Single-tablet HIV regimen (INSTI + booster + 2× NRTI) Pregnancy: eMC §4.6: use must be accompanied by effective contraception. There are no adequate and well-controlled studies and no or limited data (fewer than 300 pregnancy outcomes) in pregnant women, although a large amount of data (more than 1,000 exposed outcomes) indicate no malformative or foetal/neonatal toxicity associated with emtricitabine. Cobicistat and elvitegravir treatment during the second and third trimesters results in lower elvitegravir exposure and cobicistat levels may not provide sufficient boosting, which may cause virological failure and increase the risk of mother-to-child transmission. Therefore therapy should NOT be initiated during pregnancy, and women who become pregnant on it should be switched to an alternative regimen. Should not be used during breast-feeding; women living with HIV are recommended not to breast-feed.

Elvitegravir with cobicistat, emtricitabine and tenofovir alafenamide

Brand names: Genvoya

A once-daily single-tablet HIV-1 regimen combining the integrase strand transfer inhibitor elvitegravir, the booster cobicistat, and the nucleos(t)ide analogues emtricitabine and tenofovir alafenamide, providing complete antiretroviral therapy for adults and adolescents.

Adult dose

Dose: One tablet (elvitegravir 150 mg / cobicistat 150 mg / emtricitabine 200 mg / tenofovir alafenamide 10 mg) once daily, taken with food

Route: Oral - do not chew or crush the tablet (bitter taste); if the patient cannot swallow it whole the tablet may be split in half and both halves taken one after the other so the full dose is taken immediately

Frequency: Once daily

eMC SPC §4.2 (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Gilead 150 mg/150 mg/200 mg/10 mg film-coated tablets, previously known as Genvoya). Therapy should be initiated by a physician experienced in the management of HIV infection. POPULATION: one tablet once daily with food in adults and paediatric patients weighing at least 25 kg. MISSED DOSE: if missed within 18 hours of the usual time, take with food as soon as possible and resume the normal schedule; if missed by more than 18 hours, skip it and resume the usual schedule. VOMITING: if the patient vomits within 1 hour of taking the tablet, another tablet should be taken. ELDERLY: no dose adjustment required. HEPATIC IMPAIRMENT: no dose adjustment in mild (Child-Pugh A) or moderate (Child-Pugh B) impairment; not studied in severe impairment (Child-Pugh C), therefore not recommended in those patients. PREGNANCY: therapy should NOT be initiated during pregnancy and women who become pregnant on it should be switched to an alternative regimen, because cobicistat and elvitegravir exposures fall in the second and third trimesters; use must be accompanied by effective contraception. HBV CO-INFECTION (§4.4): tenofovir alafenamide is active against hepatitis B virus; discontinuation in HIV/HBV co-infected patients may be associated with severe acute exacerbations of hepatitis - monitor clinically and with laboratory follow-up for at least several months after stopping. PAEDIATRIC: the SPC states the same one-tablet once-daily regimen for paediatric patients weighing at least 25 kg (this is a fixed-strength tablet, not a per-kg dose). Safety and efficacy in children younger than 2 years of age, or weighing < 14 kg, have not yet been established (no data). No data are available to make dose recommendations in children under 12 years with renal impairment or in children under 18 years with end stage renal disease. Verify any under-18 use against a children's formulary.

Dose adjustments

Renal

eMC §4.2: no dose adjustment required in adults or 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 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.

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 highly dependent on CYP3A for clearance for which elevated plasma concentrations are associated with serious or life-threatening reactions, including but not limited to: alfuzosin; amiodarone, quinidine; ergot derivatives (dihydroergotamine, ergometrine, ergotamine); cisapride; lovastatin, simvastatin; lomitapide; pimozide, lurasidone; sildenafil for the treatment of pulmonary arterial hypertension; orally administered midazolam, triazolam
Co-administration with strong CYP3A inducers, due to potential loss of virologic response and possible resistance, including but not limited to: carbamazepine, phenobarbital, phenytoin; rifampicin; St John's wort (Hypericum perforatum)
Co-administration with dabigatran etexilate (a P-glycoprotein substrate)

Side effects

Nausea (11%) - very common (eMC §4.8, clinical studies through 144 weeks)
Diarrhoea (7%), vomiting, abdominal pain and flatulence - common; dyspepsia uncommon
Headache (6%) and dizziness - common
Rash - common; angioedema, pruritus and urticaria uncommon
Abnormal dreams and fatigue - common; anaemia, depression, and suicidal ideation and suicide attempt (in patients with a pre-existing history of depression or psychiatric illness) uncommon. Also reported: increases in weight, blood lipids and glucose; immune reactivation syndrome; osteonecrosis (frequency unknown); increases in serum creatinine due to cobicistat inhibition of tubular secretion

Interactions

CYP3A-dependent medicines with narrow safety margins (alfuzosin, amiodarone, quinidine, ergot derivatives, cisapride, lovastatin, simvastatin, lomitapide, pimozide, lurasidone, sildenafil for pulmonary arterial hypertension, orally administered midazolam, triazolam) - contraindicated (eMC §4.3)
Strong CYP3A inducers (carbamazepine, phenobarbital, phenytoin, rifampicin, St John's wort) - contraindicated; risk of loss of virologic response and resistance (eMC §4.3)
Dabigatran etexilate, a P-glycoprotein substrate - contraindicated (eMC §4.3)
Cobicistat inhibits tubular secretion of creatinine and increases serum creatinine without affecting actual glomerular filtration - relevant when interpreting renal monitoring and co-administered renally cleared drugs (eMC §4.8)
This interaction list may be incomplete — check the full SPC.

Clinical monograph

How it works

Elvitegravir inhibits HIV integrase to block insertion of viral DNA into the host genome and is boosted by cobicistat's inhibition of CYP3A; emtricitabine and tenofovir alafenamide cause chain termination during reverse transcription.

Prescribing in practice

Cobicistat is a potent CYP3A inhibitor producing numerous serious interactions, so review all co-medications including statins, sedatives, ergot derivatives and steroids before prescribing.
Elvitegravir requires food and adequate gastric acidity, so it must be taken with a meal and separated in time from antacids and cation-containing supplements that chelate it.
Cobicistat inhibits tubular creatinine secretion, causing a small early creatinine rise that does not reflect true loss of renal function.

Monitoring

Monitor HIV viral load and CD4 count alongside renal function, liver function and lipids during therapy.

Counselling the patient

Take once daily with food to ensure the medicine works.
Separate indigestion remedies and mineral supplements from your dose as advised.
Do not start other medicines or herbal products without checking for interactions.

Evidence & guidelines

Antiretroviral therapy selection and monitoring follow BHIVA and NICE guidance and are managed by specialist HIV services.

Reference: BHIVA HIV guidelines; EACS; SmPC; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. 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

Elvitegravir with cobicistat, emtricitabine and tenofovir disoproxil · Single-tablet HIV regimen (INSTI + booster + 2× NRTI)

Pathways