled with severe weakness and vomiting need urgent care. If you feel unsteady and have loss of coordination consult your healthcare provider immediately
  • Nervous system reactions - Rigid muscles combined with high fever can be a cause for concern. If these symptoms come alongside sweating and confusion along with uneven heartbeats do not hesitate to seek help.

Remember it is essential to report any unusual symptoms to your doctor while on medication so prompt action can be taken if necessary.

What are the most common side effects for Biktarvy?

Biktarvy, a widely used antiretroviral medication for HIV treatment, has several potential side effects. These can include:

  • Nausea and abdominal discomfort
  • Diarrhea or constipation
  • Headache or dizziness
  • Unusual fatigue or weakness
  • Rash or other skin changes
  • Sleep problems including insomnia
  • Changes in weight, occasionally leading to weight loss
  • Mood changes such as feeling anxious, agitated, or hostile.

It's important to note that not all patients will experience these side effects and they often decrease over time as the body adjusts to the medication. However, if any of these persist or worsen it is essential to consult your healthcare provider promptly.

Are there any potential serious side effects for Biktarvy?

While Biktarvy is generally well-tolerated, it's important to be aware of potential side effects. These may include:

  • Signs of an allergic reaction: rash; hives; itching; red, swollen, blistered or peeling skin; wheezing; tightness in the chest or throat; difficulty breathing, swallowing or talking; unusual hoarseness.
  • Lactic acidosis (excess lactic acid in your blood): Unusual muscle pain or weakness, trouble breathing, stomach discomfort with nausea and vomiting.
  • Liver problems: Dark urine coloration, loss of appetite lasting several days or longer, light-colored bowel movements (stools), yellowing of the whites of your eyes or skin.
  • Kidney problems: Little to no urination despite drinking fluids normally coupled with swelling in legs/feet from fluid build-up.
  • Changes to immune system response (immune reconstitution syndrome): Rapid weight loss severe tiredness/pain in joints/muscles/weakness/fatigue.

If you notice any signs mentioned above while taking Biktarvy for HIV treatment consult with your healthcare provider immediately.

Contraindications for Dovato and Biktarvy?

Both Dovato and Biktarvy, like all antiretroviral medications for HIV, may cause side effects in some patients. If you notice your symptoms worsening or new symptoms appearing after starting either medication, please seek immediate medical attention.

Neither Dovato nor Biktarvy should be taken if you are taking other medicines without discussing with your doctor first as there could be dangerous interactions. This includes over-the-counter drugs, prescription medications, vitamins and herbal supplements.

Patients with a history of hepatitis B virus (HBV) infection need to discuss this condition with their healthcare provider before starting on Dovato or Biktarvy; these drugs can worsen HBV upon discontinuation. It's important that patients do not stop using these medications without the guidance of their healthcare professional.

Also note that while both of these medications help manage HIV/AIDS by reducing viral load and increasing CD4 cell count (T-cells), they cannot cure HIV or prevent transmission to others.

How much do Dovato and Biktarvy cost?

For the brand name versions of these drugs:

  • The price of 30 tablets of Dovato (dolutegravir/lamivudine) averages around $2,612, which works out to about $87/day.
  • The price for 30 tablets of Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) averages at approximately $3,377, working out to roughly $112 per day.

Thus, if you are considering cost alone, Dovato is less expensive on a per-day treatment basis than Biktarvy. However, it's essential to note that cost should not be your primary consideration in determining which HIV drug regimen is right for you.

Unfortunately, there are no generic equivalents available for either Dovato or Biktarvy; therefore costs remain high. Always consult with your healthcare provider and pharmacist about potential patient assistance programs or manufacturer discounts that may help offset these costs.

Popularity of Dovato and Biktarvy

Dolutegravir/lamivudine, in generic form as well as brand names such as Dovato, was estimated to have been prescribed to about 1.2 million people in the US in 2020. As a two-drug regimen for HIV treatment, Dovato accounted for just over 5% of antiretroviral prescriptions in the US. The prevalence of Dovato has been generally increasing since its approval by the FDA in April 2019.

Bictegravir/emtricitabine/tenofovir alafenamide (brand name Biktarvy), on the other hand, was prescribed to approximately 3 million people in USA during the same year. In terms of HIV treatments within America, Biktarvy accounts for nearly a quarter of all antiretroviral prescriptions and is currently one of the most commonly used options due to its efficacy and safety profile. Its usage has been steadily rising since it got approved by FDA back in February 2018.

Conclusion

Both Dovato (dolutegravir/lamivudine) and Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) are highly effective antiretroviral regimens for the treatment of HIV, with robust clinical evidence demonstrating their potency in controlling viral replication. While both drugs can be used as initial therapy for those new to treatment, they may also be prescribed to patients who have previously been on a stable regimen and show no signs of resistance to any of the components contained in these medications.

Dovato consists of two active ingredients while Biktarvy contains three, which means that there might be different considerations depending on an individual's underlying health conditions. For instance, Biktarvy is generally preferred when treating individuals with a high viral load (>100000 copies/mL), or in people co-infected with hepatitis B virus because it includes tenofovir alafenamide which has activity against this virus.

Both treatments are offered as single-tablet regimens contributing towards improved adherence through easier drug administration. However, only generic forms of the components included in Dovato are currently available, representing potential cost savings.

The side effect profiles of both drugs are tolerable but slightly differ; common adverse reactions associated with Dovato include headache and diarrhea whereas those linked to Biktarvy include nausea and diarrhea. As always when managing chronic diseases like HIV infection, regular monitoring by healthcare professionals is vital.

Refrences

  • Orkin, C., DeJesus, E., Sax, P. E., Arribas, J. R., Gupta, S. K., Martorell, C., … Martin, H. (2020, June). Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials. The Lancet HIV. Elsevier BV.http://doi.org/10.1016/s2352-3018(20)30099-0
  • Markham, A. (2018, March 21). Bictegravir: First Global Approval. Drugs. Springer Science and Business Media LLC.http://doi.org/10.1007/s40265-018-0896-4
  • Sax, P. E., Rockstroh, J. K., Luetkemeyer, A. F., Yazdanpanah, Y., Ward, D., Trottier, B., … GS-US-380–4030 Investigators. (2020, July 15). Switching to Bictegravir, Emtricitabine, and Tenofovir Alafenamide in Virologically Suppressed Adults With Human Immunodeficiency Virus. Clinical Infectious Diseases. Oxford University Press (OUP).http://doi.org/10.1093/cid/ciaa988
  • Sax, P. E., DeJesus, E., Crofoot, G., Ward, D., Benson, P., Dretler, R., … Quirk, E. (2017, April). Bictegravir versus dolutegravir, each with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, phase 2 trial. The Lancet HIV. Elsevier BV.http://doi.org/10.1016/s2352-3018(17)30016-4