Two-drug HIV maintenance regimen (INSTI + NNRTI) Pregnancy: eMC §4.6: use during pregnancy is NOT recommended - lower exposures of both dolutegravir and rilpivirine occur during pregnancy, and in Phase 3 studies lower rilpivirine exposure has been associated with an increased risk of virological failure. A large amount of data (more than 1,000 exposed outcomes) indicate no malformative or feto/neonatal toxicity for dolutegravir, and a moderate amount (300-1,000 outcomes) none for rilpivirine, but there are no or limited data (fewer than 300 exposed outcomes) for the dual combination and it has 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.

Dolutegravir with rilpivirine

Brand names: Juluca

A two-drug, once-daily oral maintenance regimen combining the integrase strand transfer inhibitor dolutegravir with the non-nucleoside reverse transcriptase inhibitor rilpivirine, used to maintain virological suppression in adults with HIV-1 who are already stable on antiretroviral therapy.

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 / rilpivirine 25 mg) once daily, taken with a meal

Route: Oral - swallow the film-coated tablet whole with water; do not chew or crush

Frequency: Once daily

eMC SPC §4.2 (Juluca 50 mg/25 mg film-coated tablets). Should be prescribed by physicians experienced in the management of HIV infection. Must be taken with a meal. DOSE ADJUSTMENT: separate preparations of dolutegravir or rilpivirine are available where discontinuation or dose adjustment of one active substance is indicated - refer to the individual Summaries of Product Characteristics in those cases. MISSED DOSE: take with a meal as soon as possible provided the next dose is not due within 12 hours; if the next dose is due within 12 hours, skip the missed dose and resume the usual schedule. VOMITING: if the patient vomits within 4 hours of taking the tablet, take another tablet with a meal; if more than 4 hours after, no extra tablet is needed until the next regularly scheduled dose. ELDERLY: limited data in patients aged 65 years and over; no evidence a different dose is required. HEPATIC IMPAIRMENT: no dosage adjustment in mild or moderate impairment (Child-Pugh A or B), but use with caution in moderate impairment; no data in severe impairment (Child-Pugh C) so it is not recommended in those patients. PREGNANCY: safety and efficacy in pregnancy have not been established, lower dolutegravir and rilpivirine exposures were observed during pregnancy, no dose-adjustment recommendation can be made, and use during pregnancy is not recommended. HYPERSENSITIVITY (§4.4): discontinue immediately if signs or symptoms of hypersensitivity develop (severe rash, or rash with raised liver enzymes, fever, malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, eosinophilia, angioedema); delay in stopping may result in a life-threatening allergic reaction. QT: use with caution when co-administered with medicinal products with a known risk of Torsade de Pointes. PAEDIATRIC: safety and efficacy in children and adolescents aged under 18 years have not yet been established and no posology recommendation can be made - verify any under-18 use against a children's formulary. NOTE ON US LABELLING: the openFDA label in this bundle is for Triumeq (abacavir/dolutegravir/lamivudine), a different product, and was not used.

Dose adjustments

Renal

eMC §4.2: no dosage adjustment required in patients with mild or moderate renal impairment. In severe renal impairment or end stage renal disease, combination with a strong CYP3A inhibitor should only be used if the benefit outweighs the risk. No data are available in patients receiving dialysis, although differences in pharmacokinetics are not expected.

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 to any of the excipients (eMC §4.3)
Co-administration with fampridine (also known as dalfampridine)
Co-administration with carbamazepine, oxcarbazepine, phenobarbital or phenytoin
Co-administration with rifampicin or rifapentine
Co-administration with proton pump inhibitors such as omeprazole, esomeprazole, lansoprazole, pantoprazole or rabeprazole
Co-administration with systemic dexamethasone, except as a single dose treatment
Co-administration with St John's wort (Hypericum perforatum)

Side effects

Headache (2%) and dizziness - very common; somnolence common (eMC §4.8)
Nausea and diarrhoea (2%) - very common, with increased pancreatic amylase; abdominal pain, vomiting, flatulence, increased lipase, abdominal discomfort, upper abdominal pain and dry mouth common
Insomnia - very common; abnormal dreams, depression, sleep disorders, depressed mood and anxiety common; suicidal ideation or suicide attempt and panic attack uncommon (particularly in patients with a pre-existing history of depression or psychiatric illness); completed suicide rare
Increased transaminases (ALT and/or AST) and increased total and LDL cholesterol (fasted) - very common; increased bilirubin, increased triglycerides and decreased appetite common; hepatitis uncommon; acute hepatic failure rare
Hypersensitivity (uncommon) - the most severe reaction seen with dolutegravir was a hypersensitivity reaction including rash and severe liver effects; rash and pruritus, fatigue, decreased white blood cell count, decreased haemoglobin and decreased platelet count are common; creatine phosphokinase elevations and weight increased common

Interactions

Fampridine (dalfampridine) - co-administration contraindicated (eMC §4.3)
Enzyme-inducing anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin) and rifampicin/rifapentine - co-administration contraindicated (eMC §4.3)
Proton pump inhibitors (omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole) - co-administration contraindicated (eMC §4.3)
Systemic dexamethasone, except as a single dose treatment, and St John's wort - co-administration contraindicated (eMC §4.3)
Medicinal products with a known risk of Torsade de Pointes - use with caution; rilpivirine has been associated with QTc prolongation at supra-therapeutic doses of 75 mg and 300 mg once daily (eMC §4.4). 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

Dolutegravir blocks integration of viral DNA into the host genome by inhibiting HIV integrase, while rilpivirine binds and inhibits reverse transcriptase to prevent transcription of viral RNA into DNA.

Prescribing in practice

This is a switch (maintenance) regimen only for patients with no history of virological failure or known resistance to either component and stable suppression, not for initiating treatment.
Rilpivirine absorption depends on gastric acidity, so proton pump inhibitors are contraindicated and antacids or H2 antagonists must be separated in time and taken with food.
Dolutegravir chelates polyvalent cations, so dose timing must be separated from magnesium-, aluminium- or calcium-containing antacids, iron and other mineral supplements.

Monitoring

Monitor HIV viral load to confirm continued suppression, together with liver function during therapy.

Counselling the patient

Take both as a single dose once daily with a meal to ensure the medicine is absorbed properly.
Avoid indigestion remedies and supplements around dosing time unless advised on correct spacing.
Report mood changes or thoughts of self-harm, as these have been linked to the integrase inhibitor.

Evidence & guidelines

Two-drug maintenance regimens are supported by the SWORD trials and are reflected in BHIVA guidance for selected suppressed patients.

Reference: BHIVA HIV guidelines; EACS; SmPC; 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