NRTI + INSTI dual regimen Pregnancy: eMC §4.6: Dovato can be used during pregnancy if clinically needed. Large datasets (more than 1000 exposed outcomes each) for dolutegravir and for lamivudine individually indicate no malformative or feto/neonatal toxicity, but there are no or limited data (fewer than 300 exposed outcomes) on this dual combination and its safety and efficacy have not been studied in pregnancy. Two large birth-outcome surveillance studies (Tsepamo in Botswana and an Eswatini study, over 14,000 pregnancy outcomes) do not indicate an increased risk of neural tube defects after dolutegravir exposure.

Lamivudine with dolutegravir

Brand names: Dovato

Lamivudine with dolutegravir is a fixed-dose oral combination of a nucleoside reverse transcriptase inhibitor and an integrase strand transfer inhibitor, licensed as a complete two-drug regimen for HIV-1 infection in suitable adults.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: One tablet (dolutegravir 50 mg / lamivudine 300 mg) once daily

Route: Oral - can be taken with or without food

Frequency: Once daily

eMC §4.2 (Dovato 50 mg/300 mg film-coated tablets). Should be prescribed by physicians experienced in the management of HIV infection. The recommended dose in adults and adolescents above 12 years of age weighing at least 40 kg is one 50 mg/300 mg tablet once daily. DOSE ADJUSTMENT: a separate preparation of dolutegravir is available where a dose adjustment is indicated because of drug-drug interactions (e.g. rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St John's wort, etravirine without boosted protease inhibitors, efavirenz, nevirapine or tipranavir/ritonavir) - in these cases refer to the individual product information for dolutegravir. MISSED DOSE: take as soon as possible provided the next dose is not due within 4 hours; if the next dose is due within 4 hours, skip the missed dose and simply resume the usual dosing schedule. ELDERLY: limited data in patients aged 65 years and over; no dose adjustment is necessary. HEPATIC IMPAIRMENT: no dosage adjustment in mild or moderate impairment (Child-Pugh grade A or B); no data in severe impairment (Child-Pugh grade C), so use with caution. HEPATITIS B CO-INFECTION (§4.4): Dovato includes lamivudine, which is active against hepatitis B, while dolutegravir is not; lamivudine monotherapy is generally not considered adequate treatment for hepatitis B because the risk of resistance is high, so an additional antiviral is generally needed in co-infected patients, and if Dovato is discontinued, periodic monitoring of liver function tests and markers of HBV replication is recommended because lamivudine withdrawal may cause acute exacerbation of hepatitis. PAEDIATRIC: safety and efficacy in children aged less than 12 years or weighing less than 40 kg have not been established and no data are available - verify any such use against a children's formulary.

Dose adjustments

Renal

eMC §4.2: not recommended for use in patients with a creatinine clearance below 30 mL/min. No dose adjustment is required in mild or moderate renal impairment; however lamivudine exposure is significantly increased in patients with a creatinine clearance below 50 mL/min.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substances or to any of the excipients (eMC §4.3)
Co-administration with medicinal products with narrow therapeutic windows that are substrates of organic cation transporter 2 (OCT2), including but not limited to fampridine (also known as dalfampridine) (eMC §4.3)

Side effects

Headache (3%) - very common; also dizziness and somnolence (common)
Nausea (2%) and diarrhoea - very common; vomiting, flatulence, abdominal pain/discomfort (common)
Insomnia (2%) - common; also depression, anxiety, abnormal dreams (common); suicidal ideation, suicide attempt and panic attack (uncommon) and completed suicide (rare), particularly in patients with a pre-existing history of depression or psychiatric illness
Hypersensitivity reaction (uncommon) - the most severe reaction reported with dolutegravir, including rash and severe liver effects; immune reconstitution syndrome (uncommon)
ALT and/or AST elevations, rash, pruritus, alopecia, arthralgia, muscle disorders including myalgia, fatigue, CPK elevations and weight increased (common); hepatitis (uncommon); acute hepatic failure, rhabdomyolysis, pancreatitis and angioedema (rare)
Neutropenia, anaemia and thrombocytopenia (uncommon); lactic acidosis, pure red cell aplasia and sideroblastic anaemia (very rare)

Interactions

Narrow-therapeutic-window OCT2 substrates including fampridine (dalfampridine) - co-administration is contraindicated (eMC §4.3)
Drugs requiring a dose adjustment made with a separate dolutegravir preparation (eMC §4.2): rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St John's wort, etravirine without boosted protease inhibitors, efavirenz, nevirapine, tipranavir/ritonavir
Concomitant antiviral therapy for hepatitis B or C (eMC §4.4) - refer also to the product information for those medicinal products; combination antiretroviral therapy in patients with chronic hepatitis B or C carries an increased risk of severe and potentially fatal hepatic adverse reactions
The full eMC §4.5 interaction section was not captured in this bundle - clinician to review it in the SPC

Clinical monograph

How it works

Lamivudine is intracellularly phosphorylated and incorporated into viral DNA to cause chain termination during reverse transcription, while dolutegravir inhibits HIV integrase, preventing integration of viral DNA into the host genome.

Prescribing in practice

Suitability depends on confirmed absence of resistance to either component and exclusion of hepatitis B co-infection, since neither agent fully suppresses HBV and stopping can cause a hepatitis flare.
Dolutegravir absorption is reduced by polyvalent cations, so antacids, iron, calcium and similar products require separated dosing as detailed in the SPC.
Dolutegravir can cause hypersensitivity reactions and modest rises in serum creatinine through reduced tubular creatinine secretion without a true fall in renal function.

Monitoring

Monitor HIV viral load and CD4 count, hepatitis B status, renal and hepatic function, and review for hypersensitivity and neuropsychiatric effects.

Counselling the patient

Take every day as prescribed to keep the virus suppressed and reduce the risk of resistance.
Separate antacids, indigestion remedies and iron or calcium supplements from your dose as advised.
Report rash with fever or feeling generally unwell, and tell your team if you become pregnant or plan to.

Evidence & guidelines

Use as a two-drug regimen is supported by the GEMINI trials and reflected in BHIVA and NICE-endorsed HIV treatment guidance.

Reference: BHIVA HIV guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways