Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (H... | NCT00507689

NCT00507689

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FTC/TDF+HBIg	Experimental	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.	Drug: FTC/TDF Drug: Hepatitis B Immunoglobulin (HBIg)
FTC/TDF	Experimental	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.	Drug: FTC/TDF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FTC/TDF	Drug	Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg was administered as a fixed-dose combination tablet orally once daily.	FTC/TDF FTC/TDF+HBIg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Pretreatment baseline through Week 72

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With HBV Recurrence at Week 96	HBV recurrence was defined as HBV DNA ≥ 400 at the Week 96 visit.	Week 96
Percentage of Subjects With HBV DNA < 169 Copies/mL at Week 72

Eligibility Module

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 < 60,000/mm^3, serum albumin < 3.0 g/dL
Must have had at least 12 weeks of center-specific prophylactic therapy including hepatitis B immunoglobulin (HBIg) posttransplant
Calculated creatinine clearance ≥ 40 mL/min using the Cockcroft-Gault equation
No significant evidence of ongoing deterioration of renal function
Negative serum beta-human chorionic gonadotropin (for females of childbearing potential only)

Exclusion Criteria:

Subjects with HBV recurrence, ie, confirmed HBV DNA ≥ 400 copies/mL, following liver transplant
Pregnant women, women who were breast feeding or who believed they may have wished to become pregnant during the course of the study
Males and females of reproductive potential who were unwilling to use an effective method of contraception during the study and for at least 30 days from the date of last dose of study drug
Evidence of hepatocellular carcinoma (HCC), eg, alpha-fetoprotein > 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

Contacts/Locations Module

Name	Affiliation	Role
Lewis Teperman, MD	NYU Langone Health	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
		Los Angeles	California	90048	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Three groups are reported for baseline characteristics: the 2 treatment groups in the randomized period, and non-randomized participants who discontinued prior to the randomized period.

Arm/Group Information

ID	Title	Description
BG000	FTC/TDF+HBIg	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.
BG001	FTC/TDF	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.
BG002	Not Randomized	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.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00019 BG00118 BG0023 BG00340

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00054± 9.7 BG00159± 9.1 BG00264± 6.0 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0004 BG0013 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0012 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG0006 BG0018 BG002

Baseline hepatitis B virus (HBV) DNA Below 169 copies/mL

Number

participants

Title

Denominators

Categories

< 169 copies/mL

Title	Measurements
	BG00019 BG00118 BG002

Baseline alanine aminotransferase (ALT) above the upper limit of the normal range (ULN)

The upper limit of the normal range (ULN) for ALT was 34 U/L for females 18-69 years of age, and 32 U/L for females over age 69; the ULN was 43 U/L for males 18-69 years of age, and 35 U/L for males over age 69.

Number

participants

Title

Denominators

Categories

> ULN

Title	Measurements
	BG0000 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Full Analysis Set

Posted

Number

percentage of participants

Pretreatment baseline through Week 72

ID	Title	Description
OG000	FTC/TDF+HBIg	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.
OG001	FTC/TDF	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.

Units	Counts
Participants	OG00019 OG00118

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010

Secondary

Percentage of Participants With HBV Recurrence at Week 96

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

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

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	FTC/TDF+HBIg	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.
OG001	FTC/TDF	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.

Units	Counts
Participants

Secondary

Percentage of Subjects With HBV DNA < 169 Copies/mL at Week 72

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

Posted

Number

percentage of participants

Week 72

ID	Title	Description
OG000	FTC/TDF+HBIg	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.
OG001	FTC/TDF	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.

Units	Counts
Participants

Secondary

Percentage of Participants With HBV DNA < 169 Copies/mL at Week 96

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

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	FTC/TDF+HBIg	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.
OG001	FTC/TDF	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.

Units	Counts
Participants

Secondary

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.

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

Posted

Number

percentage of participants

Week 72

ID	Title	Description
OG000	FTC/TDF+HBIg	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.
OG001	FTC/TDF	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.

Units	Counts

Secondary

Percentage of Participants With Normal ALT at Week 96

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

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	FTC/TDF+HBIg	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.
OG001	FTC/TDF	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.

Units	Counts

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	FTC/TDF+HBIg, Pre-randomization Period	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.	2	40	22	40
EG001	FTC/TDF+HBIg, Randomized Period	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.	6	19	15	19
EG002	FTC/TDF, Randomized Period	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.	3	18	11	18

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected40 at risk EG0010 affected19 at risk EG0020 affected18 at risk
Cytomegalovirus hepatitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected40 at risk EG0010 affected19 at risk EG0020 affected18 at risk
Aphasia	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Syncope	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Liver transplant rejection	Immune system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Transplant rejection	Immune system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Pneumonia	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Psychotic disorder	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Hypertension	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0003 affected40 at risk EG0011 affected19 at risk EG0021 affected18 at risk
Nausea	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0003 affected40 at risk EG0010 affected19 at risk EG0020 affected18 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected40 at risk EG0010 affected19 at risk EG0020 affected18 at risk
Oedema peripheral	General disorders	MedDRA (9.1)	Systematic Assessment	EG0005 affected40 at risk EG0011 affected19 at risk EG0021 affected18 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0003 affected40 at risk EG0010 affected19 at risk EG0020 affected18 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected40 at risk EG0011 affected19 at risk EG0021 affected18 at risk
Creatine renal clearance decreased	Investigations	MedDRA (9.1)	Systematic Assessment	EG0003 affected40 at risk EG0010 affected19 at risk EG0020 affected18 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected40 at risk EG0011 affected19 at risk EG0021 affected18 at risk
Dizziness	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected40 at risk EG0013 affected19 at risk EG0021 affected18 at risk
Headache	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected40 at risk EG0012 affected19 at risk EG0021 affected18 at risk
Pharyngolarylngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0003 affected40 at risk EG0010 affected19 at risk EG0020 affected18 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected40 at risk EG0010 affected19 at risk EG0020 affected18 at risk
Vomiting	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0022 affected18 at risk
Chapped lips	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Helicobacter gastritis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0021 affected18 at risk
Nasopharyngitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0012 affected19 at risk EG0020 affected18 at risk
Bronchiectasis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Bronchitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Oral herpes	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Sinusitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Fatigue	General disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0013 affected19 at risk EG0020 affected18 at risk
Pyrexia	General disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0012 affected19 at risk EG0021 affected18 at risk
Chest pain	General disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Noncardiac chest pain	General disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0021 affected18 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Pruritis	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0022 affected18 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Palmar erythema	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Hepatic enzyme increased	Investigations	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0021 affected18 at risk
Cardiac murmur	Investigations	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Electrocardiogram T wave abnormal	Investigations	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0012 affected19 at risk EG0020 affected18 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Angina pectoris	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Cardiomegaly	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Seasonal allergies	Immune system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0012 affected19 at risk EG0020 affected18 at risk
Transplant rejection	Immune system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Hypertension	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Varicose vein	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Vein disorder	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Macular degeneration	Eye disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Vision blurred	Eye disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Dysuria	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Pollakiurua	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Adrenal disorder	Endocrine disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Hepatic fibrosis	Hepatobiliary disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk
Depression	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0010 affected19 at risk EG0021 affected18 at risk
Tremor	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0021 affected18 at risk
Sciatica	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected40 at risk EG0011 affected19 at risk EG0020 affected18 at risk

ID	Term
D019694	Hepatitis B, Chronic

Ancestor Terms

ID	Term
D006509	Hepatitis B
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D006525	Hepatitis, Viral, Human
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000069480	Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
C045213	hepatitis B hyperimmune globulin

Ancestor Terms

ID	Term
D000068698	Tenofovir
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D000068679	Emtricitabine
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D000225	Adenine
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D004338	Drug Combinations
D004364	Pharmaceutical Preparations