{"doi":"10.1177/0091270007302564","title":"Lopinavir/Ritonavir Pharmacokinetic Profile: Impact of Sex and Other Covariates Following a Change From Twice‐Daily to Once‐Daily Therapy","abstract":"<jats:p>The aim of this study was to determine the impact of sex on the pharmacokinetics of lopinavir/ritonavir. Interaction between lopinavir/ritonavir and tenofovir was also evaluated. Steady‐state plasma samples were obtained from virologically suppressed HIV‐infected patients on lopinavir/ritonavir 800/200‐mg soft gel capsule taken once daily. Drug assays were performed by high‐performance liquid chromatography. Pharmacokinetic parameters estimated by noncompartmental method were reported as 90% confidence intervals (CIs) about the geometric mean ratio (GMR). There were 9 males and 11 females. No sex differences were observed in lopinavir/ritonavir pharmacokinetics profile. The GMR<jats:sub>sex</jats:sub> (women compared with men) for lopinavir area under the concentration‐time curve (AUC<jats:sub>24</jats:sub>), maximum concentration (C<jats:sub>max</jats:sub>), and minimum concentration (C<jats:sub>min</jats:sub>) was 0.95 (90% CI, 0.70–1.29), 0.88 (90% CI, 0.67–1.15), and 1.27 (90% CI, 0.60–2.66), respectively. Similarly, the GMR<jats:sub>sex</jats:sub> for ritonavir AUC<jats:sub>24</jats:sub>, C<jats:sub>max</jats:sub>, and C<jats:sub>min</jats:sub> was 0.84 (90% CI, 0.57–1.24), 0.79 (90% CI, 0.50–1.22), and 1.02 (90% CI, 0.58–1.80), respectively. Tenofovir coadministration led to a reduction in lopinavir/ritonavir plasma exposure, giving a lopinavir GMR<jats:sub>tenofovir</jats:sub> for C<jats:sub>max</jats:sub> of 0.72 (90% CI, 0.57–0.93) and AUC<jats:sub>24</jats:sub> of 0.74 (90% CI, 0.56–0.98), respectively. No difference in lopinavir/ritonavir plasma concentrations between sexes was demonstrated in this study. However, tenofovir coadministration lowered lopinavir/ritonavir plasma exposure.</jats:p>","journal":"The Journal of Clinical Pharmacology","year":2007,"id":682409,"datarank":0.4335557636844247,"base_score":2.8903717578961645,"endowment":2.8903717578961645,"self_citation_contribution":0.4335557636844247,"citation_network_contribution":0.0,"self_endowment_contribution":0.4335557636844247,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":17,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1782795,"name":"Susan K. 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Steady‐state plasma samples were obtained from virologically suppressed HIV‐infected patients on lopinavir/ritonavir 800/200‐mg soft gel capsule taken once daily. Drug assays were performed by high‐performance liquid chromatography. Pharmacokinetic parameters estimated by noncompartmental method were reported as 90% confidence intervals (CIs) about the geometric mean ratio (GMR). There were 9 males and 11 females. No sex differences were observed in lopinavir/ritonavir pharmacokinetics profile. The GMR<jats:sub>sex</jats:sub> (women compared with men) for lopinavir area under the concentration‐time curve (AUC<jats:sub>24</jats:sub>), maximum concentration (C<jats:sub>max</jats:sub>), and minimum concentration (C<jats:sub>min</jats:sub>) was 0.95 (90% CI, 0.70–1.29), 0.88 (90% CI, 0.67–1.15), and 1.27 (90% CI, 0.60–2.66), respectively. Similarly, the GMR<jats:sub>sex</jats:sub> for ritonavir AUC<jats:sub>24</jats:sub>, C<jats:sub>max</jats:sub>, and C<jats:sub>min</jats:sub> was 0.84 (90% CI, 0.57–1.24), 0.79 (90% CI, 0.50–1.22), and 1.02 (90% CI, 0.58–1.80), respectively. Tenofovir coadministration led to a reduction in lopinavir/ritonavir plasma exposure, giving a lopinavir GMR<jats:sub>tenofovir</jats:sub> for C<jats:sub>max</jats:sub> of 0.72 (90% CI, 0.57–0.93) and AUC<jats:sub>24</jats:sub> of 0.74 (90% CI, 0.56–0.98), respectively. No difference in lopinavir/ritonavir plasma concentrations between sexes was demonstrated in this study. However, tenofovir coadministration lowered lopinavir/ritonavir plasma exposure.</jats:p>","is_dataset_classified":null,"base_score":2.8903717578961645,"endowment":2.8903717578961645,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"17615254","pmcid":"PMC3073482","openalex_id":"https://openalex.org/W2067601295","authors":[],"funders":[{"funder_name":"NCRR NIH HHS","grant_id":"KL2 RR025009","title":null},{"funder_name":"NCRR NIH HHS","grant_id":"M01 RR00039","title":null},{"funder_name":"NIAID NIH HHS","grant_id":"R38 AI140299","title":null},{"funder_name":"NIAID NIH HHS","grant_id":"K23 AI073119","title":null},{"funder_name":"NCATS NIH HHS","grant_id":"KL2 TR000455","title":null},{"funder_name":"NCATS NIH HHS","grant_id":"UL1 TR000454","title":null},{"funder_name":"NIA NIH HHS","grant_id":"U54 AG062334","title":null},{"funder_name":"NCRR NIH HHS","grant_id":"UL1 RR025008","title":null},{"funder_name":"NCRR NIH HHS","grant_id":"M01 RR000039","title":null},{"funder_name":"NIAID NIH HHS","grant_id":"P30 AI050409","title":null},{"funder_name":"PHS HHS","grant_id":"U01 A138858","title":null}],"total_grants":11,"fwci":0.6211,"citation_percentile":0.66737958,"influential_citations":0,"citation_trend":[{"year":2012,"count":1},{"year":2013,"count":1},{"year":2015,"count":1},{"year":2016,"count":1},{"year":2018,"count":1},{"year":2020,"count":2},{"year":2021,"count":1}],"oa_status":"closed","license":"http://onlinelibrary.wiley.com/termsAndConditions#vor","oa_locations":[{"url":"https://api.wiley.com/onlinelibrary/tdm/v1/articles/10.1177%2F0091270007302564","host_type":"publisher"},{"url":"https://accp1.onlinelibrary.wiley.com/doi/pdf/10.1177/0091270007302564","host_type":"publisher"},{"url":"https://doi.org/10.1177/0091270007302564","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/17615254","host_type":"repository"},{"url":"https://www.ncbi.nlm.nih.gov/pmc/articles/3073482","host_type":"repository"}],"fields_of_study":["HIV/AIDS drug development and treatment","Pharmacological Effects and Toxicity Studies","HIV Research and Treatment"],"mesh_terms":["Tenofovir","Adenine","Adult","Capsules","Chromatography, High Pressure Liquid","Drug Administration Schedule","Drug Combinations","Drug Interactions","Female","Humans","Male","Pyrimidinones","Sex Factors","HIV Infections","HIV Protease Inhibitors","Reverse Transcriptase Inhibitors","Ritonavir","Area Under Curve","Lopinavir","Organophosphonates"],"keywords":["Lopinavir","Ritonavir","Lopinavir/ritonavir","Pharmacokinetics","Medicine","Pharmacology","Internal medicine","Human immunodeficiency virus (HIV)","Viral load","Virology","Antiretroviral therapy"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Good health and well-being"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-17T20:18:18.444924Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}