Integrase strand-transfer inhibitor (INSTI) — antiretroviral Pregnancy: Dovato can be used during pregnancy if clinically needed. Large datasets on dolutegravir and on lamivudine individually indicate no increased malformative or feto/neonatal toxicity and no increased risk of neural tube defects; however data on the dual combination in pregnancy are limited (<300 exposed outcomes).

Dolutegravir

Brand names: Tivicay, Triumeq (with abacavir + lamivudine), Juluca (with rilpivirine), Dovato (with lamivudine)

Dolutegravir is an HIV integrase strand transfer inhibitor used as part of combination antiretroviral therapy for HIV infection.

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 50 mg/300 mg tablet once daily (delivering dolutegravir 50 mg once daily)

Route: Oral (with or without food)

Frequency: Once daily

IMPORTANT: the UK SPC used is the fixed-dose combination Dovato (dolutegravir 50 mg + lamivudine 300 mg); dolutegravir dose here is 50 mg once daily as part of that combination. Should be prescribed by physicians experienced in HIV management. Adults and adolescents above 12 years weighing at least 40 kg: one tablet once daily. A separate single-agent dolutegravir preparation is available where a dose adjustment is indicated due to drug-drug interactions (e.g. rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St John's wort, etravirine without boosted PIs, efavirenz, nevirapine, or tipranavir/ritonavir) - refer to the individual dolutegravir product information. Missed dose: take as soon as possible unless the next dose is due within 4 hours. Elderly (>=65 years): no dose adjustment necessary (limited data). Hepatic impairment: no adjustment in mild/moderate (Child-Pugh A/B); use with caution in severe (Child-Pugh C, no data). Paediatric: safety and efficacy in children under 12 years or under 40 kg not established.

Dose adjustments

Renal

Dovato (this combination) is not recommended for use in patients with creatinine clearance <30 mL/min. No dose adjustment required in mild or moderate renal impairment, but lamivudine exposure is significantly increased at CrCl <50 mL/min.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

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

Side effects

Headache (very common)
Nausea and diarrhoea (very common)
Insomnia, depression, anxiety, abnormal dreams (common)
Rash, pruritus, alopecia (common); hypersensitivity reaction with severe liver effects (uncommon/most severe)
ALT/AST elevations (common); dizziness, somnolence, fatigue (common)

Interactions

Fampridine (dalfampridine) - contraindicated (OCT2 substrate, narrow therapeutic window)
Enzyme inducers (rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St John's wort) - require a separate dolutegravir dose adjustment
Etravirine (without boosted protease inhibitors), efavirenz, nevirapine, tipranavir/ritonavir - require dolutegravir dose adjustment

Clinical monograph

How it works

It inhibits HIV integrase, preventing integration of viral DNA into the host cell genome and thereby blocking viral replication.

Prescribing in practice

Follow current MHRA and specialist advice on use around conception and in pregnancy, as a possible signal of neural tube defects with early exposure has been kept under review; weigh the benefits of effective HIV control accordingly.
Dolutegravir can raise serum creatinine by inhibiting its tubular secretion without reducing true renal function.
Absorption is reduced by polyvalent cation-containing products, so separate dosing from antacids, and iron or calcium supplements.

Monitoring

Monitor HIV viral load and CD4 count to confirm response, with liver function checks particularly in those with hepatitis co-infection.

Counselling the patient

Take indigestion remedies, or iron and calcium supplements, well apart from your dose to avoid reducing its absorption.
If you could become pregnant or are planning pregnancy, discuss this with your HIV team.
Take the medicine consistently every day to keep the virus suppressed.

Evidence & guidelines

Dolutegravir-based regimens are recommended in UK and international HIV guidelines, supported by large randomised controlled trials.

Reference: SmPC Tivicay / Triumeq / Dovato; BHIVA Adult HIV Guidelines 2022; EACS Guidelines 12.0 (2024); WHO Consolidated ART Guidelines 2021; Tsepamo NEJM 2019; 381:827; SINGLE / SPRING-2 / FLAMINGO trials; 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