doravirine: clinical use

Prescribing considerations

• Initiate under a clinician experienced in HIV management and use with other active antiretrovirals.
• Confirm HIV-1 status and review previous treatment and resistance results; evidence is insufficient where NNRTI resistance is present.
• Complete an interaction review, particularly for CYP3A inducers.
• Use caution in severe hepatic impairment; doravirine has not been studied in this group.
• End-stage renal disease and dialysis have not been studied.
• The tablet contains lactose and is unsuitable for certain rare hereditary carbohydrate-intolerance disorders.

Contraindications and cautions

• Hypersensitivity to doravirine or an excipient.
• Concurrent strong CYP3A inducers, including specified anticonvulsants, rifampicin, rifapentine, St John’s wort, mitotane, enzalutamide and lumacaftor.

Monitoring

• Monitor HIV viral load, adherence and emerging resistance.
• Monitor for severe cutaneous reactions and discontinue the doravirine-containing regimen immediately if suspected.
• Assess new inflammatory or autoimmune symptoms for immune reactivation syndrome.
• Monitor tacrolimus or sirolimus concentrations when co-administered.

Clinical pharmacology

Doravirine is a non-competitive HIV-1 reverse-transcriptase inhibitor. It is primarily metabolised through CYP3A4, has minor unchanged renal excretion and has limited potential to alter most CYP-metabolised medicines clinically.

Formulation and product differences

• The selected product is a single-ingredient film-coated tablet rather than a fixed-combination HIV product.
• The tablet contains lactose and should be swallowed whole.
• It is supplied in a moisture-protective bottle containing a desiccant.

Tablet

Route: Oral

Strengths: 100 mg