Study to Evaluate Efficacy and Safety of Switching From T... | NCT02979613

ID	Type	Description	Link
2016-003632-20	EudraCT Number

Label	Type	Description	Intervention Names
TAF 25 mg	Experimental	Double-blind (DB) phase: TAF 25 mg + TDF placebo for up to 53 weeks. Open-label extension (OLE) phase: TAF 25 mg for up to 52 weeks.	Drug: TAF Drug: TDF Placebo
TDF 300 mg	Active Comparator	DB phase: TDF 300 mg + TAF placebo for up to 50 weeks. OLE phase: TAF 25 mg for up to 52 weeks.	Drug: TAF Drug: TDF Drug: TAF Placebo

Name	Type	Description	Arm Group Labels	Other Names
TAF	Drug	25 mg tablet administered orally once daily	TAF 25 mg TDF 300 mg

Measure	Description	Time Frame
Percentage of Participants With Hepatitis B Virus (HBV) DNA Levels ≥ 20 IU/mL at Week 48, as Determined by the Modified United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm	The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who: Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 48 analysis window (from Day 295 to Day 378, inclusive), or Did not have on-treatment HBV DNA data available in the Week 48 analysis window and Discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or Discontinued study drug prior to or in the Week 48 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL	Week 48

Measure	Description	Time Frame
Percentage of Participants With HBV DNA Levels ≥ 20 IU/mL at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm	The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 96 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who: Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 96 analysis window (from Day 589 to Day 840, inclusive), or Did not have on-treatment HBV DNA data available in the Week 96 analysis window and Discontinued study drug prior to or in the Week 96 analysis window due to lack of efficacy, or Discontinued study drug prior to or in the Week 96 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

PubMed Identifier	Type	Citation	Retractions
32087795	Result	Lampertico P, Buti M, Fung S, Ahn SH, Chuang WL, Tak WY, Ramji A, Chen CY, Tam E, Bae H, Ma X, Flaherty JF, Gaggar A, Lau A, Liu Y, Wu G, Suri V, Tan SK, Subramanian GM, Trinh H, Yoon SK, Agarwal K, Lim YS, Chan HLY. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. Lancet Gastroenterol Hepatol. 2020 May;5(5):441-453. doi: 10.1016/S2468-1253(19)30421-2. Epub 2020 Feb 20.

ID	Title	Description
FG000	TAF 25 mg	Participants who were virologically suppressed and taking tenofovir disoproxil fumarate (TDF) 300 mg tablet orally once daily received tenofovir alafenamide (TAF) 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the double-blind (DB) phase. Participants who completed DB treatment and were willing to enter in the open-label extension (OLE) phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol: Original	Sep 30, 2016	Jul 21, 2019

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 Hepatitis B Virus (HBV) DNA Levels ≥ 20 IU/mL at Week 48, as Determined by the Modified United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm

The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:

Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 48 analysis window (from Day 295 to Day 378, inclusive), or
Did not have on-treatment HBV DNA data available in the Week 48 analysis window and
- Discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or
- Discontinued study drug prior to or in the Week 48 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL

The Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Units	Counts
Participants	OG000243 OG001245

Title

Denominators

Categories

Title	Measurements
	OG0000.4 OG0010.4

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	The null hypothesis was that the TAF group is at least 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48.					Difference in the Percentages	0.0			2-Sided	95	-1.9	2.0			Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted Mantel-Haenszel (MH) percentage, adjusted by baseline age groups (< 50, ≥ 50 years) and baseline HBeAg status strata.

Secondary

Percentage of Participants With HBV DNA Levels ≥ 20 IU/mL at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm

The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 96 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:

Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 96 analysis window (from Day 589 to Day 840, inclusive), or
Did not have on-treatment HBV DNA data available in the Week 96 analysis window and
- Discontinued study drug prior to or in the Week 96 analysis window due to lack of efficacy, or
- Discontinued study drug prior to or in the Week 96 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL

Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 48

Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Weeks 48

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 48

The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 48, was handled by M = F, and Missing=Excluded (M = E) approaches.

Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 96

Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 96

The percentage of participants with HBV DNA < 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 96, was handled by Missing=Failure (M = F), and Missing=Excluded (M = E) approaches.

Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 48

HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis.

The Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion included all participants who were randomized and received at least 1 dose of study drug and were HBeAg-positive and HBeAb-negative or had a missing value at baseline. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percentage of Participants With HBeAg Seroconversion at Week 48

HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.

Participants in the Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percentage of Participants With HBeAg Loss at Week 96

HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis.

Participants in the Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percentage of Participants With HBeAg Seroconversion at Week 96

HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.

Participants in the Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48

HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis.

The Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion included all participants who were randomized and received at least 1 dose of study drug and were HBsAg-positive and HBsAb-negative or had a missing value at baseline. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percentage of Participants With HBsAg Seroconversion at Week 48

HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.

Participants in the Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percentage of Participants With HBsAg Loss at Week 96

HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis.

Participants in the Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percentage of Participants With HBsAg Seroconversion at Week 96

HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.

Participants in the Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48 (by Central Laboratory and the American Association for the Study of Liver Diseases [AASLD] Criteria)

Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.

Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percentage of Participants With Normalized ALT at Week 48 (by Central Laboratory and AASLD Criteria)

ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.

Participants in the Full Analysis Set with Baseline ALT > ULN were analyzed. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percentage of Participants With Normal ALT at Week 96 (by Central Laboratory and the AASLD Criteria)

Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percentage of Participants With Normalized ALT at Week 96 (by Central Laboratory and AASLD Criteria)

Participants in the Full Analysis Set with Baseline ALT > ULN were analyzed. Participants were analyzed according to the treatment to which they were randomized.

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Change From Baseline in FibroTest® Score at Week 48

The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 48 minus the value at Baseline.

Participants in the Full Analysis Set with available data were analyzed. Participants were analyzed according to the treatment to which they were randomized.

Posted

Mean

Standard Deviation

scores on a scale

Baseline; Week 48

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Change From Baseline in FibroTest® Score at Week 96

Participants in the Full Analysis Set with available data were analyzed. Participants were analyzed according to the treatment to which they were randomized.

Posted

Mean

Standard Deviation

scores on a scale

Baseline; Week 96

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.

Participants in the Hip DXA Analysis Set (included all participants who were randomized into the study, received at least 1 dose of study drug, and had non-missing baseline hip BMD values) with available data were analysed. Participants were analyzed according to the treatment they actually received.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 48

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percent Change From Baseline in Hip BMD at Week 96

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.

Participants in the Hip DXA Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 96

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Units	Counts

Secondary

Percent Change From Baseline in Spine BMD at Week 48

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.

Participants in the Spine DXA Analysis Set (included all participants who were randomized into the study, received at least 1 dose of study drug, and had non-missing baseline spine BMD values) with available data were analysed. Participants were analyzed according to the treatment they actually received.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 48

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Percent Change From Baseline in Spine BMD at Week 96

Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.

Participants in the Spine DXA Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 96

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Units	Counts

Secondary

Change From Baseline in Estimated Glomerular Filtration Rate Calculated Using the Cockcroft-Gault Equation (eGFR-CG) at Week 48

Cockcroft-Gault formula is as follows:

For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)
For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).

Change from baseline was calculated as the value at Week 48 minus the value at Baseline.

Participants in the Safety Analysis Set (included all randomized participants who received at least 1 dose of study drug) with available data were analyzed. Participants were analyzed according to the treatment they actually received.

Posted

Median

Inter-Quartile Range

mL/min

Baseline; Week 48

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

Secondary

Change From Baseline in eGFR-CG at Week 96

Cockcroft-Gault formula is as follows:

For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)
For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).

Change from baseline was calculated as the value at Week 96 minus the value at Baseline.

Participants in the Safety Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received.

Posted

Median

Inter-Quartile Range

mL/min

Baseline; Week 96

ID	Title	Description
OG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
OG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.

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

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	TAF 25 mg	Adverse events reported in this group occurred during the DB phase. Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase.	0	243	11	243	31	243
EG001	TDF 300 mg	Adverse events reported in this group occurred during the DB phase. Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase.	0	245	3	245	28	245
EG002	OLE TAF 25 mg From TAF 25 mg	Adverse events reported in this group occurred during the OLE phase. Participants who completed TAF treatment in the DB phase and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.	0	235	8	235	15	235
EG003	OLE TAF 25 mg From TDF 300 mg	Adverse events reported in this group occurred during the OLE phase. Participants who completed TDF treatment in the DB phase and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.	1	237	5	237	15	237

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG0031 affected237 at risk
Angina pectoris	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG003
Pancreatic mass	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected243 at risk EG0010 affected245 at risk EG0021 affected235 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected243 at risk EG0010 affected245 at risk EG0021 affected235 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected243 at risk EG0011 affected245 at risk EG0020 affected235 at risk EG003
Necrotising fasciitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected243 at risk EG0010 affected245 at risk EG0021 affected235 at risk EG003
Pneumonia necrotising	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG003
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG003
Tendon injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected243 at risk EG0010 affected245 at risk EG0021 affected235 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 affected243 at risk EG0011 affected245 at risk EG0022 affected235 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG003
Lung squamous cell carcinoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 affected243 at risk EG0010 affected245 at risk EG0021 affected235 at risk EG003
Testicular neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG003
Bipolar I disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG003
Homicidal ideation	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG003
Calculus bladder	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG003
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected243 at risk EG0010 affected245 at risk EG0020 affected235 at risk EG003
Prostatitis	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected243 at risk EG0010 affected245 at risk EG0021 affected235 at risk EG003
Varicose vein	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected243 at risk EG0011 affected245 at risk EG0020 affected235 at risk EG003

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment		EG00018 affected243 at risk EG00116 affected245 at risk EG00211 affected235 at risk EG00312 affected237 at risk
Nasopharyngitis	Infections and infestations	MedDRA 22.1	Systematic Assessment		EG00013 affected243 at risk EG00112 affected245 at risk EG0024 affected235 at risk EG003

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	Title	Description
BG000	TAF 25 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
BG001	TDF 300 mg	Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.
BG002	Total	Total of all reporting groups

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