Dovato

Dovato (dolutegravir/lamivudine) is a complete, once-daily HIV-1 treatment combining two antiretroviral medications in a single tablet. Dovato is FDA-approved to treat HIV-1 infection in adults and adolescents 12 years and older weighing at least 55 pounds (25 kg). Unlike traditional three-drug HIV regimens, Dovato uses only two medications to effectively suppress HIV viral loads, offering a simplified treatment approach for eligible patients.

Dovato contains 50 mg of dolutegravir (an integrase strand transfer inhibitor) and 300 mg of lamivudine (a nucleoside reverse transcriptase inhibitor). This 2-drug combination provides complete HIV treatment without requiring additional antiretroviral medications.

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

Dovato Quick Facts

• Generic Name: Dolutegravir/Lamivudine
• Brand Name: Dovato
• Drug Class: HIV-1 Treatment (INSTI + NRTI combination)
• Suitable for: Treatment-naïve patients and stable, virologically suppressed adults and adolescents ≥ 12 years
• Manufacturer: ViiV Healthcare
• FDA Approved: April 8, 2019
• Dosage Form: Oral tablet
• Typical Dose: One tablet (50mg/300mg) once daily
• Administration: With or without food
• Prescription Required: Yes
• Availability: Brand-name only (no generic)

Dovato is used to treat HIV-1 infection in two main patient populations:

• Treatment-Naïve Patients: Adults and adolescents (12 years and older, ≥55 lbs/25 kg) who have never received HIV treatment before and have no known resistance to dolutegravir or lamivudine.
• Treatment-Experienced Patients: Adults and adolescents who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on their current antiretroviral regimen for at least 3-6 months, with no history of treatment failure or resistance to either component of Dovato.

Dovato is a complete HIV treatment regimen and does not require additional antiretroviral medications to be effective.

Dovato works through two distinct mechanisms to prevent HIV from replicating in your body.

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

• Blocks the HIV integrase enzyme, essential for viral replication
• Prevents viral DNA from integrating into host cell chromosomes
• Provides a high barrier to resistance with proven efficacy
• Achieves 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. By targeting two different steps in the HIV lifecycle, Dovato effectively prevents the virus from multiplying in the body.

Most patients taking Dovato achieve undetectable viral loads (HIV-1 RNA <50 copies/mL) within 12 to 24 weeks of starting treatment.

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.

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 Information

Dovato can pass to your baby through your 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.

Most Common Side Effects

• 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.

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.

Dovato Administration Instructions

• With or without food: Dovato can be taken with or without meals - there are no dietary restrictions
• Same time daily: Take Dovato at approximately the same time each day for optimal effectiveness
• Swallow whole: Do not crush, chew, or split Dovato tablets
• Long-term use: Continue taking Dovato long-term as directed by your healthcare provider
• Never stop abruptly: Do not discontinue Dovato without medical supervision

Standard Dovato Dosage for All Eligible Patients:

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

Special Dosing Considerations for Dovato

Drug Interactions Requiring Dose Adjustments:

• Your healthcare provider may prescribe an additional 50 mg dolutegravir tablet if you take certain medications such as carbamazepine, rifampin, or other enzyme-inducing drugs

Mineral Supplements and Dovato:

• Calcium or iron supplements can be taken with Dovato if taken with food
• If not taken with food, separate Dovato from calcium/iron supplements by 2 hours before or 6 hours after

Antacids and Dovato:

• Take antacids containing aluminum, magnesium, or calcium at least 2 hours before or 6 hours after Dovato.

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.

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

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).

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.

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.

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.

Store at room temperature away from moisture and heat.

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.

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.