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Brand Name: Tivicay
Disease: HIV
Drug Class: HIV integrase inhibitor
Version: 21
Date Updated: March 2023
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Absorption Model |
ADAM (precipitation with solution) |
| Volume of Distribution Details |
Full PBPK (Method 3) |
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Route of Elimination |
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Perpetrator DDI |
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Validation |
Model can recover positive food effect for single and multiple dose. The UGT1A1 fm was verified against UGT1A1 genotype study and with rifampin and atazanavir DDI studies. The fm of CYP3A4 was verified against nevirapine, rifabutin, rifampin, atazanavir, efavirenz, and carbamazepine. One clinical study in which dolutegravir was administered with metformin was used to verify the Ki of OCT2 and MATE. Nine clinical DDI studies where dolutegravir was administered with either nevirapine, rifampicin, rifabutin, ritonavir, atazanavir, efavirenz, and carbamazepine were used to verify the PBPK model. In comparison of predicted vs. observed AUC, 100% of the studies were 2-fold and 67% were within 1.25-fold. |
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Limitations |
DDI with efavirenz and carbamazepine are underpredicted, likely because efavirenz and carbamazepine are inducers of UGT1A1 which is not considered in the current efavirenz and carbamazepine compound files. |
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14 |