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What are 9 key Dovato side effects to watch out for?

Medically reviewed by Kristianne Hannemann, PharmD. Last updated on May 29, 2024.

Official answer

by Drugs.com

Key Points

  • Dovato (dolutegravir and lamivudine) is a once-daily combination medication that may be given to treat HIV-1 infection in people 12 years and older who weigh at least 25 kg.
  • Potential side effects of Dovato include abnormal labs, headache, nausea, diarrhea, insomnia, and fatigue.
  • Less common side effects from taking Dovato that can be serious include severe allergic reactions, liver damage, and immune reconstitution syndrome.

What is Dovato?

Dovato (dolutegravir and lamivudine) is combination antiviral medication that may be used to treat HIV-1 in adults and adolescents ages 12 years and older who weigh at least 25 kg. It contains an integrase strand transfer inhibitor (INSTI) and a nucleoside analogue reverse transcriptase inhibitor (NRTI). Dovato comes as a tablet that’s taken by mouth once a day.

9 side effects of Dovato and how to manage them

The safety of Dovato in treatment-naïve adults was assessed in two clinical trials: GEMINI-1 and GEMINI-2. In people taking other HIV medications, Dovato was studied as a replacement medication in a clinical trial called TANGO. It was also studied in people ages 12 to less than 18 years old weighing at least 25 kg in a clinical trial called DANCE. Researchers concluded that the side effects seen in the TANGO and DANCE trials were similar to those seen in the GEMINI trials.

Below, we’ll review 9 side effects* of Dovato that you should watch out for. Most side effects are mild and can be managed at home. We’ll also go over some tips on how to feel better so that you can continue your treatment.

1. Abnormal labs

In 144-week studies, abnormal lab values were observed in people taking Dovato. These included liver enzymes, bilirubin, creatine kinase, blood glucose, phosphate, and lipase. Additionally, people taking Dovato had a 15 mg/dL average increase in cholesterol and a 10 mg/dL average increase in triglycerides.

Make sure to get all blood work and tests done that are ordered by your doctor. This will help your healthcare team make sure Dovato is not causing any abnormal lab values.

2. Headache

Headaches are a common complaint among people infected with HIV. Therefore, it can be hard to know if headache symptoms are due to the infection or if they are a side effect from taking medication. About 3% of people taking Dovato reported headache as a side effect during clinical studies.

Tips for managing headache

  • Drink plenty of fluids to stay hydrated
  • Keep your environment quiet
  • Rest in a dark room
  • Perform relaxation techniques, like deep breathing, yoga, or meditation
  • Try using over-the-counter pain relievers to manage pain
  • Apply a warm or cold compress to your forehead

If your headache is severe or is not getting better after trying the tips above, get medical attention. Your doctor can evaluate you and make sure it is not due to an infection or other serious medical condition.

3. Nausea

Around 2% of people who take Dovato experience nausea. Because Dovato can be taken with or without food, try taking it with a snack or meal if you are feeling nauseous. You can also try to take your dose at night instead of in the morning. Below are a few other tips you can try that may help you feel better.

Tips for managing nausea

  • Eat small meals throughout the day
  • Do not eat greasy or spicy foods
  • Choose bland foods (e.g., rice, broth, crackers)
  • Avoid eating too quickly
  • Drink fluids throughout the day to stay hydrated
  • Keep upright after eating
  • Try drinking ginger or peppermint tea

Contact your doctor if you feel so nauseous that it is interfering with your normal daily activities or causing you to eat less food than usual.

4. Diarrhea

You may experience diarrhea while taking Dovato. In clinical trials, around 2% of people taking Dovato reported having diarrhea. Diarrhea is having more frequent and watery stool than normal. It has many causes, including infection, eating spoiled food, and medications.

If your diarrhea is mild, it can typically be managed at home until it resolves. However, if it is severe or you develop symptoms of dehydration, you should contact your doctor or get medical attention.

Tips for managing diarrhea

  • Stay well-hydrated
  • Avoid greasy or spicy foods
  • Try an over-the-counter antidiarrheal

Related questions

5. Insomnia

Another possible side effect from taking Dovato is insomnia, with around 2% of people taking it reporting trouble sleeping. Not getting enough sleep can have a large impact on your mood and ability to function normally during the day.

Tips for managing insomnia

  • Reduce the noise in your sleeping environment
  • Make the room where you are sleeping dark
  • Adjust the temperature in your room so you feel comfortable
  • Avoid caffeine late in the day or at night
  • Do not take naps too late in the day
  • Avoid using electronics before bedtime
  • Exercise regularly
  • Do not eat too close to bedtime

Practicing good sleep hygiene can help make it easier for you to get the rest you need. However, it is important that you contact your doctor if you are struggling with sleep despite making some changes. They can recommend other ways to help you get better sleep at night, or prescribe a sleep medication if needed.

6. Fatigue

In studies, around 2% of people taking Dovato reported feeling tired, weak, or unwell. Sometimes, it can take time for your body to get used to a new medication. If you are having persistent low energy levels, talk to your doctor. They can help you find out the cause and suggest things you can try to feel better again.

Tips for managing fatigue

  • Get enough sleep at night
  • Maintain a healthy, well-balanced diet
  • Drink enough fluids to stay hydrated each day
  • Build breaks into your schedule to rest

7. Severe allergic reactions

Although rare, serious allergic reactions from Dovato are possible. In some cases, these reactions can cause difficulty breathing and damage to your organs.

If you notice a rash, let your doctor know. Stop taking Dovato and get medical attention if you develop a rash with any of the following symptoms:

  • Fever
  • Feeling unwell
  • Extreme tiredness
  • Muscle aches
  • Blisters
  • Peeling skin
  • Mouth sores
  • Eye irritation
  • Facial swelling
  • Difficulty breathing
  • Nausea or vomiting
  • Dark urine
  • Pale-colored stools

These can be signs of a serious allergic reaction that will require immediate treatment.

8. Liver problems

Liver injury is also possible from taking Dovato. The risk might be higher in patients who also have a hepatitis B or C infection. However, people without a history of liver problems have also had liver damage.

Additionally, Dovato may cause a serious condition called lactic acidosis and severe hepatomegaly with steatosis (a type of fatty liver disease). Female patients and those who are identified as obese are at a higher risk.

Your doctor will monitor your liver health through blood work, so make sure to get your labs done on time. Contact your doctor if you notice any of the following signs of liver damage:

  • Yellowing of the skin or whites of the eyes
  • Nausea or vomiting
  • Stomach pain or tenderness on the right side of your stomach
  • Pale-colored stools
  • Dark urine

8. Immune reconstitution syndrome

After starting an HIV treatment like Dovato, your immune system becomes stronger and starts to fight infections in your body. This could lead to an exaggerated response, which can cause inflammation. Symptoms are mild for some people, but for others they can be life-threatening. Call your doctor right away if you experience new symptoms such as:

  • Fever
  • Eye inflammation
  • Stomach pain
  • Swollen lymph nodes
  • Trouble breathing
  • Yellowing of the skin or whites of the eyes

* This is not a complete list of side effects. See here for more information.

References

Bosamiya, S. (2011). The Immune Reconstitution Inflammatory Syndrome. Accessed 05/29/2024 at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3221202/

Dovato (dolutegravir sodium and lamivudine) [package insert]. Revised April 2024. ViiV Healthcare Company. Accessed 05/28/2024 at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=68e45422-43ed-4cfb-9356-fae88d14a53a

Joshi, S., et. al. (2014). Pathophysiological mechanisms of headache in patients with HIV. In: Headache. Available at: https://headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.12356

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