Single-tablet HIV regimen (INSTI + booster + 2× NRTI) Pregnancy: eMC §4.6: use MUST be accompanied by effective contraception. There are no or limited data (fewer than 300 pregnancy outcomes) in pregnant women, although a large amount of data (more than 1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with emtricitabine and tenofovir disoproxil. 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 disoproxil

Brand names: Stribild

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 disoproxil, used as complete antiretroviral therapy in adults and adolescents.

Adult dose

Dose: One tablet (elvitegravir 150 mg / cobicistat 150 mg / emtricitabine 200 mg / tenofovir disoproxil 245 mg) once daily, taken with food

Route: Oral - the film-coated tablet should not be chewed or crushed

Frequency: Once daily

eMC SPC §4.2 (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Gilead 150 mg/150 mg/200 mg/245 mg film-coated tablets, previously known as Stribild). Therapy should be initiated by a physician experienced in the management of HIV infection. POPULATION: one tablet once daily with food in adults and adolescents aged 12 years and older weighing at least 35 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 and it is almost time for the next dose, 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 data are available on which to base a dose recommendation for patients over 65 years - administer with caution. 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. HBV CO-INFECTION: if discontinued in patients co-infected with HIV and hepatitis B virus, monitor closely for evidence of exacerbation of hepatitis. RENAL MONITORING (§4.4): calculate creatinine clearance and determine urine glucose and urine protein in all patients before initiation; monitor creatinine clearance, serum phosphate, urine glucose and urine protein every four weeks during the first year and every three months thereafter (more frequently in patients at risk of renal impairment). Patients with a confirmed increase in serum creatinine of more than 26.5 micromol/L (0.3 mg/dL) from baseline should be closely monitored for renal safety; if serum phosphate is < 0.48 mmol/L (1.5 mg/dL) or creatinine clearance falls below 70 mL/min, re-evaluate renal function within one week. PREGNANCY: therapy should NOT be initiated during pregnancy and women who become pregnant on it should be switched to an alternative regimen; use must be accompanied by effective contraception. PAEDIATRIC: safety and efficacy in children under 12 years of age or weighing < 35 kg have not been established, and use is not recommended in paediatric patients under 18 years with renal impairment - verify any under-18 use against a children's formulary.

Dose adjustments

Renal

eMC §4.2/§4.4: do NOT initiate in patients with creatinine clearance below 70 mL/min; it is also recommended not to initiate at a creatinine clearance below 90 mL/min unless, after review of available treatment options, this is considered the preferred treatment for the individual patient. Discontinue if creatinine clearance declines below 50 mL/min during treatment, since dose interval adjustment of emtricitabine and tenofovir disoproxil is then required and cannot be achieved with the fixed-dose combination tablet; discontinuation is also recommended if creatinine clearance falls below 70 mL/min on treatment unless it is considered the preferred option. Use is not recommended in paediatric patients under 18 years with renal impairment.

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)
Patients who have previously discontinued treatment with tenofovir disoproxil due to renal toxicity, with or without reversal of the effects post-discontinuation
Co-administration with medicinal products highly dependent on CYP3A for clearance for which elevated plasma concentrations are associated with serious and/or life-threatening events, including but not limited to: alfuzosin; amiodarone, quinidine; ergot derivatives (dihydroergotamine, ergometrine, ergotamine); cisapride; lovastatin, simvastatin; 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 (16% in treatment-naive adults through 144 weeks; 3-5% in virologically suppressed adults), diarrhoea (12%) and vomiting - very common (eMC §4.8)
Headache and dizziness - very common; insomnia and abnormal dreams common; suicidal ideation and suicide attempt (in patients with a pre-existing history of depression or psychiatric illness) and depression uncommon
Hypophosphataemia - very common; hyperglycaemia, hypertriglyceridaemia and decreased appetite common; hypokalaemia uncommon; lactic acidosis rare
Renal impairment and renal failure (rare) and proximal renal tubulopathy including Fanconi syndrome (uncommon) with tenofovir disoproxil, sometimes leading to bone abnormalities and infrequently contributing to fractures - renal function monitoring is recommended
Neutropenia and allergic reaction (common), anaemia (uncommon), elevated amylase, fatigue (6% in suppressed patients). Discontinuation in HIV/HBV co-infected patients may be associated with severe acute exacerbations of hepatitis

Interactions

CYP3A-dependent medicines with narrow safety margins (alfuzosin, amiodarone, quinidine, ergot derivatives, cisapride, lovastatin, simvastatin, 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 may cause modest increases in serum creatinine and modest declines in creatinine clearance; there are inadequate data on whether tenofovir disoproxil with cobicistat carries a greater risk of renal adverse reactions than tenofovir disoproxil without cobicistat (eMC §4.4)
This interaction list may be incomplete — check the full SPC.

Clinical monograph

How it works

Elvitegravir inhibits HIV integrase, boosted by cobicistat through CYP3A inhibition, while emtricitabine and tenofovir disoproxil are incorporated into viral DNA by reverse transcriptase to terminate chain elongation.

Prescribing in practice

The tenofovir disoproxil component carries a risk of renal tubular injury and reduced bone mineral density, so it should be avoided in significant renal impairment and with other nephrotoxic drugs.
Cobicistat is a potent CYP3A inhibitor with numerous serious interactions, requiring review of all co-medications before and during treatment.
Elvitegravir must be taken with food and separated in time from antacids and cation-containing supplements that reduce its absorption.

Monitoring

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

Counselling the patient

Take once daily with food for reliable absorption.
Separate antacids and mineral supplements from your dose as advised.
Report any new medicines so interactions can be checked.

Evidence & guidelines

Antiretroviral regimens are selected and monitored according to BHIVA and NICE guidance within specialist HIV care.

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 alafenamide · Single-tablet HIV regimen (INSTI + booster + 2× NRTI)

Pathways