cobicistat + elvitegravir + emtricitabine + tenofovir alafenamide fumarate: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
cobicistat + elvitegravir + emtricitabine + tenofovir alafenamide fumarate: clinical details
Prescribing considerations
- Confirm HIV genotype and treatment history, including absence of relevant resistance.
- Complete an interaction review before initiation and whenever another product is started or stopped.
- Establish hepatitis B status.
- Avoid initiation during pregnancy and arrange specialist review if pregnancy occurs.
- Consider lactose content in relevant rare hereditary disorders.
Contraindications and cautions
- Hypersensitivity to an active substance or excipient.
- Co-administration with strong CYP3A inducers listed in the product information.
- Co-administration with medicines whose CYP3A-mediated accumulation may cause serious harm.
- Co-administration with dabigatran etexilate.
- Renal-function ranges and severe hepatic impairment specified in the product information.
Monitoring
- HIV viral load, adherence and evidence of resistance or treatment failure.
- Renal function; investigate significant deterioration or proximal tubulopathy.
- Liver function, particularly with viral hepatitis or pre-existing liver disease.
- Weight, blood lipids and glucose as clinically appropriate.
- New inflammatory, autoimmune, psychiatric or bone symptoms.
Clinical pharmacology
Elvitegravir inhibits HIV integrase. Emtricitabine and intracellular tenofovir diphosphate inhibit reverse transcriptase and terminate viral DNA chains. Cobicistat inhibits CYP3A and transporters including P-glycoprotein. It can raise serum creatinine by inhibiting tubular creatinine secretion without directly reducing glomerular filtration.
Formulation and product differences
- The lower-strength film-coated tablet is intended for eligible children in the specified lower weight range.
- A higher-strength film-coated tablet is available for eligible adults and heavier children.
- The tablet score aids swallowing; the halves are not equal-dose units.
cobicistat + elvitegravir + emtricitabine + tenofovir alafenamide fumarate preparations and strengths
Tablet
Route: Oral
Strengths: 90 mg + 90 mg + 120 mg + 6 mg, 150 mg + 150 mg + 200 mg + 10 mg
cobicistat + elvitegravir + emtricitabine + tenofovir alafenamide fumarate interactions
Cobicistat strongly inhibits CYP3A and several transporters, while CYP3A-inducing medicines can reduce elvitegravir exposure. A full interaction check is essential.
Carbamazepine, phenobarbital, phenytoin, rifampicin or St John’s wort
Contraindicated because they can lower elvitegravir and cobicistat exposure, risking loss of viral control and resistance.
Simvastatin, lovastatin or lomitapide
Contraindicated because cobicistat can substantially increase exposure and serious toxicity.
Dabigatran etexilate
Contraindicated because transporter inhibition may substantially increase anticoagulant exposure and bleeding risk.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.