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Effects of Acid-Reducing Agents on the Pharmacokinetics of Lopinavir/Ritonavir and Ritonavir-Boosted Atazanavir

From Abbott Laboratories, Abbott Park, Illinois (Dr Klein, Dr Chiu, Dr Cai, Ms King, Ms Causemaker, Dr Doan, Dr Podsadecki, Dr Hanna) and Abbott GmbH & Co KG, Ludwigshafen, Germany (Ms Beck, Dr Esslinger).

A total of 71 HIV-negative healthy adults were randomized to 1 of 6 regimens to receive lopinavir/ritonavir tablets 400/100 mg twice daily (bid) or 800/200 mg once daily (qd) or atazanavir 300 mg + ritonavir 100 mg qd from study days 1 to 15 with a moderate-fat meal. One hour before breakfast, either omeprazole 40 mg qd was administered on study days 11 through 15, or a single dose of ranitidine 150 mg was administered on study day 11. Lopinavir, atazanavir, and ritonavir pharmacokinetics were determined on study days 10, 11, and 15 and compared using point estimates and 90% confidence intervals (CIs). The point estimates for lopinavir C_max and AUC were in the range of 0.92 to 1.08, with 90% CI contained within the range of 0.80 to 1.25 after coadministration of omeprazole or ranitidine. The point estimates for atazanavir C_max and AUC were decreased by 48% to 62% with the upper bound of the 90% CI 0.55 after coadministration of omeprazole or ranitidine. The results indicated that lopinavir bioavailability was not affected by the coadministration of omeprazole or ranitidine. In contrast, atazanavir bioavailability was decreased by 48% to 62% when coadministered with ritonavir and either omeprazole or ranitidine.

Key Words: Acid-reducing agents • lopinavir • ritonavir • atazanavir • pharmacokinetics

Address for correspondence: Cheri E. Klein, Department of Clinical Pharmacokinetics and Pharmacodynamics, Abbott Laboratories Department R4PK, Bldg AP13A, 100 Abbott Park, Abbott Park, IL 60064-6140; e-mail: cheri.klein{at}abbott.com.