Hepatitis C Virus Infection
Conditions
Brief summary
The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan.
Interventions
DRUGLDV/SOF
90/400 mg FDC tablet administered orally once daily
Sponsors
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Individuals ≥ 40 kg in weight with chronic genotype 1 or 2 HCV and HBV coinfection * Individuals must not be taking or requiring treatment with HBV antiviral therapy at screening. For participants that are HBV treatment experienced, the most recent treatment must have been completed at least 6 months prior to Day 1. * Cirrhosis determination by Fibroscan * Screening laboratory values within defined thresholds * Use of two effective contraception methods if female or male is of childbearing potential Key
Exclusion criteria
* Current or prior history of clinically-significant illness or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol * Pregnant or nursing female * Infection with human immunodeficiency virus (HIV) or hepatitis delta virus (HDV) * Hepatocellular carcinoma (HCC) or other malignancy * Current or prior history of clinical hepatic decompensation Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | Posttreatment Week 12 | SVR12 was defined as HCV RNA \< the lower limit of quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment. |
| Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug | First dose date up to 12 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 | Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 | LLOQ = 15 IU/mL |
| HCV RNA Change From Baseline While on Treatment | Weeks 1, 2, 4, 8, and 12 | — |
| Percentage of Participants With Virologic Failure | First dose date up to Posttreatment Week 12 | Virologic failure was defined as : * Breakthrough (confirmed HCV RNA ≥ LLOQ \[15 IU/mL\] after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or * Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement) |
| Plasma HBV DNA Change From Baseline While on Treatment | Weeks 1, 2, 4, 8, and 12 | — |
| Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | — |
| HBsAg Level Change From Baseline While on Treatment | Weeks 1, 2, 4, 8, and 12 | — |
| Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | Posttreatment Week 4 | SVR4 was defined as HCV RNA \< LLOQ (15 IU/mL) at 4 weeks after stopping study treatment. |
| Serum LOXL-2 Level Change From Baseline While on Treatment | Weeks 1, 2, 4, 8, and 12 | — |
| Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36 | Posttreatment Weeks 4, 12, and 36 | — |
| Percentage of Participants That Required HBV Therapy During the Study | First dose date up to Posttreatment Week 108 | — |
| Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108 | Posttreatment Weeks 12, 60, and 108 | FibroScan is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows: * Presence of cirrhosis = FibroScan result of \> 12.5 kPa * Absence of cirrhosis = FibroScan result of ≤ 12.5 kPa |
| Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study | First dose date up to Posttreatment Week 108 | — |
| HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | — |
| Percentage of Participants With HCV RNA < LLOQ While on Treatment | Weeks 1, 2, 4, 8, and 12 | LLOQ = 15 IU/mL |
Countries
Taiwan
Participant flow
Recruitment details
Participants were enrolled at study sites in Taiwan. The first participant was screened on 22 December 2015. The last study visit occurred on 07 November 2018.
Pre-assignment details
135 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| LDV/SOF FDC LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks. | 111 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Withdrew Consent | 1 |
Baseline characteristics
| Characteristic | LDV/SOF FDC |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 9.3 |
| Cirrhosis status Absence | 93 Participants |
| Cirrhosis status Presence | 18 Participants |
| Fibroscan Score | 9.3 kPa STANDARD_DEVIATION 7.05 |
| HBsAg | 578.6 IU/mL STANDARD_DEVIATION 1113.56 |
| HCV Genotype Genotype 1 | 1 Participants |
| HCV Genotype Genotype 1a | 3 Participants |
| HCV Genotype Genotype 1b | 64 Participants |
| HCV Genotype Genotype 2 | 43 Participants |
| HCV RNA | 5.9 log10 IU/mL STANDARD_DEVIATION 0.73 |
| HCV RNA Category < 800,000 IU/mL | 44 Participants |
| HCV RNA Category ≥ 800,000 IU/mL | 67 Participants |
| Hepatitis B Virus (HBV) DNA | 2.1 log10 IU/mL STANDARD_DEVIATION 0.92 |
| IL28b Status CC | 85 Participants |
| IL28b Status CT | 26 Participants |
| Plasma HBV DNA | 9423.1 IU/mL STANDARD_DEVIATION 69641.9 |
| Race/Ethnicity, Customized Asian | 111 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 99 Participants |
| Race/Ethnicity, Customized Ethnicity Not Permitted | 12 Participants |
| Serum Lysyl Oxidase-Like 2 (LOXL-2) Level | 98 pg/mL STANDARD_DEVIATION 64.4 |
| Sex: Female, Male Female | 69 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 111 |
| other Total, other adverse events | 24 / 111 |
| serious Total, serious adverse events | 4 / 111 |
Outcome results
Primary
Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug
Time frame: First dose date up to 12 weeks
Population: Safety Analysis Set included participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF FDC | Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug | 0.0 percentage of participants |
Primary
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment.
Time frame: Posttreatment Week 12
Population: Full Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LDV/SOF FDC | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | Genotype 1 | 100.0 percentage of participants |
| LDV/SOF FDC | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | Genotype 2 | 100.0 percentage of participants |
| LDV/SOF FDC | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | Total | 100.0 percentage of participants |
Secondary
Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108
FibroScan is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows: * Presence of cirrhosis = FibroScan result of \> 12.5 kPa * Absence of cirrhosis = FibroScan result of ≤ 12.5 kPa
Time frame: Posttreatment Weeks 12, 60, and 108
Population: Participants in Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LDV/SOF FDC | Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108 | Posttreatment Week 12 | 8.0 kPa | Standard Deviation 7.01 |
| LDV/SOF FDC | Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108 | Posttreatment Week 60 | 7.2 kPa | Standard Deviation 4.99 |
| LDV/SOF FDC | Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108 | Posttreatment Week 108 | 7.1 kPa | Standard Deviation 4.79 |
Secondary
HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Time frame: Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Population: Participants in Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LDV/SOF FDC | HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 60 | -0.16 log10 IU/mL | Standard Deviation 0.664 |
| LDV/SOF FDC | HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 72 | -0.20 log10 IU/mL | Standard Deviation 0.619 |
| LDV/SOF FDC | HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 84 | -0.25 log10 IU/mL | Standard Deviation 0.608 |
| LDV/SOF FDC | HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 96 | -0.32 log10 IU/mL | Standard Deviation 0.618 |
| LDV/SOF FDC | HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 108 | -0.37 log10 IU/mL | Standard Deviation 0.658 |
| LDV/SOF FDC | HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 4 | -0.16 log10 IU/mL | Standard Deviation 0.347 |
| LDV/SOF FDC | HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 12 | -0.01 log10 IU/mL | Standard Deviation 0.338 |
| LDV/SOF FDC | HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 24 | -0.02 log10 IU/mL | Standard Deviation 0.405 |
| LDV/SOF FDC | HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 36 | -0.07 log10 IU/mL | Standard Deviation 0.484 |
| LDV/SOF FDC | HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 48 | -0.10 log10 IU/mL | Standard Deviation 0.526 |
Secondary
HBsAg Level Change From Baseline While on Treatment
Time frame: Weeks 1, 2, 4, 8, and 12
Population: Participants in Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LDV/SOF FDC | HBsAg Level Change From Baseline While on Treatment | Change at Week 1 | -0.14 log10 IU/mL | Standard Deviation 0.184 |
| LDV/SOF FDC | HBsAg Level Change From Baseline While on Treatment | Change at Week 2 | -0.18 log10 IU/mL | Standard Deviation 0.181 |
| LDV/SOF FDC | HBsAg Level Change From Baseline While on Treatment | Change at Week 4 | -0.25 log10 IU/mL | Standard Deviation 0.185 |
| LDV/SOF FDC | HBsAg Level Change From Baseline While on Treatment | Change at Week 8 | -0.41 log10 IU/mL | Standard Deviation 0.234 |
| LDV/SOF FDC | HBsAg Level Change From Baseline While on Treatment | Change at Week 12 | -0.47 log10 IU/mL | Standard Deviation 0.266 |
Secondary
HCV RNA Change From Baseline While on Treatment
Time frame: Weeks 1, 2, 4, 8, and 12
Population: Participants in Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LDV/SOF FDC | HCV RNA Change From Baseline While on Treatment | Change at Week 1 | -4.14 log10 IU/mL | Standard Deviation 0.551 |
| LDV/SOF FDC | HCV RNA Change From Baseline While on Treatment | Change at Week 2 | -4.63 log10 IU/mL | Standard Deviation 0.702 |
| LDV/SOF FDC | HCV RNA Change From Baseline While on Treatment | Change at Week 4 | -4.73 log10 IU/mL | Standard Deviation 0.727 |
| LDV/SOF FDC | HCV RNA Change From Baseline While on Treatment | Change at Week 8 | -4.73 log10 IU/mL | Standard Deviation 0.727 |
| LDV/SOF FDC | HCV RNA Change From Baseline While on Treatment | Change at Week 12 | -4.73 log10 IU/mL | Standard Deviation 0.727 |
Secondary
Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study
Time frame: First dose date up to Posttreatment Week 108
Population: Participants in Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF FDC | Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study | 0.0 percentage of participants |
Secondary
Percentage of Participants That Required HBV Therapy During the Study
Time frame: First dose date up to Posttreatment Week 108
Population: Participants in Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF FDC | Percentage of Participants That Required HBV Therapy During the Study | 7.2 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
LLOQ = 15 IU/mL
Time frame: Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
Population: Participants in Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LDV/SOF FDC | Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 | Posttreatment Week 72 | 100 percentage of participants |
| LDV/SOF FDC | Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 | Posttreatment Week 84 | 100 percentage of participants |
| LDV/SOF FDC | Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 | Posttreatment Week 96 | 100 percentage of participants |
| LDV/SOF FDC | Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 | Posttreatment Week 24 | 100 percentage of participants |
| LDV/SOF FDC | Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 | Posttreatment Week 36 | 100 percentage of participants |
| LDV/SOF FDC | Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 | Posttreatment Week 48 | 100 percentage of participants |
| LDV/SOF FDC | Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 | Posttreatment Week 60 | 100 percentage of participants |
| LDV/SOF FDC | Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108 | Posttreatment Week 108 | 100 percentage of participants |
Secondary
Percentage of Participants With HCV RNA < LLOQ While on Treatment
LLOQ = 15 IU/mL
Time frame: Weeks 1, 2, 4, 8, and 12
Population: Participants in Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LDV/SOF FDC | Percentage of Participants With HCV RNA < LLOQ While on Treatment | Week 1 | 33.3 percentage of participants |
| LDV/SOF FDC | Percentage of Participants With HCV RNA < LLOQ While on Treatment | Week 2 | 82.0 percentage of participants |
| LDV/SOF FDC | Percentage of Participants With HCV RNA < LLOQ While on Treatment | Week 4 | 100.0 percentage of participants |
| LDV/SOF FDC | Percentage of Participants With HCV RNA < LLOQ While on Treatment | Week 8 | 100.0 percentage of participants |
| LDV/SOF FDC | Percentage of Participants With HCV RNA < LLOQ While on Treatment | Week 12 | 100.0 percentage of participants |
Secondary
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA \< LLOQ (15 IU/mL) at 4 weeks after stopping study treatment.
Time frame: Posttreatment Week 4
Population: Participants in Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF FDC | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | 100.0 percentage of participants |
Secondary
Percentage of Participants With Virologic Failure
Virologic failure was defined as : * Breakthrough (confirmed HCV RNA ≥ LLOQ \[15 IU/mL\] after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or * Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)
Time frame: First dose date up to Posttreatment Week 12
Population: Participants in Full Analysis Set were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LDV/SOF FDC | Percentage of Participants With Virologic Failure | 0 percentage of participants |
Secondary
Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Time frame: Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108
Population: Participants in Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LDV/SOF FDC | Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 48 | 0.68 log10 IU/mL | Standard Deviation 1.269 |
| LDV/SOF FDC | Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 60 | 0.70 log10 IU/mL | Standard Deviation 1.399 |
| LDV/SOF FDC | Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 72 | 0.55 log10 IU/mL | Standard Deviation 1.131 |
| LDV/SOF FDC | Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 84 | 0.50 log10 IU/mL | Standard Deviation 1.008 |
| LDV/SOF FDC | Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 96 | 0.41 log10 IU/mL | Standard Deviation 0.963 |
| LDV/SOF FDC | Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 4 | 0.49 log10 IU/mL | Standard Deviation 0.727 |
| LDV/SOF FDC | Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 12 | 0.66 log10 IU/mL | Standard Deviation 0.955 |
| LDV/SOF FDC | Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 24 | 0.56 log10 IU/mL | Standard Deviation 1.036 |
| LDV/SOF FDC | Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 36 | 0.67 log10 IU/mL | Standard Deviation 1.19 |
| LDV/SOF FDC | Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108 | Change at Posttreatment Week 108 | 0.38 log10 IU/mL | Standard Deviation 0.923 |
Secondary
Plasma HBV DNA Change From Baseline While on Treatment
Time frame: Weeks 1, 2, 4, 8, and 12
Population: Participants in Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LDV/SOF FDC | Plasma HBV DNA Change From Baseline While on Treatment | Change at Week 4 | 0.37 log10 IU/mL | Standard Deviation 0.705 |
| LDV/SOF FDC | Plasma HBV DNA Change From Baseline While on Treatment | Change at Week 1 | -0.06 log10 IU/mL | Standard Deviation 0.237 |
| LDV/SOF FDC | Plasma HBV DNA Change From Baseline While on Treatment | Change at Week 2 | 0.08 log10 IU/mL | Standard Deviation 0.366 |
| LDV/SOF FDC | Plasma HBV DNA Change From Baseline While on Treatment | Change at Week 8 | 0.51 log10 IU/mL | Standard Deviation 0.906 |
| LDV/SOF FDC | Plasma HBV DNA Change From Baseline While on Treatment | Change at Week 12 | 0.24 log10 IU/mL | Standard Deviation 0.746 |
Secondary
Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36
Time frame: Posttreatment Weeks 4, 12, and 36
Population: Participants in Full Analysis Set were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LDV/SOF FDC | Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36 | Change at Posttreatment Week 4 | -30 pg/mL | Standard Deviation 45 |
| LDV/SOF FDC | Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36 | Change at Posttreatment Week 12 | -32 pg/mL | Standard Deviation 51.8 |
| LDV/SOF FDC | Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36 | Change at Posttreatment Week 36 | -41 pg/mL | Standard Deviation 53 |
Secondary
Serum LOXL-2 Level Change From Baseline While on Treatment
Time frame: Weeks 1, 2, 4, 8, and 12
Population: Participants in Full Analysis Set with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LDV/SOF FDC | Serum LOXL-2 Level Change From Baseline While on Treatment | Change at Week 1 | -2 pg/mL | Standard Deviation 29.4 |
| LDV/SOF FDC | Serum LOXL-2 Level Change From Baseline While on Treatment | Change at Week 2 | -6 pg/mL | Standard Deviation 26.9 |
| LDV/SOF FDC | Serum LOXL-2 Level Change From Baseline While on Treatment | Change at Week 4 | -15 pg/mL | Standard Deviation 27.8 |
| LDV/SOF FDC | Serum LOXL-2 Level Change From Baseline While on Treatment | Change at Week 8 | -22 pg/mL | Standard Deviation 36.6 |
| LDV/SOF FDC | Serum LOXL-2 Level Change From Baseline While on Treatment | Change at Week 12 | -27 pg/mL | Standard Deviation 36 |