Phase I study, and dosing regimen selection for a pivotal COVID-19 trial of GST-HG171
This study is aimed to evaluate the safety, tolerability, and pharmacokinetics (PK), as well as to select an appropriate dosing regimen for the pivotal clinical trial of GST-HG171, an orally bioavailable, potent, and selective 3CL protease inhibitor by a randomized, double-blind, and placebo-controlled phase I trial in healthy subjects. We conducted a Ph1 study involving 78 healthy subjects to assess the safety, tolerability, and PK of single ascending doses (150-900 mg) as well as multiple ascending doses (MADs) (150 and 300 mg) of GST-HG171. Additionally, we examined the food effect and drug-drug interaction of GST-HG171...
Source: Antimicrobial Agents and Chemotherapy - December 15, 2023 Category: Microbiology Authors: Hong Zhang Jing Zhou Hong Chen John Mao Yanan Tang Wenhao Yan Tianxiang Zhang Chuanjing Li Shikui Chen Guoping Li George Zhang Yanhua Ding Li Liu Source Type: research
Phase I study, and dosing regimen selection for a pivotal COVID-19 trial of GST-HG171
This study is aimed to evaluate the safety, tolerability, and pharmacokinetics (PK), as well as to select an appropriate dosing regimen for the pivotal clinical trial of GST-HG171, an orally bioavailable, potent, and selective 3CL protease inhibitor by a randomized, double-blind, and placebo-controlled phase I trial in healthy subjects. We conducted a Ph1 study involving 78 healthy subjects to assess the safety, tolerability, and PK of single ascending doses (150-900 mg) as well as multiple ascending doses (MADs) (150 and 300 mg) of GST-HG171. Additionally, we examined the food effect and drug-drug interaction of GST-HG171...
Source: Antimicrobial Agents and Chemotherapy - December 15, 2023 Category: Microbiology Authors: Hong Zhang Jing Zhou Hong Chen John Mao Yanan Tang Wenhao Yan Tianxiang Zhang Chuanjing Li Shikui Chen Guoping Li George Zhang Yanhua Ding Li Liu Source Type: research
Phase I study, and dosing regimen selection for a pivotal COVID-19 trial of GST-HG171
This study is aimed to evaluate the safety, tolerability, and pharmacokinetics (PK), as well as to select an appropriate dosing regimen for the pivotal clinical trial of GST-HG171, an orally bioavailable, potent, and selective 3CL protease inhibitor by a randomized, double-blind, and placebo-controlled phase I trial in healthy subjects. We conducted a Ph1 study involving 78 healthy subjects to assess the safety, tolerability, and PK of single ascending doses (150-900 mg) as well as multiple ascending doses (MADs) (150 and 300 mg) of GST-HG171. Additionally, we examined the food effect and drug-drug interaction of GST-HG171...
Source: Antimicrobial Agents and Chemotherapy - December 15, 2023 Category: Microbiology Authors: Hong Zhang Jing Zhou Hong Chen John Mao Yanan Tang Wenhao Yan Tianxiang Zhang Chuanjing Li Shikui Chen Guoping Li George Zhang Yanhua Ding Li Liu Source Type: research
Phase I study, and dosing regimen selection for a pivotal COVID-19 trial of GST-HG171
This study is aimed to evaluate the safety, tolerability, and pharmacokinetics (PK), as well as to select an appropriate dosing regimen for the pivotal clinical trial of GST-HG171, an orally bioavailable, potent, and selective 3CL protease inhibitor by a randomized, double-blind, and placebo-controlled phase I trial in healthy subjects. We conducted a Ph1 study involving 78 healthy subjects to assess the safety, tolerability, and PK of single ascending doses (150-900 mg) as well as multiple ascending doses (MADs) (150 and 300 mg) of GST-HG171. Additionally, we examined the food effect and drug-drug interaction of GST-HG171...
Source: Antimicrobial Agents and Chemotherapy - December 15, 2023 Category: Microbiology Authors: Hong Zhang Jing Zhou Hong Chen John Mao Yanan Tang Wenhao Yan Tianxiang Zhang Chuanjing Li Shikui Chen Guoping Li George Zhang Yanhua Ding Li Liu Source Type: research
Optimizing COVID-19 treatment in immunocompromised patients: early combination therapy with remdesivir, nirmatrelvir/ritonavir and sotrovimab
Morbidity and mortality are higher in immunocompromised patients affected by COVID-19 than in the general population. Some authors have successfully used antiviral combination, but never in the early phase of ... (Source: Virology Journal)
Source: Virology Journal - December 15, 2023 Category: Virology Authors: Ivan Gentile, Maria Foggia, Maria Silvitelli, Alessia Sardanelli, Letizia Cattaneo and Giulio Viceconte Tags: Brief Report Source Type: research
Simultaneous pharmacokinetic modeling of unbound and total darunavir with ritonavir in adolescents: a substudy of the SMILE trial
Antimicrob Agents Chemother. 2023 Dec 11:e0100423. doi: 10.1128/aac.01004-23. Online ahead of print.ABSTRACTDarunavir (DRV) is an HIV protease inhibitor commonly used as part of antiretroviral treatment regimens globally for children and adolescents. It requires a pharmacological booster, such as ritonavir (RTV) or cobicistat. To better understand the pharmacokinetics (PK) of DRV in this younger population and the importance of the RTV boosting effect, a population PK substudy was conducted within SMILE trial, where the maintenance of HIV suppression with once daily integrate inhibitor + darunavir/ritonavir in children and...
Source: Antimicrobial Agents and Chemotherapy - December 13, 2023 Category: Microbiology Authors: Seef Abdalla Alexandra Compagnucci Yoann Riault Man K Chan Alasdair Bamford Aoife Nolan Jos é T Ramos Valentin Constant Thao-Nguyen Nguyen Yi Zheng Jean-Marc Tr éluyer L éo Froelicher-Bournaud Nathalie Neveux Yacine Saidi Tim R Cressey D éborah Hirt S Source Type: research
Simultaneous pharmacokinetic modeling of unbound and total darunavir with ritonavir in adolescents: a substudy of the SMILE trial
Antimicrob Agents Chemother. 2023 Dec 11:e0100423. doi: 10.1128/aac.01004-23. Online ahead of print.ABSTRACTDarunavir (DRV) is an HIV protease inhibitor commonly used as part of antiretroviral treatment regimens globally for children and adolescents. It requires a pharmacological booster, such as ritonavir (RTV) or cobicistat. To better understand the pharmacokinetics (PK) of DRV in this younger population and the importance of the RTV boosting effect, a population PK substudy was conducted within SMILE trial, where the maintenance of HIV suppression with once daily integrate inhibitor + darunavir/ritonavir in children and...
Source: Antimicrobial Agents and Chemotherapy - December 13, 2023 Category: Microbiology Authors: Seef Abdalla Alexandra Compagnucci Yoann Riault Man K Chan Alasdair Bamford Aoife Nolan Jos é T Ramos Valentin Constant Thao-Nguyen Nguyen Yi Zheng Jean-Marc Tr éluyer L éo Froelicher-Bournaud Nathalie Neveux Yacine Saidi Tim R Cressey D éborah Hirt S Source Type: research
Nirmatrelvir/ritonavir for COVID-19: an overview of systematic reviews
ConclusionsThere is low to moderate certainty of evidence from SRs that nirmatrelvir/ritonavir reduces mortality, clinical progression and hospitalization rate in COVID-19 patients compared with controls, without increasing the occurrence of overall and serious adverse events. Based on the overall methodological assessment, on average we can have high confidence in the quality of results generated by the SRs. (Source: Journal of Antimicrobial Chemotherapy)
Source: Journal of Antimicrobial Chemotherapy - December 12, 2023 Category: Microbiology Source Type: research
Prevalence and risk factors of metabolic syndrome in Ethiopia: describing an emerging outbreak in HIV clinics of the sub-Saharan Africa - a cross-sectional study
Conclusion
Our study revealed 38% of the participants had MetS indicating considerable cardiovascular disease (CVD) risks. Independent risk factors for MetS were BMI≥25 kg/m2, efavirenz and lopinavir/ritonavir-based cART, female sex and age ≥45 years. In addition to prevention, CVD risk stratification and management will reduce morbidity and mortality in people with HIV infection. (Source: BMJ Open)
Source: BMJ Open - December 9, 2023 Category: General Medicine Authors: Abdela, A. A., Yifter, H., Reja, A., Shewaamare, A., Ofotokun, I., Degu, W. A. Tags: Open access, Diabetes and Endocrinology Source Type: research
Mitochondrial DNA mutations in HIV-exposed uninfected infants following the cessation of triple antiretroviral drugs
ConclusionsFurther studies are needed to determine the effects of these mutations on the development of HEU infants and whether stopping ART leads to the restoration of mitochondrial function. (Source: Journal of Antimicrobial Chemotherapy)
Source: Journal of Antimicrobial Chemotherapy - December 9, 2023 Category: Microbiology Source Type: research
Biden wants NIH to have ‘march-in’ power to override patent rights for high-priced drugs
President Joe Biden today stepped into a long-running debate about whether the National Institutes of Health (NIH) has legal authority to override an exclusive patent license granted to drug developers if they charge too much for treatments that relied on agency-funded research. In draft policy guidance, the Biden administration says federal agencies would be able to use so-called “march-in” rights when a company is not charging a “reasonable” price for a product.
The “
proposed framework
” was released today as part of other White House
actions
aimed at the high drug prices that have ...
Source: Science of Aging Knowledge Environment - December 7, 2023 Category: Geriatrics Source Type: research
Strategies to Mitigate the Drug-Drug Interaction between Nirmatrelvir/Ritonavir and Tacrolimus in Allogeneic Hematopoietic Stem Cell Transplant Recipients on Azole Antifungals: Results of a Case Series
CONCLUSION: NIM/r-tacrolimus is a serious drug-drug interaction which can be mitigated by early discontinuation of tacrolimus and azole antifungals, close monitoring, and reinitiation of tacrolimus and antifungal 48-72 h after completion of therapy.PMID:38059378 | DOI:10.1159/000534445 (Source: Acta Haematologica)
Source: Acta Haematologica - December 7, 2023 Category: Hematology Authors: Shawn P Griffin Benjamin Lee Jean Doh Alexander R Paradyse Deepa Jeyakumar Zhaohui Arter Hannah Nam Emily Blodget Julie Smith Anitram Valek Pongthep Vittayawacharin Piyanuch Kongtim Stefan O Ciurea Source Type: research
Strategies to Mitigate the Drug-Drug Interaction between Nirmatrelvir/Ritonavir and Tacrolimus in Allogeneic Hematopoietic Stem Cell Transplant Recipients on Azole Antifungals: Results of a Case Series
CONCLUSION: NIM/r-tacrolimus is a serious drug-drug interaction which can be mitigated by early discontinuation of tacrolimus and azole antifungals, close monitoring, and reinitiation of tacrolimus and antifungal 48-72 h after completion of therapy.PMID:38059378 | DOI:10.1159/000534445 (Source: Acta Haematologica)
Source: Acta Haematologica - December 7, 2023 Category: Hematology Authors: Shawn P Griffin Benjamin Lee Jean Doh Alexander R Paradyse Deepa Jeyakumar Zhaohui Arter Hannah Nam Emily Blodget Julie Smith Anitram Valek Pongthep Vittayawacharin Piyanuch Kongtim Stefan O Ciurea Source Type: research
Strategies to Mitigate the Drug-Drug Interaction between Nirmatrelvir/Ritonavir and Tacrolimus in Allogeneic Hematopoietic Stem Cell Transplant Recipients on Azole Antifungals: Results of a Case Series
CONCLUSION: NIM/r-tacrolimus is a serious drug-drug interaction which can be mitigated by early discontinuation of tacrolimus and azole antifungals, close monitoring, and reinitiation of tacrolimus and antifungal 48-72 h after completion of therapy.PMID:38059378 | DOI:10.1159/000534445 (Source: Acta Haematologica)
Source: Acta Haematologica - December 7, 2023 Category: Hematology Authors: Shawn P Griffin Benjamin Lee Jean Doh Alexander R Paradyse Deepa Jeyakumar Zhaohui Arter Hannah Nam Emily Blodget Julie Smith Anitram Valek Pongthep Vittayawacharin Piyanuch Kongtim Stefan O Ciurea Source Type: research
Strategies to Mitigate the Drug-Drug Interaction between Nirmatrelvir/Ritonavir and Tacrolimus in Allogeneic Hematopoietic Stem Cell Transplant Recipients on Azole Antifungals: Results of a Case Series
CONCLUSION: NIM/r-tacrolimus is a serious drug-drug interaction which can be mitigated by early discontinuation of tacrolimus and azole antifungals, close monitoring, and reinitiation of tacrolimus and antifungal 48-72 h after completion of therapy.PMID:38059378 | DOI:10.1159/000534445 (Source: Acta Haematologica)
Source: Acta Haematologica - December 7, 2023 Category: Hematology Authors: Shawn P Griffin Benjamin Lee Jean Doh Alexander R Paradyse Deepa Jeyakumar Zhaohui Arter Hannah Nam Emily Blodget Julie Smith Anitram Valek Pongthep Vittayawacharin Piyanuch Kongtim Stefan O Ciurea Source Type: research
