letermovir and Renal-Insufficiency

Human cytomegalovirus remains a significant issue for immunocompromised patients and existing viral polymerase targeting therapies are associated with significant toxicity. Accordingly, the viral terminase complex inhibitor, letermovir, is in development. We assessed letermovir pharmacokinetics in renal impairment.. This was a Phase 1, open-label, nonrandomised trial. Estimated glomerular filtration rate based on the Modification of Diet Renal Disease equation was used to create three groups of eight subjects: healthy function (estimated glomerular filtration rate ≥ 90 ml min. All 24 subjects enrolled completed the trial. Moderate and severe renal impairment increased mean unbound letermovir fractions by 11% and 26%, respectively, vs. healthy subjects. Exposure (AUC. Renal impairment increased exposure to letermovir, although age was a confounding factor.

Topics: Acetates; Aged; Antiviral Agents; Female; Glomerular Filtration Rate; Humans; Male; Middle Aged; Quinazolines; Renal Insufficiency