carbamates and Adverse Drug Event

carbamates has been researched along with Adverse Drug Event in 29 studies

Research

Studies (29)

Authors

Clinical Trials (10)

Trial Overview

Trial Outcomes

Mean Time to First Achievement of Undetectable HCV RNA During Treatment

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm in the Full Analysis Set (FAS). (NCT01932762)
Timeframe: From TW1 until first achievement of undetectable HCV RNA (up to 12 weeks)

Percentage of Participants Achieving SVR24

SVR24 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 24 weeks after the end of all study therapy. The percentage of participants with SVR24 and accompanying 95% CIs were reported for each treatment arm of the PP Population. (NCT01932762)
Timeframe: 24 weeks after end of all therapy (Study Week 36)

Percentage of Participants Achieving SVR4

SVR4 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 4 weeks after the end of all study therapy. The percentage of participants with SVR4 and accompanying 95% CIs were reported for each treatment arm of the PP Population. (NCT01932762)
Timeframe: 4 weeks after end of all therapy (Study Week 16)

Percentage of Participants With Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)

SVR12 was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) <25 IU/mL, either target detected but unquantifiable (TD[u]) or target not detected (TND), at 12 weeks after the end of all study therapy. The percentage of participants with SVR12 and accompanying 95% confidence intervals (CIs) were reported for each treatment arm in the Per-Protocol (PP) Population. (NCT01932762)
Timeframe: 12 weeks after end of all therapy (Study Week 24)

Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. The Roche COBAS™ Taqman™ HCV Test (v.2.0) has a lower limit of quantification (LLoQ) of 25 IU/ml and a limit of detection of 9.3 IU/ml. The percentage of participants with HCV RNA levels <25 IU/ml (either TD[u] or TND) and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population. (NCT01932762)
Timeframe: From TW 2 through TW 12 (up to 12 weeks)

Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint

HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population. (NCT01932762)
Timeframe: From TW 2 through TW 12 (up to 12 weeks)

Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE During the Treatment Period and First 14 Follow-up Days

AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. An SAE was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. The investigator determined the relationship of the AE to the treatment as unrelated or possibly, probably, or definitely related. (NCT01932762)
Timeframe: Treatment period plus the first 14 days of follow-up (up to 14 weeks)

Number of Participants With HCV Nonstructural Protein 3/4A (NS3/4A), NS5A and NS5B Sequence in Participants Not Achieving SVR

Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify preexisting sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. (NCT02349048)
Timeframe: Up to Week 30 for Arm A and up to Week 32 for Arm B

Number of Participants With Late Viral Relapse

Late Viral Relapse: Participant who achieved SVR12 and the post treatment HCV RNA measurement fulfilled 1 the following conditions: a) at least 2 consecutive measurements not lesser than (<)15 IU/mL undetectable, of which at least the second measurement was >=15 IU/mL quantifiable or b) the last available measurement was >=15 IU/mL quantifiable. (NCT02349048)
Timeframe: From Week 18 to Week 30 (for Arm A), From Week 20 to Week 32 (for Arm B)

Number of Participants With Viral Relapse

Viral Relapse: Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during followup. (NCT02349048)
Timeframe: From Week 6 to Week 18 (for Arm A) and From Week 8 to Week 20 (for Arm B)

Percentage of Participants With On-Treatment Failure

Participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. Includes participants with: 1) viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA 2) confirmed detectable HCV RNA at the actual end of treatment (example, completed treatment, discontinued due to adverse events, withdrawal of consent) of >100 IU/mL in participants whose HCV RNA had previously been NCT02349048)
Timeframe: Baseline up to End of Treatment (Week 6 for Arm A and Week 8 for Arm B)

Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After End of Study Drug Treatment (SVR12)

Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the end of study drug treatment. (NCT02349048)
Timeframe: 12 weeks after end of study drug treatment (week 18 for Arm A and week 20 for Arm B)

Percentage of Participants With On-treatment Virologic Response

"On-treatment virologic response was determined by hepatitis C virus (HCV) ribonucleic acid (RNA) results satisfying a specified threshold.~The following thresholds were considered at any time point: NCT02349048)
Timeframe: Day 2, Day 3, Week 1, 2, 3, 4, 6 (for Arm A) and 8 (for Arm B only)

Percentage of Participants With or Without an NS3 Q80K Polymorphism at Baseline Achieving SVR

The Q80K polymorphism, associated with low level SMV in vitro resistance. Percentage of participants who achieved SVR with or without an NS3 Q80K polymorphism at baseline were reported. (NCT02349048)
Timeframe: up to Week 30 for Arm A and Week 32 for Arm B

Percentage of Participants With Sustained Virologic Response at 4 Weeks (SVR4) and 24 Weeks (SVR24) After End of Study Drug Treatment

Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was NCT02349048)
Timeframe: 4 weeks after end of study drug treatment (week 10 for Arm A and 12 for Arm B); 24 weeks after end of study drug treatment (week 30 for Arm A and 32 for Arm B)

Percentage of Participants With Hemoglobin < 10 g/dL During Treatment

The percentage of participants with hemoglobin <10 g/dL during treatment is provided. (NCT02609659)
Timeframe: up to 12 weeks

Percentage of Participants With On-treatment Virologic Failure

On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment. (NCT02609659)
Timeframe: Up to 12 weeks

Percentage of Participants With Post-treatment Relapse

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug, excluding reinfection, among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment. (NCT02609659)
Timeframe: From the end of treatment through 12 weeks after the last dose of study drug

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [NCT02609659)
Timeframe: 12 weeks after the last actual dose of study drug

Mean Change in Hemoglobin Values From Baseline to End of Treatment

The mean change in hemoglobin (g/L) from baseline to each study visit and to the final treatment visit (up to 12 weeks) is provided. (NCT02609659)
Timeframe: Baseline (Day 1) to Weeks 2, 4, 8, and 12, and the Final Treatment Visit (up to 12 weeks)

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

(NCT02346721)
Timeframe: Up to 12 weeks

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

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. (NCT02346721)
Timeframe: Posttreatment Week 12

Percentage of Participants With Virologic Failure

"Virologic failure was defined as:~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)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit." (NCT02346721)
Timeframe: Up to Posttreatment Week 24

HCV RNA Change From Baseline

(NCT02346721)
Timeframe: Baseline to Week 12

Percentage of Participants With HCV RNA < LLOQ While on Treatment

(NCT02346721)
Timeframe: Baseline to Week 12

Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. (NCT02346721)
Timeframe: Posttreatment Weeks 4 and 24

Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)

SVR12 was defined as HCV RNA <25 IU/mL 12 weeks after the end of all study therapy. HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. (NCT01716156)
Timeframe: Up to Week 36

Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR 24)

HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA <25 IU/mL 24 weeks after the end of all study therapy. (NCT01716156)
Timeframe: Up to Week 48

Percentage of Participants Discontinuing Study Therapy Due to an AE

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment. (NCT01716156)
Timeframe: Up to 24 weeks

Percentage of Participants Experiencing at Least One Adverse Event (AE) on Study

An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment. (NCT01716156)
Timeframe: Fourteen days following last dose of study drug (up to 26 weeks)

Percentage of Participants With Sustained Virologic Response 4 Weeks After Ending Study Therapy (SVR4)

HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA <25 IU/mL 4 weeks after the end of all study therapy. (NCT01716156)
Timeframe: Up to Week 28

Time to Achievement of First Undetectable HCV RNA

The mean time (in days) to first achievement of undetectable HCV RNA was assessed using Kaplan-Meier plot and summary statistics. HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL. (NCT01716156)
Timeframe: Up to Week 24

Percentage of Participants With HCV RNA <25 IU/mL by Time Point

HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL. (NCT01716156)
Timeframe: From Week 2 through end of treatment (up to 24 weeks)

Percentage of Participants With Undetectable HCV RNA by Time Point

HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL. (NCT01716156)
Timeframe: From Week 2 through end of treatment (up to 24 weeks)

Percentage of Participants With On-treatment Failure

On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment. (NCT02262728)
Timeframe: Week 12

Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)

Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the end of study drug treatment. (NCT02262728)
Timeframe: Week 24

Percentage of Participants With SVR12 Who Maintained to Have HCV RNA

Percentage of participants with SVR12 who maintained to have HCV RNA NCT02262728)
Timeframe: Week 24 post treatment until the end of 3-year follow-up

Intervention	Percentage of participants (Number)
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A	78.9
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B	85.7

Absolute Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels at Follow-up Week 24 (Week 36)

(NCT02262728)
Timeframe: Follow-up Week 24 (Week 36)

,

Intervention	Units per Liter (U/L) (Mean)
	Baseline : ALT	Baseline : AST	Follow-Up Week 24 : ALT	Follow-Up Week 24 : AST
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A	137.8	119.1	34.8	39.2
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B	60.9	83.5	32.3	35.0

Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)

The AUC(0-24) is area under the plasma concentration-time curve from time 0 to 24 hours after dosing. (NCT02262728)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8

,

Intervention	ng.h/mL (Mean)
	Simeprevir : Week 2	Simeprevir : Week 8	Daclatasvir : Week 2	Daclatasvir : Week 8	Sofosbuvir : Week 2	Sofosbuvir : Week 8	GS-331007 : Week 2	GS-331007 : Week 8
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A	113835	98568	16487	15574	2870	2746	17900	18132
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B	142162	207221	17858	20787	3915	3933	21118	22829

Maximum Plasma Concentration (Cmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)

The Cmax is the maximum observed plasma concentration. (NCT02262728)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8

,

Intervention	nanogram per milliliter (ng/mL) (Mean)
	Simeprevir : Week 2 (reference)	Simeprevir : Week 8 (test)	Daclatasvir : Week 2	Daclatasvir : Week 8	Sofosbuvir : Week 2	Sofosbuvir : Week 8	GS-331007 : Week 2	GS-331007 : Week 8
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A	6976	6029	1187	1072	1571	1276	1403	1404
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B	7726	10498	1145	1210	1615	1527	1561	1594

Minimum Plasma Concentration (Cmin) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)

The Cmin is the minimum observed plasma concentration. (NCT02262728)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8

,

Intervention	ng/mL (Mean)
	Simeprevir : Week 2	Simeprevir : Week 8	Daclatasvir : Week 2	Daclatasvir : Week 8	Sofosbuvir : Week 2	Sofosbuvir : Week 8	GS-331007 : Week 2	GS-331007 : Week 8
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A	3133	2639	414	442	NA	NA	419	443
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B	4363	6955	519	660	NA	NA	441	523

Percentage of Participants With On-Treatment Virologic Response

On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. The following thresholds were considered at any time point: NCT02262728)
Timeframe: Week 1, 2, 4, 6, 8, 10, 12

,

Intervention	Percentage of Participants (Number)
	Week 1 : >= 15 IU/mL	Week 1 : < 100 IU/mL	Week 1: < 15 IU/mL undetect/detectable	Week 1 : < 15 IU/mL detectable	Week 1 : < 15 IU/mL Undetectable	Week 2 : >= 15 IU/mL	Week 2 : < 100 IU/mL	Week 2: < 15 IU/mL undetect/detectable	Week 2 : < 15 IU/mL detectable	Week 2: < 15 IU/mL undetectable (vRVR)	Week 4 : >= 15 IU/mL	Week 4 : < 100 IU/mL	Week 4: < 15 IU/mL undetect/detectable	Week 4 : < 15 IU/mL detectable	Week 4 : < 15 IU/mL undetectable (RVR)	Week 6 : >= 15 IU/mL	Week 6 : < 100 IU/mL	Week 6: < 15 IU/mL undetect/detectable	Week 6 : < 15 IU/mL detectable	Week 6 : < 15 IU/mL undetectable	Week 8 : >= 15 IU/mL	Week 8 : < 100 IU/mL	Week 8: < 15 IU/mL undetect/detectable	Week 8 : < 15 IU/mL detectable	Week 8 : < 15 IU/mL undetectable	Week 10 : >= 15 IU/mL	Week 10 : < 100 IU/mL	Week 10: < 15 IU/mL undetect/detectable	Week 10 : < 15 IU/mL detectable	Week 10 : < 15 IU/mL undetectable	Week 12 : >= 15 IU/mL	Week 12 :< 100 IU/mL	Week 12: < 15 IU/mL undetect/detectable	Week 12 : < 15 IU/mL detectable	Week 12 : < 15 IU/mL undetectable
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A	72.2	61.1	27.8	11.1	16.7	10.5	94.7	89.5	36.8	52.6	0	100.0	100.0	5.6	94.4	0	100.0	100.0	5.3	94.7	0	100.0	100.0	0	100.0	0	100.0	100.0	0	100.0	0	100.0	100.0	0	100.0
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B	76.2	38.1	23.8	19.0	4.8	47.6	71.4	52.4	19.0	33.3	9.5	100.0	90.5	28.6	61.9	0	100.0	100.0	20.0	80.0	0	100.0	100.0	4.8	95.2	0	100.0	100.0	0	100.0	0	100.0	100.0	0	100.0

Percentage of Participants With SVR 4 Weeks After End of Study Drug Treatment (SVR4) and SVR 24 Weeks After End of Study Drug Treatment (SVR24)

Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was NCT02262728)
Timeframe: Week 16 and Week 36

,

Intervention	Percentage of Participants (Number)
	SVR 4	SVR 24
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A	100	100
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B	100	100

Pre-dose (Trough) Concentration (C0h) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)

The C0h is the pre-dose plasma concentration. (NCT02262728)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8

,

Intervention	nanogram/milliliter (ng/mL) (Mean)
	Simeprevir : Week 2	Simeprevir : Week 8	Daclatasvir : Week 2	Daclatasvir : Week 8	Sofosbuvir : Week 2	Sofosbuvir : Week 8	GS-331007 : Week 2	GS-331007 : Week 8
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A	3577	3160	494	492	NA	NA	484	478
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B	5218	8577	646	824	NA	NA	490	572

Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)

Tmax is the time to reach maximum observed plasma concentration. (NCT02262728)
Timeframe: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8

,

Intervention	Hours (Median)
	Simeprevir: Week 2	Simeprevir: Week 8	Daclatasvir: Week 2	Daclatasvir: Week 8	Sofosbuvir: Week 2	Sofosbuvir: Week 8	GS-331007: Week 2	GS-331007: Week 8
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A	6.00	6.00	3.00	2.50	1.00	1.75	4.00	4.00
SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B	8.00	8.00	4.00	4.00	2.00	2.00	4.00	4.00

Reviews

4 reviews available for carbamates and Adverse Drug Event

Article	Year
Safety of the 2D/3D direct-acting antiviral regimen in HCV-induced Child-Pugh A cirrhosis - A pooled analysis. Journal of hepatology, 2017, Volume: 67, Issue:4 Topics: 2-Naphthylamine; Administration, Oral; Adult; Aged; Aged, 80 and over; Anilides; Antiviral Agents; C	2017
Beclabuvir in combination with asunaprevir and daclatasvir for hepatitis C virus genotype 1 infection: A systematic review and meta-analysis. Journal of medical virology, 2018, Volume: 90, Issue:5 Topics: Antiviral Agents; Benzazepines; Carbamates; Drug Therapy, Combination; Drug-Related Side Effects and	2018
Elvitegravir: a once-daily, boosted, HIV-1 integrase inhibitor. Expert review of anti-infective therapy, 2012, Volume: 10, Issue:1 Topics: Adenine; Carbamates; Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic; Clinical	2012
Defining the role of repaglinide in the management of type 2 diabetes mellitus: a review. American journal of cardiovascular drugs : drugs, devices, and other interventions, 2007, Volume: 7, Issue:5 Topics: Carbamates; Clinical Trials as Topic; Diabetes Mellitus, Type 2; Drug-Related Side Effects and Adver	2007

Trials

10 trials available for carbamates and Adverse Drug Event

Article	Year
A Phase Ib/II Study of the BRAF Inhibitor Encorafenib Plus the MEK Inhibitor Binimetinib in Patients with Clinical cancer research : an official journal of the American Association for Cancer Research, 2020, 10-01, Volume: 26, Issue:19 Topics: Adult; Aged; Alanine Transaminase; Antineoplastic Combined Chemotherapy Protocols; Benzimidazoles; C	2020
Efficacy and safety of 12 weeks of elbasvir ± grazoprevir ± ribavirin in participants with hepatitis C virus genotype 2, 4, 5 or 6 infection: The C-SCAPE study. Journal of viral hepatitis, 2018, Volume: 25, Issue:5 Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclo	2018
Efficacy and safety of 6 or 8 weeks of simeprevir, daclatasvir, sofosbuvir for HCV genotype 1 infection. Journal of viral hepatitis, 2018, Volume: 25, Issue:6 Topics: Adolescent; Adult; Aged; Antiviral Agents; Carbamates; Drug-Related Side Effects and Adverse Reactio	2018
Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in patients with chronic hepatitis C virus genotype 1a infection without cirrhosis. Journal of viral hepatitis, 2019, Volume: 26, Issue:8 Topics: 2-Naphthylamine; Anilides; Antiviral Agents; Carbamates; Cyclopropanes; Drug Administration Schedule	2019
Cardiovascular safety of revefenacin, a once-daily, lung-selective, long-acting muscarinic antagonist for nebulized therapy of chronic obstructive pulmonary disease: Evaluation in phase 3 clinical trials. Pulmonary pharmacology & therapeutics, 2019, Volume: 57 Topics: Administration, Inhalation; Adult; Aged; Aged, 80 and over; Benzamides; Bronchodilator Agents; Carba	2019
Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection. Journal of viral hepatitis, 2019, Volume: 26, Issue:10 Topics: Antiviral Agents; Carbamates; Drug Combinations; Drug-Related Side Effects and Adverse Reactions; Fe	2019
A randomized double blind, placebo controlled phase 2 trial of BIIL 284 BS (an LTB4 receptor antagonist) for the treatment of lung disease in children and adults with cystic fibrosis. Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society, 2014, Volume: 13, Issue:2 Topics: Adolescent; Adult; Amidines; Anti-Inflammatory Agents; Bronchoalveolar Lavage Fluid; Carbamates; Chi	2014
Efficacy of Sofosbuvir and Daclatasvir in Patients With Fibrosing Cholestatic Hepatitis C After Liver Transplantation. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2015, Volume: 13, Issue:11 Topics: Antiviral Agents; Belgium; Carbamates; Cholestasis; Drug Therapy, Combination; Drug-Related Side Eff	2015
Efficacy and safety of grazoprevir + ribavirin for 12 or 24 weeks in treatment-naïve patients with hepatitis C virus genotype 1 infection. Journal of viral hepatitis, 2016, Volume: 23, Issue:10 Topics: Adult; Amides; Antiviral Agents; Carbamates; Cyclopropanes; Drug-Related Side Effects and Adverse Re	2016
Simeprevir, daclatasvir and sofosbuvir for hepatitis C virus-infected patients with decompensated liver disease. Journal of viral hepatitis, 2017, Volume: 24, Issue:4 Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug-Related Side Effects and Adverse Reactions; Female;	2017

Other Studies

15 other studies available for carbamates and Adverse Drug Event

Article	Year
Initial Real-World Experience With Cenobamate in Adolescents and Adults: A Single Center Experience. Pediatric neurology, 2022, Volume: 129 Topics: Adolescent; Anticonvulsants; Carbamates; Chlorophenols; Double-Blind Method; Drug-Related Side Effec	2022
Ledipasvir/Sofosbuvir versus Daclatasvir/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype 4 Patients. Current drug safety, 2020, Volume: 15, Issue:1 Topics: Adult; Aged; Antiviral Agents; Benzimidazoles; Carbamates; Drug Therapy, Combination; Drug-Related S	2020
Potential drug-drug interactions of OMBITASVIR, PARITAPREVIR/ritonavir ± DASABUVIR ± ribavirin in clinical practice. Journal of gastroenterology and hepatology, 2018, Volume: 33, Issue:5 Topics: 2-Naphthylamine; Adult; Aged; Aged, 80 and over; Anilides; Carbamates; Cyclopropanes; Drug Interacti	2018
Sofosbuvir-based Interferon-Free Direct Acting Antiviral Regimens for Heart Transplant Recipients With Chronic Hepatitis C Virus Infection. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018, 01-06, Volume: 66, Issue:2 Topics: Adult; Antiviral Agents; Benzimidazoles; Carbamates; Drug Therapy, Combination; Drug-Related Side Ef	2018
Effectiveness and safety of original and generic sofosbuvir for the treatment of chronic hepatitis C: A real world study. Journal of medical virology, 2018, Volume: 90, Issue:5 Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antiviral Agents; Argentina; Carbamates; Drug-Related Si	2018
High Cure Rates With Grazoprevir-Elbasvir With or Without Ribavirin Guided by Genotypic Resistance Testing Among Human Immunodeficiency Virus/Hepatitis C Virus-coinfected Men Who Have Sex With Men. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019, 02-01, Volume: 68, Issue:4 Topics: Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Resistance, Vira	2019
Efficacy and safety of sofosbuvir and daclatasvir with or without ribavirin in elderly patients with chronic hepatitis C virus infection. Journal of medical virology, 2019, Volume: 91, Issue:2 Topics: Aged; Aged, 80 and over; Antiviral Agents; Carbamates; Drug Therapy, Combination; Drug-Related Side	2019
Daclatasvir-based regimens in HCV cirrhosis: experience from the Italian early access program. Scientific reports, 2019, 01-24, Volume: 9, Issue:1 Topics: Adult; Aged; Antiviral Agents; Carbamates; Drug Therapy, Combination; Drug-Related Side Effects and	2019
Drug-Induced Lung Injury in a Liver Transplant Patient Treated With Sofosbuvir. Transplantation proceedings, 2016, Volume: 48, Issue:7 Topics: Antiviral Agents; Carbamates; Drug Therapy, Combination; Drug-Related Side Effects and Adverse React	2016
Real World Data of Daclatasvir and Asunaprevir Combination Therapy for HCV Genotype 1b Infection in Patients With Renal Dysfunction. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2017, Volume: 15, Issue:5 Topics: Antiviral Agents; Carbamates; Chemical and Drug Induced Liver Injury; Drug Therapy, Combination; Dru	2017
Real-World Efficacy of Daclatasvir and Sofosbuvir, With and Without Ribavirin, in HIV/HCV Coinfected Patients With Advanced Liver Disease in a French Early Access Cohort. Journal of acquired immune deficiency syndromes (1999), 2017, 05-01, Volume: 75, Issue:1 Topics: Adult; Aged; Antiviral Agents; Carbamates; Coinfection; Drug-Related Side Effects and Adverse Reacti	2017
POISON CONTROL OUTLINES: TOXICITY OF INSECTICIDES AND HERBICIDES. The Nebraska state medical journal, 1963, Volume: 48 Topics: Anti-Anxiety Agents; Antifungal Agents; Carbamates; Chlordan; DDT; Drug-Related Side Effects and Adv	1963
STUDIES WITH NEW INSECTICIDES AS RESIDUAL SPRAYS IN BUILDINGS NATURALLY INFESTED WITH ANOPHELES QUADRIMACULATUS. Bulletin of the World Health Organization, 1964, Volume: 30 Topics: Aerosols; Animals; Anopheles; Carbamates; Communicable Diseases; Drug-Related Side Effects and Adver	1964
Drug-related hepatitis. Annals of internal medicine, 1979, Volume: 91, Issue:1 Topics: Carbamates; Chemical and Drug Induced Liver Injury; Drug-Related Side Effects and Adverse Reactions;	1979
The acute oral toxicity of 369 pesticidal, pharmaceutical and other chemicals to wild birds. Toxicology and applied pharmacology, 1972, Volume: 21, Issue:3 Topics: Administration, Oral; Aniline Compounds; Animals; Barbiturates; Benzoates; Birds; Carbamates; Drug-R	1972