Rita Humeniuk
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View article: Efficacy and Safety of Obeldesivir in High-Risk Nonhospitalized Patients With Coronavirus Disease 2019 (BIRCH): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study
Efficacy and Safety of Obeldesivir in High-Risk Nonhospitalized Patients With Coronavirus Disease 2019 (BIRCH): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Open
Background Obeldesivir is an oral nucleoside analog prodrug inhibitor of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods Nonhospitalized adults with risk factors for developing severe coronavirus disease 2019 (COVID-1…
View article: Efficacy and safety of obeldesivir in low-risk, non-hospitalised patients with COVID-19 (OAKTREE): a phase 3, randomised, double-blind, placebo-controlled study
Efficacy and safety of obeldesivir in low-risk, non-hospitalised patients with COVID-19 (OAKTREE): a phase 3, randomised, double-blind, placebo-controlled study Open
View article: Pharmacokinetics of <scp>SARS</scp>‐<scp>CoV</scp>‐2 <scp>RNA</scp> Polymerase Inhibitor Remdesivir in Participants With Moderate and Severe Hepatic Impairment
Pharmacokinetics of <span>SARS</span>‐<span>CoV</span>‐2 <span>RNA</span> Polymerase Inhibitor Remdesivir in Participants With Moderate and Severe Hepatic Impairment Open
Remdesivir is an RNA polymerase inhibitor of severe acute respiratory syndrome coronavirus 2 administered intravenously (IV) that is approved for the treatment of coronavirus disease 2019 in hospitalized and nonhospitalized patients. The c…
View article: P-2026. Obeldesivir for the Treatment of COVID-19 in People with Risk Factors for Progression to Severe Disease: the BIRCH Study
P-2026. Obeldesivir for the Treatment of COVID-19 in People with Risk Factors for Progression to Severe Disease: the BIRCH Study Open
Background COVID-19 remains a serious condition, as the risk of severe outcomes increases with age and comorbid conditions. Early antiviral therapy has been shown to prevent disease progression. Obeldesivir (ODV) is an oral, broad spectrum…
View article: P-2036. Obeldesivir for Treatment of COVID-19 in Adults and Adolescents Without Risk Factors for Progression to Severe Disease: the OAKTREE Study
P-2036. Obeldesivir for Treatment of COVID-19 in Adults and Adolescents Without Risk Factors for Progression to Severe Disease: the OAKTREE Study Open
Background COVID-19 continues to cause morbidity. Obeldesivir (ODV) is an oral, broad spectrum, nucleoside analog prodrug inhibitor of SARS-CoV-2 RNA-dependent RNA polymerase. Methods OAKTREE was a Phase 3, randomized, double-blind, placeb…
View article: Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia: A Randomized Clinical Trial
Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia: A Randomized Clinical Trial Open
Background Few antiviral therapies have been studied in patients with coronavirus disease 2019 (COVID-19) and kidney impairment. Herein, the efficacy, safety, and pharmacokinetics of remdesivir, its metabolites, and sulfobutylether-β-cyclo…
View article: Pharmacokinetics and Safety of Remdesivir in Pregnant and Nonpregnant Women With COVID-19: Results From IMPAACT 2032
Pharmacokinetics and Safety of Remdesivir in Pregnant and Nonpregnant Women With COVID-19: Results From IMPAACT 2032 Open
Background Pregnant people with coronavirus disease 2019 (COVID-19) experience higher risk for severe disease and adverse pregnancy outcomes, but no pharmacokinetic (PK) data exist to support dosing of COVID-19 therapeutics during pregnanc…
View article: Impact of <scp>COVID</scp>‐19 on the Conduct and Design of Clinical Trials: <scp>IQ</scp> Consortium Perspective
Impact of <span>COVID</span>‐19 on the Conduct and Design of Clinical Trials: <span>IQ</span> Consortium Perspective Open
To assess the impact of the coronavirus disease 2019 (COVID-19) pandemic on clinical trials design and conduct, a Working Group was formed by the Clinical Pharmacology Leadership Group within the International Consortium for Innovation and…
View article: 539. Efficacy in Multiple SARS-CoV-2 Animal Models Supports Phase 3 Dose Selection for Obeldesivir
539. Efficacy in Multiple SARS-CoV-2 Animal Models Supports Phase 3 Dose Selection for Obeldesivir Open
Background Remdesivir (RDV, Veklury) is the first FDA-approved direct-acting antiviral treatment for COVID-19. While RDV requires IV administration, obeldesivir (ODV, GS-5245) is an oral prodrug of GS-441524, the parent nucleoside of RDV, …
View article: 505. Drug-drug Interaction Profiling of Obeldesivir, A Promising Oral Treatment for COVID-19
505. Drug-drug Interaction Profiling of Obeldesivir, A Promising Oral Treatment for COVID-19 Open
Background Obeldesivir (ODV), an orally administered RNA-dependent RNA polymerase inhibitor, is a GS-441524 prodrug under investigation for the treatment of COVID-19. Herein, we assessed ODV as both perpetrator and victim of DDIs in health…
View article: 538. Clinical Evaluation of Drug-drug Interactions with Remdesivir
538. Clinical Evaluation of Drug-drug Interactions with Remdesivir Open
Background Remdesivir (RDV), a nucleotide prodrug approved for COVID-19, is a substrate and inhibitor of organic anion-transporter polyprotein (OATP) transporters and cytochrome P450 3A4 (CYP3A4) metabolizing enzyme based on in vitro data.…
View article: Pharmacokinetics, safety, and tolerability of inhaled remdesivir in healthy participants
Pharmacokinetics, safety, and tolerability of inhaled remdesivir in healthy participants Open
Intravenous remdesivir (RDV) is US Food and Drug Administration–approved for hospitalized and nonhospitalized individuals with coronavirus disease 2019. RDV undergoes intracellular metabolic activation to form the active triphosphate, GS‐4…
View article: Supplementary Fig. from Decreased levels of UMP kinase as a mechanism of fluoropyrimidine resistance
Supplementary Fig. from Decreased levels of UMP kinase as a mechanism of fluoropyrimidine resistance Open
Supplementary Fig. from Decreased levels of UMP kinase as a mechanism of fluoropyrimidine resistance
View article: Supplementary Fig. from Epigenetic reversal of acquired resistance to 5-fluorouracil treatment
Supplementary Fig. from Epigenetic reversal of acquired resistance to 5-fluorouracil treatment Open
Supplementary Fig. from Epigenetic reversal of acquired resistance to 5-fluorouracil treatment
View article: Data from Epigenetic reversal of acquired resistance to 5-fluorouracil treatment
Data from Epigenetic reversal of acquired resistance to 5-fluorouracil treatment Open
Acquired and intrinsic resistance still remains a limitation to the clinical use of 5-fluorouracil (5-FU). The contribution of epigenetic changes to the development of drug resistance remains to be elucidated. Several genes that are hyperm…
View article: Supplemental Figure 4 from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia
Supplemental Figure 4 from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia Open
Supplemental Figure 4. Free BTK levels at baseline and trough TIRA concentration for CLL patients treated with 80 mg TIRA
View article: Supplementary Fig. from Decreased levels of UMP kinase as a mechanism of fluoropyrimidine resistance
Supplementary Fig. from Decreased levels of UMP kinase as a mechanism of fluoropyrimidine resistance Open
Supplementary Fig. from Decreased levels of UMP kinase as a mechanism of fluoropyrimidine resistance
View article: Supplemental Figure 3a from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia
Supplemental Figure 3a from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia Open
Supplemental Figure 3. Mean (SD) TIRA plasma concentration. Cycle 1 Day 8 data are shown in patients receiving TIRA monotherapy with A) TIRA/IDELA, and B) TIRA/ENTO*
View article: Supplemental Figure 4 from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia
Supplemental Figure 4 from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia Open
Supplemental Figure 4. Free BTK levels at baseline and trough TIRA concentration for CLL patients treated with 80 mg TIRA
View article: Supplemental Figure 2 from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia
Supplemental Figure 2 from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia Open
Supplemental Figure 2. Patient disposition
View article: Data from Epigenetic reversal of acquired resistance to 5-fluorouracil treatment
Data from Epigenetic reversal of acquired resistance to 5-fluorouracil treatment Open
Acquired and intrinsic resistance still remains a limitation to the clinical use of 5-fluorouracil (5-FU). The contribution of epigenetic changes to the development of drug resistance remains to be elucidated. Several genes that are hyperm…
View article: Supplemental Figure 2 from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia
Supplemental Figure 2 from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia Open
Supplemental Figure 2. Patient disposition
View article: Data from Decreased levels of UMP kinase as a mechanism of fluoropyrimidine resistance
Data from Decreased levels of UMP kinase as a mechanism of fluoropyrimidine resistance Open
5-Fluorouracil (5-FU) continues to be widely used for treatment of gastrointestinal cancers. Because many tumors show primary or acquired resistance, it is important to understand the molecular basis underlying the mechanism of resistance …
View article: Supplemental Figure 1 from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia
Supplemental Figure 1 from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia Open
Supplemental Figure 1. Study design
View article: Data from Decreased levels of UMP kinase as a mechanism of fluoropyrimidine resistance
Data from Decreased levels of UMP kinase as a mechanism of fluoropyrimidine resistance Open
5-Fluorouracil (5-FU) continues to be widely used for treatment of gastrointestinal cancers. Because many tumors show primary or acquired resistance, it is important to understand the molecular basis underlying the mechanism of resistance …
View article: Supplemental Figure 3b from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia
Supplemental Figure 3b from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia Open
Supplemental Figure 3. Mean (SD) TIRA plasma concentration. Cycle 1 Day 8 data are shown in patients receiving TIRA monotherapy with A) TIRA/IDELA, and B) TIRA/ENTO*
View article: Data from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia
Data from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia Open
Purpose:Bruton tyrosine kinase (BTK) inhibition alone leads to incomplete responses in chronic lymphocytic leukemia (CLL). Combination therapy may reduce activation of escape pathways and deepen responses. This open-label, phase Ib, sequen…
View article: Data from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia
Data from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia Open
Purpose:Bruton tyrosine kinase (BTK) inhibition alone leads to incomplete responses in chronic lymphocytic leukemia (CLL). Combination therapy may reduce activation of escape pathways and deepen responses. This open-label, phase Ib, sequen…
View article: Supplementary Data from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia
Supplementary Data from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia Open
Supplemental Table 1 summarizes study inclusion and exclusion criteria. Supplemental Table 2 shows the doses and dose-escalation strategy used in this study. Supplemental Table 3 defines the dose-limiting toxicities that guided dose escala…
View article: Supplemental Figure 1 from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia
Supplemental Figure 1 from Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia Open
Supplemental Figure 1. Study design