1-anilino-8-naphthalenesulfonate has been researched along with Hepatitis B, Chronic in 17 studies
1-anilino-8-naphthalenesulfonate: RN given refers to parent cpd
8-anilinonaphthalene-1-sulfonic acid : A naphthalenesulfonic acid that is naphthalene-1-sulfonic acid substituted by a phenylamino group at position 8.
Hepatitis B, Chronic: INFLAMMATION of the LIVER in humans caused by HEPATITIS B VIRUS lasting six months or more. It is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact.
Excerpt | Relevance | Reference |
---|---|---|
" Overall, 32 (26%) patients reported an adverse event." | 6.90 | Safety and efficacy of stopping tenofovir disoproxil fumarate in patients with chronic hepatitis B following at least 8 years of therapy: a prespecified follow-up analysis of two randomised trials. ( Buti, M; Crans, G; Flaherty, J; Flisiak, R; Gaggar, A; Gane, E; Janssen, HLA; Jump, B; Kaita, K; Kitrinos, K; Manns, M; Marcellin, P; Op den Brouw, M; Wong, DK, 2019) |
" Overall, 32 (26%) patients reported an adverse event." | 2.90 | Safety and efficacy of stopping tenofovir disoproxil fumarate in patients with chronic hepatitis B following at least 8 years of therapy: a prespecified follow-up analysis of two randomised trials. ( Buti, M; Crans, G; Flaherty, J; Flisiak, R; Gaggar, A; Gane, E; Janssen, HLA; Jump, B; Kaita, K; Kitrinos, K; Manns, M; Marcellin, P; Op den Brouw, M; Wong, DK, 2019) |
"Currently, the population prevalence of NAFLD in Asia is around 25%, like many Western countries." | 2.55 | New trends on obesity and NAFLD in Asia. ( Fan, JG; Kim, SU; Wong, VW, 2017) |
"The prevalence of steatohepatitis increased with PNPLA3 CC (14%), CG (20%) and GG (43%) (P < 0." | 1.42 | The impact of PNPLA3 (rs738409 C>G) polymorphisms on liver histology and long-term clinical outcome in chronic hepatitis B patients. ( Boonstra, A; Brouwer, WP; de Knegt, RJ; de Man, RA; Hansen, BE; Janssen, HL; Pas, SD; ten Kate, FJ; van der Meer, AJ, 2015) |
"In patients with both CHB and NAFLD, these genotypes of PNPLA3 polymorphisms were associated with increased susceptibility to nonalcoholic steatohepatitis (NASH) (NAFLD activity score ≥ 3; P = 0." | 1.42 | Linked PNPLA3 polymorphisms confer susceptibility to nonalcoholic steatohepatitis and decreased viral load in chronic hepatitis B. ( Chen, GY; Chen, YM; Fan, JG; Liu, WB; Lu, JF; Mi, YQ; Pan, Q; Shen, F; Sun, WL; Wang, YQ; Zhang, RN; Zhang, SY; Zheng, RD; Zhu, CY, 2015) |
"Patients with liver cirrhosis had serum levels of amylase and lipase significantly higher than both the healthy subjects and the patients with CAH, while no significant differences were found in serum levels of these enzymes in patients with CAH as compared to the healthy subjects." | 1.30 | Serum pancreatic enzyme concentrations in chronic viral liver diseases. ( Andreone, P; Barakat, B; Bernardi, M; Billi, P; Cursaro, C; Fiocchi, M; Gramenzi, A; Miglio, F; Morselli-Labate, AM; Pezzilli, R; Sama, C, 1999) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 1 (5.88) | 18.2507 |
2000's | 2 (11.76) | 29.6817 |
2010's | 13 (76.47) | 24.3611 |
2020's | 1 (5.88) | 2.80 |
Authors | Studies |
---|---|
Wang, P | 1 |
Wu, C | 1 |
Li, Y | 1 |
Gong, Y | 1 |
Shen, N | 1 |
Gao, X | 1 |
Liu, W | 1 |
Yang, L | 1 |
Zhang, X | 1 |
Ma, N | 1 |
Wang, L | 1 |
Yan, L | 1 |
Tang, L | 1 |
Yang, H | 1 |
Liu, D | 1 |
Fan, JG | 2 |
Kim, SU | 1 |
Wong, VW | 1 |
Ghalamkari, S | 1 |
Sharafi, H | 1 |
Alavian, SM | 1 |
Raksayot, M | 1 |
Chuaypen, N | 1 |
Khlaiphuengsin, A | 1 |
Pinjaroen, N | 1 |
Treeprasertsuk, S | 1 |
Poovorawan, Y | 1 |
Tanaka, Y | 1 |
Tangkijvanich, P | 1 |
Wang, LQ | 1 |
Guo, WH | 1 |
Guo, ZW | 1 |
Qin, P | 1 |
Zhang, R | 1 |
Zhu, XM | 1 |
Liu, DW | 1 |
Buti, M | 1 |
Wong, DK | 1 |
Gane, E | 1 |
Flisiak, R | 1 |
Manns, M | 1 |
Kaita, K | 1 |
Janssen, HLA | 1 |
Op den Brouw, M | 1 |
Jump, B | 1 |
Kitrinos, K | 1 |
Crans, G | 1 |
Flaherty, J | 1 |
Gaggar, A | 1 |
Marcellin, P | 1 |
Viganò, M | 1 |
Valenti, L | 2 |
Lampertico, P | 1 |
Facchetti, F | 1 |
Motta, BM | 1 |
D'Ambrosio, R | 1 |
Romagnoli, S | 1 |
Dongiovanni, P | 2 |
Donati, B | 2 |
Fargion, S | 1 |
Colombo, M | 1 |
Fares, R | 1 |
Lombardi, R | 1 |
Mancina, RM | 1 |
Romeo, S | 1 |
Jiang, M | 1 |
Xin, Y | 1 |
Wang, W | 1 |
Lin, Z | 1 |
Zhang, D | 1 |
Li, C | 1 |
Jiang, X | 1 |
Xuan, S | 1 |
Brouwer, WP | 1 |
van der Meer, AJ | 1 |
Boonstra, A | 1 |
Pas, SD | 1 |
de Knegt, RJ | 1 |
de Man, RA | 1 |
Hansen, BE | 1 |
ten Kate, FJ | 1 |
Janssen, HL | 1 |
Zampino, R | 1 |
Coppola, N | 1 |
Cirillo, G | 1 |
Boemio, A | 1 |
Grandone, A | 1 |
Stanzione, M | 1 |
Capoluongo, N | 1 |
Marrone, A | 1 |
Macera, M | 1 |
Sagnelli, E | 1 |
Adinolfi, LE | 1 |
del Giudice, EM | 1 |
Pan, Q | 1 |
Zhang, RN | 1 |
Wang, YQ | 1 |
Zheng, RD | 1 |
Mi, YQ | 1 |
Liu, WB | 1 |
Shen, F | 1 |
Chen, GY | 1 |
Lu, JF | 1 |
Zhu, CY | 1 |
Zhang, SY | 1 |
Chen, YM | 1 |
Sun, WL | 1 |
Takeuchi, Y | 1 |
Ikeda, F | 1 |
Moritou, Y | 1 |
Hagihara, H | 1 |
Yasunaka, T | 1 |
Kuwaki, K | 1 |
Miyake, Y | 1 |
Ohnishi, H | 1 |
Nakamura, S | 1 |
Shiraha, H | 1 |
Takaki, A | 1 |
Iwasaki, Y | 1 |
Nouso, K | 1 |
Yamamoto, K | 1 |
Katakura, Y | 1 |
Yotsuyanagi, H | 1 |
Hashizume, K | 1 |
Okuse, C | 1 |
Okuse, N | 1 |
Nishikawa, K | 1 |
Suzuki, M | 1 |
Iino, S | 1 |
Itoh, F | 1 |
Chen, CL | 1 |
Yang, HI | 1 |
Yang, WS | 1 |
Liu, CJ | 1 |
Chen, PJ | 1 |
You, SL | 1 |
Wang, LY | 1 |
Sun, CA | 1 |
Lu, SN | 1 |
Chen, DS | 1 |
Chen, CJ | 1 |
Pezzilli, R | 1 |
Andreone, P | 1 |
Morselli-Labate, AM | 1 |
Sama, C | 1 |
Billi, P | 1 |
Cursaro, C | 1 |
Barakat, B | 1 |
Gramenzi, A | 1 |
Fiocchi, M | 1 |
Miglio, F | 1 |
Bernardi, M | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
Non Invasive Evaluation of Liver Fibrosis and Steatosis in Type 2 Diabetic Patient in Assiut University Hospitals[NCT05605717] | 60 participants (Anticipated) | Observational | 2022-11-01 | Not yet recruiting | |||
Clinical Study on the Value of Quantitative MRI Imaging in Diffuse Liver Diseases[NCT04626492] | 150 participants (Anticipated) | Observational [Patient Registry] | 2020-08-01 | Recruiting | |||
Effect of Intermittent Calorie Restriction on Metabolic Dysfunction-Associated Steatotic Liver Disease Patients With Abnormal Glucose Metabolism[NCT04283942] | 60 participants (Actual) | Interventional | 2020-07-30 | Completed | |||
A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF Versus Adefovir Dipivoxil for the Treatment of Presumed Pre-Core Mutant Chronic Hepatitis B[NCT00117676] | Phase 3 | 382 participants (Actual) | Interventional | 2005-02-28 | Completed | ||
A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF Versus Adefovir Dipivoxil for the Treatment of HBeAg Positive Chronic Hepatitis B[NCT00116805] | Phase 3 | 266 participants (Actual) | Interventional | 2005-06-30 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
ALT normalization was defined as ALT > upper limit of normal (ULN) at baseline and within the normal range at the end of blinded treatment. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. (NCT00117676)
Timeframe: Baseline; Week 48
Intervention | percentage of participants (Number) |
---|---|
TDF-TDF | 76.3 |
ADV-TDF | 77.1 |
ALT normalization was defined as ALT > ULN at baseline and within the normal range at Week 96. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. (NCT00117676)
Timeframe: Baseline; Week 96
Intervention | percentage of participants (Number) |
---|---|
TDF-TDF | 72.4 |
ADV-TDF | 68.5 |
(NCT00117676)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|---|
TDF-TDF | 93.2 |
ADV-TDF | 63.2 |
(NCT00117676)
Timeframe: Week 96
Intervention | percentage of participants (Number) |
---|---|
TDF-TDF | 90.6 |
ADV-TDF | 89.3 |
(NCT00117676)
Timeframe: Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480
Intervention | units per liter (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 48 | Week 96 | Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | Week 432 | Week 480 | |
ADV-TDF | -124.4 | -138.5 | -140.0 | -140.3 | -139.5 | -134.7 | -143.1 | -132.6 | -131.9 | -129.2 |
TDF-TDF | -95.0 | -93.7 | -99.1 | -99.6 | -97.7 | -98.9 | -98.9 | -96.1 | -97.0 | -94.9 |
(NCT00117676)
Timeframe: Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480
Intervention | log10 copies/mL (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 48 | Week 96 | Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | Week 432 | Week 480 | |
ADV-TDF | -4.07 | -4.74 | -4.77 | -4.75 | -4.77 | -4.81 | -4.81 | -4.79 | -4.69 | -4.75 |
TDF-TDF | -4.57 | -4.54 | -4.61 | -4.56 | -4.59 | -4.61 | -4.61 | -4.56 | -4.60 | -4.57 |
The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst). (NCT00117676)
Timeframe: Baseline; Week 240
Intervention | units on a scale (Mean) | |
---|---|---|
Knodell Score | Ishak Score | |
ADV-TDF | -4.9 | -4.2 |
TDF-TDF | -4.6 | -4.0 |
The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst). (NCT00117676)
Timeframe: Baseline; Week 48
Intervention | units on a scale (Mean) | |
---|---|---|
Knodell Necroinflammatory Score | Ishak Necroinflammatory Score | |
ADV-TDF | -3.4 | -2.6 |
TDF-TDF | -3.5 | -2.6 |
(NCT00117676)
Timeframe: Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480
Intervention | units per liter (Mean) | ||||||||
---|---|---|---|---|---|---|---|---|---|
Week 96 | Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | Week 432 | Week 480 | |
ADV-TDF | -0.6 | -0.3 | -3.6 | -3.9 | -4.1 | -2.0 | -3.9 | -8.9 | -5.9 |
TDF-TDF | 2.4 | -0.6 | 0.7 | -2.5 | -3.9 | -2.6 | -2.9 | -4.6 | -2.8 |
(NCT00117676)
Timeframe: Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480
Intervention | log10 copies/mL (Mean) | ||||||||
---|---|---|---|---|---|---|---|---|---|
Week 96 | Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | Week 432 | Week 480 | |
ADV-TDF | -0.60 | -0.63 | -0.61 | -0.61 | -0.64 | -0.65 | -0.66 | -0.67 | -0.72 |
TDF-TDF | 0.02 | -0.03 | 0.01 | -0.04 | -0.04 | -0.05 | -0.02 | -0.04 | -0.05 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 144 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 96 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 96 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 97 to 144
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to genotype | |
ADV-TDF | 0 | 0 | 0 | 0 | 0 |
TDF-TDF | 4 | 0 | 1 | 2 | 1 |
TDF-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 192 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 144 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 144 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 145 to 192
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to genotype | |
ADV-TDF | 0 | 0 | 0 | 0 | 0 |
TDF-TDF | 3 | 0 | 1 | 1 | 1 |
TDF-TDF With Addition of FTC | 1 | 0 | 0 | 1 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 240 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 192 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 192 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 193 to 240
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to genotype | |
ADV-TDF | 2 | 0 | 0 | 0 | 2 |
TDF-TDF | 1 | 1 | 0 | 0 | 0 |
TDF-TDF With Addition of FTC | 2 | 0 | 2 | 0 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 288 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 240 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 240 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 241 to 288
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to genotype | |
ADV-TDF | 1 | 0 | 1 | 0 | 0 |
TDF-TDF | 3 | 0 | 2 | 1 | 0 |
TDF-TDF With Addition of FTC | 1 | 0 | 1 | 0 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 336 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 288 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 288 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 289 to 336
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to genotype | |
ADV-TDF | 1 | 0 | 0 | 0 | 1 |
TDF-TDF | 0 | 0 | 0 | 0 | 0 |
TDF-TDF With Addition of FTC | 1 | 0 | 0 | 1 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 384 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 336 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 336 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 337 to 384
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to genotype | |
ADV-TDF | 0 | 0 | 0 | 0 | 0 |
TDF-TDF | 1 | 0 | 0 | 0 | 1 |
TDF-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 432 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 384 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 384 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 385 to 432
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to genotype | |
ADV-TDF | 1 | 0 | 1 | 0 | 0 |
TDF-TDF | 2 | 0 | 0 | 2 | 0 |
TDF-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 48, those with viral breakthrough, and those who discontinued after Week 24 with HBV DNA ≥ 400 copies/mL. (NCT00117676)
Timeframe: Baseline; Week 48
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
ADV-TDF | 42 | 7 | 14 | 20 | 1 |
TDF-TDF | 8 | 0 | 3 | 4 | 1 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 480 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 432 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 432 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 433 to 480
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to genotype | |
ADV-TDF | 0 | 0 | 0 | 0 | 0 |
TDF-TDF | 0 | 0 | 0 | 0 | 0 |
TDF-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 96 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 48 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00117676)
Timeframe: Baseline; Weeks 49 to 96
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites within HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
ADV-TDF | 0 | 0 | 0 | 0 | 0 |
TDF-TDF | 6 | 0 | 2 | 4 | 0 |
TDF-TDF With Addition of FTC | 1 | 0 | 1 | 0 | 0 |
ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. (NCT00117676)
Timeframe: Baseline; Weeks 144, 192, 240, 288, 336, and 384
Intervention | percentage of participants (Number) | |||||
---|---|---|---|---|---|---|
Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | |
ADV-TDF | 70.0 | 76.4 | 75.7 | 72.9 | 65.4 | 69.2 |
TDF-TDF | 74.3 | 68.2 | 70.3 | 69.9 | 65.9 | 65.3 |
ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. (NCT00117676)
Timeframe: Baseline; Weeks 432 and 480
Intervention | percentage of participants (Number) | |
---|---|---|
Week 432 | Week 480 | |
ADV-TDF | 87.2 | 88.9 |
TDF-TDF | 86.5 | 80.0 |
HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 96. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 96. (NCT00117676)
Timeframe: Baseline; Week 96
Intervention | percentage of participants (Number) | |
---|---|---|
HBsAg Loss | Anti-HBs Seroconversion | |
ADV-TDF | 0 | 0 |
TDF-TDF | 0 | 0 |
HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point. (NCT00117676)
Timeframe: Baseline; Weeks 144, 192, 240, 288, 336, 384, 432, and 480
Intervention | percentage of participants (Number) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
HBsAg Loss - Week 144 | Anti-HBs Seroconversion - Week 144 | HBsAg Loss - Week 192 | Anti-HBs Seroconversion - Week 192 | HBsAg Loss - Week 240 | Anti-HBs Seroconversion - Week 240 | HBsAg Loss - Week 288 | Anti-HBs Seroconversion - Week 288 | HBsAg Loss - Week 336 | Anti-HBs Seroconversion - Week 336 | HBsAg Loss - Week 384 | Anti-HBs Seroconversion - Week 384 | HBsAg Loss - Week 432 | Anti-HBs Seroconversion - Week 432 | HBsAg Loss - Week 480 | Anti-HBs Seroconversion - Week 480 | |
ADV-TDF | 0 | 0 | 0 | 0 | 0.8 | 0 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 | 0.8 | 1.6 | 0.8 | 2.4 | 0.8 |
TDF-TDF | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.8 | 0.4 | 1.2 | 0.4 | 1.2 | 0.8 |
"Complete response was a composite endpoint defined as histological response and HBV DNA < 400 copies/mL. Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.~A participant was a nonresponder for the primary endpoint if either biopsy (baseline or end-of-treatment) was missing or if there was not an HBV DNA value available at or beyond Week 40." (NCT00117676)
Timeframe: Baseline; Week 48
Intervention | percentage of participants (Number) | |
---|---|---|
Yes | No | |
ADV-TDF | 48.8 | 51.2 |
TDF-TDF | 70.8 | 29.2 |
(NCT00117676)
Timeframe: Weeks 144, 192, 240, 288, 336, and 384
Intervention | percentage of participants (Number) | |||||
---|---|---|---|---|---|---|
Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | |
ADV-TDF | 88.4 | 86.8 | 83.9 | 82.9 | 78.0 | 76.3 |
TDF-TDF | 86.7 | 84.0 | 82.8 | 80.5 | 77.0 | 74.3 |
(NCT00117676)
Timeframe: Weeks 432 and 480
Intervention | percentage of participants (Number) | |
---|---|---|
Week 432 | Week 480 | |
ADV-TDF | 97.7 | 100.0 |
TDF-TDF | 97.6 | 100.0 |
HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 48. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 48. (NCT00117676)
Timeframe: Baseline; Week 48
Intervention | percentage of participants (Number) | |
---|---|---|
HBsAg Loss | Seroconversion to anti-HBs | |
ADV-TDF | 0 | 0 |
TDF-TDF | 0 | 0 |
Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4. (NCT00117676)
Timeframe: Baseline; Week 240
Intervention | percentage of participants (Number) | |
---|---|---|
Yes | No | |
ADV-TDF | 85.1 | 14.9 |
TDF-TDF | 87.3 | 12.7 |
Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4. (NCT00117676)
Timeframe: Baseline; Week 48
Intervention | percentage of participants (Number) | |
---|---|---|
Yes | No | |
ADV-TDF | 68.8 | 31.2 |
TDF-TDF | 72.4 | 27.6 |
Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening. (NCT00117676)
Timeframe: Baseline; Week 240
Intervention | percentage of participants (Number) | |||||
---|---|---|---|---|---|---|
Improvement - Necroinflammation | No Change - Necroinflammation | Worsening - Necroinflammation | Improvement - Fibrosis | No Change - Fibrosis | Worsening - Fibrosis | |
ADV-TDF | 94.6 | 1.4 | 4.1 | 59.5 | 33.8 | 6.8 |
TDF-TDF | 96.7 | 2.7 | 0.7 | 62.0 | 34.0 | 4.0 |
Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening. (NCT00117676)
Timeframe: Baseline; Week 48
Intervention | percentage of participants (Number) | |||||||
---|---|---|---|---|---|---|---|---|
Improvement - Necroinflammation | No Change - Necroinflammation | Worsening - Necroinflammation | Missing Data - Necroinflammation | Improvement - Fibrosis | No Change - Fibrosis | Worsening - Fibrosis | Missing Data - Fibrosis | |
ADV-TDF | 81.6 | 8.0 | 0.8 | 9.6 | 25.6 | 54.4 | 10.4 | 9.6 |
TDF-TDF | 82.0 | 6.8 | 4.8 | 6.4 | 22.0 | 63.2 | 8.4 | 6.4 |
ALT normalization was defined as ALT > upper limit of normal (ULN) at baseline and within the normal range at the end of blinded treatment. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. (NCT00116805)
Timeframe: Baseline; Week 48
Intervention | percentage of participants (Number) |
---|---|
TDF-TDF | 68.0 |
ADV-TDF | 54.4 |
ALT normalization was defined as ALT > ULN at baseline and within the normal range at Week 96. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. (NCT00116805)
Timeframe: Baseline; Week 96
Intervention | percentage of participants (Number) |
---|---|
TDF-TDF | 65.2 |
ADV-TDF | 74.4 |
"Complete response was a composite endpoint defined as histological response and HBV DNA < 400 copies/mL. Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4.~A participant was a nonresponder for the primary endpoint if either biopsy (baseline or end-of-treatment) was missing or if there was not an HBV DNA value available at or beyond Week 40." (NCT00116805)
Timeframe: Baseline; Week 48
Intervention | percentage of participants (Number) |
---|---|
TDF-TDF | 66.5 |
ADV 10 mg | 12.2 |
(NCT00116805)
Timeframe: Week 48
Intervention | percentage of participants (Number) |
---|---|
TDF-TDF | 76.1 |
ADV-TDF | 13.3 |
(NCT00116805)
Timeframe: Week 96
Intervention | percentage of participants (Number) |
---|---|
TDF-TDF | 77.6 |
ADV-TDF | 77.9 |
(NCT00116805)
Timeframe: Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480
Intervention | U/L (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 48 | Week 96 | Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | Week 432 | Week 480 | |
ADV-TDF | -106.1 | -120.4 | -126.2 | -139.6 | -134.8 | -130.9 | -132.3 | -133.7 | -162.1 | -157.5 |
TDF-TDF | -107.2 | -107.8 | -100.7 | -101.4 | -95.9 | -102.3 | -101.9 | -108.1 | -105.0 | -92.3 |
(NCT00116805)
Timeframe: Baseline; Weeks 48, 96, 144, 192, 240, 288, 336, 384, 432, and 480
Intervention | log10 IU/mL (Mean) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Week 48 | Week 96 | Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | Week 432 | Week 480 | |
ADV-TDF | -3.93 | -6.38 | -6.31 | -6.49 | -6.45 | -6.49 | -6.46 | -6.28 | -6.45 | -6.37 |
TDF-TDF | -6.17 | -6.26 | -6.32 | -6.30 | -6.22 | -6.27 | -6.35 | -6.38 | -6.13 | -6.18 |
The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst). (NCT00116805)
Timeframe: Baseline; Week 240
Intervention | units on a scale (Mean) | |
---|---|---|
Knodell Necroinflammatory Score | Ishak Necroinflammatory Score | |
ADV-TDF | -5.1 | -4.5 |
TDF-TDF | -4.8 | -4.1 |
The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, and ranges from 0 (best) to 14 (worst). The Ishak score measures the degree of liver fibrosis (scarring) caused by chronic necroinflammation (inflammation leading to cell death) and ranges from 0 (best) to 6 (worst). (NCT00116805)
Timeframe: Baseline; Week 48
Intervention | units on a scale (Mean) | |
---|---|---|
Knodell Necroinflammatory Score | Ishak Necroinflammatory Score | |
ADV-TDF | -3.2 | -2.6 |
TDF-TDF | -3.6 | -2.7 |
(NCT00116805)
Timeframe: Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480
Intervention | U/L (Mean) | ||||||||
---|---|---|---|---|---|---|---|---|---|
Week 96 | Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | Week 432 | Week 480 | |
ADV-TDF | -6.9 | -0.7 | -7.8 | -8.1 | -10.3 | -9.3 | -6.9 | -11.6 | -7.1 |
TDF-TDF | -2.0 | -0.4 | -1.3 | 3.7 | -1.6 | -1.2 | -4.4 | -4.3 | -5.5 |
(NCT00116805)
Timeframe: Week 48; Weeks 96, 144, 192, 240, 288, 336, 384, 432, and 480
Intervention | log10 IU/mL (Mean) | ||||||||
---|---|---|---|---|---|---|---|---|---|
Week 96 | Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | Week 432 | Week 480 | |
ADV-TDF | -2.43 | -2.27 | -2.41 | -2.49 | -2.62 | -2.59 | -2.34 | -2.32 | -2.16 |
TDF-TDF | -0.10 | -0.19 | -0.20 | -0.14 | -0.18 | -0.25 | -0.29 | -0.13 | -0.24 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 144 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 96 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 96 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 97 to 144
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
ADV-TDF | 5 | 2 | 3 | 0 | 0 |
ADV-TDF With Addition of FTC | 5 | 0 | 0 | 3 | 1 |
TDF-TDF | 2 | 1 | 0 | 1 | 0 |
TDF-TDF With Addition of FTC | 7 | 2 | 3 | 2 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 192 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 144 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 144 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 145 to 192
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
ADV-TDF | 1 | 0 | 1 | 0 | 0 |
ADV-TDF With Addition of FTC | 1 | 0 | 1 | 0 | 0 |
TDF-TDF | 2 | 0 | 1 | 0 | 1 |
TDF-TDF With Addition of FTC | 5 | 0 | 0 | 1 | 3 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 240 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 192 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 192 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 193 to 240
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
ADV-TDF | 0 | 0 | 0 | 0 | 0 |
ADV-TDF With Addition of FTC | 1 | 1 | 0 | 0 | 0 |
TDF-TDF | 3 | 0 | 2 | 1 | 0 |
TDF-TDF With Addition of FTC | 3 | 0 | 0 | 2 | 1 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 288 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 240 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 240 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 241 to 288
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
ADV-TDF | 0 | 0 | 0 | 0 | 0 |
ADV-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
TDF-TDF | 3 | 0 | 0 | 2 | 1 |
TDF-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 336 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 288 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 288 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 289 to 336
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
ADV-TDF | 1 | 0 | 0 | 1 | 0 |
ADV-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
TDF-TDF | 1 | 0 | 0 | 0 | 1 |
TDF-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 384 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 336 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 336 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 337 to 384
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
ADV-TDF | 2 | 1 | 1 | 0 | 0 |
ADV-TDF With Addition of FTC | 2 | 0 | 1 | 1 | 0 |
TDF-TDF | 1 | 0 | 0 | 0 | 1 |
TDF-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 432 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 384 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 384 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 385 to 432
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
ADV-TDF | 0 | 0 | 0 | 0 | 0 |
ADV-TDF With Addition of FTC | 1 | 0 | 0 | 1 | 0 |
TDF-TDF | 1 | 0 | 1 | 0 | 0 |
TDF-TDF With Addition of FTC | 3 | 0 | 0 | 3 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL, those with viral breakthrough, and those who discontinued after Week 24 with HBV DNA ≥ 400 copies/mL. (NCT00116805)
Timeframe: Baseline; Week 48
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
ADV-TDF | 75 | 8 | 17 | 43 | 7 |
TDF-TDF | 31 | 2 | 13 | 7 | 9 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 480 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 432 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen after Week 432 and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 433 to 480
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
ADV-TDF | 1 | 0 | 0 | 1 | 0 |
ADV-TDF With Addition of FTC | 0 | 0 | 0 | 0 | 0 |
TDF-TDF | 0 | 0 | 0 | 0 | 0 |
TDF-TDF With Addition of FTC | 3 | 0 | 1 | 2 | 0 |
Of the total number analyzed, participants evaluated for resistance included those with HBV DNA ≥ 400 copies/mL at Week 96 on TDF monotherapy, those with viral breakthrough, those who discontinued after Week 48 with HBV DNA ≥ 400 copies/mL, and those who added emtricitabine to the open-label TDF regimen and had HBV DNA ≥ 400 copies/mL at the time of the addition. (NCT00116805)
Timeframe: Baseline; Weeks 49 to 96
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
Participants evaluated | Changes at conserved sites in HBV polymerase | Changes at polymorphic sites in HBV polymerase | No genotypic changes (wild-type virus) | Unable to be genotyped | |
ADV-TDF | 16 | 2 | 1 | 12 | 1 |
ADV-TDF With Addition of FTC | 10 | 3 | 2 | 3 | 2 |
TDF-TDF | 18 | 2 | 3 | 10 | 3 |
TDF-TDF With Addition of FTC | 13 | 0 | 1 | 5 | 7 |
ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. (NCT00116805)
Timeframe: Baseline; Weeks 144, 192, 240, 288, 336, and 384
Intervention | percentage of participants (Number) | |||||
---|---|---|---|---|---|---|
Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | |
ADV-TDF | 67.8 | 69.4 | 65.9 | 70.1 | 67.9 | 67.1 |
TDF-TDF | 60.2 | 59.6 | 50.0 | 51.3 | 46.2 | 52.6 |
ALT normalization was defined as ALT > ULN at baseline and within the normal range at the subsequent time point. The ULN was 43 U/L for males and 34 U/L for females aged 18 to < 69, and 35 U/L for males and 32 U/L for females aged ≥ 69. (NCT00116805)
Timeframe: Baseline; Weeks 432 and 480
Intervention | percentage of participants (Number) | |
---|---|---|
Week 432 | Week 480 | |
ADV-TDF | 78.6 | 82.8 |
TDF-TDF | 79.6 | 75.0 |
HBeAg loss was defined as HBeAg positive at baseline and HBeAg negative at Week 96. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative at baseline to positive at Week 96. (NCT00116805)
Timeframe: Baseline; Week 96
Intervention | percentage of participants (Number) | |
---|---|---|
HBeAg Loss | Seroconversion to Anti-HBe | |
ADV-TDF | 25.6 | 22.0 |
TDF-TDF | 25.9 | 22.8 |
HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point. (NCT00116805)
Timeframe: Baseline; Week 96
Intervention | percentage of participants (Number) | |
---|---|---|
HBsAg Loss | Anti-HBs Seroconversion | |
ADV-TDF | 5.8 | 4.7 |
TDF-TDF | 5.3 | 4.1 |
HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at the subsequent time point. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at the subsequent time point. (NCT00116805)
Timeframe: Baseline; Weeks 144, 192, 240, 288, 336, 384, 432, and 480
Intervention | percentage of participants (Number) | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
HBsAg Loss - Week 144 | Anti-HBs Seroconversion - Week 144 | HBsAg Loss - Week 192 | Anti-HBs Seroconversion - Week 192 | HBsAg Loss - Week 240 | Anti-HBs Seroconversion - Week 240 | HBsAg Loss - Week 288 | Anti-HBs Seroconversion - Week 288 | HBsAg Loss - Week 336 | Anti-HBs Seroconversion - Week 336 | HBsAg Loss - Week 384 | Anti-HBs Seroconversion - Week 384 | HBsAg Loss - Week 432 | Anti-HBs Seroconversion - Week 432 | HBsAg Loss - Week 480 | Anti-HBs Seroconversion - Week 480 | |
ADV-TDF | 8.0 | 6.8 | 7.9 | 6.7 | 8.0 | 8.0 | 8.0 | 8.0 | 7.9 | 7.9 | 9.0 | 7.9 | 10.2 | 8.0 | 10.1 | 7.9 |
TDF-TDF | 7.5 | 5.2 | 9.4 | 6.4 | 9.2 | 6.3 | 9.2 | 6.4 | 10.3 | 7.5 | 11.0 | 8.1 | 10.9 | 7.6 | 10.9 | 8.0 |
(NCT00116805)
Timeframe: Weeks 144, 192, 240, 288, 336, and 384
Intervention | percentage of participants (Number) | |||||
---|---|---|---|---|---|---|
Week 144 | Week 192 | Week 240 | Week 288 | Week 336 | Week 384 | |
ADV-TDF | 70.5 | 71.6 | 66.3 | 64.8 | 62.1 | 60.5 |
TDF-TDF | 71.7 | 67.9 | 63.4 | 61.3 | 59.4 | 56.1 |
(NCT00116805)
Timeframe: Weeks 432 and 480
Intervention | percentage of participants (Number) | |
---|---|---|
Week 432 | Week 480 | |
ADV-TDF | 100.0 | 96.6 |
TDF-TDF | 93.0 | 98.0 |
HBeAg loss was defined as HBeAg positive at baseline and HBeAg negative at Week 48. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative at baseline to positive at Week 48. (NCT00116805)
Timeframe: Baseline; Week 48
Intervention | percentage of participants (Number) | |
---|---|---|
HBeAg Loss | HBeAg Seroconversion | |
ADV-TDF | 17.5 | 17.5 |
TDF-TDF | 22.2 | 20.9 |
HBsAg loss was defined as HBsAg positive at baseline and HBsAg negative at Week 48. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative at baseline to positive at Week 48. (NCT00116805)
Timeframe: Baseline; Week 48
Intervention | percentage of participants (Number) | |
---|---|---|
HBsAg Loss | HBsAg Seroconversion | |
ADV-TDF | 0 | 0 |
TDF-TDF | 3.2 | 1.3 |
Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4. (NCT00116805)
Timeframe: Baseline; Week 240
Intervention | percentage of participants (Number) | |
---|---|---|
Yes | No | |
ADV-TDF | 89.6 | 10.4 |
TDF-TDF | 88.2 | 11.8 |
Histological response was based on the Knodell numerical scoring of liver biopsy specimens and defined as at least a 2-point reduction in Knodell necroinflammatory score without worsening in Knodell fibrosis score. The Knodell necroinflammatory score is the combined necrosis and inflammation domain scores and ranges from 0 to 14; the Knodell fibrosis domain score ranges from 0 to 4. (NCT00116805)
Timeframe: Baseline; Week 48
Intervention | percentage of participants (Number) | |
---|---|---|
Yes | No | |
ADV-TDF | 67.8 | 32.2 |
TDF-TDF | 74.4 | 25.6 |
Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening. (NCT00116805)
Timeframe: Baseline; Week 240
Intervention | percentage of participants (Number) | |||||
---|---|---|---|---|---|---|
Improvement - Necroinflammation | No Change - Necroinflammation | Worsening - Necroinflammation | Improvement - Fibrosis | No Change - Fibrosis | Worsening - Fibrosis | |
ADV-TDF | 97.9 | 2.1 | 0 | 58.3 | 39.6 | 2.1 |
TDF-TDF | 96.1 | 3.9 | 0 | 56.6 | 39.5 | 3.9 |
Participants were ranked as having improvement, no change, worsening, or missing data (compared to Baseline) based on the Knodell scoring system, and results are presented as the percentage of participants in each category. The Knodell necroinflammatory score is the combined score for necrosis and inflammation domains of the Knodell scoring system, which ranges from 0 (best) to 14 (worst). The Knodell fibrosis domain score ranges from 0 (best) to 4 (worst). A decrease of 1 point or more indicated improvement, and an increase of 1 point or more indicated worsening. (NCT00116805)
Timeframe: Baseline; Week 48
Intervention | percentage of participants (Number) | |||||||
---|---|---|---|---|---|---|---|---|
Improvement - Necroinflammation | No Change - Necroinflammation | Worsening - Necroinflammation | Missing Data - Necroinflammation | Improvement - Fibrosis | No Change - Fibrosis | Worsening - Fibrosis | Missing Data - Fibrosis | |
ADV-TDF | 78.9 | 3.3 | 5.6 | 12.2 | 20.0 | 61.1 | 6.7 | 12.2 |
TDF-TDF | 81.3 | 4.5 | 3.4 | 10.8 | 19.9 | 63.6 | 5.1 | 11.4 |
4 reviews available for 1-anilino-8-naphthalenesulfonate and Hepatitis B, Chronic
Article | Year |
---|---|
PNPLA3 rs738409 is not associated with the risk of hepatocellular carcinoma and persistent infection of hepatitis B virus (HBV) in HBV-related subjects: A case-control study and meta-analysis on Asians.
Topics: Adult; Aged; Asian People; Carcinoma, Hepatocellular; Case-Control Studies; Female; Genetic Predispo | 2020 |
New trends on obesity and NAFLD in Asia.
Topics: Asia; Body Mass Index; Diet; Genetic Predisposition to Disease; Hepatitis B, Chronic; Humans; Incide | 2017 |
New trends on obesity and NAFLD in Asia.
Topics: Asia; Body Mass Index; Diet; Genetic Predisposition to Disease; Hepatitis B, Chronic; Humans; Incide | 2017 |
New trends on obesity and NAFLD in Asia.
Topics: Asia; Body Mass Index; Diet; Genetic Predisposition to Disease; Hepatitis B, Chronic; Humans; Incide | 2017 |
New trends on obesity and NAFLD in Asia.
Topics: Asia; Body Mass Index; Diet; Genetic Predisposition to Disease; Hepatitis B, Chronic; Humans; Incide | 2017 |
New trends on obesity and NAFLD in Asia.
Topics: Asia; Body Mass Index; Diet; Genetic Predisposition to Disease; Hepatitis B, Chronic; Humans; Incide | 2017 |
New trends on obesity and NAFLD in Asia.
Topics: Asia; Body Mass Index; Diet; Genetic Predisposition to Disease; Hepatitis B, Chronic; Humans; Incide | 2017 |
New trends on obesity and NAFLD in Asia.
Topics: Asia; Body Mass Index; Diet; Genetic Predisposition to Disease; Hepatitis B, Chronic; Humans; Incide | 2017 |
New trends on obesity and NAFLD in Asia.
Topics: Asia; Body Mass Index; Diet; Genetic Predisposition to Disease; Hepatitis B, Chronic; Humans; Incide | 2017 |
New trends on obesity and NAFLD in Asia.
Topics: Asia; Body Mass Index; Diet; Genetic Predisposition to Disease; Hepatitis B, Chronic; Humans; Incide | 2017 |
Association of PNPLA3 rs738409 polymorphism with liver steatosis but not with cirrhosis in patients with HBV infection: Systematic review with meta-analysis.
Topics: Fatty Liver; Hepatitis B virus; Hepatitis B, Chronic; Humans; Incidence; Lipase; Liver Cirrhosis; Me | 2018 |
PNPLA3 I148M polymorphism and progressive liver disease.
Topics: Carcinoma, Hepatocellular; Cholangitis, Sclerosing; Disease Progression; Fatty Liver; Fatty Liver, A | 2013 |
1 trial available for 1-anilino-8-naphthalenesulfonate and Hepatitis B, Chronic
12 other studies available for 1-anilino-8-naphthalenesulfonate and Hepatitis B, Chronic
Article | Year |
---|---|
Association between PNPLA3 gene polymorphisms and risk of hepatitis B virus-related hepatocellular carcinoma in Han population in China:a case-control study.
Topics: Adult; Aged; Asian People; Carcinoma, Hepatocellular; Case-Control Studies; China; Female; Genetic P | 2017 |
Independent and additive effects of PNPLA3 and TM6SF2 polymorphisms on the development of non-B, non-C hepatocellular carcinoma.
Topics: Acyltransferases; Aged; Alleles; Carcinoma, Hepatocellular; Case-Control Studies; Chondroitin Sulfat | 2019 |
[Effects of PNPLA3, TM6SF2 gene polymorphisms and its interactions with smoking and alcohol drinking on hepatitis B virus-associated hepatocellular carcinoma].
Topics: Alcohol Drinking; Carcinoma, Hepatocellular; Case-Control Studies; Epistasis, Genetic; Gene-Environm | 2018 |
Patatin-like phospholipase domain-containing 3 I148M affects liver steatosis in patients with chronic hepatitis B.
Topics: Adult; Alcoholism; Cohort Studies; Disease Progression; Fatty Liver; Female; Genetic Predisposition | 2013 |
[Association between the PNPLA3 I148M polymorphism and chronic hepatitis B in a Qingdao Han Chinese population].
Topics: Adult; Aged; Asian People; Case-Control Studies; China; Female; Gene Frequency; Genetic Predispositi | 2014 |
The impact of PNPLA3 (rs738409 C>G) polymorphisms on liver histology and long-term clinical outcome in chronic hepatitis B patients.
Topics: Body Weight; Carcinoma, Hepatocellular; Fatty Liver; Female; Hepatitis B, Chronic; Humans; Iron; Lip | 2015 |
Patatin-Like Phospholipase Domain-Containing 3 I148M Variant Is Associated with Liver Steatosis and Fat Distribution in Chronic Hepatitis B.
Topics: Abdominal Fat; Adult; Aged; Anthropometry; Body Mass Index; Chi-Square Distribution; Cohort Studies; | 2015 |
Linked PNPLA3 polymorphisms confer susceptibility to nonalcoholic steatohepatitis and decreased viral load in chronic hepatitis B.
Topics: Adult; Asian People; Biomarkers; Biopsy; Case-Control Studies; China; DNA, Viral; Female; Gene Frequ | 2015 |
The impact of patatin-like phospholipase domain-containing protein 3 polymorphism on hepatocellular carcinoma prognosis.
Topics: Adult; Aged; Aged, 80 and over; Body Mass Index; Carcinoma, Hepatocellular; Female; Follow-Up Studie | 2013 |
Pancreatic involvement in chronic viral hepatitis.
Topics: Adult; Aged; Amylases; Female; Hepatitis B, Chronic; Hepatitis C, Chronic; Humans; Lipase; Male; Mid | 2005 |
Metabolic factors and risk of hepatocellular carcinoma by chronic hepatitis B/C infection: a follow-up study in Taiwan.
Topics: Adult; Carbolines; Carcinoma, Hepatocellular; Diabetes Mellitus; Female; Follow-Up Studies; Hepatiti | 2008 |
Serum pancreatic enzyme concentrations in chronic viral liver diseases.
Topics: Adolescent; Adult; Aged; Amylases; Chronic Disease; Female; Hepatitis B, Chronic; Hepatitis C, Chron | 1999 |