Phase 3
Completed N=379
Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B
Hepatitis B, Chronic
Source: ClinicalTrials.gov NCT00410072 ↗
Enrolled (actual)
379
Serious AEs
7.1%
Results posted
Feb 2012
Primary outcomePrimary: Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96 — 76.4; 83.2 Percentage of participants — p=0.0882
Summary
The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Hepatitis B Virus DNA (HBV DNA) Levels <50 IU/mL by Polymerase Chain Reaction (PCR) at Week 96 |
76.4; 83.2 | 0.0882 |
| SECONDARY Percentage of Participants Who Achieved HBV DNA Levels <50 IU/mL by PCR at Week 48 and Week 96 by Hepatitis B e Antigen (HBeAg) Status |
61.1; 74.6; 91.1; 93.2; 69.8; 80.4 | 0.0460 sig |
| SECONDARY Percentage of Participants Who Achieved HBV DNA Levels <LOQ by PCR at Weeks 48 and 96 |
67.6; 74.6; 74.7; 81.7 | — |
| SECONDARY Percentage of Participants Who Achieved HBV DNA Levels <LOD by PCR at Weeks 48 and 96 |
58.2; 66.0; 68.1; 76.6 | — |
| SECONDARY Mean Log 10 HBV DNA at Weeks 48 and 96 |
7.48; 7.53; 1.88; 1.56; 1.68; 1.51 | — |
| SECONDARY Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48 and 96 |
83.0; 72.6; 81.9; 68.0 | — |
| SECONDARY Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48 and 96 |
25.4; 19.6; 3.97; 29.7 | — |
| SECONDARY Percentage of Participants With HBeAg Seroconversion [( at Weeks 48 and 96 |
22.2; 18.1; 32.5; 21.7 | — |
| SECONDARY Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48 and 96 |
3.2; 1.4; 4.0; 5.1 | — |
| SECONDARY Percentage of Participants With HBsAg Seroconversion at Weeks 48 and 96 |
0.8; 0.7; 1.6; 2.9 | — |
| SECONDARY Number of Participants With HBV DNA in Relevant Categories at Weeks 48 and 96 |
67.6; 74.6; 2.7; 5.6; 7.1; 6.6 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events, and Discontinuations From Study Drug Due to Adverse Events or Laboratory Abnormalities |
0; 3; 12; 14; 132; 131 | — |
| SECONDARY Number of Participants With HBV Resistance Through Week 48 |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With HBV Resistance at Week 96 |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Virologic Breakthrough at Week 48 |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Virologic Breakthrough at Week 96 |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Chronic hepatitis B virus (HBV) infection (hepatitis B e antigen [HbeAg]-positive or negative) disease
- Nucleoside- and nucleotide-naive
- Males or females ≥16 years of age (or minimum age of consent in a given country)
- Compensated liver function
- HBV DNA >1.72*10*5*IU/mL (approximately 10*6*copies/mL) for HbeAg-positive participants
- HBV DNA >1.72*10*4*IU/mL (approximately 10*5*copies/mL) for Hbe-Ag-negative participants
- Alanine aminotransferase level ≥*upper limit of normal (ULN) and ≤10*ULN
Exclusion Criteria
- Evidence of decompensated cirrhosis
- Coinfection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
- Laboratory values out of protocol-specified range
Data sourced from ClinicalTrials.gov (NCT00410072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.