Trial Outcomes & Findings for A Study to Compare Tenofovir DF Versus the Combination of Emtricitabine Plus Tenofovir DF for the Treatment of Chronic Hepatitis B in Patients With Normal Alanine Aminotransferase (ALT) (NCT NCT00507507)

Last Updated: 2015-07-17

Results Overview

The percentage of participants with HBV DNA \< 400 copies/mL at Week 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

126 participants

Primary outcome timeframe

Week 192

Results posted on

2015-07-17

Participant Flow

Participants were enrolled at 34 sites in the North America, Europe, Asia, Australia, and New Zealand. The first participant was screened on 04 September 2007. The last participant observation for the Week 192 analysis was on 03 February 2012.

309 participants were screened and 129 were randomized; 126 randomized participants received at least one dose of study drug, and comprise the Safety Analysis Set and the Full Analysis Set.

Participant milestones

Participant milestones
Measure	Tenofovir DF Participants were randomized to receive tenofovir disoproxil fumarate (tenofovir DF; 300 mg tablet) plus placebo to match emtricitabine (FTC; tablet) orally once daily.	FTC+Tenofovir DF Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
Treatment Period STARTED	64	62
Treatment Period Completed 192 Weeks of Treatment	52	52
Treatment Period COMPLETED	12	9
Treatment Period NOT COMPLETED	52	53
24-week Treatment-free Follow-up Period STARTED	26	29
24-week Treatment-free Follow-up Period COMPLETED	16	12
24-week Treatment-free Follow-up Period NOT COMPLETED	10	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Tenofovir DF Participants were randomized to receive tenofovir disoproxil fumarate (tenofovir DF; 300 mg tablet) plus placebo to match emtricitabine (FTC; tablet) orally once daily.	FTC+Tenofovir DF Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
Treatment Period Lost to Follow-up	0	2
Treatment Period Physician Decision	4	1
Treatment Period Protocol Violation	1	2
Treatment Period Adverse Event	1	1
Treatment Period Withdrawal by Subject	46	47
24-week Treatment-free Follow-up Period Physician Decision	1	0
24-week Treatment-free Follow-up Period Adverse Event	0	1
24-week Treatment-free Follow-up Period Withdrawal by Subject	9	16

Baseline Characteristics

A Study to Compare Tenofovir DF Versus the Combination of Emtricitabine Plus Tenofovir DF for the Treatment of Chronic Hepatitis B in Patients With Normal Alanine Aminotransferase (ALT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tenofovir DF n=64 Participants Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.	FTC+Tenofovir DF n=62 Participants Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.	Total n=126 Participants Total of all reporting groups
Region of Enrollment United Kingdom	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	8 participants n=7 Participants	22 participants n=5 Participants
Age, Continuous	33 years STANDARD_DEVIATION 9.5 • n=5 Participants	33 years STANDARD_DEVIATION 11.2 • n=7 Participants	33 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants n=5 Participants	62 Participants n=7 Participants	126 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	56 participants n=5 Participants	56 participants n=7 Participants	112 participants n=5 Participants
Race/Ethnicity, Customized White	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Black	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Pacific Islander	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Australia	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Canada	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment France	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Germany	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Hong Kong	28 participants n=5 Participants	33 participants n=7 Participants	61 participants n=5 Participants
Region of Enrollment New Zealand	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Poland	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Singapore	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Taiwan	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Hepatitis B Virus (HBV) DNA	9.18 log_10 copies/mL STANDARD_DEVIATION 0.402 • n=5 Participants	9.16 log_10 copies/mL STANDARD_DEVIATION 0.395 • n=7 Participants	9.17 log_10 copies/mL STANDARD_DEVIATION 0.397 • n=5 Participants
Alanine Aminotransferase (ALT)	26.9 U/L STANDARD_DEVIATION 14.05 • n=5 Participants	26.2 U/L STANDARD_DEVIATION 9.88 • n=7 Participants	26.6 U/L STANDARD_DEVIATION 12.13 • n=5 Participants
Hepatitis B e Antigen (HBeAg) Negative	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Hepatitis B e Antigen (HBeAg) Positive	63 participants n=5 Participants	62 participants n=7 Participants	125 participants n=5 Participants
Antibody to HBeAg (Anti-HBe) Negative	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Antibody to HBeAg (Anti-HBe) Positive	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Antibody to HBeAg (Anti-HBe) Missing/Unevaluable	63 participants n=5 Participants	61 participants n=7 Participants	124 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 192

Population: Full Analysis Set: participants who were randomized and received at least one dose of study drug

The percentage of participants with HBV DNA \< 400 copies/mL at Week 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=64 Participants Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.	FTC+Tenofovir DF n=62 Participants Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
Percentage of Participants With HBV DNA < 400 Copies/mL at Week 192	54.7 percentage of participants	75.8 percentage of participants

SECONDARY outcome

Timeframe: Weeks 48, 96, and 144

Population: Full Analysis Set

The percentage of participants with HBV DNA \< 400 copies/mL at Weeks 48, 96, and 144 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=64 Participants Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.	FTC+Tenofovir DF n=62 Participants Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, and 144 Week 48	40.6 percentage of participants	59.7 percentage of participants
Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, and 144 Week 96	53.1 percentage of participants	75.8 percentage of participants
Percentage of Participants With HBV DNA < 400 Copies/mL at Weeks 48, 96, and 144 Week 144	62.5 percentage of participants	80.6 percentage of participants

SECONDARY outcome

Timeframe: Weeks 48, 96, 144, and 192

Population: Full Analysis Set

The percentage of participants with HBV DNA \< 169 copies/mL at Weeks 48, 96, 144, and 192 was analyzed. Participants with missing data were considered to have failed to achieve the criteria for evaluation.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=64 Participants Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.	FTC+Tenofovir DF n=62 Participants Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, and 192 Week 48	29.7 percentage of participants	33.9 percentage of participants
Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, and 192 Week 96	45.3 percentage of participants	64.5 percentage of participants
Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, and 192 Week 144	50.0 percentage of participants	72.6 percentage of participants
Percentage of Participants With HBV DNA < 169 Copies/mL at Weeks 48, 96, 144, and 192 Week 192	45.3 percentage of participants	69.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 48

Population: Participants in the Full Analysis Set with evaluable change data at Week 48 were analyzed.

The change from baseline in HBV DNA at Week 48 was analyzed.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=64 Participants Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.	FTC+Tenofovir DF n=58 Participants Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
Change From Baseline in HBV DNA at Week 48	-6.22 log_10 copies/mL Standard Deviation 0.608	-6.49 log_10 copies/mL Standard Deviation 0.577

SECONDARY outcome

Timeframe: Baseline to Week 96

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

The change from baseline in HBV DNA at Week 96 was analyzed.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=59 Participants Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.	FTC+Tenofovir DF n=56 Participants Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
Change From Baseline in HBV DNA at Week 96	-6.46 log_10 copies/mL Standard Deviation 0.763	-6.55 log_10 copies/mL Standard Deviation 1.176

SECONDARY outcome

Timeframe: Baseline to Week 144

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

The change from baseline in HBV DNA at Week 144 was analyzed.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=55 Participants Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.	FTC+Tenofovir DF n=56 Participants Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
Change From Baseline in HBV DNA at Week 144	-6.66 log_10 copies/mL Standard Deviation 0.655	-6.62 log_10 copies/mL Standard Deviation 1.318

SECONDARY outcome

Timeframe: Baseline to Week 192

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

The change from baseline in HBV DNA at Week 192 was analyzed.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=53 Participants Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.	FTC+Tenofovir DF n=54 Participants Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
Change From Baseline in HBV DNA at Week 192	-6.32 log_10 copies/mL Standard Deviation 1.463	-6.70 log_10 copies/mL Standard Deviation 0.913

SECONDARY outcome

Timeframe: Weeks 48, 96, 144, and 192

Population: Full Analysis Set

Range of normal ALT was 6 to 34 U/L for females, 6 to 43 U/L for males. Participants with missing data were considered to have failed to achieve the criteria for evaluation.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=64 Participants Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.	FTC+Tenofovir DF n=62 Participants Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
Number of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 96, 144, and 192 Week 48	52 participants	54 participants
Number of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 96, 144, and 192 Week 96	52 participants	50 participants
Number of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 96, 144, and 192 Week 144	51 participants	46 participants
Number of Participants With Normal Alanine Aminotransferase (ALT) at Weeks 48, 96, 144, and 192 Week 192	41 participants	44 participants

SECONDARY outcome

Timeframe: Weeks 48, 96, 144, and 192

Population: Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed.

The number of participants with HBeAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. No statistical analysis is presented for Week 48 because no participants met the criteria at that time point.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=63 Participants Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.	FTC+Tenofovir DF n=62 Participants Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48, 96, 144, and 192 Week 48	0 participants	0 participants
Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48, 96, 144, and 192 Week 96	2 participants	0 participants
Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48, 96, 144, and 192 Week 144	4 participants	0 participants
Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Weeks 48, 96, 144, and 192 Week 192	4 participants	1 participants

SECONDARY outcome

Timeframe: Weeks 48, 96, 144, and 192

Population: Participants in the Full Analysis Set who were HBeAg positive at baseline were analyzed.

The number of participants with seroconversion to anti-HBe at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBe was defined as change of detectable antibody to HBeAg from negative to positive. No statistical analysis is presented for Week 48 because no participants met the criteria at that time point.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=63 Participants Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.	FTC+Tenofovir DF n=62 Participants Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
Number of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, and 192 Week 48	0 participants	0 participants
Number of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, and 192 Week 96	2 participants	0 participants
Number of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, and 192 Week 144	4 participants	0 participants
Number of Participants With Seroconversion to Antibody Against HBeAg (Anti-HBe) at Weeks 48, 96, 144, and 192 Week 192	3 participants	0 participants

SECONDARY outcome

Timeframe: Weeks 48, 96, 144, and 192

Population: Full Analysis Set

The number of participants with HBsAg loss at Weeks 48, 96, 144, and 192 was analyzed. Loss of HBsAg was defined as change of detectable HBsAg from positive to negative.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=64 Participants Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.	FTC+Tenofovir DF n=62 Participants Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, and 192 Week 192	0 participants	0 participants
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, and 192 Week 48	0 participants	0 participants
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, and 192 Week 96	0 participants	0 participants
Number of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Weeks 48, 96, 144, and 192 Week 144	0 participants	0 participants

SECONDARY outcome

Timeframe: Weeks 48, 96, 144, and 192

Population: Full Analysis Set

The number of participants with seroconversion to anti-HBs at Weeks 48, 96, 144, and 192 was analyzed. Seroconversion to anti-HBs was defined as change of detectable antibody to HBsAg from negative to positive.

Outcome measures

Outcome measures
Measure	Tenofovir DF n=64 Participants Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.	FTC+Tenofovir DF n=62 Participants Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
Number of Participants With Seroconversion to Antibody to HBsAg (Anti-HBs) at Weeks 48, 96, 144, and 192 Week 48	0 participants	0 participants
Number of Participants With Seroconversion to Antibody to HBsAg (Anti-HBs) at Weeks 48, 96, 144, and 192 Week 96	0 participants	0 participants
Number of Participants With Seroconversion to Antibody to HBsAg (Anti-HBs) at Weeks 48, 96, 144, and 192 Week 144	0 participants	0 participants
Number of Participants With Seroconversion to Antibody to HBsAg (Anti-HBs) at Weeks 48, 96, 144, and 192 Week 192	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline to Week 192

Population: Genotyping was attempted for all participants with HBV DNA ≥ 400 copies/mL at Week 48, 96, 144, 192 and/or the early discontinuation visit, and for all participants (with HBV DNA ≥ 400 copies/mL) after Week 192 who were on study for at least 216 weeks when the last participant reached Week 192.

The development of HBV resistance mutations (occurrence of conserved site changes and/or polymorphic site changes) was analyzed for the overall study period (through Week 192).

Outcome measures

Outcome measures
Measure	Tenofovir DF n=40 Participants Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.	FTC+Tenofovir DF n=29 Participants Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
Occurrence of HBV Resistance Mutations Conserved (with/without polymorphic) site changes	6 participants	5 participants
Occurrence of HBV Resistance Mutations Polymorphic site changes only	16 participants	9 participants

Adverse Events

Tenofovir DF (Treatment Period)

Serious events: 6 serious events

Other events: 41 other events

Deaths: 0 deaths

FTC+Tenofovir DF (Treatment Period)

Serious events: 3 serious events

Other events: 39 other events

Deaths: 0 deaths

Tenofovir DF (24-week Treatment-free Follow-up Period)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

FTC+Tenofovir DF (24-week Treatment-free Follow-up Period)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tenofovir DF (Treatment Period) n=64 participants at risk Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily. Adverse events (AEs) for this reporting group are reported for the entire treatment period.	FTC+Tenofovir DF (Treatment Period) n=62 participants at risk Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily. AEs for this reporting group are reported for the entire treatment period.	Tenofovir DF (24-week Treatment-free Follow-up Period) n=26 participants at risk This reporting group includes participants randomized to the Tenofovir DF group who permanently discontinued study drug on or before the last subject reached Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first. AEs reported for this reporting group are those that occurred during the 24-week treatment-free follow-up period only.	FTC+Tenofovir DF (24-week Treatment-free Follow-up Period) n=29 participants at risk This reporting group includes participants randomized to the FTC+Tenofovir DF group who permanently discontinued study drug on or before the last subject reached Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first. AEs reported for this reporting group are those that occurred during the 24-week treatment-free follow-up period only.
Infections and infestations Urinary tract infection	1.6% 1/64 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	1.6% 1/62 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/26 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/29 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.
Infections and infestations Appendicitis	1.6% 1/64 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/62 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/26 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/29 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.
Infections and infestations Gastroenteritis	1.6% 1/64 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/62 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/26 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/29 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.
Infections and infestations Hepatitis B	1.6% 1/64 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/62 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/26 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/29 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.
Investigations Blood creatine phosphokinase increased	1.6% 1/64 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/62 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/26 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/29 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	1.6% 1/64 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/62 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/26 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/29 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/64 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	1.6% 1/62 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/26 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/29 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/64 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	1.6% 1/62 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/26 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.	0.00% 0/29 • Baseline until the last participant reached Week 192, and 24-week treatment-free follow-up. Treatment-emergent adverse events were collected until the last participant reached Week 192. Adverse events were also collected for those participants who permanently discontinued study drug on or before Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.

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