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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
40
Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg was administered as a fixed-dose combination tablet orally once daily.
HBIg was administered either intravenously or by intramuscular injection at a dose and frequency as prescribed by the investigative site protocol.
Unnamed facility
Los Angeles, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
New York, New York, United States
Unnamed facility
New York, New York, United States
Percentage of Participants With HBV Recurrence Prior to or at Week 72
HBV recurrence was defined as either HBV DNA ≥ 400 at 2 consecutive visits before Week 72, or HBV DNA ≥ 400 at the Week 72 visit.
Time frame: Pretreatment baseline through Week 72
Percentage of Participants With HBV Recurrence at Week 96
HBV recurrence was defined as HBV DNA ≥ 400 at the Week 96 visit.
Time frame: Week 96
Percentage of Subjects With HBV DNA < 169 Copies/mL at Week 72
Time frame: Week 72
Percentage of Participants With HBV DNA < 169 Copies/mL at Week 96
Time frame: Week 96
Percentage of Participants With Normal ALT at Week 72
Range of normal ALT was 6 to 34 U/L for females 18-69 years of age, and 6 to 32 U/L for females over age 69. Range of normal ALT was 6 to 43 U/L for males 18-69 years of age, and 6 to 35 U/L for males over age 69.
Time frame: Week 72
Percentage of Participants With Normal ALT at Week 96
Range of normal ALT was 6 to 34 U/L for females 18-69 years of age, and 6 to 32 U/L for females over age 69. Range of normal ALT was 6 to 43 U/L for males 18-69 years of age, and 6 to 35 U/L for males over age 69.
Time frame: Week 96
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