Single-tablet HIV regimen (NRTI + NNRTI + NRTI) Pregnancy: eMC §4.6: use should be accompanied by effective contraception. There are no adequate and well-controlled studies in pregnant women; limited data (fewer than 300 pregnancy outcomes) for tenofovir alafenamide, a moderate amount of data (300-1,000 outcomes) indicating no malformative or foetal/neonatal toxicity for rilpivirine, and a large amount of data (more than 1,000 exposed outcomes) indicating none for emtricitabine. Lower rilpivirine exposures were observed during pregnancy, so viral load should be monitored closely. This product should be used during pregnancy ONLY if the potential benefit justifies the potential risk to the foetus. Breast-feeding: women should be instructed not to breast-feed while receiving this product, and women living with HIV are recommended not to breast-feed.

Emtricitabine with rilpivirine and tenofovir alafenamide

Brand names: Odefsey

A once-daily single-tablet HIV-1 regimen combining the non-nucleoside reverse transcriptase inhibitor rilpivirine with the nucleos(t)ide analogues emtricitabine and tenofovir alafenamide, used as complete antiretroviral therapy in adults and adolescents.

Adult dose

Dose: One tablet (emtricitabine 200 mg / rilpivirine 25 mg / tenofovir alafenamide 25 mg) once daily, taken with food

Route: Oral - it is recommended that the film-coated tablet is not chewed, crushed or split due to the bitter taste

Frequency: Once daily

eMC SPC §4.2 (Emtricitabine/Rilpivirine/Tenofovir Alafenamide Gilead 200 mg/25 mg/25 mg film-coated tablets, previously known as Odefsey). Therapy should be initiated by a physician experienced in the management of HIV infection. MISSED DOSE: if missed within 12 hours of the usual time, take with food as soon as possible and resume the normal schedule; if missed by more than 12 hours, skip it and resume the usual schedule. VOMITING: if the patient vomits within 4 hours of taking the tablet, another tablet should be taken with food; if more than 4 hours after, no extra tablet is needed until the next regularly scheduled dose. ELDERLY: no dose adjustment required. HEPATIC IMPAIRMENT: no dose adjustment in mild (Child-Pugh A) or moderate (Child-Pugh B) impairment, but use with caution in moderate impairment; not studied in severe impairment (Child-Pugh C), therefore not recommended in those patients. VIROLOGIC FAILURE/RESISTANCE (§4.4): there are insufficient data to justify use in patients with prior NNRTI failure, and resistance testing and/or historical resistance data should guide use; patients with a baseline viral load > 100,000 HIV-1 RNA copies/mL had a greater risk of virologic failure with rilpivirine-containing therapy. Only adolescents deemed likely to have good adherence should be treated with rilpivirine. QT: rilpivirine has been associated with QTc prolongation at supratherapeutic doses (75 mg and 300 mg once daily) - use with caution when co-administered with medicinal products with a known risk of Torsade de Pointes. HBV CO-INFECTION: tenofovir alafenamide is active against hepatitis B virus; discontinuation in HIV/HBV co-infected patients may be associated with severe acute exacerbations of hepatitis. CONTRACEPTION: use should be accompanied by effective contraception (§4.6). PAEDIATRIC: safety and efficacy in children younger than 12 years of age, or weighing < 35 kg, have not yet been established (no data); §4.2 renal-impairment advice applies to adolescents aged at least 12 years and weighing at least 35 kg. Verify any under-18 use against a children's formulary.

Dose adjustments

Renal

eMC §4.2: no dose adjustment required in adults or in adolescents (aged at least 12 years and weighing at least 35 kg) with estimated creatinine clearance >= 30 mL/min. Discontinue if estimated CrCl declines below 30 mL/min during treatment. No dose adjustment is required in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis, but the product should generally be avoided and used with caution only if potential benefits outweigh risks; on haemodialysis days give it after completion of dialysis. Avoid in patients with estimated CrCl >= 15 and < 30 mL/min, or < 15 mL/min not on chronic haemodialysis, as safety has not been established. No data are available to make dose recommendations in children less than 18 years with end stage renal disease.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. 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 that can cause significant decreases in rilpivirine plasma concentrations (through CYP3A enzyme induction or gastric pH increase) and hence loss of therapeutic effect, including: carbamazepine, oxcarbazepine, phenobarbital, phenytoin; rifabutin, rifampicin, rifapentine; omeprazole, esomeprazole, dexlansoprazole, lansoprazole, pantoprazole, rabeprazole; dexamethasone (oral and parenteral doses) except as a single dose treatment; St John's wort (Hypericum perforatum)

Side effects

Nausea - very common (9-11% in the contributing studies); abdominal pain, vomiting, abdominal discomfort, dry mouth, flatulence and diarrhoea common; dyspepsia uncommon (eMC §4.8)
Headache (6%) and dizziness (8%) - very common; somnolence common
Insomnia - very common; depression, abnormal dreams (8%), sleep disorders and depressed mood common
Increased transaminases (AST and/or ALT), increased total cholesterol (fasted), increased LDL-cholesterol (fasted) and increased pancreatic amylase - very common; increased bilirubin, increased triglycerides, increased lipase and decreased appetite common
Rash and fatigue - common; decreased white blood cell count, decreased haemoglobin and decreased platelet count common; severe skin reactions with systemic symptoms, angioedema, urticaria, pruritus, anaemia, arthralgia and immune reactivation syndrome uncommon

Interactions

CYP3A inducers - carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampicin, rifapentine, St John's wort - contraindicated; significant decreases in rilpivirine plasma concentrations (eMC §4.3)
Proton pump inhibitors (omeprazole, esomeprazole, dexlansoprazole, lansoprazole, pantoprazole, rabeprazole) - contraindicated; gastric pH increase reduces rilpivirine concentrations (eMC §4.3)
Systemic dexamethasone (oral and parenteral), except as a single dose treatment - contraindicated (eMC §4.3)
Medicinal products with a known risk of Torsade de Pointes - use with caution (eMC §4.4)
This interaction list may be incomplete — check the full SPC.

Clinical monograph

How it works

Rilpivirine binds and inhibits reverse transcriptase at a non-catalytic site, while emtricitabine and tenofovir alafenamide are incorporated into viral DNA by reverse transcriptase, causing chain termination.

Prescribing in practice

Rilpivirine absorption is acid-dependent, so proton pump inhibitors are contraindicated and antacids or H2 antagonists must be carefully time-separated and the dose taken with food.
Rilpivirine has been associated with QT prolongation, so caution is needed with other QT-prolonging drugs.
It is generally reserved for patients with a lower baseline viral load because of reduced efficacy at high viraemia.

Monitoring

Monitor HIV viral load and CD4 count along with liver function and renal parameters during treatment.

Counselling the patient

Take once daily with a meal, not on an empty stomach, to ensure absorption.
Avoid heartburn medicines that reduce stomach acid unless advised on safe spacing.
Keep taking it every day to prevent the virus becoming resistant.

Evidence & guidelines

Rilpivirine-based fixed-dose combinations are established options reflected in BHIVA guidance for suitable patients.

Reference: BHIVA HIV guidelines; EACS 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