Dovato

Dovato is a type of combination antiretroviral therapy. It contains dolutegravir and lamivudine, 2 antiretroviral drugs (ARVs) that target different stages of the HIV replication process. Dolutegravir is an integrase strand transfer inhibitor (INSTI) that blocks the enzyme integrase, preventing HIV from inserting its genetic material into the host cell's DNA and stopping the virus from replicating. Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) that interferes with the reverse transcriptase enzyme, preventing HIV from converting its RNA into DNA, further hindering replication. By inhibiting these key steps in the HIV life cycle, Dovato helps reduce the amount of HIV in the body and supports viral suppression.

Follow all directions given to you by your doctor and read all documents provided, including the complete Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Dovato. However, the following is a synopsis of the general guidelines for the use of Dovato:

• Take one tablet of Dovato once daily with or without food for treatment-naïve patients. It is a complete HIV treatment regimen and should not be used with other HIV medicines.
• Swallow the tablet whole; do not chew, crush, or break it.
• Take Dovato at the same time each day to help you remember.
• If you miss a dose of Dovato, take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at once.
• Limit alcohol consumption, as it may increase the risk of side effects.
• Regular medical check-ups and monitoring are required to track treatment effectiveness and manage side effects.

The most common side effects of Dovato seen in clinical trials as compared to placebo include:

• Headache
• High blood sugar levels
• Low phosphate levels
• Nausea
• Diarrhea
• Fatigue
• Insomnia
• Dizziness
• Trouble sleeping
• Weight gain

Some individuals may experience serious adverse events while using Dovato. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe and sometimes life-threatening allergic reactions: rash, itching, swelling of the face or throat, difficulty breathing.
• Liver problems and liver failure: yellowing of the skin or eyes, dark urine, unusual tiredness.
• Lactic acidosis: deep or rapid breathing, feeling cold, muscle pain, stomach pain, nausea, or dizziness.
• Depression or suicidal thoughts: unusual mood changes or thoughts of harming yourself.
• Changes in your immune system (called immune reconstitution syndrome).

These are not all of the possible side effects of Dovato. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Dovato, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Severe liver problems, hepatitis B virus (HBV), or have risk factors and are not being closely monitored.
• A history of depression or mental health issues.
• Lactic acidosis.
• Pregnancy: Inform your doctor if you are pregnant or planning to become pregnant. Dovato may be used during pregnancy, but your doctor will weigh the benefits and risks.
• Drug interactions: Dovato may interact with other medications, so inform your doctor about all other drugs you are taking, including over-the-counter and herbal supplements.

Boxed Warning

All patients with HIV-1 should be tested for the presence of HBV before or when initiating Dovato. The emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If Dovato is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen. Severe acute exacerbations of HBV have been reported in patients who have both HIV-1 and HBV and have discontinued lamivudine, a component of Dovato. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.

You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Severe hypersensitivity to dolutegravir, lamivudine, or any other components of the medication.
• Co-infection with hepatitis B: Discontinuation of Dovato in patients with hepatitis B without proper monitoring may lead to severe liver problems.
• Severe liver disease: Patients with severe hepatic impairment should not use Dovato, as it may worsen liver function or lead to liver toxicity and failure.
• Certain drug interactions: Dovato should not be used with drugs that significantly affect its absorption or metabolism, such as strong inducers of cytochrome P450 enzymes (e.g., rifampin), as these can reduce the effectiveness of Dovato.

Dovato typically starts working to reduce HIV viral load within a few weeks of starting treatment. However, it may take several months for the full benefits to be seen in terms of viral suppression.

When Dovato is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Strong inducers of cytochrome P450 enzymes (e.g., rifampin, rifabutin, phenytoin, carbamazepine) may reduce the effectiveness of Dovato by decreasing the levels of dolutegravir.
• Other antiviral medications: Dovato should not be combined with other HIV medications that contain lamivudine or dolutegravir to avoid duplication.
• Methadone: Dovato may reduce the effectiveness of methadone, potentially leading to withdrawal symptoms.
• Antacids or supplements containing calcium, aluminum, or magnesium may reduce the absorption of dolutegravir if taken close together.
• Herbal supplements such as St. John’s Wort can reduce the effectiveness of Dovato by increasing the metabolism of dolutegravir.
• Metformin.
• Sorbitol-containing medicines.

Dovato is available in a single tablet strength of 50 mg of dolutegravir and 300 mg of lamivudine. This combination tablet is taken once daily for the treatment of HIV-1 infection.

To store Dovato, keep it at room temperature (between 68°F to 77°F or 20°C to 25°C). Do not freeze the medication. Store the tablet in its original blister pack to protect it from moisture and light. Keep it out of the reach of children and pets.

Dovato is manufactured by ViiV Healthcare, a global company specializing in the development of HIV treatments.

As of now, there is no generic version of Dovato available.

To stop taking Dovato, it is important to follow your healthcare provider's instructions. Do not abruptly discontinue the medication, as this can lead to a rebound increase in HIV viral load. Your doctor may recommend a different treatment regimen or adjust your medications to ensure effective viral suppression. Regular monitoring and follow-up with your healthcare provider are essential to managing HIV when transitioning off Dovato.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you. They can discuss the risks and benefits of taking Dovato. Dovato can increase the risk of neural tube defects in your unborn baby when it's taken during the first trimester of pregnancy. However, it might be possible to take the medication during your second and third trimesters of pregnancy.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.