Categories: DrugsNew Approvals

Dovato (dolutegravir/lamivudine): Uses, Side Effects, Dosage & FAQs

Dovato is the Brand name for the combination of two medications, such as dolutegravir and lamivudine. The US Food And Drugs Administration (FDA) has approved the treatment of HIV infection based on two drugs and a Single tablet Regime (STR).

It is used to control HIV infection. It helps reduce the amount of HIV in your body so that your immune system can function better. This reduces the likelihood of complications of HIV (for example, new infections, cancer) and improves the quality of life.

The drug Dovato, marketed by GlaxoSmithKline (GSK), has been reported as a complete regimen for the treatment of HIV-1 infection in adult patients with no history of antiretroviral treatment and no known or suspected substitutions associated with resistance to either dolutegravir or lamivudine.


Facts

  • Generic: Dolutegravir and lamivudine
  • Drug Class: Combination of antiretroviral drugs
  • Dosage Form: Tablet
  • Imprint: SV 137
  • Use: HIV-1 infection in adults
  • Manufacturer: ViiV Healthcare
  • Approval Date: 8th April 2019
  • Picture


Composition

  1. Dolutegravir 50mg
  2. Lamivudine 300mg

Dolutegravir

  • Dolutegravir is a prescription drug approved by the US Food and Drug Administration (FDA) for the treatment of HIV infection in combination with other drugs.
  • Dolutegravir is an HIV-1 interferon inhibitor that blocks the filament transfer phase of the integration of the viral genome into the host cell (INSTI).
  • Integrase inhibitors block an HIV enzyme called integrase. By blocking the integrase, integrase inhibitors prevent the proliferation of HIV and can reduce the amount of HIV in the body.
  • The effect of this drug has no similarity in human host cells, giving it excellent tolerance and minimal toxicity.

Lamivudine

  • Lamivudine is a prescription drug for the treatment of HIV infection and hepatitis B virus (HBV).
  • Lamivudine belongs to a class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs).
  • Although lamivudine does not cure HIV, it can reduce the chances of developing Acquired Immune Deficiency Syndrome (AIDS) and HIV-related diseases such as serious infections or cancer.

Dovato Uses

  • It is the first, once-daily, single-tablet for HIV1 Patients.
  • It is Indicated as a complete 2-drug regimen for the treatment of HIV infection in adults with no history of antiretroviral therapy (ART).

Mechanism

Dolutegravir is an antiretroviral agent for HIV-1. It inhibits the integrase of HIV by binding to the active site and blocking the step of transferring the retroviral DNA integration filament into the host cell. The filament transfer phase is essential in the HIV replication cycle and leads to the inhibition of virus activity.

Lamivudine is a synthetic nucleoside analog and is intracellular phosphorylated to its active metabolite, lamivudine triphosphate (L-TP), 5′-triphosphate. This nucleoside analog is incorporated into the viral DNA by HIV reverse transcriptase and HBV polymerase, resulting in the termination of the DNA chain.


Dovato Side Effects

The most common side effects with Dovato were

  • Headache,
  • Diarrhea,
  • Nausea,
  • Weakness
  • Fatigue.

Less common side effects (Occurred in less than 2% People) of Dovato includes;

  • Hepatitis
  • Anemia
  • Thrombocytopenia
  • Fever
  • Abdominal Discomfort
  • Flatulence
  • Hypersensitivity
  • Pruritus and Rash
  • Renal impairment.
  • Insomnia
  • Anxiety
  • Myositis
  • Immune reconstitution syndrome.
  • Suicidal Thoughts

Note: This is not a complete list of side effects. You may experience other side effects, consult your doctor.

Black Box Warning

All patients infected with HIV-1 should be tested for HBV before or at the beginning of Dovato treatment. The appearance of lamivudine-resistant HBV variants associated with antiretroviral therapies containing lamivudine has been reported. If Dovato is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for the appropriate treatment of chronic HBV. Otherwise, consider a different treatment scheme. Serious acute exacerbations of HBV have been reported in patients coinfected with HIV-1 and HBV who discontinued lamivudine, a component of Dovato. Monitor liver functions accurately in these patients and starts anti-HBV therapy if necessary.


Precautions

Before taking this medicine, tell your health care provider if you

  • Are allergic to dolutegravir or any other medicines.
  • Have any other medical conditions.
  • Have or have ever had liver problems, including hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV).
  • Are pregnant or plan to become pregnant.
  • Are breastfeeding or plan to breastfeed.
  • Have diabetes, you should know that there are 3 grams of sucrose in each tablespoon (15 mL) of lamivudine solution.
  • Lactic acidosis and severe hepatomegaly have been reported with the use of lamivudine.
  • Are using hormone-based birth control’
  • They are taking other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products.
  • Concomitant administration of Dovato with another antiretroviral drug for HUV1 is not recommended.
  • HIV-positive and hepatitis B-infected patients who stop using Dovato should be closely monitored by their doctor.

Contraindications

It is contraindicated in the following conditions

  • Hypersensitivity
  • Contraindicated with dofetilide
  • Pregnancy
  • Breastfeeding

Dovato in Pregnancy & Breastfeeding

As there is a known risk for neural tube defects with dolutegravir, patients are advised to avoid the use of Dovato at the time of conception through the first trimester of pregnancy. Also, It is not recommended for use in breastfeeding women.


Interactions:

Dovato should not be used with the following drugs and conditions. These drugs may increase or decrease the concentration of Dovato which may lead to side effects.

  • Dofetilide
  • Carbamazepine
  • Fosamprenavir
  • Magnesium citrate
  • Magnesium Aspartate
  • Phenobarbital
  • Fosphenytoin
  • Oxcarbazepine
  • Sorbitol
  • Phenytoin
  • Tafenoquine
  • Rifampin
  • St John’s wort
  • Tipranavir
  • Sucralfate
  • Metformin

This is not a complete list of drugs. You can consult your doctor before using Dovato along with other drugs.


Dose

It is a single tablet and containing two drugs dolutegravir 50 mg and lamivudine 300 mg. It is a once-daily regime. You should take it with or without food.


Clinical Results

Dovato has been shown to be effective in clinical trials when the treatment has maintained low levels of HIV RNA (less than 50 copies/ml) in the blood for at least 48 weeks.

The approval was based on Gemini I and II involving more than 1,400 HIV-1 infected patients. This shows that Dovato is as effective as the standard three-drug regimen.

Reduces ARV exposure from the start of treatment while maintaining the efficacy and high barrier to resistance of a conventional three-dolutegravir drug.


Frequently asked Questions

1. What is Dovato?

Dovato is the combination of two drugs like dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg. It is used for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either DTG or 3TC.

2. What is Dovato Used to Treat?

Dovato is a complete regimen for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to either dolutegravir or lamivudine.

3. What are the side effects of Dovato?

The most common side effects associated with the use of this medicine was Nausea, vomiting, Fatigue, headache, insomnia, Diarrhea, etc.

4. What is the dose of Dovato?

Dovato is a once-daily, single-tablet, two-drug regimen that combines the dolutegravir 50 mg with the lamivudine 300 mg. Take it as prescribed by your healthcare practitioner. You can take it with or without food.

5. What happens if I overdose on Dovato?

There is no known specific treatment for overdose. In case of overdose,
The patient should be supervised and standard supportive care provided as needed.

6. Is Dovato safe to use during pregnancy?

Patients are advised to avoid the use of Dovato at the time of conception through the first trimester of pregnancy. Because of dolutegravir in this drug cause neural tube defects.

7. Is Dovato safe to use while Breastfeeding?

No, Breastfeeding is not recommended due to the potential for HIV-1 transmission.

8. How should I take Dovato?

Dovato is a two-drug regimen that combines the dolutegravir 50 mg with the lamivudine 300 mg. It is a once-daily, single-tablet. Take this tablet one time a day exactly as your doctor tells you. You can Take It with or without food.

9. What should I do if I miss a dose of dovato?

If you miss a dose of this medicine, take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take your next dose at the usual time. Do not take two doses at a time to make up for the missed dose.

10. Who should not take Dovato?

You should not take this medicine if are allergic to it or to any other ingredients present in this formulation. Also, you should avoid taking this medication if you are already taking dofetilide.

11. What are the active ingredients in Dovato?

Dovato is the combination of two active ingredients such as dolutegravir and lamivudine. The inactive ingredients used in Dovato are magnesium stearate, sodium stearyl fumarate, microcrystalline cellulose, mannitol, povidone K29/32, sodium starch glycolate.

12. How to store Dovato?

Keep Dovato in the container and keep the container tightly closed. Do not use it if the original seal covering the opening of the container is broken or missing. Store it at a temperature below 30 ° C (86 ° F).


Disclaimer:

  • The Article above is only for information purposes.
  • It is not intended to replace a medical opinion, diagnosis or treatment by a health professional.
  • Always ask your doctor or another qualified practitioner if you have questions about a health problem.

References


Author Bio

A Professional Pharmacist (Doctor Of Pharmacy), a passionate blogger and fountainhead of DrugsBank. Twitter Profile: @ManzoorRph Facebook Profile: Manzoor Ahmad Learn more about me here

View Comments

  • Wow this is a great addition to the HIV medications. Hopefully this new drug will help all HIV positive people.
    Thanks for the indepth information

  • Great. This is great news for those with HIV

  • This drug is not the only medicine for HIV but still it's a great achievement.

  • Thanks you have highlighted all the important things in this article.

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