Single-tablet HIV regimen Pregnancy: eMC §4.6: there are no adequate and well-controlled studies in pregnant women. A moderate amount of data (300-1,000 pregnancy outcomes) indicates no malformative or foeto/neonatal toxicity of rilpivirine, and a large amount of data (more than 1,000 outcomes) indicates the same for emtricitabine and tenofovir disoproxil. Use may be considered during pregnancy if necessary, but lower rilpivirine exposures occur in pregnancy so viral load should be monitored closely. Use must be accompanied by effective contraception. Women should be instructed not to breast-feed while receiving this product, and women living with HIV are recommended not to breast-feed in order to avoid transmission of HIV to the infant.

Emtricitabine with rilpivirine and tenofovir disoproxil

Brand names: Eviplera

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 disoproxil, providing complete antiretroviral therapy in adults and adolescents.

Adult dose

Dose: One tablet (emtricitabine 200 mg / rilpivirine 25 mg / tenofovir disoproxil 245 mg) once daily

Route: Oral - must be taken with food; swallow whole with water. The film-coated tablet should not be chewed, crushed or split as it may impact absorption

Frequency: Once daily

eMC §4.2 (Emtricitabine/Rilpivirine/Tenofovir Disoproxil Gilead 200 mg/25 mg/245 mg film-coated tablets, previously known as Eviplera). Treatment should be initiated by a physician experienced in the management of HIV infection. MISSED DOSE: if within 12 hours of the usual time, take with food as soon as possible and resume the normal schedule; if more than 12 hours late, skip the missed dose and simply resume the usual schedule. VOMITING: if the patient vomits within 4 hours of taking a tablet, another tablet should be taken with food; if more than 4 hours after, no replacement dose is needed until the next scheduled dose. DOSE ADJUSTMENT: if co-administered with rifabutin, an additional 25 mg tablet of rilpivirine per day is recommended concomitantly, for the duration of the rifabutin co-administration. Where discontinuation of one component is indicated or dose modification is necessary, separate preparations of emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil are available. ELDERLY: has not been studied in patients over 65 years; administer with caution. HEPATIC IMPAIRMENT: no dose adjustment required in mild or moderate impairment (Child-Pugh-Turcotte Score A or B), but use with caution in moderate impairment; not studied and not recommended in severe impairment (CPT Score C). HIV/HBV CO-INFECTION: if treatment is discontinued, monitor closely for evidence of exacerbation of hepatitis. PREGNANCY: lower exposures of rilpivirine were observed during pregnancy, so viral load should be monitored closely; alternatively switching to another antiretroviral regimen could be considered. PAEDIATRIC: safety and efficacy in children under the age of 18 years have not been established and no recommendation on a posology can be made - verify any under-18 use against a children's formulary.

Dose adjustments

Renal

eMC §4.2: limited clinical study data support once daily dosing in patients with mild renal impairment (creatinine clearance 50-80 mL/min), but long-term safety data for the emtricitabine and tenofovir disoproxil components have not been evaluated in mild renal impairment, so use only if the potential benefits outweigh the potential risks. Not recommended for patients with moderate or severe renal impairment (CrCl < 50 mL/min) - these patients require a dose interval adjustment of emtricitabine and tenofovir disoproxil that cannot be achieved with the combination tablet. Treatment results in an early small increase of mean serum creatinine that remains stable over time and is not considered clinically relevant.

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 the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital or phenytoin - significant decreases in rilpivirine plasma concentrations may occur (CYP3A induction), which may result in loss of therapeutic effect
Co-administration with the antimycobacterials rifampicin or rifapentine
Co-administration with proton pump inhibitors such as omeprazole, esomeprazole, lansoprazole, pantoprazole or rabeprazole (gastric pH increase)
Co-administration with the systemic glucocorticoid dexamethasone, except as a single dose treatment
Co-administration with St John's wort (Hypericum perforatum)

Side effects

Nausea (9%) - most frequently reported in treatment-naive patients
Dizziness (8%) and abnormal dreams (8%)
Headache (6%)
Diarrhoea (5%) and insomnia (5%). In virologically suppressed patients switching to the single-tablet regimen the most frequent reactions were fatigue (3%), diarrhoea (3%), nausea (2%) and insomnia (2%)
Tenofovir disoproxil component: rare events of renal impairment and renal failure, and uncommon events of proximal renal tubulopathy (including Fanconi syndrome) sometimes leading to bone abnormalities (infrequently contributing to fractures) - monitoring of renal function is recommended. Discontinuation in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis

Interactions

Rifabutin (eMC §4.2) - an additional 25 mg rilpivirine tablet per day is recommended concomitantly for the duration of rifabutin co-administration
Other medicinal products containing emtricitabine, tenofovir disoproxil, tenofovir alafenamide, or other cytidine analogues such as lamivudine - must not be given concomitantly (eMC §4.4)
Rilpivirine hydrochloride - must not be given concomitantly unless needed for dose adjustment with rifabutin (eMC §4.4)
Adefovir dipivoxil - must not be given concomitantly (eMC §4.4)
Didanosine - co-administration is not recommended (eMC §4.4)
Medicinal products with a known risk of Torsade de Pointes - use with caution (eMC §4.4); at supratherapeutic doses rilpivirine has been associated with QTc prolongation, although 25 mg once daily is not associated with a clinically relevant effect on QTc
This interaction list may be incomplete — check the full SPC.

Clinical monograph

How it works

Rilpivirine inhibits reverse transcriptase at a non-catalytic site, while emtricitabine and tenofovir disoproxil are incorporated into viral DNA by reverse transcriptase to terminate chain elongation.

Prescribing in practice

Rilpivirine absorption is acid-dependent, so proton pump inhibitors are contraindicated and antacids or H2 antagonists must be time-separated, with the dose taken with food.
The tenofovir disoproxil component carries a risk of renal tubular injury and reduced bone mineral density, so avoid in significant renal impairment and with other nephrotoxic drugs.
It is generally reserved for patients with a lower baseline viral load owing to reduced efficacy at high viraemia.

Monitoring

Monitor HIV viral load and CD4 count alongside renal function and liver function during treatment.

Counselling the patient

Take once daily with food for proper absorption.
Avoid acid-suppressing heartburn remedies unless advised how to space them.
Take it every day to maintain control of the virus.

Evidence & guidelines

Rilpivirine-containing fixed-dose therapy is an established option reflected in BHIVA guidance for appropriate patients.

Reference: BHIVA HIV guidelines; EACS; 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

Drugs

Efavirenz with emtricitabine and tenofovir disoproxil · Single-tablet HIV regimen

Pathways