Dovato is the Brand of 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 Single tablet Regime (STR), opening a new front in the battle for supremacy in the field.
The drug Dovato, marketed by GlaxoSmithKline (GSK), is the first single tablet regime (STR) drug to be taken once a day to treat patients who have never been treated.
By providing a simpler treatment regimen for patients containing less drug, long-term treatment of the disease should be easier as patients are less likely to have side effects.
Dovato (dolutegravir and lamivudine) 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 or dolutegravir-lamivudine.
There are approximately 1.1 million people living with HIV in the United States and 15% of the population do not know they are infected. The treatment of these people must be extremely effective in suppressing the viral load in the blood that is necessary to prevent the progression of the disease. Currently, the US Food and Drug Administration (FDA) has approved the two full-dose regimens for HIV-infected adults – the dovato drug (dolutegravir and lamivudine).
Composition Of Dovato
- Dolutegravir 50mg
- Lamivudine 300mg
- 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 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 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.
- 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 antiretroviral therapy (ART) History.
Dolutegravir is an antiviral 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.
The most common adverse reactions with Dovato were
Less Common side effects (Occurred in less than 2% People) of Dovato includes;
- Abdominal Discomfort
- Pruritus and Rash
- Renal impairment.
- Immune reconstitution syndrome.
- Suicidal Thoughts
Note: This is not a complete list of side effects. You may experience other side effects, consult your doctor.
Before taking Dovato, 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 B 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 -based birth control’
- 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.
Dovato’s labeling includes a boxed warning that warns people infected with HIV and hepatitis B to add additional treatment to their hepatitis B or to consider a different treatment regimen. Patients with HIV and hepatitis B who are taking products containing lamivudine, an ingredient in Dovato, have developed hepatitis B variants associated with lamivudine resistance and may have serious liver problems, including liver failure, when discontinuing lamivudine-containing medicinal products. HIV-positive and hepatitis B-infected patients who stop using Dovato should be closely monitored by their doctor.
Dovato is contraindicated in the following conditions
- Contraindicated with dofetilide
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.
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.
- Magnesium citrate
- Magnesium aspartate
- St John’s wort
This is not a complete list of drugs. You can consult your doctor before using Dovato along with other drugs.
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.
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 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.
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. How to store Dovato?
Keep Dovato in the container into which it has entered 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).
The Article above is only for information purpose. 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.