Can Co-administration of Dabigatran with Antiretroviral Drugs Be Effective and Safe?
In 2019, the first results regarding the concurrent use of antiretroviral drugs and oral anticoagulants were published. This involved 14 patients with atrial fibrillation and HIV infection, in whom the concurrent administration of dabigatran with antiretroviral drugs was not associated with the occurrence of thromboembolic events or bleeding during follow-up lasting up to 40 months.
Study Objective
The concurrent administration of oral anticoagulants and antiretroviral drugs has so far been hampered by the concern of unverified interactions between these classes of drugs. Australian authors were the first to publish the results of monitoring a group of 14 men with atrial fibrillation and HIV infection, in whom this combination was successfully initiated.
Characteristics of Monitored Patients
The average age of the patients was 64 years (range 50–81 years), none of them had impaired liver function, and 3 had moderately impaired renal function (eGFR 45–60 ml/min/1.73 m2). The patients were followed for 2–40 months, with a median of 12 months.
All patients were taking antiretroviral agents: nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, HIV integrase inhibitors, protease inhibitors, or CCR5 receptor antagonists.
Pharmacokinetics and Safety Profile of Dabigatran
All patients were taking dabigatran from the group of new oral anticoagulants (NOACs), in a dose of 110 mg 2× daily. The median peak serum level of dabigatran was 125 ng/ml and the median trough level was 48 ng/ml. For 5 of them, the dose of dabigatran was increased to 150 mg 2× daily due to a trough level of dabigatran < 69.3 ng/ml. Nevertheless, for this subgroup, 60% of cases remained with a trough level < 40 ng/ml and the median peak level was only 76 ng/ml, which are significantly lower levels than in the RE-LY study.
None of the patients experienced any adverse bleeding or thromboembolic events during the follow-up period.
Conclusion
Although it is a small group of patients, it represents the largest analysis of the concurrent administration of oral anticoagulants and antiretroviral drugs at the time of its publication. Despite the fact that monitoring of dabigatran therapy is not required in the general population, the authors suggest that it may be an appropriate procedure in the population treated simultaneously with antiretrovirals due to the absence of pharmacological interaction studies between these classes of drugs.
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Source: Perram J., O'Dwyer E., Holloway C. Use of dabigatran with antiretrovirals. HIV Med 2019; 20 (5): 344−346, doi: 10.1111/hiv.12722.
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