Drug reference
HIV infection, in combination with other antiretroviral drugs (initiated by a specialist) ▶BY MOUTH ▶Adult: 800/150 mg once daily, dosage should not be altered or therapy discontinued without instruction from the healthcare provider DOSE EQUIVALENCE AND CONVERSION ▶Dose expressed as x/y mg of darunavir/cobicistat.
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Treatment-experienced patients with 1 or more darunavir resistance-associated mutations, plasma HIV-RNA concentration of 100 000 copies/mL or greater, or CD4 count less than 100 cells 6106/litre
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Elderly
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Scottish Medicines Consortium (SMC) decisions SMC No. 1081/15 The Scottish Medicines Consortium has advised (August 2015) that darunavir with cobicistat (Rezolsta ®) is accepted for use within NHS Scotland for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults, in combination with other antiretrovirals. Genotypic testing should guide its use.
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MHRA/CHM ADVICE: DARUNAVIR BOOSTED WITH COBICISTAT: AVOID USE IN PREGNANCY DUE TO RISK OF TREATMENT FAILURE AND MATERNAL-TO-CHILD TRANSMISSION OF HIV-1 (JULY 2018) Pharmacokinetic data show mean exposure of darunavir boosted with cobicistat (available in combination in Rezolsta ® and Symtuza ®) to be lower during the second and third trimesters of pregnancy than during 6–12 weeks postpartum. Low darunavir exposure may be associated with an increased risk of treatment failure and an increased risk of HIV-1 transmission to the unborn child. For further information, see Pregnancy.
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→Appendix 1: cobicistat. HIV-protease inhibitors
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Manufacturer advises not to be initiated during pregnancy due to low darunavir exposure; women who become pregnant during therapy should be switched to an alternative regimen. Darunavir with ritonavir may be considered as an alternative.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 21 ▶Rezolsta (Janssen-Cilag Ltd) Cobicistat 150 mg, Darunavir (as Darunavir ethanolate) 800 mg Rezolsta 800mg/150mg tablets | 30 tablet P £317.24
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800/150 mg once daily, dosage should not be
First-line fragment. Read the complete Indications and Dose section above.
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