Reviewed by: HU Medical Review Board | Last reviewed: March 2023

Dovato is a combination medication that contains dolutegravir, and lamivudine. It is used on its own as a standalone antiretroviral therapy (ART) regimen for HIV-1 in adults with no previous HIV antiviral treatment history. Dovato can also be used to replace current antiretroviral treatment in those who have achieved viral suppression (HIV-1 RNA less that 50 copies per mL) with no treatment failure and no known resistance mutations to the ingredients in Dovato.

Although it is not a cure for HIV, when taken as directed, it allows for the virus to be suppressed. This prevents further transmission of HIV and allows an individual’s immune system to improve through increasing CD4 cell counts and decreasing the amount of active virus in the blood (viral load).

What are the ingredients in Dovato?

The main ingredients in Dovato are dolutegravir and lamivudine. Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI), while dolutegravir is an integrase strand transfer inhibitor (INSTI, also known as an integrase inhibitor).

If you take carbamazepine or rifampin at the same time as Dovato, you will need to adjust your dosage of Novato. Talk to your doctor about how to do this.

How does Dovato work for HIV?

Dovato is a combination of an NRTI medication and an integrase inhibitor. NRTIs stop the reverse transcription step of the HIV life cycle. Normally, HIV uses its reverse transcriptase enzyme to build a strand of DNA from its original RNA form. In order to do this, it uses genetic building blocks called nucleosides that come from the host cell. These nucleosides are strung together one at a time, like beads on a string, to create the final DNA product.

NRTIs act as nucleoside mimics that stop the DNA-building process. NRTIs look like normal nucleosides, except they’re missing a special chemical group on one side. Without this group, the reverse transcriptase enzyme is unable to attach more nucleosides to the chain after them. This prevents the full string of DNA from being formed, preventing HIV RNA from making it all the way through the reverse transcription process.

How do integrase inhibitors work?

After HIV RNA is reverse transcribed into newly-formed DNA, it gets integrated into the host cell DNA using an enzyme called integrase. This allows HIV to be actively replicated with the rest of our DNA as our cell carries out its normal functions.

Integrase inhibitors can be used to block the integrase enzyme and prevent the integration of HIV DNA into our host cells. If HIV’s DNA cannot be inserted into our host cells’ genome, the virus cannot continue to be replicated, assembled into mature virus particles, and released into the blood to continue infecting other cells.

Possible side effects

The most common side effects of Dovato include, but are not limited to:

  • Insomnia
  • Headache
  • Nausea
  • Diarrhea
  • Fatigue
  • Anxiety

These are not all the possible side effects of Dovato. Talk to your doctor about what to expect when taking Dovato. You also should call your doctor if you have any changes that concern you when taking Dovato.

Things to note

Dovato has a boxed warning, the strictest warning from the US Food and Drug Administration (FDA). It has this warning because of the possibility of serious side effects as described below.

As with any medication, there are several very rare but serious risks that need to be considered before taking Dovato. Your healthcare provider can help determine what issues you may be at risk for and help determine what treatment options are the safest for you. It’s also important to remember that the risk of one or more of these issues occurring is low, and the benefits of treating the virus often greatly outweigh the risks.

Several of these rare but serious side effects of Dovato include liver issues and an increase of lactic acid in the blood (lactic acidosis). Signs of liver issues include, but are not limited to:

  • Dark-colored urine
  • Loss of appetite
  • Nausea
  • Yellowing of the whites of the eyes or skin
  • Light-colored bowel movements
  • Pain or tenderness on the right side of your stomach

Signs of lactic acidosis include, but are not limited to:

  • Trouble breathing
  • Feeling cold, especially in the limbs
  • Dizziness or lightheadedness
  • Feeling tired or weak
  • Muscle pain
  • Nausea and vomiting
  • Irregular or fast heartbeat

If you have hepatitis B virus and start taking Dovato, your hepatitis B may get worse. Individuals taking a medication called dofetilide should not take Dovato, as serious or life-threatening side effects may occur.

Rarely, allergic reactions may occur with Dovato and may be serious. Alert your healthcare provider if you notice any of the following:

  • Skin blisters or peeling
  • Mouth sores
  • Swelling of the lips, mouth, face, or throat
  • Fever
  • Trouble breathing or swallowing
  • Redness or swelling of the eyes
  • Generally feeling ill
  • Tiredness
  • Muscles or joint aches

Before starting Dovato, tell your doctor if you:

  • Have or previously had hepatitis B virus
  • Have or previously had hepatitis C virus
  • Have a history of liver or kidney problems
  • Are pregnant or planning to become pregnant (pregnancy testing is recommended before starting therapy as Dovato can cause fetal harm)
  • Are breastfeeding or planning to breastfeed
  • Are taking any over-the-counter vitamins, supplements, medicines, or herbal remedies
  • Are on any other medications or are about to start any other medications, including hormonal birth control or medications for hepatitis viruses

Dovato may cause a condition called IRIS (immune reconstitution inflammatory syndrome). IRIS occurs when an individual’s immune system gets stronger after being weak and responds aggressively to previously hidden infections. This heightened response may make the person fighting the infection feel worse. Alert your healthcare provider immediately if you begin to have new symptoms after taking Dovato.

Pregnancy and lactation risk

Preliminary data suggests that using dolutegravir at the time of conception may increase the risk of neural tube defects in embryos. These defects occur during the first 6 weeks of pregnancy. Due to limited understanding and uncertainty about the specific types of neural tube defects, it is advised to avoid using Dovato from conception to the first trimester.

No neural tube defects have been reported when dolutegravir is taken after the first trimester.

If you are planning to become pregnant or are already pregnant and in the first trimester, it is recommended that you switch to an alternative treatment.

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