{"doi":"10.1007/s40261-014-0198-x","title":"Steady-State Pharmacokinetics of Darunavir/Ritonavir and Pitavastatin when Co-administered to Healthy Adult Volunteers","abstract":null,"journal":"Clinical Drug Investigation","year":2014,"id":678844,"datarank":0.40620753016533157,"base_score":2.70805020110221,"endowment":2.70805020110221,"self_citation_contribution":0.40620753016533157,"citation_network_contribution":0.0,"self_endowment_contribution":0.40620753016533157,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":14,"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":1773651,"name":"Stuart E. Campbell","orcid":null,"position":1,"is_corresponding":false},{"id":442603,"name":"Craig A. Sponseller","orcid":null,"position":2,"is_corresponding":false},{"id":1773653,"name":"David S. Small","orcid":null,"position":3,"is_corresponding":false},{"id":1773655,"name":"Matthew M. Medlock","orcid":null,"position":4,"is_corresponding":false},{"id":1773656,"name":"Roger E. Morgan","orcid":null,"position":5,"is_corresponding":false},{"id":1773650,"name":"Christine Y. Yu","orcid":null,"position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Steady-State Pharmacokinetics of Darunavir/Ritonavir and Pitavastatin when Co-administered to Healthy Adult Volunteers","abstract":"<h4>Background</h4>The treatment of hyperlipidaemia in human immunodeficiency virus (HIV)-infected patients has become increasingly important. However, treatment options are limited because of the drug-drug interaction between certain statins and HIV medications metabolized by cytochrome P450 (CYP) enzymes.<h4>Objectives</h4>The primary objective was to investigate the steady-state pharmacokinetics of pitavastatin when co-administered with darunavir/ritonavir. The secondary objective was to investigate the steady-state pharmacokinetics of both darunavir and ritonavir when co-administered with pitavastatin.<h4>Methods</h4>This was a single-centre, open-label, multi-dose, fixed-sequence study in HIV seronegative healthy volunteers. Pitavastatin 4 mg was administered once daily on days 1-5 and on days 12-16, and darunavir 800 mg/ritonavir 100 mg once daily on days 6-16. Pharmacokinetic blood sampling was performed on days 5, 11 and 16. No significant interaction was concluded if the 90 % confidence intervals (CIs) of the geometric mean ratios (GMRs) for total exposure [i.e. the area under the plasma concentration-time curve over a dosing interval at steady state (AUC(0-τ))] and for peak exposure [i.e. the maximum plasma concentration (C(max))] of the two treatments were within the 80-125 % range.<h4>Results</h4>Twenty-eight subjects (mean age 30.5 years) were enrolled, and pharmacokinetic data were available for 27 subjects. For pitavastatin, the GMRs and 90 % CIs for the AUC(0-τ) and C(max) ratios with co-administration were 0.74 (0.69-0.80) and 0.96 (0.84-1.09), respectively. For both darunavir and ritonavir, the 90 % CIs for the AUC(0-τ) and C max ratios were within 80-125 % with pitavastatin co-administration. No significant safety issues were reported.<h4>Conclusion</h4>Darunavir/ritonavir decreased total exposure to pitavastatin by 26 %, while peak exposures were similar. Pitavastatin did not influence the pharmacokinetics of darunavir or ritonavir. There is limited interaction between pitavastatin and darunavir/ritonavir.","is_dataset_classified":null,"base_score":2.70805020110221,"endowment":2.70805020110221,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"24825411","pmcid":null,"openalex_id":"https://openalex.org/W2083707054","authors":[],"funders":[],"total_grants":0,"fwci":0.8667,"citation_percentile":0.72916788,"influential_citations":0,"citation_trend":[{"year":2015,"count":2},{"year":2017,"count":3},{"year":2019,"count":1},{"year":2020,"count":2},{"year":2021,"count":2},{"year":2023,"count":3},{"year":2024,"count":1}],"oa_status":"closed","license":"https://www.springer.com/tdm","oa_locations":[{"url":"https://link.springer.com/content/pdf/10.1007/s40261-014-0198-x.pdf","host_type":"publisher"},{"url":"https://link.springer.com/article/10.1007/s40261-014-0198-x/fulltext.html","host_type":"publisher"},{"url":"http://link.springer.com/content/pdf/10.1007/s40261-014-0198-x","host_type":"publisher"},{"url":"https://doi.org/10.1007/s40261-014-0198-x","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/24825411","host_type":"repository"}],"fields_of_study":["HIV/AIDS drug development and treatment","HIV-related health complications and treatments","Biological Research and Disease Studies","Administration, Oral","Adolescent","Adult","Darunavir","Female","Healthy Volunteers","Humans","Male","Middle Aged","Quinolines","Ritonavir","Sulfonamides","Young Adult"],"mesh_terms":["Darunavir","Administration, Oral","Adolescent","Adult","Female","Humans","Male","Middle Aged","Quinolines","Sulfonamides","Ritonavir","Young Adult","Healthy Volunteers"],"keywords":["Darunavir","Ritonavir","Medicine","Pitavastatin","Pharmacology","Pharmacokinetics","Pharmacotherapy","Pravastatin","Human immunodeficiency virus (HIV)","Antiretroviral therapy","Internal medicine","Atorvastatin","Virology","Viral load","Cholesterol"],"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":"2026-08-17T11:36:55.193540Z","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":[]}