Dovato: Uses, Side Effects, Precautions, Dosage & FAQs
Dovato is a recently approved HIV/AIDS medicine. It 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. Dovato 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 properly. 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. 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. 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
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