This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Dolutegravir and lamivudine oral


Oral formulations containing dolutegravir and lamivudine.

Drugs List

  • dolutegravir 50mg and lamivudine 300mg tablets
  • DOVATO 50mg+300mg tablets
  • Therapeutic Indications


    HIV infection - combination therapy


    This fixed dose presentation should not be used in patients that require dose adjustments due to drug to drug interactions. The individual preparations of dolutegravir is available in cases where discontinuation or dose adjustment is needed. For further information, refer to the individual monograph of each preparation.


    One tablet once a day.


    Children over 12 years of age and weighing at least 40kg
    One tablet once a day.

    Additional Dosage Information

    Missed dose
    Advise patient if a dose is missed to take the missed dose as soon as possible provided there are more than 4 hours until the next scheduled dose. If a dose has been missed and the next dose is due within 4 hours, advise the patient to avoid taking the missed dose and resume the normal dosing schedule.


    Children under 12 years
    Children with body weight under 40kg
    First trimester of pregnancy
    Renal impairment - creatinine clearance below 50ml/minute
    Severe hepatic impairment - Child-Pugh score greater than or equal to 10

    Precautions and Warnings

    Females of childbearing potential
    Hepatic impairment
    Hepatitis B
    Hepatitis C
    Psychiatric disorder
    Second trimester of pregnancy
    Third trimester of pregnancy

    Treatment does not prevent risk of transmission of HIV
    Treatment should be initiated by doctor experienced in HIV management
    Exclude pregnancy prior to initiation of treatment
    Autoimmune disorders can occur many months after initiation of treatment
    Avoid sorbitol or other polyalcohols, may reduce lamivudine efficacy
    Blood lipid and glucose levels may increase requiring treatment
    Monitor children exposed in utero for mitochondrial impairment
    Monitor for signs of osteonecrosis
    Monitor levels of hepatic enzymes and bilirubin
    On discontinuation, may cause recurrence of hepatitis B
    Autoimmune diseases may occur during treatment
    Contact doctor immediately with any signs of hypersensitivity reactions
    Inflammatory symptoms should be evaluated and treated appropriately
    Neonate exposed in utero: Risk of mitochondrial dysfunction
    Risk of developing opportunistic infections
    Discontinue if drug-related rash or other hypersensitivity reactions occur
    Discontinue if hepatic function deteriorates in pts with hepatic impairment
    Advise patient not to take St John's wort concurrently
    Avoid antacids/mineral supplements 2 hrs after or 6 hrs before dose
    Advise patients that hypersensitivity reactions may be life threatening

    Blood lipid and glucose levels may increase during antiretroviral therapy. This may be linked to disease control and lifestyle. Refer to established HIV treatment guidelines for monitoring and manage lipid and glucose level disorders as appropriate.

    Treatment regimens containing nucleoside or nucleotide analogues have been reported to cause mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally. Adverse reactions such as haematological (anaemia, neutropenia), metabolic (hyperlactataemia, hyperlipasemia) and neurological (hypertonia, convulsions, abnormal behaviour) have been reported. Consider in children exposed to nucleoside or nucleotide analogues in utero (including HIV-negative infants) and who present with neurological symptoms or severe clinical findings of unknown cause.

    Pregnancy and Lactation


    Dolutegravir and lamivudine is contraindicated during the first trimester of pregnancy. Use dolutegravir and lamivudine with caution during the second and third trimester of pregnancy.

    The manufacturer does not recommend the use of dolutegravir and lamivudine during the first trimester of pregnancy due to the potential risk of neural tube defects to the infant. The manufacturer also recommends that dolutegravir and lamivudine should be used in the second and third trimester of pregnancy only if the potential benefits justifies the potential risk to the foetus.

    At the time of writing there are limited data on the use of dolutegravir in pregnant women. The effect of dolutegravir on human pregnancy is unknown. Reproductive toxicity studies in animals have shown dolutegravir to cross the placenta. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

    The MHRA states that due to results from an observational study there is evidence of an increased risk of neural tube defects in babies born to mothers who became pregnant while taking dolutegravir. They advise that dolutegravir should not be prescribed to women seeking to become pregnant and that pregnancy should be excluded in women of child bearing potential before starting dolutegravir. Women of childbearing potential are advised to use effective contraception throughout treatment with dolutegravir.

    Animal studies indicate that lamivudine may inhibit cellular DNA replication.


    Dolutegravir and lamivudine is contraindicated during breastfeeding.

    The manufacturer does not recommend the use of dolutegravir and lamivudine during breastfeeding to avoid the potential risk of HIV transmission to the infant.

    In order to avoid HIV transmission, it is recommend that infants are not breastfed by HIV infected women. It is not known if dolutegravir is excreted into human milk. Lamivudine is excreted into breast milk, the low levels ingested by the infant are likely to result in sub-optimal antiviral effect. At the time of writing there are no evidence that the low concentrations in human milk leads to adverse reactions in the breastfed infant.

    Side Effects

    Abdominal discomfort
    Abdominal pain
    Creatine phosphokinase increased
    Dream abnormalities
    Elevated amylase levels
    Hypersensitivity reactions
    Immune Reactivation/Reconstitution Syndrome
    Increase in serum ALT/AST
    Lactic acidosis
    Muscle disorders
    Peripheral neuropathy
    Red cell aplasia

    Further Information

    Last full review date: September 2019.

    Reference Sources

    MHRA Drug Safety Update December 2015 - Volume 9, Issue 5A
    Available at:
    Last Accessed: 09 August 2019

    Summary of Product Characteristics: Dovato 50mg/300mg film-coated tablets. ViiV Healthcare UK Ltd. Revised July 2019.

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.