carbamates and Infections, Respiratory studies

Research Excerpts

Excerpt	Relevance	Reference
"The most common adverse events were upper respiratory tract infection (36 [10%] patients) and headache (18 [5%] patients)."	6.90	Sofosbuvir-velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial. ( Brainard, DM; Cheng, J; Dao, L; Dou, X; Duan, Z; Dvory-Sobol, H; Gao, Y; Gao, ZL; Gong, G; Hou, JL; Hu, P; Huang, Y; Jia, J; Le Manh, H; Le, TTP; Li, J; Lim, SG; Lin, F; Lu, S; Mao, Y; Mo, H; Mohamed, R; Mou, Z; Nan, Y; Ning, Q; Piratvisuth, T; Shang, J; Sobhonslidsuk, A; Stamm, LM; Su, M; Tan, CK; Tang, H; Tangkijvanich, P; Tanwandee, T; Tee, HP; Thongsawat, S; Văn, KN; Wang, GQ; Wei, L; Wu, S; Xie, Q; Xu, M; Yang, YF; Zhang, L, 2019)
"The most common adverse events were upper respiratory tract infection (36 [10%] patients) and headache (18 [5%] patients)."	2.90	Sofosbuvir-velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial. ( Brainard, DM; Cheng, J; Dao, L; Dou, X; Duan, Z; Dvory-Sobol, H; Gao, Y; Gao, ZL; Gong, G; Hou, JL; Hu, P; Huang, Y; Jia, J; Le Manh, H; Le, TTP; Li, J; Lim, SG; Lin, F; Lu, S; Mao, Y; Mo, H; Mohamed, R; Mou, Z; Nan, Y; Ning, Q; Piratvisuth, T; Shang, J; Sobhonslidsuk, A; Stamm, LM; Su, M; Tan, CK; Tang, H; Tangkijvanich, P; Tanwandee, T; Tee, HP; Thongsawat, S; Văn, KN; Wang, GQ; Wei, L; Wu, S; Xie, Q; Xu, M; Yang, YF; Zhang, L, 2019)
" In another study using the same dosage regimen, amelubant appeared to be safe and well tolerated."	2.43	Leukotriene receptor antagonists in children with cystic fibrosis lung disease : anti-inflammatory and clinical effects. ( Schmitt-Grohé, S; Zielen, S, 2005)

Research

Studies (4)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Percentage of Participants With Overall Virologic Failure

Timeframe	Studies, this research(%)	All Research%
pre-1990	1 (25.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	2 (50.00)	29.6817
2010's	1 (25.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Wei, L	1
Lim, SG	1
Xie, Q	1
Văn, KN	1
Piratvisuth, T	1
Huang, Y	1
Wu, S	1
Xu, M	1
Tang, H	1
Cheng, J	1
Le Manh, H	1
Gao, Y	1
Mou, Z	1
Sobhonslidsuk, A	1
Dou, X	1
Thongsawat, S	1
Nan, Y	1
Tan, CK	1
Ning, Q	1
Tee, HP	1
Mao, Y	1
Stamm, LM	1
Lu, S	1
Dvory-Sobol, H	1
Mo, H	1
Brainard, DM	1
Yang, YF	1
Dao, L	1
Wang, GQ	1
Tanwandee, T	1
Hu, P	1
Tangkijvanich, P	1
Zhang, L	1
Gao, ZL	1
Lin, F	1
Le, TTP	1
Shang, J	1
Gong, G	1
Li, J	1
Su, M	1
Duan, Z	1
Mohamed, R	1
Hou, JL	1
Jia, J	1
Schmitt-Grohé, S	1
Zielen, S	1
Ma, Z	1
Clark, RF	1
Brazzale, A	1
Wang, S	1
Rupp, MJ	1
Li, L	1
Griesgraber, G	1
Zhang, S	1
Yong, H	1
Phan, LT	1
Nemoto, PA	1
Chu, DT	1
Plattner, JJ	1
Zhang, X	1
Zhong, P	1
Cao, Z	1
Nilius, AM	1
Shortridge, VD	1
Flamm, R	1
Mitten, M	1
Meulbroek, J	1
Ewing, P	1
Alder, J	1
Or, YS	1
Miodek, J	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV[NCT02671500]	Phase 3	375 participants (Actual)	Interventional	2016-04-19	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Intervention	Percentage of participants (Number)
SOF/VEL	0

Virologic failure was defined as: (1) On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) or (2) Virologic relapse: confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. (NCT02671500)
Timeframe: Up to Posttreatment Week 24

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

Intervention	percentage of participants (Number)
SOF/VEL	3.2

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. (NCT02671500)
Timeframe: Posttreatment Week 12

Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)

Intervention	Percentage of participants (Number)
SOF/VEL (Overall)	96.5
SOF/VEL (China - Region 1)	96.2
SOF/VEL (Southeast Asia - Region 2)	97.3

SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. (NCT02671500)
Timeframe: Posttreatment Week 24

Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

Intervention	percentage of participants (Number)
SOF/VEL	96.5

SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. (NCT02671500)
Timeframe: Posttreatment Week 4

Intervention	log10 IU/mL (Mean)
	Change at Week 1	Change at Week 2	Change at Week 4	Change at Week 6	Change at Week 8	Change at Week 10	Change at Week 12
SOF/VEL	-4.38	-4.89	-5.02	-5.03	-5.03	-5.03	-5.03

Intervention	Percentage of participants (Number)
	Week 1	Week 2	Week 4	Week 6	Week 8	Week 10	Week 12
SOF/VEL	27.7	73.8	95.5	99.7	100.0	100.0	100.0

Article	Year
Novel erythromycin derivatives with aryl groups tethered to the C-6 position are potent protein synthesis inhibitors and active against multidrug-resistant respiratory pathogens. Journal of medicinal chemistry, 2001, Nov-22, Volume: 44, Issue:24 Topics: Animals; Anti-Bacterial Agents; Carbamates; Cell-Free System; Drug Resistance, Multiple; Erythromyci	2001
[Mallebrinettes in the treatment of bacterial and viral diseases of the throat and pharyngeal cavity]. Die Medizinische Welt, 1970, Dec-26, Volume: 51 Topics: Adolescent; Aluminum; Anti-Infective Agents; Benzoates; Benzyl Compounds; Carbamates; Child; Child,	1970

carbamates and Infections, Respiratory