Trial Outcomes & Findings for Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant (NCT NCT00507689)

Last Updated: 2014-03-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Pretreatment baseline through Week 72

Results posted on

2014-03-14

Participant Flow

Participants were enrolled at 7 sites in the United States. The first participant was screened on 12 September 2007. The last participant observation was on 03 May 2011.

51 participants were screened; 40 received emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)+HBIg in the pre-randomization period; 37 received FTC/TDF+HBIg or FTC/TDF in the randomized period.

Participant milestones

Participant milestones
Measure	FTC/TDF+HBIg For the Participant Flow, this group includes all participants who received any treatment in the pre-randomization period, and participants who received FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.	FTC/TDF For the Participant Flow, this group includes participants who received FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily.
Pre-Randomization Period STARTED	40	0
Pre-Randomization Period COMPLETED	37	0
Pre-Randomization Period NOT COMPLETED	3	0
Randomized Period STARTED	19	18
Randomized Period COMPLETED	18	16
Randomized Period NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	FTC/TDF+HBIg For the Participant Flow, this group includes all participants who received any treatment in the pre-randomization period, and participants who received FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.	FTC/TDF For the Participant Flow, this group includes participants who received FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily.
Pre-Randomization Period Adverse Event	1	0
Pre-Randomization Period Physician Decision	1	0
Pre-Randomization Period Withdrawal by Subject	1	0
Randomized Period Adverse Event	1	1
Randomized Period Withdrawal by Subject	0	1

Baseline Characteristics

Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FTC/TDF+HBIg n=19 Participants For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period, and were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.	FTC/TDF n=18 Participants For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period, and were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.	Not Randomized n=3 Participants For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period only. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.	Total n=40 Participants Total of all reporting groups
Age, Continuous	54 years STANDARD_DEVIATION 9.7 • n=5 Participants	59 years STANDARD_DEVIATION 9.1 • n=7 Participants	64 years STANDARD_DEVIATION 6.0 • n=5 Participants	57 years STANDARD_DEVIATION 9.6 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	2 Participants n=5 Participants	32 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	16 Participants n=7 Participants	3 Participants n=5 Participants	36 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian	6 participants n=5 Participants	8 participants n=7 Participants	1 participants n=5 Participants	15 participants n=4 Participants
Race/Ethnicity, Customized White	7 participants n=5 Participants	5 participants n=7 Participants	1 participants n=5 Participants	13 participants n=4 Participants
Race/Ethnicity, Customized Black	5 participants n=5 Participants	4 participants n=7 Participants	1 participants n=5 Participants	10 participants n=4 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Baseline hepatitis B virus (HBV) DNA Below 169 copies/mL < 169 copies/mL	19 participants n=5 Participants	18 participants n=7 Participants	3 participants n=5 Participants	40 participants n=4 Participants
Baseline hepatitis B virus (HBV) DNA Below 169 copies/mL ≥ 169 copies/mL	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Baseline alanine aminotransferase (ALT) above the upper limit of the normal range (ULN) > ULN	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Baseline alanine aminotransferase (ALT) above the upper limit of the normal range (ULN) ≤ ULN	19 participants n=5 Participants	16 participants n=7 Participants	3 participants n=5 Participants	38 participants n=4 Participants

PRIMARY outcome

Timeframe: Pretreatment baseline through Week 72

Population: Full Analysis Set

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.

Outcome measures

Outcome measures
Measure	FTC/TDF+HBIg n=19 Participants Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.	FTC/TDF n=18 Participants Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Percentage of Participants With HBV Recurrence Prior to or at Week 72	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: Participants in the Full Analysis Set with available data at Week 96 were analyzed.

HBV recurrence was defined as HBV DNA ≥ 400 at the Week 96 visit.

Outcome measures

Outcome measures
Measure	FTC/TDF+HBIg n=17 Participants Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.	FTC/TDF n=16 Participants Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Percentage of Participants With HBV Recurrence at Week 96	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 72

Population: Participants in the Full Analysis Set with available data at Week 72 were analyzed.

Outcome measures

Outcome measures
Measure	FTC/TDF+HBIg n=19 Participants Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.	FTC/TDF n=16 Participants Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Percentage of Subjects With HBV DNA < 169 Copies/mL at Week 72	100 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: Participants in the Full Analysis Set with available data at Week 96 were analyzed.

Outcome measures

Outcome measures
Measure	FTC/TDF+HBIg n=17 Participants Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.	FTC/TDF n=16 Participants Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Percentage of Participants With HBV DNA < 169 Copies/mL at Week 96	100 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Week 72

Population: Participants in the Full Analysis Set with available data at Week 72 were analyzed.

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.

Outcome measures

Outcome measures
Measure	FTC/TDF+HBIg n=19 Participants Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.	FTC/TDF n=16 Participants Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Percentage of Participants With Normal ALT at Week 72	89 percentage of participants	81 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: Participants in the Full Analysis Set with available data at Week 96 were analyzed.

Outcome measures

Outcome measures
Measure	FTC/TDF+HBIg n=17 Participants Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.	FTC/TDF n=15 Participants Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Percentage of Participants With Normal ALT at Week 96	88 percentage of participants	80 percentage of participants

Adverse Events

FTC/TDF+HBIg, Pre-randomization Period

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

FTC/TDF+HBIg, Randomized Period

Serious events: 6 serious events

Other events: 15 other events

Deaths: 0 deaths

FTC/TDF, Randomized Period

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FTC/TDF+HBIg, Pre-randomization Period n=40 participants at risk For the reporting of Adverse Events, this group includes participants who received FTC/TDF+HBIg during the pre-randomization period, and were analyzed from pretreatment baseline to Week 24 (pre-randomization period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.	FTC/TDF+HBIg, Randomized Period n=19 participants at risk For the reporting of Adverse Events, this group includes participants who received FTC/TDF+HBIg during the randomized period, and were analyzed from randomization (at the Week 24 visit) to Week 96 (randomized period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.	FTC/TDF, Randomized Period n=18 participants at risk For the reporting of Adverse Events, this group includes participants who received FTC/TDF during the randomized period, and were analyzed from randomization (at the Week 24 visit) to Week 96 (randomized period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
Infections and infestations Pneumonia	0.00% 0/40 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	5.3% 1/19 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	0.00% 0/18 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.
Immune system disorders Liver transplant rejection	0.00% 0/40 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	5.3% 1/19 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	0.00% 0/18 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.
Immune system disorders Transplant rejection	0.00% 0/40 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	5.3% 1/19 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	0.00% 0/18 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.
Gastrointestinal disorders Diarrhoea	2.5% 1/40 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	0.00% 0/19 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	0.00% 0/18 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.
Infections and infestations Cytomegalovirus hepatitis	2.5% 1/40 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	0.00% 0/19 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	0.00% 0/18 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.
Nervous system disorders Aphasia	0.00% 0/40 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	5.3% 1/19 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	0.00% 0/18 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.
Nervous system disorders Cerebrovascular accident	0.00% 0/40 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	0.00% 0/19 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	5.6% 1/18 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.
Nervous system disorders Syncope	0.00% 0/40 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	5.3% 1/19 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	0.00% 0/18 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/40 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	5.3% 1/19 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	0.00% 0/18 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/40 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	0.00% 0/19 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	5.6% 1/18 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/40 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	0.00% 0/19 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	5.6% 1/18 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.
Psychiatric disorders Psychotic disorder	0.00% 0/40 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	5.3% 1/19 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	0.00% 0/18 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.
Vascular disorders Hypertension	0.00% 0/40 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	5.3% 1/19 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.	0.00% 0/18 • Pretreatment baseline to Week 96 Adverse events are presented for 3 reporting groups: a single group of all participants who were enrolled and received FTC/TDF+HBIg in the 24-week pre-randomization period, and 2 groups (FTC/TDF with or without HBIg) in the 72-week randomized period that followed.

Other adverse events

Additional Information

Clinical Trial Disclosures

Gilead Sciences, Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER