Phase 2
N=40
Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant
Chronic Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT00507689 ↗Enrolled (actual)
40
Serious AEs
14.3%
Results posted
Sep 2013
Primary outcome: Primary: Percentage of Participants With HBV Recurrence Prior to or at Week 72 — 0; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- FTC/TDF (Drug); Hepatitis B Immunoglobulin (HBIg) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With HBV Recurrence Prior to or at Week 72 |
0; 0 | — |
| SECONDARY Percentage of Participants With HBV Recurrence at Week 96 |
0; 0 | — |
| SECONDARY Percentage of Subjects With HBV DNA < 169 Copies/mL at Week 72 |
100; 100 | — |
| SECONDARY Percentage of Participants With HBV DNA < 169 Copies/mL at Week 96 |
100; 100 | — |
| SECONDARY Percentage of Participants With Normal ALT at Week 72 |
89; 81 | — |
| SECONDARY Percentage of Participants With Normal ALT at Week 96 |
88; 80 | — |
Summary
The objective of this 96-week study was to evaluate the safety and antiviral efficacy of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, coformulated; Truvada®) with or without hepatitis B immunoglobulin (HBIg) in preventing the recurrence of chronic hepatitis B following liver transplantation, in participants who were chronically infected with hepatitis B prior to transplantation.
Prior to enrollment, participants were required to have received at least 12 weeks of HBIg therapy following liver transplantation. Enrolled participants then received FTC/TDF plus HBIg for an initial 24-week pre-randomization treatment period. Participants who completed the pre-randomization period and who achieved sustained viral suppression were randomized to continue treatment with FTC/TDF with or without HBIg for an additional 72 weeks (randomized period). The antiviral efficacy of treatment was assessed by measuring hepatitis B virus levels in the blood (HBV DNA). Safety and tolerability was monitored by assessing adverse events and various laboratory parameters.
Eligibility Criteria
Inclusion Criteria
- Adult subjects (18-75 years of age) with either hepatitis e antigen (HBeAg) positive or HBeAg negative chronic HBV prior to transplant
- Willing and able to provide written informed consent
- Subjects with detectable antibody to hepatitis B surface antigen performed by a local laboratory result within 30 days of screening
- Subjects must have been stable and may not have had 2 or more of the following laboratory parameters associated with decompensated liver disease: conjugated bilirubin > 1.5 x the upper limit of the normal range (ULN), prothrombin time > 1.5 x ULN, platelets 50 ng/mL, or by any other standard of care measure or presence of multifocal HCC at the time of transplantation if transplantation was within 144 weeks of screening
- Prior TDF or FTC/TDF experience post-transplant or > 12 months treatment with TDF or FTC/TDF treatment pretransplant
- Coinfection with hepatitis C virus (by serology), HIV, or hepatitis D virus pretransplant or at screening
- Significant renal, cardiovascular, pulmonary, or neurological disease
- Known hypersensitivity to the study drugs, the metabolites, or formulation excipients
- Were likely to receive systemic drugs with nephrotoxic potential, except immunosuppressive agents (eg, cyclosporine, tacrolimus), during the course of the study
- History of variceal bleeding or hepatic encephalopathy following orthotopic liver transplantation
Data sourced from ClinicalTrials.gov (NCT00507689). 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.