Dovato
Dovato (dolutegravir / lamivudine) is used to treat human immunodeficiency virus (HIV) infections. It's considered a complete HIV treatment regimen with only two antiretroviral (ARV) medications: dolutegravir and lamivudine. One of the benefits of Dovato (dolutegravir / lamivudine) is that it combines two medications into a single tablet so it's convenient to take. Possible side effects of Dovato (dolutegravir / lamivudine) can include headache and weight gain, but they aren't very common with this medication.
What is Dovato (dolutegravir / lamivudine)?
What is Dovato (dolutegravir / lamivudine) used for?
Treatment of HIV infection in adults
How Dovato (dolutegravir / lamivudine) works
Dovato (dolutegravir / lamivudine) is a combination of two medications that help fight HIV.
Dolutegravir is an integrase inhibitor. Integrase is an enzyme (protein) that HIV uses to insert its genetic information into your cells. Once inserted, HIV uses your cells to make more copies of itself. Dolutegravir works by blocking integrase, which then helps prevent HIV from spreading.
Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI). It blocks an enzyme found in HIV called reverse transcriptase that usually helps the virus make copies of itself. By blocking reverse transcriptase, lamivudine prevents HIV from making copies of itself and spreading.
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What are the side effects of Dovato (dolutegravir / lamivudine)?
Common Side Effects
- Higher blood sugar levels (up to 11%)
- Lower phosphate levels (up to 11%)
- Higher creatine kinase levels in the blood (up to 8%)
- Higher lipase levels (up to 7%)
- Abnormal liver labs (up to 5%)
- Headache (3%)
- Weight gain (3%)
- Nausea (2%)
- Diarrhea (2%)
- Trouble sleeping (2%)
- Feeling tired (2%)
- Anxiety (2%)
Other Side Effects
- Dizziness
- Belly pain
- Vomiting
- Passing gas
- Feeling depressed
- Strange dreams
Serious Side Effects
- Severe allergic reactions: fever, rash, extreme tiredness, body aches, mouth sores, blisters, trouble breathing
- Serious liver problems: nausea, vomiting, not feeling hungry, pain in the right side of the stomach, yellowing of the whites of the eyes or skin, dark-colored urine, light-colored stool
- Too much lactic acid in the blood: weakness, tiredness, fast and shallow breathing, nausea, vomiting, fast heartbeat, confusion
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- High lactic acid level—muscle pain or cramps, stomach pain, trouble breathing, general discomfort and fatigue
- Infection—fever, chills, cough, or sore throat
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Diarrhea
- Fatigue
- Headache
- Nausea
- Trouble sleeping
- Worsening mood, feelings of depression
Pros and cons of Dovato (dolutegravir / lamivudine)
Pros
First-choice treatment option for most adults starting HIV medications
Only contains two ARVs and is considered a complete HIV treatment regimen, which is less medications than other complete regimens
Combines two medications into one pill for convenience
Only taken once a day
Can take with or without food
Cons
Interacts with a lot of medications, such as anti-seizure medications (e.g., oxcarbazepine (Trileptal)), metformin, and antacids
Can't take with dofetilide (Tikosyn) because of risk of serious side effects
Not approved for use in children
Not recommended for use if you have severe kidney or liver problems
Shouldn't use if you have both HIV and hepatitis B (HBV)
Pharmacist tips for Dovato (dolutegravir / lamivudine)
Make sure to get your routine blood tests done on time while you’re taking Dovato (dolutegravir / lamivudine). This helps your provider make sure the medication is working for you and not causing side effects.
Let your provider or pharmacist know what medications you're taking or planning to take, including over-the-counter products and supplements. Dovato (dolutegravir / lamivudine) can interact with many medications. These interactions can affect how well your medications work or how safe they are for you.
Take Dovato (dolutegravir / lamivudine) 2 hours before or 6 hours after antacids (e.g., Tums) and medications containing calcium, iron, magnesium, or aluminum. These medications can interfere with how your body absorbs Dovato (dolutegravir / lamivudine) and cause it to not work as well at treating HIV.
You can take iron and calcium supplements at the same time as Dovato (dolutegravir / lamivudine) as long as you take everything together with food. Otherwise, take Dovato (dolutegravir / lamivudine) 2 hours before or 6 hours after the supplement.
Dovato (dolutegravir / lamivudine) can cause life-threatening allergic reactions. If you experience fever, rash, extreme tiredness, body aches, or trouble breathing, get medical attention right away.
Talk to your provider before stopping Dovato (dolutegravir / lamivudine) or any of your HIV medications. Doing so can cause the virus to spread and become harder to treat. And if you also have hepatitis B, stopping Dovato (dolutegravir / lamivudine) suddenly can cause your hepatitis B infection to come back or worsen.
Frequently asked questions about Dovato (dolutegravir / lamivudine)
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What are the risks and warnings for Dovato (dolutegravir / lamivudine)?
Dovato (dolutegravir / lamivudine) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Worsening of hepatitis B infection if you have HIV and hepatitis B
Risk factors: Have hepatitis B and HIV | Stopping Dovato (dolutegravir / lamivudine) | Severe liver problems
If you have hepatitis B virus (HBV), taking Dovato (dolutegravir / lamivudine) can make it easier for HBV to change form. This means the virus can become harder to treat. Before you begin Dovato (dolutegravir / lamivudine) treatment, your provider will test you for HBV. If you have HBV, your provider will make sure you're getting appropriate treatment for both HIV and HBV.
If you have HBV, suddenly stopping Dovato (dolutegravir / lamivudine) can also make your liver condition worse (also called an HBV flare-up). Don't stop taking Dovato (dolutegravir / lamivudine) without talking with your provider first. Make sure to get your refills on time so that your treatment isn't interrupted. If you need to stop taking Dovato (dolutegravir / lamivudine), your provider will follow up with you for several months after you stop treatment. They'll order blood work to check your liver for an HBV flare-up.
Allergic reaction
Risk factor: History of allergy to dolutegravir
Although rare, Dovato (dolutegravir / lamivudine) can cause allergic reactions that are sometimes severe and life-threatening. Watch out for allergic reactions, such as severe rash with fever, general discomfort, muscle or joint pain, mouth sores, blisters, facial swelling, or trouble breathing. Stop taking Dovato (dolutegravir / lamivudine) right away and get medical attention if you experience these symptoms.
If you have a serious allergic reaction, your provider will probably switch you to a different medication to treat HIV. Your provider might also check your liver function through blood work since severe allergic reactions can sometimes lead to liver injury.
Liver problems and lactic acidosis
Risk factors: Obesity | Females | Hepatitis B or C
Rarely, people who take medications that contain dolutegravir, such as Dovato (dolutegravir / lamivudine), can experience liver problems. While liver injury can happen to anyone taking these medications, the risk of worsening liver problems might be higher if you also have hepatitis B or hepatitis C. Talk with your provider about your medical history before starting this medication so they can decide how you can safely take Dovato (dolutegravir / lamivudine).
Additionally, lamivudine in Dovato (dolutegravir / lamivudine) can cause a buildup of lactic acid in the blood (lactic acidosis) and fatty liver. Both conditions can be life-threatening, and you might be more likely to experience them if you're female or obese.
Make sure to get blood tests done while you take Dovato (dolutegravir / lamivudine) so your provider can check your liver health. If you experience signs and symptoms of liver damage, such as upper right stomach pain, yellowing of the skin or whites of the eyes, or dark urine, talk with your provider right away. Also, let your provider know if you experience symptoms of lactic acidosis, such as feeling weak, muscle pain, and trouble breathing.
Overactive immune system
Taking Dovato (dolutegravir / lamivudine) can cause changes to your immune system called immune reconstitution syndrome. This medical condition happens when your immune system becomes more active after you start Dovato (dolutegravir / lamivudine) treatment. Your immune system begins to fight off different infections that it was too weak to fight off before you started treatment. In rare cases, your immune system might improve so much with treatment that it starts to attack normal cells in your body (autoimmune). You can develop immune reconstitution syndrome as early as during the first few weeks of Dovato (dolutegravir / lamivudine) treatment or many months later. Tell your healthcare provider right away if you start having any new symptoms, such as fever, pain, hair loss, bulging eyes, or sweating, after starting Dovato (dolutegravir / lamivudine).
Interaction with other medications
Some medications can interfere with how your body gets rid of Dovato (dolutegravir / lamivudine) from your system. This can affect the amount of Dovato (dolutegravir / lamivudine) in your body, how well it works, and the risk of side effects.
When taken with Dovato (dolutegravir / lamivudine), certain medications can lower the amount of Dovato (dolutegravir / lamivudine) in your body and cause it to not work as well at treating HIV. Because of this effect, avoid taking certain medications for seizures (e.g., carbamazepine (Tegretol), phenytoin (Dilantin)) or antibiotics (e.g., rifampin (Rifadin)) along with Dovato (dolutegravir / lamivudine). Also make sure to take Dovato (dolutegravir / lamivudine) 2 hours before or 6 hours after taking antacids like calcium carbonate (Tums) to prevent this interaction from happening.
Harm to unborn baby
Taking Dovato (dolutegravir / lamivudine) during early pregnancy might raise the risk for birth defects called neural tube defects in babies. Because of this potential risk, if you're able to have a child, your provider will ask you to take a pregnancy test to check if it's safe for you to take Dovato (dolutegravir / lamivudine). They'll also discuss with you about birth control options during your treatment with Dovato (dolutegravir / lamivudine). It might be possible to take Dovato (dolutegravir / lamivudine) in the second and third trimesters of pregnancy, but only if the benefit is greater than the risk of harm to the unborn baby. If you're pregnant or are planning to become pregnant, discuss your HIV treatment options with your provider.
Dovato (dolutegravir / lamivudine) dosage forms
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 50mg/300mg | 30 tablets | $2896.68 | $96.56 |
Typical dosing for Dovato (dolutegravir / lamivudine)
The typical dose is 1 tablet by mouth once daily. Each tablet contains 50 mg of dolutegravir and 300 mg of lamivudine.
Your dose might differ if you're also taking carbamazepine (Tegretol) or rifampin (Rifadin).
How much does Dovato (dolutegravir / lamivudine) cost?
Dovato (dolutegravir / lamivudine) contraindications
Taking dofetilide (Tikosyn) at the same time
What are alternatives to Dovato (dolutegravir / lamivudine)?
Treatment of HIV infection in adults
Treatment of HIV infection (in people who weigh at least 22 pounds)
Starting HIV treatment for the first time, or
Have a HIV viral load of less than 50 copies/mL from a previous ART
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References
Best studies we foundCenters for Disease Control and Prevention. (2023). Facts about neural tube defects.
Clinical Info HIV.gov. (n.d.). Immune reconstitution inflammatory syndrome (IRIS).
Clinical Info HIV.gov. (n.d.). Integrase.
Clinical Info HIV.gov. (n.d.). Nucleoside reverse transcriptase inhibitor (NRTI).
Clinical Info HIV.gov. (n.d.). Reverse transcriptase (RT).
Clinical Info HIV.gov. (n.d.). Viral load test.
Clinical Info HIV.gov. (2022). Guidelines for the use of antiretroviral agents in adults and adolescents with HIV: What to start.
Department of Health and Human Services and Centers for Disease Control and Prevention. (2021). Preexposure prophylaxis for the prevention of HIV infection in the United States – 2021 update: Clinical practice guidelines.
Eckard, A. R., et al. (2020). Weight gain and integrase inhibitors. Current Opinion in Infectious Diseases.
Gilead Sciences, Inc. (2022). Biktarvy- bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate tablet [package insert]. DailyMed.
HIVinfo.NIH.gov. (2021). Drug resistance.
Kanters, S., et al. (2022). Evidence synthesis evaluating body weight gain among people treating HIV with antiretroviral therapy - A systematic literature review and network meta-analysis. eClinicalMedicine.
MedlinePlus. (2017). Fatty liver disease.
MedlinePlus. (2021). Hypophosphatemia.
MedlinePlus. (2022). Lipase tests.
MedlinePlus. (2023). Creatine kinase.
Panza, E., et al. (2020). Behavioral weight loss: A promising treatment for obesity in adults with HIV. AIDS and Behavior.
Thapa, S., et al. (2023). Immune reconstitution inflammatory syndrome. StatPearls.
ViiV Healthcare Company. (2023). Dovato- dolutegravir sodium and lamivudine tablet, film coated [package insert]. DailyMed.
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