Dovato: Uses, Side Effects, Precautions, Dosage & FAQs

Dovato is the brand name for the two antiretroviral medications (Dolutegravir and Lamivudine) to treat Human Immunodeficiency Virus-1 (HIV-1)/AIDs in adults and in children aged above 12 years. 

It is the first once-daily, two-drugs, single tablet, and complete regime approved by the US Food and Drugs Administration (FDA) [01] for treating HIV infection.

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

The drug Dovato is marketed by GlaxoSmithKline (GSK) [02] and has been reported as a complete regimen for treating HIV-1 infection in adult patients with no history of antiretroviral treatment 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
  • Dovato Price: $2295 per month or $27,540 per year
  • Approval Date: 8th April 2019

Dovato

Dovato Composition

  1. Dolutegravir 50mg
  2. Lamivudine 300mg

Dolutegravir

  • Dolutegravir is a prescription drug approved by the US Food and Drug Administration (FDA) to treat HIV infection in combination with other drugs.
  • Dolutegravir is an HIV-1 interferon inhibitor that blocks the filament transfer phase of the viral genome integration into the host cell.
  • Integrase inhibitors block an HIV enzyme called integrase. Blocking the integrase enzyme prevents the proliferation of HIV and reduces 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 another prescription drug for treating HIV infection and hepatitis B (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

The drug is approved for the following conditions. Please note that this drug comes with a black box warning of the risk of hepatitis B virus (HBV) that’s lamivudine-resistant and worsening hepatitis B.

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

Dovato 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 inhibits 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
  • Belly Pain,
  • Loss of appetite,
  • Fatigue.

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

  • 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.

Although the chances of developing severe allergic reactions are low, it may, in rare cases, causes swelling under the skin, tongue, lips, hands, and eyelids. Talk to your doctor if you experience these symptoms.

To avoid liver-related issues, your GP may recommend some tests from time to time to check your enzyme level.

Black Box Warning: All patients infected with HIV-1 should be tested for HBV before or at the beginning of Dovato treatment. Lamivudine-resistant HBV variants associated with antiretroviral therapies containing lamivudine have been reported. If Dovato is used in patients coinfected 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 you ever had liver problems, including hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV)?
  • Are you pregnant or plan to become pregnant?
  • Are you breastfeeding or plan to breastfeed?
  • Have diabetes; you should know that 3 grams of sucrose are 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.’
  • Avoid it if you take other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products.
  • Also, the concomitant administration of Dovato with another antiretroviral drug for HUV1 is not recommended.
  • Their doctor should closely monitor HIV-positive and hepatitis B-infected patients who stop using this medicine.

Dovato Contraindications

It is contraindicated in the following conditions.

  • Hypersensitivity to the ingredients used in Dovato. 
  • It is also contraindicated in combination with dofetilide.
  • Avoid Dovato in pregnancy and breastfeeding women. 

Dovato in Pregnancy & Breastfeeding

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

Interactions

Talk to your pharmacist or doctor whether you’re taking any other medications, including those you obtain without a prescription from your pharmacist or health food store. 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

Acid reducers are used for treating indigestion and heartburn, and iron and calcium supplements can stop Dovato absorption in the body and make it less effective. So, it’s better not to use this medication with antacid, iron, and calcium. 

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

Dovato Dosage

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

Clinical Results

Dovato is 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

What is Dovato?

Dovato combines two drugs: Dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg. It is used to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history and no known resistance to either DTG or 3TC.

What is Dovato Used to Treat?

As discussed earlier, it is a complete regimen for treating HIV-1 infection in adults with no antiretroviral treatment history and no known or suspected substitutions associated with resistance to either dolutegravir or lamivudine.

What are the side effects of Dovato?

This medicine’s most common side effects were Nausea, vomiting, Fatigue, headache, insomnia, Diarrhea, etc. Read more in the side effects section above. 

What is the dose of Dovato?

It is a once-daily, single-tablet, two-drug regimen that combines the dolutegravir 50 mg with the lamivudine 300 mg. Take it as your healthcare practitioner prescribes. You can take it with or without food. You will need to swallow the tablets with a full glass of water. 

Does Dovato cause weight gain?

Weight gain is possible, but studies have not reported any such thing. However, people taking these drugs have experience weight gain.

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.

Is Dovato safe to use during pregnancy?

Patients are advised to avoid using this medicine from conception through the first trimester of pregnancy. Because dolutegravir in this drug causes neural tube defects such as spina bifida

(malformed spinal cord).

Is Dovato safe to use while Breastfeeding?

No, Breastfeeding is not recommended due to the potential for HIV-1 transmission. This virus can be passed on to the baby in breast milk. Some studies suggest that a small amount of Dovato can also be passed on to the baby. Consult your doctor if formula feeding is not possible.

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.

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 simultaneously to make up for the missed dose.

Who should not take Dovato?

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

What are the active ingredients in Dovato?

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

How to store Dovato HIV?

Please keep it 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) because heat can cause some medicines. Please keep it away from children and don’t leave it in the window or the car. 

How much does Dovato cost?

The Price of a 30 days supply is around 2500$, but it also depends on the pharmacy. The drug’s price is high because it is only available in the brand and not in generic form.

Is Dovato better than Biktarvy?

It is a two-drug single-tablet regimen, while Biktarvy is a three-drug single-tablet regimen. Although this is a safe and more effective drug, many doctors still prefer to use Biktarvy because of its three drugs combination.

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.

4 thoughts on “Dovato: Uses, Side Effects, Precautions, Dosage & FAQs

  1. 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

  2. Great. This is great news for those with HIV

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

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

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