Immunodeficiency Clinic > Drug Interaction Guide
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Dolutegravir & vitamin B1 (Thiamine) [class:green]
Summary/Recommendation:
Use standard doses of both drugs.
Data:
Significant interaction not anticipated.
Dolutegravir is not an inhibitor of cytochrome P450 enzymes, major UGTs, or P-glycoprotein and does not induce CYP3A. It is primarily metabolized via UGT1A1 with some contribution from CYP3A. Dolutegravir is not a substrate of OATP1B1 or OATP1B3.
Dolutegravir should be administered 2 hours before or 6 hours after taking medications containing polyvalent cations (Mg, Al, Fe, Ca)
Effect of Dolutegravir on the Kinetics of Other Agents
- Inhibits OCT2 in vitro Does NOT inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A, UGT1A1, UGT2B7, P-gp, BRCP, OATP1B1, OATP1B3, OCT1 or MRP2 in vitro
- Does NOT induce CYP1A2, CYP2B6, or CYP3A4 in vitro
Effect of Other Agents on the Pharmacokinetics of Dolutegravir
- Strong inducers of UGT1A1 (ex Rifampin) will reduce plasma concentrations of dolutegravir
- Strong inhibitors of UGT1A1 (Ex ATV/r) will increase plasma concentrations of dolutegravir
- Strong inducers of UGT1A3, UGT1A9, BCRP, and P-gp may decrease dolutegravir plasma concentration in vitro
Tivicay®:
Treatment-naïve or treatment experienced INSTI-naïve:
50 mg daily with or without food
Co-administered with potent UGT1A/CYP3A inducers OR INSTI- associated resistance:
50 mg twice daily with or without food
Dolutegravir film-coated tablets must be swallowed whole.
Triumeq®:
1 tablet daily with or without food (treatment-naïve or treatment experienced INSTI-naïve only)
Juluca®:
1 tablet daily with a meal
Dolutegravir plasma concentrations increased in a less than dose- proportional manner above 50 mg.
Bioequivalence of a fixed-dose combination of dolutegravir 50 mg, abacavir 600 mg and lamivudine 300 mg compared to dolutegravir administered as a single agent and abacavir/lamivudine administered as a combined agent.2987
Children
At doses of ~1 mg/kg once daily, adequate mean AUC and C24 were achieved in HIV-infected children between 6-11 years of age.2985
Obese adults
In a PBPK model, dolutegravir Cmax and AUC were predicted to be reduced by 13% and 3%, respectively, in obese (BMI 30-40 kg/m2) vs. non-obese (BM 18.5-30 kg/m2) individuals. Dose adjustment of dolutegravir is not required in this population.3578
Cervicovaginal fluid (CVF) concentrations
A total of 8 healthy females given DTG 50 mg daily for 5–7 days had 11 paired blood plasma (BP) and cervicovaginal fluid (CVF) samples collected over 24 h following the first dose (PK1) and multiple dosing (PK2). Each woman underwent cervical tissue (CT) and vaginal tissue (VT) biopsies at 1/4 time points at PK1 and PK2. After single and multiple dosing, CVF concentrations were approximately 6% of blood plasma exposure with low inter-individual variability. After multiple dosing, CT and VT exposures were 9-10% of blood plasma concentrations. After multiple dosing, DTG accumulated to a greater extent in tissue than in blood plasma or CVF, suggesting increased tissue affinity.2977
Colorectal tissue concentrations
Following single-dose, colorectal tissue concentrations were approximately 18 % of plasma concentrations.2979
Vitamin B1 is metabolized in the liver. When large doses are administered, body stores may become saturated, and unchanged vitamin B1 may be renally excreted.
Alternative Options: Interaction Check with Drugs from Similar Classes
HIV Integrase Inhibitor with vitamin B1
[green] 4
Dolutegravir with Vitamins/Minerals
[yellow] 2[green] 4
- Dolutegravir (Tivicay®) & calcium (e.g. Caltrate, Tums, Rolaids®)[class:yellow]
- Dolutegravir (Tivicay®) & Iron(ferrous fumarate, ferrous gluconate, ferrous sulfate) [class:yellow]
- Dolutegravir (Tivicay®) & vitamin B3 (Niacin, niacinamide, nicotinic acid, Niaspan®)[class:green]
- Dolutegravir (Tivicay®) & vitamin D (Cholecalciferol®)[class:green]
- Dolutegravir (Tivicay®) & vitamin B12 (Cyanocobalamin®)[class:green]
- Dolutegravir (Tivicay®) & vitamin B6 (Pyridoxine®)[class:green]
HIV Integrase Inhibitor with vitamin B1 [green] 4
Dolutegravir with Vitamins/Minerals [yellow] 2[green] 4
- Dolutegravir (Tivicay®) & calcium (e.g. Caltrate, Tums, Rolaids®)[class:yellow]
- Dolutegravir (Tivicay®) & Iron(ferrous fumarate, ferrous gluconate, ferrous sulfate) [class:yellow]
- Dolutegravir (Tivicay®) & vitamin B3 (Niacin, niacinamide, nicotinic acid, Niaspan®)[class:green]
- Dolutegravir (Tivicay®) & vitamin D (Cholecalciferol®)[class:green]
- Dolutegravir (Tivicay®) & vitamin B12 (Cyanocobalamin®)[class:green]
- Dolutegravir (Tivicay®) & vitamin B6 (Pyridoxine®)[class:green]
Interaction Classification
- These Drugs should not be coadministered[class:red]
- Potential interaction - may require close monitoring, alteration of drug dosage or timing of administration[class:yellow]
- No clinically significant interaction expected[class:green]
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The information in this website/app is intended for use by and with experienced physicians and pharmacists. The information is not intended to replace sound professional judgment in individual situations, and should be used in conjunction with other reliable sources of information. Due to the rapidly changing nature of information about HIV treatment and therapies, users are advised to recheck the information contained herein with the original source before applying it to patient care. Decisions about particular medical treatments should always be made in consultation with a qualified medical practitioner knowledgeable about HIV-related illness and the treatments in question.
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Also, program content focuses primarily on pharmacokinetic based interactions, and will not include comprehensive data on pharmacodynamics interactions, including QT prolongation.
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The Toronto General Hospital website has been in operation since 2000. The main objectives of the drug information portion of the website/app are to provide a comprehensive and centralized repository of current data on HIV/HCV drug therapy for health care professionals with a main focus on drug interactions, and to promote safe and rational prescribing of antiretrovirals and directly acting antivirals. The website/app content is updated regularly, and includes information from key international HIV/HCV conferences and recent publications in the medical/pharmacy literature.
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