Dovato dosage, forms, and strengths

Dovato is a brand-name prescription drug that serves as a complete two-drug antiretroviral treatment for HIV-1 infections. The human immunodeficiency virus or HIV-1 causes HIV/AIDS. The virus attacks the body’s immune system. Although daily HIV/AIDS treatment usually involves three antiretroviral drugs, Dovato’s two-drug antiretroviral regimen (dolutegravir and lamivudine) reduces the amount of virus in the body by blocking its ability to reproduce. Healthcare providers only use the drug at the start of therapy and in people whose viral levels are low. People prescribed Dovato will take a single fixed-dose tablet once per day. 

Dovato forms and strengths

Dovato is a fixed-dose tablet that’s taken once per day.

• Tablet: Dolutegravir 50 mg/lamivudine 300 mg

Dovato dosage for adults

Dovato is a complete two-drug, fixed-dose antiretroviral treatment for HIV-1 infections in adults. Antiretroviral therapy aims not to eradicate the infection but to reduce the number of viruses in the body called the viral load. As a two-dose regimen, Dovato is only approved by the U.S. Food and Drug Administration (FDA) to treat people who have not yet taken antiretroviral drugs or have sustained low virus counts on their current antiretroviral treatment.

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Dovato dosage for HIV-1 infections

The two components of Dovato, dolutegravir and lamivudine, reduce HIV-1 levels in the body. HIV-1 viral suppression helps to prevent full-blown AIDS. It’s designed to keep people healthy even with an HIV infection. 

Human immunodeficiency virus is a primitive virus called a retrovirus that needs extra steps to copy its genetic information in order to make more virus particles. Drug treatment that targets those extra steps is called antiretroviral therapy or ART. The two drugs in Dovato work by interfering with the virus’s ability to copy its genetic information, but they do so in different ways. 

Most antiretroviral therapies consist of three drugs that target at least two separate processes in viral reproduction. Dovato only has two active ingredients. For this reason, it’s only considered appropriate in people who are first starting antiretroviral therapy (called ART-naïve patients) or people already taking ART drugs who have undetectable viral counts (called virally-suppressed patients), are stable on their ART drugs, have no history of treatment failure, and are not infected with hepatitis B virus (HBV).

Dovato doses are fixed and taken once per day. 

• Standard dosage for HIV-1 infection: One 50/300 mg tablet taken once per day

• Maximum dosage for HIV-1 infection: One 50/300 mg tablet taken once per day

Dovato dosage for children

The Food and Drug Administration has not approved the use of Dovato in children or adolescents younger than 18. Dovato doses cannot be adjusted for children.

Dovato dosage restrictions

Dovato is a fixed-dose treatment, so no dosage adjustments are possible. If someone requires a dosage adjustment, healthcare professionals must prescribe each drug separately, such as Tivicay (dolutegravir) tablets and lamivudine tablets. 

• Moderate renal impairment (creatinine clearance 30-49 mL/min): Monitor for blood problems or adjust lamivudine dose by prescribing separate tablets

• Severe or end-stage renal impairment (creatinine clearance < 30 mL/min): Adjust dose by prescribing separate tablets

• Hepatically impaired patients (mild to moderate): No dose adjustment required

• Severe hepatic impairment: Dovato is not recommended in people with severe liver disease

How to take Dovato

Dovato is taken every day. While taking Dovato is like taking any other tablet, it’s vital that you do not miss doses. Dovato can successfully hold back the replication of an HIV infection only if doses are taken almost every day. If doses are missed, this may make the virus resistant to the drugs and more challenging to treat. 

• Your doctor will tell you how much medicine to use. Use only directed.

• Read the Patient Information Sheet that comes with this medicine.

• Take one tablet per day.

• Dovato tablets can be taken with a meal or on an empty stomach.

• Calcium or iron supplements may be a problem:

  • Calcium or iron supplements can be taken with Dovato if everything is taken with food.

  • If Dovato is taken on an empty stomach, then Dovato should be taken at least two hours before or six hours after you’ve taken a calcium or iron supplement.

• Don’t change the dose, and don’t stop taking Dovato until you talk to the doctor.

• Store Dovato tablets at room temperature below 86˚F.

Dovato dosage FAQs

How long does it take Dovato to work?

The two drugs in Dovato immediately begin to block the ability of HIV-1 to replicate. However, people usually do not notice this. Dovato’s effects are typically evident with blood tests that measure the amount of HIV genetic material (HIV-1 RNA) in the blood. 

No news is good for people with undetectable virus counts on a stable antiretroviral regimen. The goal of Dovato treatment is to maintain those low virus counts. In clinical trials, Dovato kept viral counts low in 93% of participants after two years of treatment. 

Dovato very quickly reduces the viral load for people just starting antiretroviral therapy. In clinical trials, participants experienced a 70% drop in their virus counts in the first four weeks. Maximum reduction in virus counts—about 90%—occurred at 24 months of treatment.

What happens if I miss a dose of Dovato?

Dovato is taken once per day. Take a missed dose as soon as it’s remembered on the same scheduled day. If it’s the next day, take that day’s dose and skip the missed dose. Do not take two doses to make up for a missed dose.

It’s important never to miss a Dovato dose. For HIV antiretroviral treatment to succeed, 95% of the daily doses must be taken on time. That’s a very demanding expectation, but missed doses allow the virus to grow back. This increases the risk that the virus will develop drug resistance. If you forget too many doses, ask a pharmacist for suggestions. They can suggest tools to help remember daily doses, such as alarms, apps, calendars, or other aids. 

How do I stop taking Dovato?

Dovato can be safely stopped without causing withdrawal symptoms. However, only stop taking Dovato if told to do so by a doctor. Antiretroviral therapy does not cure HIV-1. It just reduces the amount of virus in the body. Quitting anti-HIV drugs causes the virus to start replicating again. People with a hepatitis B virus infection may experience a worsening of the hepatitis infection if they stop taking lamivudine.

You may need to stop taking Dovato if you have an allergic reaction such as itching (pruritus), rash, facial swelling, or trouble breathing. However, you must call the doctor so there’s no treatment break.

Before doctors discontinue Dovato, they will prescribe an alternative drug regimen for HIV-1. The combination of drugs will vary depending on virus counts, your history, and any evidence of treatment failure. Dovato combines two classes of antiretroviral drugs: a nucleoside reverse transcriptase inhibitor (NRTI) and an integrase inhibitor (INSTI). You may be switched to a combination of two NRTIs (emtricitabine-tenofovir) and a different INSTI (such as bictegravir). Alternatively, you may be switched to a three-drug combination involving other drug classes.

What is the maximum dosage for Dovato?

The maximum dosage of Dovato is one 50 mg/300 mg tablet daily. People taking the antibiotic rifampin or the seizure medication carbamazepine will need to take an additional dolutegravir 50 mg tablet 12 hours after each day’s Dovato dose.

What interacts with Dovato?

Dovato may cause problems when combined with other medications. One potentially hazardous drug interaction involves the atrial fibrillation treatment dofetilide. The combination may cause serious or life-threatening adverse reactions, so the coadministration of dofetilide and Dovato is contraindicated.

Because of possible drug interactions, tell the prescribing doctor about all prescription drugs, over-the-counter medications, and supplements that you’re taking. You especially need to tell the doctor about drugs or supplements such as:

• Other antiretroviral drugs

• The anticonvulsants carbamazepine, oxcarbazepine, phenytoin, and phenobarbital

• The antibiotic rifampin

• The diabetes drug metformin

• The multiple sclerosis drug dalfampridine

• The ulcer medication sucralfate

• Any buffered medicine

• Dietary supplements, antacids, or laxatives containing cations such as calcium, iron, or magnesium

• St. John’s wort

• The artificial sweetener sorbitol

What happens when you mix Dovato and alcohol?

Drinking alcohol is not forbidden for people taking Dovato. However, drinking may add to some of Dovato’s side effects, such as nausea or dizziness. 

Is it safe to take Dovato during pregnancy?

Dovato should only be continued in pregnant patients who are currently on it. Healthcare providers use Dovato in pregnant women with low viral counts but use other drugs in women with higher virus counts. Dovato is not entirely safe for an unborn baby. There’s a minimal risk of neural tube defects if Dovato is taken during the first six weeks following conception. Neural tube defects can result in serious birth defects such as spina bifida or not being born with a complete brain. Women with childbearing potential may need to use contraception or have regular pregnancy testing when taking Dovato. Women who are pregnant while taking Dovato will be asked to register with a pregnancy registry to monitor the effects of the drug during their pregnancy.

Is it safe to take Dovato while breastfeeding?

The Centers for Disease Control and Prevention (CDC) advises all HIV-infected women not to breastfeed their infants. There’s a risk they can infect their nursing baby. Women with detectable levels of HIV should not breastfeed because of this risk. However, the risk of transmission is less than 1% for women who have sustained undetectable virus levels throughout pregnancy. However, 1% isn’t the same as “never.” Infants possibly exposed to HIV through breastfeeding will need to be tested for HIV. For virologically suppressed women who do decide to breastfeed, Dovato treatment is not considered a problem. Healthcare professionals don’t know if Dovato affects lactation. However, both dolutegravir and lamivudine are present in breast milk, but it’s uncertain if they might harm the nursing infant.

What should I know about the side effects of Dovato?

The most common side effects of Dovato are headache, nausea, diarrhea, and elevations of liver enzymes. However, only a small percentage of people have these complaints when taking Dovato. The most serious adverse events are liver toxicity, severe anemia, pancreatitis, muscle damage, lactic acidosis, peripheral neuropathy, suicidal thoughts, hypersensitivity reactions, and immune reconstitution syndrome (a potentially serious side effect of any HIV treatment). 

What should I know about the risks of taking Dovato?

The FDA has mandated a black box warning that Dovato could cause serious side effects in people infected with hepatitis B virus, including the growth of a drug-resistant strain of HBV and worsening of HBV when people stop taking lamivudine, one of the individual components of Dovato.

Sources

• Dovato dolutegravir sodium and lamivudine tablet prescribing information, NIH National Library of Medicine

• Dovato HCP website, ViiV Healthcare

• Guidelines for the use of antiretroviral agents in adults and adolescents with HIV, HIV.gov 

• HIV antiretroviral therapy, StatPearls