dolutegravir sodium + lamivudine: clinical use

Prescribing considerations

• Confirm that integrase-inhibitor and lamivudine resistance is neither known nor suspected.
• Review hepatitis B status: this combination is not adequate hepatitis B treatment by itself, and withdrawal can trigger an exacerbation.
• Check renal and hepatic function, concurrent medicines, supplements and herbal products.
• Review previous psychiatric illness and counsel about hypersensitivity symptoms.
• Use below the licensed age or weight thresholds is not established.

Contraindications and cautions

• Hypersensitivity to dolutegravir, lamivudine or an excipient.
• Concurrent fampridine or another narrow-therapeutic-window OCT2 substrate.

Monitoring

• HIV viral load and clinical response.
• Renal function, particularly where reduced clearance increases lamivudine exposure.
• Liver chemistry, especially with hepatitis B or C coinfection or pre-existing liver disease.
• Blood count when moderate renal impairment could increase lamivudine-related anaemia or neutropenia.
• Weight, blood lipids and glucose as clinically appropriate.
• New rash, systemic hypersensitivity symptoms, mood changes and interacting medicines.

Clinical pharmacology

Dolutegravir inhibits integrase-mediated strand transfer. Intracellular lamivudine triphosphate inhibits HIV reverse transcriptase and terminates viral DNA chains. Dolutegravir can raise serum creatinine by inhibiting tubular creatinine transport without reducing glomerular filtration.

Formulation and product differences

• Fixed-ratio oral film-coated tablet.
• Individual component adjustment is not possible; separate preparations may be needed for certain interactions, renal toxicity or haematological toxicity.
• The tablet is oval, white and marked “SV 137”.

Tablet

Route: Oral

Strengths: 50 mg + 300 mg