Page last updated: 2024-11-08

alanine and Nasopharyngitis

alanine has been researched along with Nasopharyngitis in 1 studies

Alanine: A non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases IMMUNITY, and provides energy for muscle tissue, BRAIN, and the CENTRAL NERVOUS SYSTEM.
alanine : An alpha-amino acid that consists of propionic acid bearing an amino substituent at position 2.

Nasopharyngitis: Inflammation of the NASOPHARYNX, usually including its mucosa, related lymphoid structure, and glands.

Research Excerpts

ExcerptRelevanceReference
"Treatment with tenofovir disoproxil fumarate has been associated with renal toxicity or reductions in bone mineral density, or both, in some patients with chronic hepatitis B virus (HBV) infection."9.34Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. ( Agarwal, K; Ahn, SH; Bae, H; Buti, M; Chan, HLY; Chen, CY; Chuang, WL; Flaherty, JF; Fung, S; Gaggar, A; Lampertico, P; Lau, A; Lim, YS; Liu, Y; Ma, X; Ramji, A; Subramanian, GM; Suri, V; Tak, WY; Tam, E; Tan, SK; Trinh, H; Wu, G; Yoon, SK, 2020)
"Treatment with tenofovir disoproxil fumarate has been associated with renal toxicity or reductions in bone mineral density, or both, in some patients with chronic hepatitis B virus (HBV) infection."5.34Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. ( Agarwal, K; Ahn, SH; Bae, H; Buti, M; Chan, HLY; Chen, CY; Chuang, WL; Flaherty, JF; Fung, S; Gaggar, A; Lampertico, P; Lau, A; Lim, YS; Liu, Y; Ma, X; Ramji, A; Subramanian, GM; Suri, V; Tak, WY; Tam, E; Tan, SK; Trinh, H; Wu, G; Yoon, SK, 2020)

Research

Studies (1)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's0 (0.00)24.3611
2020's1 (100.00)2.80

Authors

AuthorsStudies
Lampertico, P1
Buti, M1
Fung, S1
Ahn, SH1
Chuang, WL1
Tak, WY1
Ramji, A1
Chen, CY1
Tam, E1
Bae, H1
Ma, X1
Flaherty, JF1
Gaggar, A1
Lau, A1
Liu, Y1
Wu, G1
Suri, V1
Tan, SK1
Subramanian, GM1
Trinh, H1
Yoon, SK1
Agarwal, K1
Lim, YS1
Chan, HLY1

Clinical Trials (2)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Switching From Tenofovir Disoproxil Fumarate (TDF) 300 mg QD to Tenofovir Alafenamide (TAF) 25 mg QD in Subjects With Chronic Hepatitis B Who Are Virologically Suppressed[NCT02979613]Phase 3490 participants (Actual)Interventional2016-12-29Completed
A Prospective Cohort Study of Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients With Chronic Hepatitis B Virus Infection[NCT05410496]Phase 450 participants (Anticipated)Interventional2021-06-22Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in eGFR-CG at Week 96

"Cockcroft-Gault formula is as follows:~For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)~For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).~Change from baseline was calculated as the value at Week 96 minus the value at Baseline." (NCT02979613)
Timeframe: Baseline; Week 96

InterventionmL/min (Median)
TAF 25 mg1.626
TDF 300 mg0.544

Change From Baseline in Estimated Glomerular Filtration Rate Calculated Using the Cockcroft-Gault Equation (eGFR-CG) at Week 48

"Cockcroft-Gault formula is as follows:~For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)~For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).~Change from baseline was calculated as the value at Week 48 minus the value at Baseline." (NCT02979613)
Timeframe: Baseline; Week 48

InterventionmL/min (Median)
TAF 25 mg2.240
TDF 300 mg-1.722

Change From Baseline in FibroTest® Score at Week 48

The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 48 minus the value at Baseline. (NCT02979613)
Timeframe: Baseline; Week 48

Interventionscores on a scale (Mean)
TAF 25 mg-0.02
TDF 300 mg-0.01

Change From Baseline in FibroTest® Score at Week 96

The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 96 minus the value at Baseline. (NCT02979613)
Timeframe: Baseline; Week 96

Interventionscores on a scale (Mean)
TAF 25 mg-0.03
TDF 300 mg-0.03

Percent Change From Baseline in Hip BMD at Week 96

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 96

Interventionpercent change (Mean)
TAF 25 mg1.157
TDF 300 mg0.180

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 48

Interventionpercent change (Mean)
TAF 25 mg0.659
TDF 300 mg-0.507

Percent Change From Baseline in Spine BMD at Week 48

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 48

Interventionpercent change (Mean)
TAF 25 mg1.743
TDF 300 mg-0.138

Percent Change From Baseline in Spine BMD at Week 96

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%. (NCT02979613)
Timeframe: Baseline; Week 96

Interventionpercent change (Mean)
TAF 25 mg2.330
TDF 300 mg1.726

Percentage of Participants With HBeAg Loss at Week 96

HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 96

Interventionpercentage of participants (Number)
TAF 25 mg17.9
TDF 300 mg9.0

Percentage of Participants With HBeAg Seroconversion at Week 48

HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TAF 25 mg2.6
TDF 300 mg0.0

Percentage of Participants With HBeAg Seroconversion at Week 96

HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 96

Interventionpercentage of participants (Number)
TAF 25 mg5.1
TDF 300 mg2.6

Percentage of Participants With HBsAg Loss at Week 96

HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 96

Interventionpercentage of participants (Number)
TAF 25 mg1.6
TDF 300 mg2.4

Percentage of Participants With HBsAg Seroconversion at Week 48

HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TAF 25 mg0.0
TDF 300 mg0.0

Percentage of Participants With HBsAg Seroconversion at Week 96

HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 96

Interventionpercentage of participants (Number)
TAF 25 mg0.8
TDF 300 mg0.4

Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 48

The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. Missing=Failure (M = F) approach was used for analysis. (NCT02979613)
Timeframe: Weeks 48

Interventionpercentage of participants (Number)
TAF 25 mg96.3
TDF 300 mg96.3

Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 96

The percentage of participants with HBV DNA < 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. M = F approach was used for analysis. (NCT02979613)
Timeframe: Week 96

Interventionpercentage of participants (Number)
TAF 25 mg94.7
TDF 300 mg93.9

Percentage of Participants With HBV DNA Levels ≥ 20 IU/mL at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm

"The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 96 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:~Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 96 analysis window (from Day 589 to Day 840, inclusive), or~Did not have on-treatment HBV DNA data available in the Week 96 analysis window and~Discontinued study drug prior to or in the Week 96 analysis window due to lack of efficacy, or~Discontinued study drug prior to or in the Week 96 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL" (NCT02979613)
Timeframe: Week 96

Interventionpercentage of participants (Number)
TAF 25 mg0.4
TDF 300 mg0.4

Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 48

HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TAF 25 mg7.7
TDF 300 mg6.4

Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48

HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis. (NCT02979613)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TAF 25 mg0.0
TDF 300 mg2.0

Percentage of Participants With Hepatitis B Virus (HBV) DNA Levels ≥ 20 IU/mL at Week 48, as Determined by the Modified United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm

"The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:~Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 48 analysis window (from Day 295 to Day 378, inclusive), or~Did not have on-treatment HBV DNA data available in the Week 48 analysis window and~Discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or~Discontinued study drug prior to or in the Week 48 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL" (NCT02979613)
Timeframe: Week 48

Interventionpercentage of participants (Number)
TAF 25 mg0.4
TDF 300 mg0.4

Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 48

The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 48, was handled by M = F, and Missing=Excluded (M = E) approaches. (NCT02979613)
Timeframe: Week 48

,
Interventionpercentage of participants (Number)
M = F Approach: < 20 IU/mL Target Not DetectedM = F Approach: < 20 IU/mL Target DetectedM = E Approach: < 20 IU/mL Target Not DetectedM = E Approach: < 20 IU/mL Target Detected
TAF 25 mg63.432.965.534.0
TDF 300 mg62.034.364.135.4

Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 96

The percentage of participants with HBV DNA < 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 96, was handled by Missing=Failure (M = F), and Missing=Excluded (M = E) approaches. (NCT02979613)
Timeframe: Week 96

,
Interventionpercentage of participants (Number)
M = F Approach: < 20 IU/mL Target Not DetectedM = F Approach: < 20 IU/mL Target DetectedM = E Approach: < 20 IU/mL Target Not DetectedM = E Approach: < 20 IU/mL Target Detected
TAF 25 mg65.828.869.330.3
TDF 300 mg66.127.870.129.4

Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48 (by Central Laboratory and the American Association for the Study of Liver Diseases [AASLD] Criteria)

Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis. (NCT02979613)
Timeframe: Week 48

,
Interventionpercentage of participants (Number)
Central Laboratory CriteriaAASLD Criteria
TAF 25 mg89.379.0
TDF 300 mg84.975.1

Percentage of Participants With Normal ALT at Week 96 (by Central Laboratory and the AASLD Criteria)

Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis. (NCT02979613)
Timeframe: Week 96

,
Interventionpercentage of participants (Number)
Central Laboratory CriteriaAASLD Criteria
TAF 25 mg88.580.7
TDF 300 mg91.486.5

Percentage of Participants With Normalized ALT at Week 48 (by Central Laboratory and AASLD Criteria)

ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis. (NCT02979613)
Timeframe: Week 48

,
Interventionpercentage of participants (Number)
Central Laboratory CriteriaAASLD Criteria
TAF 25 mg50.050.0
TDF 300 mg36.826.4

Percentage of Participants With Normalized ALT at Week 96 (by Central Laboratory and AASLD Criteria)

ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis. (NCT02979613)
Timeframe: Week 96

,
Interventionpercentage of participants (Number)
Central Laboratory CriteriaAASLD Criteria
TAF 25 mg56.355.8
TDF 300 mg78.973.6

Trials

1 trial available for alanine and Nasopharyngitis

ArticleYear
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study.
    The lancet. Gastroenterology & hepatology, 2020, Volume: 5, Issue:5

    Topics: Adenine; Alanine; Antiviral Agents; Bone Density; Creatinine; DNA, Viral; Double-Blind Method; Drug

2020
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study.
    The lancet. Gastroenterology & hepatology, 2020, Volume: 5, Issue:5

    Topics: Adenine; Alanine; Antiviral Agents; Bone Density; Creatinine; DNA, Viral; Double-Blind Method; Drug

2020
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study.
    The lancet. Gastroenterology & hepatology, 2020, Volume: 5, Issue:5

    Topics: Adenine; Alanine; Antiviral Agents; Bone Density; Creatinine; DNA, Viral; Double-Blind Method; Drug

2020
Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study.
    The lancet. Gastroenterology & hepatology, 2020, Volume: 5, Issue:5

    Topics: Adenine; Alanine; Antiviral Agents; Bone Density; Creatinine; DNA, Viral; Double-Blind Method; Drug

2020