Pronunciation: doe VAH toe
Generic name: dolutegravir and lamivudine
Dosage form: oral tablet (contains dolutegravir 50 mg and lamivudine 300 mg)
Drug class: Antiviral combinations

Medically reviewed by Carmen Pope, BPharm. Last updated on Sep 2, 2025.

What is Dovato? FDA-Approved 2-Drug HIV-1 Treatment Regimen

Dovato (dolutegravir/lamivudine) is a complete HIV-1 treatment regimen in a single tablet, used to treat adults and adolescents 12 years and older weighing at least 55 pounds [25 kg]. This 2-drug HIV medication combines two powerful antiretroviral drugs (dolutegravir and lamivudine) to effectively suppress HIV viral loads when taken once daily. 

Dovato gained FDA approval on April 8, 2019. There is no generic.

Key Benefits of Dovato HIV Treatment:

• Complete regimen, no additional HIV medications needed
• Once-daily dosing for improved treatment adherence
• 2-drug combination. Fewer medications than traditional 3-drug regimens
• Suitable for treatment-naïve patients and stable, virologically suppressed individuals
• FDA-approved for adolescents 12 years and older
• Can be taken with or without food for convenience.

How does Dovato work? Dual-Action HIV Suppression

Dovato contains two distinct antiretroviral medications that work synergistically to prevent HIV replication through different mechanisms. 

Dolutegravir (50 mg) - Integrase Strand Transfer Inhibitor (INSTI)

• Blocks the HIV integrase enzyme, essential for viral replication
• Prevents viral DNA integration into host cell chromosomes
• High barrier to resistance with proven efficacy
• Rapid viral suppression, typically within 12-24 weeks.

Lamivudine (300mg) - Nucleoside Reverse Transcriptase Inhibitor (NRTI):

• Inhibits the reverse transcriptase enzyme crucial for viral replication
• Acts as a faulty building block for viral DNA synthesis
• Well-established safety profile with decades of clinical use
• Synergistic effect when combined with integrase inhibitors.

This dual-mechanism approach provides robust viral suppression while minimizing the risk of drug resistance development.

Dovato Side Effects: What to Expect

Common Side Effects (Most Frequently Reported)

• Headache, usually mild to moderate
• Fatigue/tiredness may improve over time
• Nausea often decreases with continued use
• Diarrhea, typically temporary
• Anxiety, monitor for mood changes
• Insomnia/sleep problems, discuss with a healthcare provider if persistent.

Serious Side Effects Requiring Immediate Medical Attention

Severe Allergic Reactions:

Dovato may cause an allergic reaction. Call your healthcare provider right away if you develop:

• A skin rash with fever or systemic symptoms
• Breathing difficulties or shortness of breath
• Swelling of the face, lips, tongue, or throat
• Severe skin reactions with blistering or peeling.

Hepatitis B Risks (Boxed Warning):

Pre-treatment HBV testing is required. HBV may mutate and become resistant during treatment, or flare up severely if Dovato is stopped. Never discontinue without medical supervision - requires intensive liver monitoring and possible additional HBV therapy. Always maintain an adequate supply of Dovato and refill before running out.

Liver problems:

People with a history of hepatitis B or C virus may have an increased risk of developing new or worsening changes in certain liver tests during treatment with Dovato. Liver problems, including liver failure, have also happened in people without a history of liver disease or other risk factors. Your healthcare provider may do blood tests to check your liver. Tell your healthcare provider right away if you get any of the following signs or symptoms of liver problems:

• Jaundice: yellowing of skin or eyes
• Dark urine or light-colored stools
• Severe abdominal pain on the right side
• Persistent nausea and vomiting
• Loss of appetite with unexplained weight loss.

Lactic Acidosis (Rare but Serious):

Too much lactic acid is a serious medical emergency that can lead to death. Tell your healthcare provider immediately if you get any symptoms of lactic acidosis, such as:

• Severe weakness or unusual fatigue
• Difficulty breathing or rapid breathing
• Severe stomach pain with nausea
• Cold extremities or unusual temperature changes
• Irregular heartbeat or chest discomfort.

Lactic acidosis may also cause severe liver problems, which can lead to death. Your liver may become large (hepatomegaly), and you may develop fat in your liver (steatosis). Tell your healthcare provider right away if you get any of the signs or symptoms of liver problems, listed above.

Immune Reconstitution Inflammatory Syndrome (IRIS):

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having the following new symptoms after taking Dovato.

• New or worsening infections
• Inflammatory conditions as the immune system recovers
• Autoimmune disorders.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Who Should Not Take Dovato?

Absolute Contraindications:

• Hypersensitivity to dolutegravir, lamivudine, Dovato, or any of the inactive ingredients in the tablets
• Concurrent dofetilide use (life-threatening drug interaction)
• Severe liver impairment, without careful monitoring
• Pregnancy.

Who Should Consider Dovato?

Ideal Candidates:

• Treatment-naïve adults and adolescents 12+ years (≥55 lbs/25 kg)
• Stable, virologically suppressed patients seeking regimen simplification
• Patients preferring fewer medications (2-drug vs 3-drug regimen)
• Those seeking once-daily dosing convenience
• Individuals without dolutegravir or lamivudine resistance.

Pre-Treatment Requirements:

• HIV-1 RNA <50 copies/mL (for treatment-experienced patients)
• No history of treatment failure with current regimen
• No known resistance mutations to dolutegravir or lamivudine
• Comprehensive drug interaction assessment
• Hepatitis B testing before initiation

Before Taking

Before starting treatment, tell your doctor about:

• Kidney problems
• Liver disease or a liver infection, especially hepatitis B or C
• Pregnancy or breastfeeding plans.

It is not known if dolutegravir/lamivudine is safe and effective in children under the age of 12 weighing less than 55 pounds (25 kg).

Pregnancy and Breastfeeding Considerations

Pregnancy Safety Warnings

One of the medicines in Dovato, dolutegravir, may harm an unborn baby if you take the medicine at the time of conception or during the first 12 weeks of pregnancy. Your healthcare provider may prescribe a different medicine if you are planning to become pregnant or if a pregnancy is confirmed during the first 12 weeks of treatment.

If you can become pregnant, you may need to have a negative pregnancy test before starting treatment with Dovato. You and your healthcare provider should talk about the use of effective birth control (contraception) while taking Dovato.

Tell your healthcare provider right away if you are planning to become pregnant, you become pregnant, or think you may be pregnant during treatment with Dovato. There is a pregnancy registry for those who take Dovato during pregnancy that collects information about your health and that of your baby. Talk with your healthcare provider about how you can take part in this registry.

Breastfeeding Considerations

Dovato can pass to your baby in breast milk. Talk with your healthcare provider about the following risks to your baby from breastfeeding during treatment, such as:

• HIV-1 transmission risk through breast milk. 
• HIV-1 may become harder to treat if your baby already has an HIV-1 infection
• Your baby may get side effects from Dovato.
• Avoid breastfeeding is recommended for all HIV-positive individuals.

How should I take Dovato?

Before you start Dovato, your doctor may perform tests to make sure you do not have hepatitis B. Follow all directions in the Dovato Package Insert. Use the medicine exactly as directed.

Standard Dosing for All Eligible Patients:

Recommended Dose: 1 tablet (50 mg dolutegravir + 300 mg lamivudine) once daily.

Administration Instructions:

• With or without food. There are no dietary restrictions
• Same time each day for optimal effectiveness
• Swallow whole, do not crush, chew, or split tablets
• Continue long-term as directed by your healthcare provider
• Never stop abruptly without medical supervision.

Special Considerations:

• Drug interactions: May require dose adjustments with certain medications
• Mineral supplements: Take calcium/iron supplements with food or separate by 2-6 hours
• Antacids: Separate administration by 2 hours before or 6 hours after Dovato

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

If you take too much Dovato, call your healthcare provider or go to the nearest hospital emergency room right away. 

Latest Clinical Updates (2024-2025)

Recent FDA Approvals:

ViiV Healthcare announced FDA approval of Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 in adolescents, expanding access to younger patients meeting weight requirements.

Comparative Effectiveness Data:

Recent findings from AIDS 2024 showed that switching to DTG/3TC in virologically suppressed adults demonstrated non-inferior efficacy in maintaining viral suppression compared with switching to BIC/FTC/TAF, supporting Dovato as an effective maintenance therapy option.

Global Resistance Monitoring:

WHO reports highlight high levels of HIV viral load suppression (>90%) in populations receiving dolutegravir-containing antiretroviral therapy, confirming the continued effectiveness of dolutegravir-based regimens worldwide.

Dovato Cost & Patient Assistance Programs

Pricing & Insurance:

List price: $3,095.69/month (retail up to $3,700). Most patients pay significantly less through insurance coverage.

Financial Assistance Available:

ViiVConnect Savings Card: Eligible patients may pay $0 copay with commercial insurance. Call 1-844-588-3288.

ViiV Patient Assistance Program: Free medication for qualifying uninsured/underinsured patients based on income.

AIDS Drug Assistance Program (ADAP): Federal program covering HIV medications and insurance copays.

Additional Resources: Patient Advocate Foundation, RxAssist, and pharmacy discount programs (up to 80% off cash prices).

What to avoid

Avoid taking an herbal supplement containing St. John's wort. Talk to your healthcare provider about other medications that may interact with Dovato.

If you take antacids, laxatives, or other medicines that contain aluminum, magnesium, or buffered
medicines, you should take Dovato at least 2 hours before or 6 hours after you take these medicines.

Do not run out of Dovato. The virus in your blood may increase, and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy. If you do stop Dovato, you will need regular monitoring to check your health.

What other drugs will affect Dovato?

Some medicines can make Dovato much less effective when taken at the same time. Tell your healthcare provider about all the medicines you take, including OTC medicines, supplements, herbals, or prescription medicines. Especially tell them about:

• antacids or laxatives that contain calcium, magnesium, or aluminum (such as Amphojel, Di-Gel Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, Rulox, Tums, and others), or the ulcer medicine sucralfate (Carafate)

• buffered medicine

• carbamazepine

• rifampin

• St. Johns Wort

• vitamin or mineral supplements that contain calcium or iron (but if you take dolutegravir with food, you can take these supplements at the same time).

Your healthcare provider may give you an extra 50 mg of dolutegravir if you take some other medications, such as carbamazepine. 

If you need to take iron or calcium supplements, including multivitamins that contain iron or calcium, by
mouth during treatment with Dovato:

• You may take these supplements at the same time that you take Dovato with food.
• If you do not take these supplements at the same time as Dovato and food, take Dovato at least 2 hours before or 6 hours after you take these supplements.

Many drugs interact with Dovato. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using. See the prescribing information for a complete list of interactions.

Storage

Store at room temperature away from moisture and heat.

Dovato ingredients

Active ingredients: dolutegravir/lamivudine

Inactive ingredients: magnesium stearate, mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, sodium stearyl fumarate.

Film-coating: hypromellose, polyethylene glycol, titanium dioxide.

Each Dovato tablet contains 50 mg of dolutegravir and 300 mg of lamivudine.

Manufacturer

Dovato is manufactured by ViiV Healthcare, an independent specialist HIV company that focuses exclusively on HIV treatment and prevention. ViiV Healthcare's headquarters are in London, England.

Frequently Asked Questions About Dovato

How effective is Dovato for HIV treatment?

Clinical trials demonstrate that Dovato achieves viral suppression (HIV RNA <50 copies/mL) in >90% of patients when used as prescribed, comparable to traditional 3-drug regimens.

Can I switch to Dovato from my current HIV medications?

Yes, if you're virologically suppressed on your current regimen with no history of treatment failure or resistance to dolutegravir or lamivudine, switching to Dovato may be appropriate.

Is Dovato safe for long-term use?

Yes, both dolutegravir and lamivudine have extensive long-term safety data. Regular monitoring ensures early detection of any potential issues.

Does Dovato interact with birth control pills?

Dovato doesn't significantly affect hormonal contraceptive effectiveness, but discuss all contraceptive methods with your healthcare provider.

Can I drink alcohol while taking Dovato?

Moderate alcohol consumption is generally acceptable, but excessive alcohol use can worsen liver problems. Discuss alcohol use with your healthcare provider.

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