Daily Dosing for Bedaquiline in Patients with Tuberculosis

Area of Science:

• Pharmacology
• Infectious Diseases
• Clinical Pharmacy

Background:

• The current standard regimen for multidrug-resistant tuberculosis (MDR-TB) involves a specific dosing schedule for bedaquiline.
• Most co-administered antibiotics for tuberculosis (TB) are administered once daily (QD).

Purpose of the Study:

• To explore alternative, simplified daily (QD) bedaquiline dosing regimens for MDR-TB treatment.
• To determine if alternative QD regimens provide comparable pharmacokinetic exposure to the approved bedaquiline regimen.

Main Methods:

• Utilized pharmacokinetic simulations to model drug exposure levels.
• Evaluated a proposed alternative regimen of 200 mg QD for 8 weeks, followed by 100 mg QD.

Main Results:

• The simulated alternative regimen of 200 mg QD for 8 weeks followed by 100 mg QD demonstrated comparable bedaquiline exposure to the current approved regimen.
• This simplified regimen has the potential to improve treatment adherence and simplify drug administration.

Conclusions:

• A simplified daily bedaquiline regimen (200 mg QD for 8 weeks, then 100 mg QD) is pharmacokinetically similar to the standard regimen.
• This simpler regimen is currently undergoing clinical evaluation for MDR-TB treatment.