Combination Therapy of Pegylated Interferon Alfa-2a and T... | NCT01369212

ID	Type	Description	Link
U01DK082864	U.S. NIH Grant/Contract		View source
U01DK082843	U.S. NIH Grant/Contract		View source
U01DK082863	U.S. NIH Grant/Contract		View source
U01DK082866	U.S. NIH Grant/Contract		View source
U01DK082867	U.S. NIH Grant/Contract		View source
U01DK082871	U.S. NIH Grant/Contract		View source
U01DK082872	U.S. NIH Grant/Contract		View source
U01DK082874	U.S. NIH Grant/Contract		View source
U01DK082919	U.S. NIH Grant/Contract		View source
U01DK082923	U.S. NIH Grant/Contract		View source
U01DK082927	U.S. NIH Grant/Contract		View source
U01DK082943	U.S. NIH Grant/Contract		View source
U01DK082944	U.S. NIH Grant/Contract		View source
UL1TR000004	U.S. NIH Grant/Contract		View source
UL1TR001111	U.S. NIH Grant/Contract		View source
UL1TR000058	U.S. NIH Grant/Contract		View source
P30DK050306	U.S. NIH Grant/Contract		View source
A-DK-3002-001	Other Grant/Funding Number	Interagency agreement with NIDDK
M01RR000040	U.S. NIH Grant/Contract		View source
UL1RR024986	U.S. NIH Grant/Contract		View source

Name	Class
University of Pittsburgh	OTHER
National Center for Research Resources (NCRR)	NIH

Label	Type	Description	Intervention Names
Tenofovir	Experimental	Tenofovir 192 weeks	Drug: Tenofovir
Peginterferon-alfa 2a and tenofovir	Experimental	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks	Drug: Peginterferon-alfa 2a and tenofovir

Name	Type	Description	Arm Group Labels	Other Names
Tenofovir	Drug	300 mg daily for 192 weeks (4 years)	Tenofovir	Hepatitis B

Measure	Description	Time Frame
Percent of Participants With Hepatitis B Surface Antigen (HBsAg) Loss by Week 240	Estimated percent of participants who became HBsAg negative by week 240 from randomization	Week 240

Measure	Description	Time Frame
Cumulative Percent of Participants With HBsAg Loss at Week 192	Cumulative percentage of participants with HBsAg loss at week 192 estimated using Kaplan-Meier method	Week 192
Number of Participants With Serious Adverse Events

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Participant is enrolled in the HBRN Cohort Study (NCT01263587) or completed the necessary components of the cohort baseline evaluation by the end of the baseline visit for this study
18 years or older
Chronic hepatitis B infection as evidenced by at least one of the following:
1. HBsAg positive result within 8 weeks prior to randomization and another time at least 24 weeks prior to randomization with no HBsAg negative result in between.
2. HBsAg positive within 8 weeks prior to randomization and HBV DNA ≥1000 IU/mL on 2 occasions at least 24 weeks apart (can include result from screening visit within 8 weeks of randomization)
Hepatitis B e antigen positive or negative
Serum HBV DNA ≥1000 IU/mL on 2 occasions at least 4 weeks apart within the 32 weeks prior to randomization (can include result from screening visit within 8 weeks of randomization)
At least 2 elevated serum alanine aminotransferase (ALT) levels (> 30 U/L for males, >20 U/L for females) 4 weeks apart, and no more than 32 weeks apart, with the second being within 8 weeks of randomization
Compensated liver disease
No evidence of hepatocellular carcinoma (HCC)
Liver biopsy done that shows findings consistent with chronic hepatitis B with histology activity index (HAI) ≥3 (necroinflammatory component only) or Ishak fibrosis score ≥1 or both, as assessed by the local study pathologist on review of a liver biopsy done within 144 weeks of randomization
Females of child bearing potential must agree to use an adequate method of contraception throughout the study and must have a negative pregnancy test immediately prior to the start of treatment

Exclusion criteria:

Serum ALT ≥450 U/L for males and ≥300 U/L for females
Treatment with interferon or nucleos(t)ide analogues for hepatitis B within 48 weeks of randomization
More than 48 weeks of therapy with nucleos(t)ide analogues for hepatitis B at any time in the past
History of hepatic decompensation including but not limited to ascites, variceal bleeding, or hepatic encephalopathy
Known allergy or intolerance to any of the study medications
Females who are pregnant or breastfeeding
Previous organ transplantation including engrafted bone marrow transplant
Any other concomitant liver disease, including hemochromatosis, hepatitis C or D; Participants with severe steatohepatitis will be excluded (participants with non-alcoholic fatty liver disease [NAFLD] with steatosis only and/or mild to moderate steatohepatitis are acceptable)
Positive anti-HIV
Renal insufficiency with calculated (by Modification of Diet in Renal Disease (MDRD) method) creatinine clearance <60 mL/min within 8 weeks prior to randomization
Platelet count <90,000 /mm3, hemoglobin <13 g/dL (males) or <12 g/dL (females), absolute neutrophil count <1500 /mm^3 (<1000/mm^3 for African-Americans) within 8 weeks prior to randomization
History of active alcohol or drug abuse within 48 weeks of screening.
Pre-existing psychiatric condition(s), including but not limited to: Current moderate or severe depression as determined by the study physician, history of depression requiring hospitalization within past 10 years, history of suicidal or homicidal attempt within the past 10 years, or history of severe psychiatric disorders including but not limited to schizophrenia, psychosis, bipolar disorder
History of immune-mediated disease, or cerebrovascular, chronic pulmonary or cardiac disease associated with functional limitation, retinopathy, uncontrolled thyroid disease, poorly controlled diabetes or uncontrolled seizure disorder
Any medical condition that would be predicted to be exacerbated by therapy or that would limit study participation
Any medical condition requiring or likely to require chronic systemic administration of corticosteroids or other immunosuppressive medications during the course of this study
Evidence of active or suspected malignancy, or a history of malignancy within the last 144 weeks (except adequately treated carcinoma in situ or basal cell carcinoma of the skin)
Need for ongoing use of any antivirals with activity against HBV during the course of the study
Any other condition that in the opinion of the investigator would make the participant unsuitable for enrollment or could interfere with the participant participating in and completing the study.
Participation in any other clinical trial involving investigational drugs within 30 days of randomization or intention to participate in another clinical trial during this study.

Name	Affiliation	Role
Averell Sherker, MD	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Study Chair
Edward Doo, MD	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Study Chair
Anna Lok, MD	University of Michigan	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Cedars Sinai Medical Center		Los Angeles	California	90048	United States
University of California Los Angeles

PubMed Identifier	Type	Citation	Retractions
39478672	Derived	Terrault NA, Sterling R, Lok AS, Ghany MG, Feld JJ, Cloherty G, Wahed AS, Yang X. Hepatitis B Virus RNA as a Biomarker for Safe Antiviral Discontinuation: A Prospective Study of Nucleos(t)ide Analogue Withdrawal. J Infect Dis. 2025 Jun 2;231(5):1290-1298. doi: 10.1093/infdis/jiae541.
36728214	Derived	Feld JJ, Wahed AS, Fried M, Ghany MG, Di Bisceglie AM, Perrillo RP, Khalili M, Yang X, Belle SH, Janssen HLA, Terrault N, Lok AS; Hepatitis B Research Network (HBRN). Withdrawal of Long-Term Nucleotide Analog Therapy in Chronic Hepatitis B: Outcomes From the Withdrawal Phase of the HBRN Immune Active Treatment Trial. Am J Gastroenterol. 2023 Jul 1;118(7):1226-1236. doi: 10.14309/ajg.0000000000002176. Epub 2023 Jan 13.

ID	Title	Description
FG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
FG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 23, 2018

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

Percent of Participants With Hepatitis B Surface Antigen (HBsAg) Loss by Week 240

Estimated percent of participants who became HBsAg negative by week 240 from randomization

This outcome is analyzed as a survival outcome with proportion estimated at week 240 using Kaplan-Meier Method

Posted

Number

Percentage of participants

Week 240

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000102 OG00199

Title

Denominators

Categories

Title	Measurements
	OG0004.1 OG0015.2

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Wald test	Proportion with HBsAg loss at week 240 in each group is estimated by Kaplan-Meier and then equality of proportion is tested using Wald test.	0.72														Superiority

Secondary

Cumulative Percent of Participants With HBsAg Loss at Week 192

Cumulative percentage of participants with HBsAg loss at week 192 estimated using Kaplan-Meier method

Posted

Number

Cumulative percentage of participants

Week 192

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000

Secondary

Number of Participants With Serious Adverse Events

Number of participants with at least one serious adverse event between randomization and week 240

All randomized participants

Posted

Count of Participants

Participants

Up to 240 weeks

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000

Secondary

Number of Participants With Adverse Events

Number of participants with at least one adverse event between randomization and week 240

All randomized participants

Posted

Count of Participants

Participants

up to 240 weeks

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000

Secondary

Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 192

Number of participants who became Hepatitis B e antigen (HBeAg) negative at week 192 among HBeAg positive participants at randomization (baseline)

Among HBeAg positive participants at baseline who had HBeAg data available at week 192

Posted

Count of Participants

Participants

week 192

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000

Secondary

Number of Participants With HBeAg Loss at Week 240

Number of participants who became HBeAg negative at week 240 among HBeAg positive participants at baseline

Participants who were HBeAg positive at baseline and who had data for HBeAg at week 240 visit

Posted

Count of Participants

Participants

week 240

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000

Secondary

Number of Participants With HBsAg Seroconversion at Week 192

Number of participants who became with HBsAg negative and developed anti-HBs at week 192

Participants with data on HBsAg and anti-HBs at week 192

Posted

Count of Participants

Participants

week 192

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000

Secondary

Number of Participants With HBsAg Seroconversion at Week 240

Number of participants who became HBsAg negative and developed anti-HBs at week 240

HBsAg and antiHBs data at week 240

Posted

Count of Participants

Participants

week 240

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000

Secondary

Number of Participants With HBeAg Seroconversion at Week 192

Number of participants who became HBeAg negative and developed anti-HBe at week 192 among HBeAg positive participants at baseline

HBeAg positives at baseline with HBeAg and anti-HBe data available at week 192

Posted

Count of Participants

Participants

week 192

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000

Secondary

Number of Participants With HBeAg Seroconversion at Week 240

Number of participants who became HBeAg negative and developed anti-HBe at week 240 among HBeAg positive participants at baseline

HBeAg positive participants at baseline with HBeAg and anti-HBe data at week 240

Posted

Count of Participants

Participants

week 240

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000

Secondary

Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 192

Number of participants with normal alanine transaminase (ALT) levels at week 192 (Normal ALT for males ≤30 U/L, for females ≤20 U/L)

Participants with ALT data at week 192

Posted

Count of Participants

Participants

week 192

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000

Secondary

Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 240

Number of participants with normal alanine transaminase (ALT) levels [males ≤30 U/L, for females ≤20 U/L] at week 240

Participants with ALT data at week 240

Posted

Count of Participants

Participants

week 240

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000

Secondary

Number of Participants With HBV DNA<1000 IU/mL at Week 192

Number of participants with HBV DNA <1000 IU/mL at week 192

Participants with HBV DNA data at week 192

Posted

Count of Participants

Participants

week 192

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000

Secondary

Number of Participants With HBV DNA<1000 IU/mL at Week 240

Number of participants with HBV DNA <1000 IU/mL at week 240

Participants with HBV DNA data available at week 240

Posted

Count of Participants

Participants

week 240

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000

Secondary

Number of Participants With HBV DNA<20 IU/mL at Week 192

Number of participants with HBV DNA<20 IU/mL at week 192

Participants with HBV DNA data at week 192

Posted

Count of Participants

Participants

week 192

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000

Secondary

Number of Participants With HBV DNA<20 IU/mL at Week 240

Number of participants with HBV DNA<20 IU/mL at week 240

Participants with HBV DNA data at week 240

Posted

Count of Participants

Participants

week 240

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000

Secondary

Absence of Detectable Antiviral Drug-Resistant HBV Mutations at Week 192

Absence of detectable antiviral drug-resistant HBV mutations at Week 192

The anti-viral drug resistance test was not done

Posted

week 192

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000

Secondary

Cumulative Percent of Participants With HBsAg Loss at Week 240

Cumulative percent of participants with HBsAg loss at week 240 estimated using Kaplan-Meier method

Posted

Number

percentage of participants

Week 240

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants	OG000

Secondary

Number of Participants With Alanine Transaminase(ALT) Levels <= 38 U/L for Males and <=25 for Females at Week 192

Number of participants with alanine transaminase(ALT) levels <= 38 U/L for males and <=25 for females at week 192. The cut-offs 38 and 25 are approximately 1.25 times the upper limit of normal (30 U/L for males and 20 U/L for females) respectively.

Participants with ALT data at week 192

Posted

Count of Participants

Participants

week 192

ID	Title	Description
OG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
OG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
ANEMIA	Blood and lymphatic system disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0013 events3 affected99 at risk
BETA-THALESSEMIA, ANEMIA	Blood and lymphatic system disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
HYPOPHOSPHATEMIA	Blood and lymphatic system disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0013 events2 affected99 at risk
IRON DEFICIENCY DEVELOPED WITHOUT ANEMIA	Blood and lymphatic system disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
LOW ANC	Blood and lymphatic system disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
LOW PLATELETS	Blood and lymphatic system disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
LOW-NORMAL POTASSIUM LEVEL AND RUQ MUSCLE CRAMPS	Blood and lymphatic system disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
LYMPHOCYTE COUNT DECREASED	Blood and lymphatic system disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
MICROCYTIC ANEMIA	Blood and lymphatic system disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
NEUTROPENIA	Blood and lymphatic system disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0012 events2 affected99 at risk
PLATELET COUNT DECREASED	Blood and lymphatic system disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0012 events2 affected99 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0013 events3 affected99 at risk
WHITE BLOOD CELL DECREASED	Blood and lymphatic system disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0013 events2 affected99 at risk
WHITE BLOOD CELL, PLATELET COUNT, AND NEUTROPHIL	Blood and lymphatic system disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
CHEST DISCOMFORT	Cardiac disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
CHEST PAIN	Cardiac disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
CHEST PRESSURE	Cardiac disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
HIGH CHOLESTEROL	Cardiac disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
HYPERTENSION	Cardiac disorders	Systematic Assessment		EG0002 events2 affected102 at risk EG0010 events0 affected99 at risk
HYPERTENSION, DIZZINESS	Cardiac disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
HYPERTRIGLYCERIDEMIA	Cardiac disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
RAPID HEART RATE	Cardiac disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
HEMOGLOBIN A1C ELEVATED	Endocrine disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
HYPERTHYROIDISM	Endocrine disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
LOW TSH EPISODE	Endocrine disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
PARATHYROID ADENOMECTOMY	Endocrine disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
VITAMIN D DEFICIENCY	Endocrine disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
DRY EYES	Eye disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
PERIORBITAL EDEMA	Eye disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	Systematic Assessment		EG0002 events2 affected102 at risk EG0010 events0 affected99 at risk
ABDOMINAL PAIN, NAUSEA, GASTRIC REFLUX	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
ACTIVE DUODENITIS WITH ULCER	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
ACUTE APPENDICITIS	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
CAMPYLOBACTER INFECTION	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
CONSTIPATION	Gastrointestinal disorders	Systematic Assessment		EG0002 events2 affected102 at risk EG0010 events0 affected99 at risk
CONSTIPATION, HEMORRHOIDS	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
DAILY NAUSEA AND DIZZINESS	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
DIARRHEA	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
DRY COUGH ASSOCIATED WITH EATING/REFLUX	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
ENDOSCOPIC ULTRASOUND SUGGESTED A SUBMUCOSAL GI TUMOR (GIST)	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
EPIGASRIC PAIN AND BLACK DIARRHEA	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
GAS AND DIARRHEA	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
GASTRITIS	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
H.PYLORI ANTIBODY POSITIVE	Gastrointestinal disorders	Systematic Assessment		EG0002 events2 affected102 at risk EG0010 events0 affected99 at risk
HELICOBACTER PYLORI	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
IRRITABLE BOWEL SYNDROME WITH DIARRHEA	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
NAUSEA	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
NAUSEA, MILD ABDOMINAL PAIN, WEAKNESS, DIZZINESS,SHORTNESS OF BREATH	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
OPEN HERNIA UMBILICAL REPAIR	Gastrointestinal disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
UPPER ABDOMINAL PAIN	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
UPSET STOMACH	Gastrointestinal disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
APHTHOUS ORAL ULCERS	General disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
CHILLS	General disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
COUGH	General disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0011 events1 affected99 at risk
DENTAL PROCEDURE	General disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
EAR ACHE POTENTIAL EAR INFECTION	General disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
EAR INFECTION/FUNGUS	General disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
EAR PAIN	General disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
FATIGUE	General disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0011 events1 affected99 at risk
FEVER	General disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0011 events1 affected99 at risk
FLU-LIKE SYMPTOMS	General disorders	Systematic Assessment		EG0003 events2 affected102 at risk EG0013 events2 affected99 at risk
HERPESVIRAL GINGIVOSTOMATITIS AND PHARYNGOTONSILLITIS	General disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
HYPOKALEMIA	General disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
INFECTION OF TOOTH	General disorders	Systematic Assessment		EG0002 events2 affected102 at risk EG0010 events0 affected99 at risk
IRRITABILITY	General disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
MALAISE	General disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
MUCUS IN THROAT	General disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
NASAL CONGESTION AND POST NASAL DRIP	General disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
OTITIS EXTERNA	General disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
PREP	General disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
SINUSITIS	General disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
SURGICAL DENTAL EXTRACTION	General disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
TOOTH EXTRACTION	General disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0012 events2 affected99 at risk
TOOTHACHE	General disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
ALT AND AST INCREASED	Hepatobiliary disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0011 events1 affected99 at risk
ALT FLARE	Hepatobiliary disorders	Systematic Assessment		EG0003 events3 affected102 at risk EG0010 events0 affected99 at risk
ELEVATED ALT	Hepatobiliary disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0013 events3 affected99 at risk
ENLARGING GALLBLADDER POLYP	Hepatobiliary disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
HCC	Hepatobiliary disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
SEVERE FLARE DEVELOPED INTO CLINICAL DECOMPENSATION	Hepatobiliary disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
SPASM LIKE PAIN IN RUQ	Hepatobiliary disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
CHEST PAIN	Immune system disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
RED ITCHY BUMPS/LESIONS ACROSS BODY	Immune system disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
SHINGLES	Immune system disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
SINUSITIS	Immune system disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
URTICARIA	Immune system disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
ACCIDENTAL OCCUPATIONAL BLOOD EXPOSURE TO HIV	Infections and infestations	Systematic Assessment		EG0002 events1 affected102 at risk EG0010 events0 affected99 at risk
CELLULITIS	Infections and infestations	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
SCRATCH BY CAT INFECTION AND PAIN	Infections and infestations	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
SHINGLES	Infections and infestations	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
SYPHILIS	Infections and infestations	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
TUBERCULOSIS	Infections and infestations	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0011 events1 affected99 at risk
WEIGHT LOSS	Metabolism and nutrition disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0015 events5 affected99 at risk
ACHES AND PAINS	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
ACUTE SCIATICA AND BACK PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
ANKLE FRACTURE	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0008 events6 affected102 at risk EG0011 events1 affected99 at risk
CERVICAL RADICULOPATHY	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
MOTORCYCLE ACCIDENT WITH MULTIPLE INJURIES	Musculoskeletal and connective tissue disorders	Systematic Assessment	CONTUSION OF RIGHT SHOULDER AND HIP, SLAP TEAR OF GLENOID LABRUM, MINIMALLY DISPLACED RIGHT PUBIC ROOT W/NONDISPLACED INFERIOR PUBIC RAMUS FRACTURES AND SUSPECTED ANTERIOR LABRAL TEAR	EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
ELBOW PAIN AND EFFUSION	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
FOOT SPRAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
GASTROCNEMIUS MUSCLE TEAR	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
INCREASED JOINT AND MUSCLE PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
JOINT ACHES	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
KNEE PAIN, LOWER BACK PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
KNEE PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
LEFT KNEE EFFUSION	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
MUSCLE PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
MYOSITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0010 events0 affected99 at risk
OSTEOPENIA	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
PINCHED NERVE , NECK BACK PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
PROXIMAL HUMERUS FRACTURE	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
RIGHT SHOULDER STIFFNESS	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
RIGHT TRIGGER AND MIDDLE FINGERS INCREASINGLY STIFF	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
SHOULDER PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0002 events2 affected102 at risk EG0010 events0 affected99 at risk
THUMB PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
TRIGGER MIDDLE FINGER	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
BELL'S PALSY	Nervous system disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
DIZZINESS	Nervous system disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
EPISODE OF SYNCOPE	Nervous system disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
HEADACHE	Nervous system disorders	Systematic Assessment		EG0002 events2 affected102 at risk EG0012 events2 affected99 at risk
INSOMNIA	Nervous system disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0012 events2 affected99 at risk
MIGRAINE	Nervous system disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
NUMBNESS	Nervous system disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
ACUTE ANXIETY	Psychiatric disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
DECREASED LIBIDO	Psychiatric disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
DEPRESSION	Psychiatric disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0017 events6 affected99 at risk
HALLUCINATIONS	Psychiatric disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
INTERMITTENT CONFUSION	Psychiatric disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
IRRITABILITY	Psychiatric disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0012 events2 affected99 at risk
MOOD DISORDER	Psychiatric disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
MOOD SWING	Psychiatric disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
POLYNEUROPATHY	Psychiatric disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
SUICIDAL THOUGHT	Psychiatric disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
SYMPTOMS OF FEELING SAD, IRRITABLE, TROUBLE SLEEP	Psychiatric disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
BLOOD IN URINE	Renal and urinary disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
BPH WITH OBSTRUCTION/LOWER URINARY TRACT SYMPTOMS	Renal and urinary disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
DYSURIA, URINARY FREQUENCY	Renal and urinary disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
E COLI INFECTION IN URINE	Renal and urinary disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
ERECTILE DYSFUNCTION	Renal and urinary disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
KIDNEY STONE	Renal and urinary disorders	Systematic Assessment		EG0002 events2 affected102 at risk EG0011 events1 affected99 at risk
LOW PHOSPHATE LEVELS	Renal and urinary disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
URETERIC STONE RECURRENCE	Renal and urinary disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
URINARY TRACT INFECTION	Renal and urinary disorders	Systematic Assessment		EG0003 events3 affected102 at risk EG0013 events3 affected99 at risk
MENSES CEASED	Reproductive system and breast disorders	Systematic Assessment	PREGNANCY TESTS REMAINED NEGATIVE	EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
POOR LIBIDO AND RECURRENT UTI	Reproductive system and breast disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
TUBAL REVERSAL	Reproductive system and breast disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
POST TUBAL REVERSION PROCEDURE WOUND INFECTION	Reproductive system and breast disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
BRONCHITIS	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0011 events1 affected99 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
LUNG INFECTION	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
MILD CHEST TIGHTNESS	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
NON-PRODUCTIVE COUGH AND SHORTNESS OF BREATH	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
REACTIVE AIRWAY DISEASE	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
UPPER RESPIRATORY INFECTION	Respiratory, thoracic and mediastinal disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0012 events2 affected99 at risk
CELLULITIS	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
DERMATITIS HERPETIFORMIS	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
DRY SKIN AND HYPOPIGMENTATION	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
EYE LID AND FACIAL SWELLING	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
HAIR LOSS	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0012 events2 affected99 at risk
HIVES	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
ITCHING	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0012 events2 affected99 at risk
POISON IVY RASH	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
PRURITUS	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0014 events3 affected99 at risk
PSORIASIS	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
RASH	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0003 events3 affected102 at risk EG0017 events7 affected99 at risk
RASH AT INJECTION SITE	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0012 events2 affected99 at risk
RASH, SKIN IRRITATION, ERYTHEMA AT INJECTION SITE	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
REDNESS AND ITCHINESS AT INJECTION SITE	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
RING WORM	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
ROSACEA	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
TICK BITE	Skin and subcutaneous tissue disorders	Systematic Assessment		EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
BACK SPRAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment		EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D006525	Hepatitis, Viral, Human
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Term
D000068698	Tenofovir
D017325	Hepatitis B Vaccines
C100416	peginterferon alfa-2a

ID	Term
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D000225	Adenine
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D014761	Viral Hepatitis Vaccines
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

ID	Title	Description
BG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)
BG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tenofovir	Tenofovir 192 weeks Tenofovir: 300 mg daily for 192 weeks (4 years)	0	102	11	102	50	102
EG001	Peginterferon-alfa 2a and Tenofovir	A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks Peginterferon-alfa 2a and tenofovir: A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).	0	99	7	99	60	99

Term	Organ System	Assessment Type	Statistical Information
ATRIAL FIBRILLATION	Cardiac disorders	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
BENIGN PAROXYSMAL POSITIONAL VERTIGO	General disorders	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 events1 affected102 at risk EG0011 events1 affected99 at risk
CHEST PAIN	Cardiac disorders	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
CHEST TIGHTNESS, LEFT SIDED WEAKNESS	Cardiac disorders	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
DEPRESSION	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
CLINICAL DECOMPENSATION	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
ELEVATED ALT	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
FRACTURE, RIGHT ANKLE	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
GASTRECTOMY	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
GERD	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
HEARING LOSS	Nervous system disorders	Systematic Assessment	EG0000 events0 affected102 at risk EG0012 events1 affected99 at risk
PREGNANCY	Pregnancy, puerperium and perinatal conditions	Systematic Assessment	EG0001 events1 affected102 at risk EG0012 events2 affected99 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
RECONSTRUCTION OF BREAST	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected102 at risk EG0011 events1 affected99 at risk
RHABDOMYOLYSIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
UTERINE FIBROIDS, OVARIAN CYST	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk
WOUND INFECTION	Infections and infestations	Systematic Assessment	EG0001 events1 affected102 at risk EG0010 events0 affected99 at risk