Efficacy and Safety Results of Hepatitis B e Antigen–Positive and –Negative Patients With Chronic Hepatitis B at 48 Weeks of Treatment With Tenofovir Alafenamide Fumarate or Tenofovir Disoproxil Fumarate
| Characteristic . | HBeAg Positive [20] . | HBeAg Negative [19] . | ||||
|---|---|---|---|---|---|---|
| TDF (n = 292) . | TAF (n = 581) . | P Value . | TDF (n = 140) . | TAF (n = 285) . | P Value . | |
| Dose, mg | 300 mg | 25 mg | … | 300 mg | 25 mg | … |
| Efficacy | ||||||
| HBeAg lossa | 34/285 (12%) | 78/565 (14%) | .47 | … | … | … |
| Anti-HBe seroconversiona | 23/285 (8%) | 58/565 (10%) | .32 | … | … | … |
| HBV DNA <29 IU/mL | 195/292 (67%) | 371581 (64%) | .25 | 130/140 (93%) | 268/285 (94%) | .47 |
| ALT normalizationc | ||||||
| Central laboratory | 179/268 (67%) | 384/537 (72%) | .18 | 91/121 (75%) | 196/236 (83%) | .076 |
| AASLD criteria | 105/290 (36%) | 257/572 (45%) | .014 | 44/138 (32%) | 137/276 (50%) | .0005 |
| HBsAg lossb | 1/288 (0.3%) | 4/576 (1%) | .52 | 0/138 (0%) | 0/281 (0%) | … |
| Safety | ||||||
| Bone mineral density | ||||||
| Hip | –1.72% | –0.10% | <.001 | –2.16% | –0.29% | <.001 |
| Spine | –2.29% | –0.42% | <.001 | –2.51% | –0.88% | .0004 |
| Renal safety | ||||||
| Serum creatinine changes, mg/dL | +0.03 | +0.01 | .02 | +0.02 | +0.01 | .32 |
| Decreases in eGFR, mL/min | –5.4 | –0.6 | <.001 | –4.8 | –1.8 | .004 |
| Characteristic . | HBeAg Positive [20] . | HBeAg Negative [19] . | ||||
|---|---|---|---|---|---|---|
| TDF (n = 292) . | TAF (n = 581) . | P Value . | TDF (n = 140) . | TAF (n = 285) . | P Value . | |
| Dose, mg | 300 mg | 25 mg | … | 300 mg | 25 mg | … |
| Efficacy | ||||||
| HBeAg lossa | 34/285 (12%) | 78/565 (14%) | .47 | … | … | … |
| Anti-HBe seroconversiona | 23/285 (8%) | 58/565 (10%) | .32 | … | … | … |
| HBV DNA <29 IU/mL | 195/292 (67%) | 371581 (64%) | .25 | 130/140 (93%) | 268/285 (94%) | .47 |
| ALT normalizationc | ||||||
| Central laboratory | 179/268 (67%) | 384/537 (72%) | .18 | 91/121 (75%) | 196/236 (83%) | .076 |
| AASLD criteria | 105/290 (36%) | 257/572 (45%) | .014 | 44/138 (32%) | 137/276 (50%) | .0005 |
| HBsAg lossb | 1/288 (0.3%) | 4/576 (1%) | .52 | 0/138 (0%) | 0/281 (0%) | … |
| Safety | ||||||
| Bone mineral density | ||||||
| Hip | –1.72% | –0.10% | <.001 | –2.16% | –0.29% | <.001 |
| Spine | –2.29% | –0.42% | <.001 | –2.51% | –0.88% | .0004 |
| Renal safety | ||||||
| Serum creatinine changes, mg/dL | +0.03 | +0.01 | .02 | +0.02 | +0.01 | .32 |
| Decreases in eGFR, mL/min | –5.4 | –0.6 | <.001 | –4.8 | –1.8 | .004 |
Abbreviations: AASLD, American Association for the Study of Liver Diseases; ALT, alanine aminotransferase; eGFR, estimated glomerular filtration rate; HBeAg, hepatitis B e antigen; HBV, hepatitis B virus; TAF, tenofovir alafenamide fumarate; TDF, tenofovir disoproxil fumarate.
aAmong patients who were seropositive for HBeAg and negative for, or missing, antibodies hepatitis B e antigen (anti-HBe) at baseline.
bAmong patients who were seropositive for HBsAg and negative for, or missing, antibodies hepatitis B s antigen (anti-HBs) at baseline.
cThe definition of ALT normalization varied among different trials (ie, decrease of ALT to ≤1.25 times the upper limit of normal.
Efficacy and Safety Results of Hepatitis B e Antigen–Positive and –Negative Patients With Chronic Hepatitis B at 48 Weeks of Treatment With Tenofovir Alafenamide Fumarate or Tenofovir Disoproxil Fumarate
| Characteristic . | HBeAg Positive [20] . | HBeAg Negative [19] . | ||||
|---|---|---|---|---|---|---|
| TDF (n = 292) . | TAF (n = 581) . | P Value . | TDF (n = 140) . | TAF (n = 285) . | P Value . | |
| Dose, mg | 300 mg | 25 mg | … | 300 mg | 25 mg | … |
| Efficacy | ||||||
| HBeAg lossa | 34/285 (12%) | 78/565 (14%) | .47 | … | … | … |
| Anti-HBe seroconversiona | 23/285 (8%) | 58/565 (10%) | .32 | … | … | … |
| HBV DNA <29 IU/mL | 195/292 (67%) | 371581 (64%) | .25 | 130/140 (93%) | 268/285 (94%) | .47 |
| ALT normalizationc | ||||||
| Central laboratory | 179/268 (67%) | 384/537 (72%) | .18 | 91/121 (75%) | 196/236 (83%) | .076 |
| AASLD criteria | 105/290 (36%) | 257/572 (45%) | .014 | 44/138 (32%) | 137/276 (50%) | .0005 |
| HBsAg lossb | 1/288 (0.3%) | 4/576 (1%) | .52 | 0/138 (0%) | 0/281 (0%) | … |
| Safety | ||||||
| Bone mineral density | ||||||
| Hip | –1.72% | –0.10% | <.001 | –2.16% | –0.29% | <.001 |
| Spine | –2.29% | –0.42% | <.001 | –2.51% | –0.88% | .0004 |
| Renal safety | ||||||
| Serum creatinine changes, mg/dL | +0.03 | +0.01 | .02 | +0.02 | +0.01 | .32 |
| Decreases in eGFR, mL/min | –5.4 | –0.6 | <.001 | –4.8 | –1.8 | .004 |
| Characteristic . | HBeAg Positive [20] . | HBeAg Negative [19] . | ||||
|---|---|---|---|---|---|---|
| TDF (n = 292) . | TAF (n = 581) . | P Value . | TDF (n = 140) . | TAF (n = 285) . | P Value . | |
| Dose, mg | 300 mg | 25 mg | … | 300 mg | 25 mg | … |
| Efficacy | ||||||
| HBeAg lossa | 34/285 (12%) | 78/565 (14%) | .47 | … | … | … |
| Anti-HBe seroconversiona | 23/285 (8%) | 58/565 (10%) | .32 | … | … | … |
| HBV DNA <29 IU/mL | 195/292 (67%) | 371581 (64%) | .25 | 130/140 (93%) | 268/285 (94%) | .47 |
| ALT normalizationc | ||||||
| Central laboratory | 179/268 (67%) | 384/537 (72%) | .18 | 91/121 (75%) | 196/236 (83%) | .076 |
| AASLD criteria | 105/290 (36%) | 257/572 (45%) | .014 | 44/138 (32%) | 137/276 (50%) | .0005 |
| HBsAg lossb | 1/288 (0.3%) | 4/576 (1%) | .52 | 0/138 (0%) | 0/281 (0%) | … |
| Safety | ||||||
| Bone mineral density | ||||||
| Hip | –1.72% | –0.10% | <.001 | –2.16% | –0.29% | <.001 |
| Spine | –2.29% | –0.42% | <.001 | –2.51% | –0.88% | .0004 |
| Renal safety | ||||||
| Serum creatinine changes, mg/dL | +0.03 | +0.01 | .02 | +0.02 | +0.01 | .32 |
| Decreases in eGFR, mL/min | –5.4 | –0.6 | <.001 | –4.8 | –1.8 | .004 |
Abbreviations: AASLD, American Association for the Study of Liver Diseases; ALT, alanine aminotransferase; eGFR, estimated glomerular filtration rate; HBeAg, hepatitis B e antigen; HBV, hepatitis B virus; TAF, tenofovir alafenamide fumarate; TDF, tenofovir disoproxil fumarate.
aAmong patients who were seropositive for HBeAg and negative for, or missing, antibodies hepatitis B e antigen (anti-HBe) at baseline.
bAmong patients who were seropositive for HBsAg and negative for, or missing, antibodies hepatitis B s antigen (anti-HBs) at baseline.
cThe definition of ALT normalization varied among different trials (ie, decrease of ALT to ≤1.25 times the upper limit of normal.
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