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Artikel ; Online: Real-World Evidence of the Top 100 Prescribed Drugs in the USA and Their Potential for Drug Interactions with Nirmatrelvir; Ritonavir.

Gerhart, Jacqueline / Draica, Florin / Benigno, Michael / Atkinson, Jo / Reimbaeva, Maya / Francis, Domenick / Baillon-Plot, Nathalie / Sidhu, Gurinder Singh / Damle, Bharat D

The AAPS journal

2023 Band 25, Heft 5, Seite(n) 73

Abstract: Nirmatrelvir (coadministered with ritonavir as ... ...

Abstract	Nirmatrelvir (coadministered with ritonavir as PAXLOVID
Mesh-Begriff(e)	Humans ; Ritonavir ; COVID-19 ; COVID-19 Drug Treatment ; Drug Interactions ; Cytochrome P-450 CYP3A ; Antiviral Agents/therapeutic use
Chemische Substanzen	nirmatrelvir and ritonavir drug combination ; Ritonavir (O3J8G9O825) ; Cytochrome P-450 CYP3A (EC 1.14.14.1) ; Antiviral Agents
Sprache	Englisch
Erscheinungsdatum	2023-07-20
Erscheinungsland	United States
Dokumenttyp	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	1550-7416
ISSN (online)	1550-7416
DOI	10.1208/s12248-023-00832-3
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: A Comprehensive Review of the Clinical Pharmacokinetics, Pharmacodynamics, and Drug Interactions of Nirmatrelvir/Ritonavir.

Gerhart, Jacqueline / Cox, Donna S / Singh, Ravi Shankar P / Chan, Phylinda L S / Rao, Rohit / Allen, Richard / Shi, Haihong / Masters, Joanna C / Damle, Bharat

Clinical pharmacokinetics

2024 Band 63, Heft 1, Seite(n) 27–42

Abstract: Nirmatrelvir is a potent and selective inhibitor of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) main protease that is used as an oral antiviral coronavirus disease 2019 (COVID-19) treatment. To sustain unbound systemic trough ... ...

Abstract	Nirmatrelvir is a potent and selective inhibitor of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) main protease that is used as an oral antiviral coronavirus disease 2019 (COVID-19) treatment. To sustain unbound systemic trough concentrations above the antiviral in vitro 90% effective concentration value (EC
Mesh-Begriff(e)	Humans ; Ritonavir/pharmacology ; Ritonavir/therapeutic use ; Pandemics ; Drug Interactions ; COVID-19 ; Antiviral Agents/pharmacology ; Antiviral Agents/therapeutic use ; Nitriles ; Drug Combinations ; Leucine ; Proline ; Lactams
Chemische Substanzen	nirmatrelvir and ritonavir drug combination ; Ritonavir (O3J8G9O825) ; Antiviral Agents ; Nitriles ; Drug Combinations ; Leucine (GMW67QNF9C) ; Proline (9DLQ4CIU6V) ; Lactams
Sprache	Englisch
Erscheinungsdatum	2024-01-04
Erscheinungsland	Switzerland
Dokumenttyp	Journal Article ; Review ; Research Support, N.I.H., Extramural
ZDB-ID	197627-8
ISSN	1179-1926 ; 0312-5963
ISSN (online)	1179-1926
ISSN	0312-5963
DOI	10.1007/s40262-023-01339-y
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: Effects of nirmatrelvir/ritonavir on midazolam and dabigatran pharmacokinetics in healthy participants.

Cox, Donna S / Rehman, Muhammad / Khan, Tahira / Ginman, Katherine / Salageanu, Joanne / LaBadie, Robert R / Wan, Katty / Damle, Bharat

British journal of clinical pharmacology

2023 Band 89, Heft 11, Seite(n) 3352–3363

Abstract: Aims: To evaluate pharmacokinetics (PK) and safety after coadministration of nirmatrelvir/ritonavir or ritonavir alone with midazolam (a cytochrome P450 3A4 substrate) and dabigatran (a P-glycoprotein substrate).: Methods: PK was studied in 2 phase 1, ...

Abstract	Aims: To evaluate pharmacokinetics (PK) and safety after coadministration of nirmatrelvir/ritonavir or ritonavir alone with midazolam (a cytochrome P450 3A4 substrate) and dabigatran (a P-glycoprotein substrate). Methods: PK was studied in 2 phase 1, open-label, fixed-sequence studies in healthy adults. Single oral doses of midazolam 2 mg (n = 12) or dabigatran 75 mg (n = 24) were administered alone and after steady state (i.e. ≥2 days) of nirmatrelvir/ritonavir 300 mg/100 mg and ritonavir 100 mg. Midazolam and dabigatran plasma concentrations and adverse events were analysed for each treatment. Results: After administration of midazolam with nirmatrelvir/ritonavir (test) or alone (reference), midazolam geometric mean area under the concentration-time curve extrapolated to infinity (AUC Conclusion: Coadministration of midazolam or dabigatran with nirmatrelvir/ritonavir increased systemic exposure of midazolam or dabigatran. Midazolam exposures were comparable when coadministered with nirmatrelvir/ritonavir or ritonavir alone, suggesting no incremental effect of nirmatrelvir. Dabigatran C
Mesh-Begriff(e)	Adult ; Humans ; Midazolam/pharmacokinetics ; Ritonavir ; Dabigatran/adverse effects ; Dabigatran/pharmacokinetics ; Healthy Volunteers ; Drug Interactions ; Area Under Curve ; Cytochrome P-450 CYP3A/metabolism
Chemische Substanzen	Midazolam (R60L0SM5BC) ; Ritonavir (O3J8G9O825) ; Dabigatran (I0VM4M70GC) ; Cytochrome P-450 CYP3A (EC 1.14.14.1)
Sprache	Englisch
Erscheinungsdatum	2023-07-12
Erscheinungsland	England
Dokumenttyp	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.15835
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: Dosing recommendation of nirmatrelvir/ritonavir using an integrated population pharmacokinetic analysis.

Chan, Phylinda L S / Singh, Ravi Shankar P / Cox, Donna S / Shi, Haihong / Damle, Bharat / Nicholas, Timothy

CPT: pharmacometrics & systems pharmacology

2023 Band 12, Heft 12, Seite(n) 1897–1910

Abstract: Protease inhibitor nirmatrelvir coadministered with ritonavir as a pharmacokinetic enhancer (PAXLOVID™; Pfizer Inc) became the first orally bioavailable antiviral agent granted Emergency Use Authorization in the United States in patients ≥12 years old ... ...

Abstract	Protease inhibitor nirmatrelvir coadministered with ritonavir as a pharmacokinetic enhancer (PAXLOVID™; Pfizer Inc) became the first orally bioavailable antiviral agent granted Emergency Use Authorization in the United States in patients ≥12 years old with mild to moderate coronavirus disease 2019 (COVID-19). This population pharmacokinetic analysis used pooled plasma nirmatrelvir concentrations from eight completed phase I and II/III studies to characterize nirmatrelvir pharmacokinetics when coadministered with ritonavir in adults with/without COVID-19. Influence of covariates (e.g., formulation, dose, COVID-19) was examined using a stepwise forward selection (α = 0.05) and backward elimination (α = 0.001) approach. Simulations with 5000 subjects for each age and weight group and renal function category were performed to support dosing recommendations of nirmatrelvir/ritonavir for adults with COVID-19 and guide dose adjustments for specific patient populations (e.g., renal insufficiency, pediatrics). The final model was a two-compartment model with first-order absorption, including allometric scaling of body weight and dose-dependent absorption (power function on relative bioavailability). Nirmatrelvir clearance (CL) increased proportionally to body surface area-normalized creatinine CL (nCLCR) up to 70 ml/min/1.73 m
Mesh-Begriff(e)	Adult ; Humans ; Child ; Ritonavir ; Antiviral Agents ; Benzodiazepines ; COVID-19
Chemische Substanzen	Ritonavir (O3J8G9O825) ; Antiviral Agents ; Benzodiazepines (12794-10-4)
Sprache	Englisch
Erscheinungsdatum	2023-10-06
Erscheinungsland	United States
Dokumenttyp	Journal Article
ZDB-ID	2697010-7
ISSN	2163-8306 ; 2163-8306
ISSN (online)	2163-8306
ISSN	2163-8306
DOI	10.1002/psp4.13039
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: Clinical Pharmacology Perspectives on the Antiviral Activity of Azithromycin and Use in COVID-19.

Damle, Bharat / Vourvahis, Manoli / Wang, Erjian / Leaney, Joanne / Corrigan, Brian

Clinical pharmacology and therapeutics

2020 Band 108, Heft 2, Seite(n) 201–211

Abstract: Azithromycin (AZ) is a broad-spectrum macrolide antibiotic with a long half-life and a large volume of distribution. It is primarily used for the treatment of respiratory, enteric, and genitourinary bacterial infections. AZ is not approved for the ... ...

Abstract	Azithromycin (AZ) is a broad-spectrum macrolide antibiotic with a long half-life and a large volume of distribution. It is primarily used for the treatment of respiratory, enteric, and genitourinary bacterial infections. AZ is not approved for the treatment of viral infections, and there is no well-controlled, prospective, randomized clinical evidence to support AZ therapy in coronavirus disease 2019 (COVID-19). Nevertheless, there are anecdotal reports that some hospitals have begun to include AZ in combination with hydroxychloroquine or chloroquine (CQ) for treatment of COVID-19. It is essential that the clinical pharmacology (CP) characteristics of AZ be considered in planning and conducting clinical trials of AZ alone or in combination with other agents, to ensure safe study conduct and to increase the probability of achieving definitive answers regarding efficacy of AZ in the treatment of COVID-19. The safety profile of AZ used as an antibacterial agent is well established.
Mesh-Begriff(e)	Antiviral Agents/pharmacology ; Antiviral Agents/therapeutic use ; Azithromycin/adverse effects ; Azithromycin/pharmacokinetics ; Azithromycin/pharmacology ; Azithromycin/therapeutic use ; Betacoronavirus/drug effects ; Betacoronavirus/pathogenicity ; Clinical Trials as Topic ; Coronavirus Infections/drug therapy ; Drug Therapy, Combination ; Humans ; Hydroxychloroquine/pharmacology ; Lung/drug effects ; Microbial Sensitivity Tests
Chemische Substanzen	Antiviral Agents ; Hydroxychloroquine (4QWG6N8QKH) ; Azithromycin (83905-01-5)
Schlagwörter	covid19
Sprache	Englisch
Erscheinungsdatum	2020-05-12
Erscheinungsland	United States
Dokumenttyp	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.1857
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: Population Pharmacokinetic Analysis of Dalteparin in Pediatric Patients With Venous Thromboembolism.

Damle, Bharat / Jen, Frank / Sherman, Nancy / Jani, Darshana / Sweeney, Kevin

Journal of clinical pharmacology

2020 Band 61, Heft 2, Seite(n) 172–180

Abstract: This article describes the population pharmacokinetics (PK) of dalteparin in pediatric patients with venous thromboembolism (VTE). A prospective multicenter open-label study was conducted in children who required anticoagulation for the treatment of VTE. ...

Abstract	This article describes the population pharmacokinetics (PK) of dalteparin in pediatric patients with venous thromboembolism (VTE). A prospective multicenter open-label study was conducted in children who required anticoagulation for the treatment of VTE. The study population included children with and without cancer. The goal was to describe the pharmacokinetics of dalteparin using anti-Xa as a surrogate marker and to determine the dose required to achieve therapeutic anti-Xa levels (0.5-1.0 IU/mL). The anti-Xa data were supplemented with 2 published studies and analyzed using population pharmacokinetic approaches. The pharmacokinetics of dalteparin following subcutaneous injection in pediatric patients was described by a 1-compartment model with linear absorption and elimination. Body weight was added as a covariate on both CL/F and Vd/F as a power function with fixed exponents of 0.75 and 1.0, respectively. The estimates of CL/F and Vd/F in the full model were 929 mL/h and 7180 mL, respectively, for a reference female patient aged 12 years with body weight of 43 kg. Body weight-normalized CL/F decreased with age. Cancer status and sex did not have significant effects on CL/F and Vd/F. Simulations were conducted to select starting doses of dalteparin that would rapidly achieve therapeutic anti-Xa levels. These simulations suggested that the recommended starting doses of dalteparin administered subcutaneously in pediatric patients of different age cohort groups for treatment of VTE were 150 IU/kg every 12 hours (1 month to <2 years), 125 IU/kg every 12 hours (≥2 to <8 years), and 100 IU/kg every 12 hours (≥8 to <19 years).
Mesh-Begriff(e)	Adolescent ; Age Factors ; Anticoagulants/administration & dosage ; Anticoagulants/adverse effects ; Anticoagulants/pharmacokinetics ; Anticoagulants/therapeutic use ; Biomarkers ; Body Weight ; Child ; Child, Preschool ; Dalteparin/administration & dosage ; Dalteparin/adverse effects ; Dalteparin/pharmacokinetics ; Dalteparin/therapeutic use ; Factor Xa Inhibitors/pharmacokinetics ; Factor Xa Inhibitors/therapeutic use ; Female ; Humans ; Infant ; Infant, Newborn ; Injections, Subcutaneous ; Male ; Metabolic Clearance Rate ; Prospective Studies ; Sex Factors ; Venous Thromboembolism/drug therapy
Chemische Substanzen	Anticoagulants ; Biomarkers ; Factor Xa Inhibitors ; Dalteparin (S79O08V79F)
Sprache	Englisch
Erscheinungsdatum	2020-08-21
Erscheinungsland	England
Dokumenttyp	Journal Article ; Multicenter Study
ZDB-ID	188980-1
ISSN	1552-4604 ; 0091-2700 ; 0021-9754
ISSN (online)	1552-4604
ISSN	0091-2700 ; 0021-9754
DOI	10.1002/jcph.1716
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: Effects of itraconazole and carbamazepine on the pharmacokinetics of nirmatrelvir/ritonavir in healthy adults.

Cox, Donna S / Van Eyck, Lien / Pawlak, Sylvester / Beckerman, Bruce / Linn, Carlos / Ginman, Katherine / Thay Cha, Youliny / LaBadie, Robert R / Shi, Haihong / Damle, Bharat

British journal of clinical pharmacology

2023 Band 89, Heft 9, Seite(n) 2867–2876

Abstract: Aims: The objective of this study was to evaluate the effects of a strong cytochrome P450 family (CYP) 3A4 inhibitor (itraconazole) and inducer (carbamazepine) on the pharmacokinetics and safety of nirmatrelvir/ritonavir.: Methods: Pharmacokinetics ... ...

Abstract	Aims: The objective of this study was to evaluate the effects of a strong cytochrome P450 family (CYP) 3A4 inhibitor (itraconazole) and inducer (carbamazepine) on the pharmacokinetics and safety of nirmatrelvir/ritonavir. Methods: Pharmacokinetics were measured in two phase 1, open-label, fixed-sequence studies in healthy adults. During Period 1, oral nirmatrelvir/ritonavir 300 mg/100 mg twice daily was administered alone; during Period 2, it was administered with itraconazole or carbamazepine. Nirmatrelvir/ritonavir was administered as repeated doses or one dose in the itraconazole and carbamazepine studies, respectively. Nirmatrelvir and ritonavir plasma concentrations and adverse event (AE) rates in both periods were analysed. Results: Each study included 12 participants. Following administration of nirmatrelvir/ritonavir with itraconazole (Test) or alone (Reference), test/reference ratios of the adjusted geometric means (90% CIs) for nirmatrelvir AUC Conclusions: Coadministration of a strong CYP3A4 inhibitor with a strong CYP3A inhibitor used for pharmacokinetic enhancement (i.e., ritonavir) resulted in small increases in plasma nirmatrelvir exposure, whereas coadministration of a strong inducer substantially decreased systemic nirmatrelvir and ritonavir exposures suggesting a contraindication in the label with CYP3A4 strong inducers. Administration of nirmatrelvir/ritonavir alone or with itraconazole or carbamazepine was generally safe.
Mesh-Begriff(e)	Adult ; Humans ; Itraconazole/adverse effects ; Ritonavir/adverse effects ; Drug Interactions ; Cytochrome P-450 CYP3A Inhibitors/pharmacology ; Cytochrome P-450 CYP3A Inducers ; Carbamazepine/adverse effects ; Area Under Curve ; Healthy Volunteers ; Cytochrome P-450 CYP3A
Chemische Substanzen	Itraconazole (304NUG5GF4) ; Ritonavir (O3J8G9O825) ; Cytochrome P-450 CYP3A Inhibitors ; Cytochrome P-450 CYP3A Inducers ; Carbamazepine (33CM23913M) ; Cytochrome P-450 CYP3A (EC 1.14.14.1)
Sprache	Englisch
Erscheinungsdatum	2023-05-31
Erscheinungsland	England
Dokumenttyp	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.15788
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: Patient Centric Microsampling to Support Paxlovid Clinical Development: Bridging and Implementation.

Wan, Katty / Kavetska, Olga / Damle, Bharat / Shi, Haihong / Cox, Donna S / Oladoyinbo, Olayide / Chan, Phylinda / Singh, Ravi Shankar P / Craft, Susan / Berthier, Erwin / Corrigan, Brian

Clinical pharmacology and therapeutics

2023 Band 115, Heft 1, Seite(n) 42–51

Abstract: Nirmatrelvir is a potent and selective severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) main protease inhibitor. Nirmatrelvir co-packaged with ritonavir (as PAXLOVID) received US Food and Drug Administration (FDA) Emergency Use Authorization ( ...

Abstract	Nirmatrelvir is a potent and selective severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) main protease inhibitor. Nirmatrelvir co-packaged with ritonavir (as PAXLOVID) received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) on December 22, 2021, as an oral treatment for coronavirus disease 2019 (COVID-19) and subsequent new drug application approval on May 25, 2023. Pharmacokinetic (PK) capillary blood sampling at-home using Tasso-M20 micro-volumetric sampling device was implemented in the program, including three phase II/III outpatient and several clinical pharmacology studies supporting the EUA. The at-home sampling complemented venous blood sampling procedures to enrich the PK dataset, to decrease the need for patients' site visit for PK sampling, and to allow different sampling approaches for flexibility and convenience. To demonstrate concordance/equivalence, bridging between venous plasma and Tasso dried blood results was conducted by comparing concentrations and derived PK parameters from both sampling approaches. In addition, a two-compartment population PK model was utilized to bridge the plasma and Tasso data by estimating the PK parameters using blood-to-plasma ratio as a slope parameter. Operational challenges were successfully managed to implement at-home PK sampling in global phase II/III trials. Sample quality was generally very good with less than 3% samples deemed as "not usable" from over 800 samples collected in all the studies. Experience gained from sites and patients will guide future broader implementations.
Mesh-Begriff(e)	United States ; Humans ; Lactams ; Leucine ; Ritonavir ; Patient-Centered Care
Chemische Substanzen	nirmatrelvir and ritonavir drug combination ; Lactams ; Leucine (GMW67QNF9C) ; Ritonavir (O3J8G9O825)
Sprache	Englisch
Erscheinungsdatum	2023-09-05
Erscheinungsland	United States
Dokumenttyp	Journal Article
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.3025
Datenquelle	MEDical Literature Analysis and Retrieval System OnLINE

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Artikel ; Online: The Weight of Evidence From Electrophysiology, Observational, and Cardiovascular End Point Studies Demonstrates the Safety of Azithromycin

Jack Cook / Milton L. Pressler / Bharat Damle / Demissie Alemayehu / Charles A. Knirsch

Clinical and Translational Science, Vol 14, Iss 1, Pp 106-

2021 Band 112

Abstract: Increased use of azithromycin (AZ) in treating infections associated with coronavirus disease 2019 (COVID‐19) and reports of increased incidence of prolonged corrected QT (QTc) interval associated with AZ used with hydroxychloroquine prompted us to ... ...

Abstract	Increased use of azithromycin (AZ) in treating infections associated with coronavirus disease 2019 (COVID‐19) and reports of increased incidence of prolonged corrected QT (QTc) interval associated with AZ used with hydroxychloroquine prompted us to review the latest evidence in the literature, present additional analyses of human cardiovascular (CV) electrophysiology studies, and to describe sequential steps in research and development that were undertaken to characterize the benefit‐risk profile of AZ. Combined QTc findings from electrocardiograms taken during oral and i.v. pharmacokinetic‐pharmacodynamic studies of AZ suggest that clinically meaningful QTc prolongation is unlikely. Findings from several observational studies were heterogeneous and not as consistent as results from at least two large randomized controlled trials (RCTs). The QTc findings presented and observational data from studies with large numbers of events are not consistent with either a proarrhythmic action of AZ or an increase in frequency of CV deaths. Well‐powered RCTs do not suggest a presence of increased risk of CV or sudden cardiac death after short‐term or protracted periods of AZ usage, even in patients at higher risk from pre‐existing coronary disease.
Schlagwörter	Therapeutics. Pharmacology ; RM1-950 ; Public aspects of medicine ; RA1-1270
Thema/Rubrik (Code)	610
Sprache	Englisch
Erscheinungsdatum	2021-01-01T00:00:00Z
Verlag	Wiley
Dokumenttyp	Artikel ; Online
Datenquelle	BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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Artikel ; Online: Clinical Pharmacology Perspectives on the Antiviral Activity of Azithromycin and Use in COVID‐19

Damle, Bharat / Vourvahis, Manoli / Wang, Erjian / Leaney, Joanne / Corrigan, Brian

Clinical Pharmacology & Therapeutics

2020 Band 108, Heft 2, Seite(n) 201–211

Schlagwörter	Pharmacology (medical) ; Pharmacology ; covid19
Sprache	Englisch
Verlag	Wiley
Erscheinungsland	us
Dokumenttyp	Artikel ; Online
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.1857
Datenquelle	BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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