Electrocardiogram abnormalities with atazanavir and lopinavir/ritonavir
Chris R Rathbun1, Michelle D Liedtke, Steve M Blevins
1Department of Clinical and Administrative Sciences, College of Pharmacy, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73117, USA. chris-rathbun@ouhsc.edu
HIV Clinical Trials
|November 13, 2009
Summary
Concurrent use of atazanavir (ATV) and lopinavir/ritonavir (LPV/r) in HIV patients showed no pharmacokinetic changes but led to prolonged PR and QRS intervals. ECG monitoring is advised due to potential conduction abnormalities.
Area of Science:
- Pharmacology
- Infectious Diseases
- Cardiology
Background:
- Concurrent atazanavir (ATV) and lopinavir/ritonavir (LPV/r) combination therapy is considered for HIV patients with extensive antiretroviral resistance.
- Limited data exists on the pharmacokinetics and safety profile of this specific drug combination.
Purpose of the Study:
- To evaluate the pharmacokinetics and safety of concurrent atazanavir (ATV) and lopinavir/ritonavir (LPV/r) in HIV-infected patients.
- To assess potential drug interactions and adverse cardiovascular effects of this combination therapy.
Main Methods:
- A parallel-arm pharmacokinetic study involving 10 HIV-infected patients.
- Intensive pharmacokinetic sampling of plasma atazanavir, lopinavir, and ritonavir concentrations.
- Electrocardiogram (12-lead) and safety laboratory assessments were performed at multiple time points.
Main Results:
- No significant changes in atazanavir (ATV) or lopinavir (LPV) pharmacokinetics were observed.
- A majority of patients experienced prolonged PR and QRS intervals (mean increase: 16 ms and 5 ms, respectively).
- Two patients developed new-onset arrhythmias, leading to study termination.
Conclusions:
- Concurrent use of atazanavir (ATV) and lopinavir/ritonavir (LPV/r) was associated with PR and QRS interval prolongation.
- Electrocardiogram monitoring is recommended for patients on this combination, particularly those with additional risk factors for conduction abnormalities.
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