Pharmacokinetics and Drug Interactions in the new HCV Clinical Management SOC.

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Presentation transcript:

Pharmacokinetics and Drug Interactions in the new HCV Clinical Management SOC

Why worry about Pharmacokinetics (PK) and Drug – Drug Interactions (DDIs) in managing HCV patients?

Interaction due to Enzyme Inhibition: Increased systemic exposure

Interaction due to Enzyme Induction: Decreased systemic exposure

The importance of Cytochrome P450 (CYP) enzymes

Drugs can be metabolised in the Gastrointestinal tract and Liver

Drugs can be transported in the Gastrointestinal tract and Liver

Understanding the disposition of the DAAs

Telaprevir DDIs

Telaprevir increases exposure to CYP3A substrates: Perpetrator

Telaprevir increases exposure to CYP3A substrates

Telaprevir decreases exposure to other CYP substrates

Telaprevir decreases total but not unbound methadone concentrations.

Enzyme inducing agents reduce telaprevir exposure: Victim

Interactions with Boosted PIs

Telaprevir: DDIs with HIV antiretrovirals

Key CROI abstract

Boceprevir DDIs

Boceprevir increases exposure to CYP3A substrates

Boceprevir decreases exposure to other CYP substrates

Boceprevir exposure is decreased by efavirenz

Interaction of Boceprevir and Boosted HIV PIs

Boceprevir does not alter the PK of Raltegravir

Key CROI abstract

DAA Clinical Pharmacology

Contraindications with telaprevir and boceprevir

Drug Survey: Outline

Management of Drug-Drug Interactions

Disposition of Antidepressants

DAAs and Lipid Lowering Agents

Implications for clinical practice

TMC435 (Simeprivir)

TMC435 (Simeprivir) Interactions

BMS-790052

DAA clinical pharmacology: conclusions

Thank you