Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB)
Sponsor
Gilead Sciences (Industry)
Overall Status
Terminated
CT.gov ID
NCT03434353
Collaborator
F-star Therapeutics, Inc. (Industry)
123
13
5
34.9
9.5
0.3
Study Details
Study Description
Brief Summary
The primary objectives of this study are to evaluate the safety and tolerability of the 12 week treatment regimens of inarigivir soproxil plus tenofovir alafenamide (TAF) or commercially available nucleoside/nucleotide (NUC) in adults with chronic hepatitis B (CHB), to evaluate the antiviral activity of 12 weeks of inarigivir soproxil plus TAF versus TAF alone in viremic CHB participants (Groups 1-3, 5), and to evaluate the antiviral activity of 12 weeks of inarigivir soproxil with commercially available NUC(s) in virally suppressed CHB participants (Group 4).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
123 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Open-Label, Active-Controlled Study to Evaluate the Safety and Antiviral Activity of GS-9992 Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Chronic Hepatitis B (CHB) Subjects
Actual Study Start Date
:
Feb 28, 2018
Actual Primary Completion Date
:
Jan 20, 2020
Actual Study Completion Date
:
Jan 26, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1: Inarigivir Soproxil 50 mg + TAF Viremic participants will be administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. |
Drug: Inarigivir Soproxil
Administered orally once daily one hour before or one hour after a meal
Other Names:
Drug: TAF
Administered orally once daily with food
Other Names:
|
| Experimental: Group 2: TAF Viremic participants will be administered TAF 25 mg tablet once daily orally with food for 48 weeks. |
Drug: TAF
Administered orally once daily with food
Other Names:
|
| Experimental: Group 3: Inarigivir Soproxil 200 mg + TAF Viremic participants will be administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks |
Drug: Inarigivir Soproxil
Administered orally once daily one hour before or one hour after a meal
Other Names:
Drug: TAF
Administered orally once daily with food
Other Names:
|
| Experimental: Group 4: Inarigivir Soproxil 100 mg + commercially available NUCs Virally suppressed participants receiving commercially available nucleoside/nucleotide (NUC) will be administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants will continue commercially available NUCs for 48 weeks. |
Drug: Inarigivir Soproxil
Administered orally once daily one hour before or one hour after a meal
Other Names:
|
| Experimental: Group 5: Inarigivir Soproxil 400 mg + TAF Viremic participants will be administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks. |
Drug: Inarigivir Soproxil
Administered orally once daily one hour before or one hour after a meal
Other Names:
Drug: TAF
Administered orally once daily with food
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1-3 and 5) [Baseline, Week 12]
- Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4) [Baseline, Week 12]
Secondary Outcome Measures
- Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1 Through 3 and 5) [Baseline, Week 12]
- Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4) [Baseline, Week 12]
- Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5) [Baseline, Weeks 12, 24, 36, and 48]
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. HBeAg seroconversion was defined as HBeAb changing from negative or missing at baseline to positive at any postbaseline visit. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.
- Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Group 4) [Baseline, Weeks 12, 24, 36, and 48]
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. HBeAg seroconversion was defined as HBeAb changing from negative or missing at baseline to positive at any postbaseline visit. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion.
- Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5) [Baseline, Weeks 12, 24, 36, and 48]
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. Participants who had missing information were assumed to have no HBeAg loss.
- Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Group 4) [Baseline, Weeks 12, 24, 36, and 48]
HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit.
- Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Had HBV DNA ≥ 69 IU/mL (Groups 1 Through 3 and 5) [Baseline, Week 48]
- Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During 12 Weeks of Inarigivir Soproxil Treatment (Group 4) [Baseline up to Week 12]
Virologic breakthrough was defined as HBV deoxyribonucleic acid (DNA) ≥69 IU/mL for 2 consecutive visits
- Change From Baseline in HBV DNA at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5) [Baseline, Weeks 12, 16, 24, 36, and 48]
- Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5) [Baseline, Weeks 12, 16, 24, 36, and 48]
- Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Group 4) [Baseline, Weeks 12, 16, 24, 36, and 48]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Groups 1-3 and 5:
-
Individuals not taking any prescribed hepatitis B virus (HBV) NUC treatment
-
Group 4:
-
HBV deoxyribonucleic acid (DNA) ≤ 20 IU/mL at Screening by Central Lab.
-
Have been on a commercially available HBV NUC treatment(s)
Key Exclusion Criteria:
-
Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV).
-
Extensive bridging fibrosis or cirrhosis
-
Evidence of hepatocellular carcinoma on imaging
-
Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage).
-
Chronic liver disease of a non-HBV etiology
-
Current alcohol or substance abuse
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alice Ho Miu Ling Nethersole Hospital | Hong Kong | Hong Kong | ||
| 2 | Prince Margaret Hospital | Hong Kong | Hong Kong | ||
| 3 | Prince of Wales Hospital-HK | Hong Kong | Hong Kong | ||
| 4 | Korea University Ansan Hospital | Ansan | Korea, Republic of | 425-707 | |
| 5 | Keimyung University Dongsan Medical Center | Daegu | Korea, Republic of | 41931 | |
| 6 | Kyungpook National University Hospital | Daegu | Korea, Republic of | 41944 | |
| 7 | Inje University Ilsan Paik Hospital | Ilsan | Korea, Republic of | 10380 | |
| 8 | Severance Hospital, Yonsei University Health System | Seoul | Korea, Republic of | 03722 | |
| 9 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
| 10 | Gangnam Severance Hospital, Yonsei University Health System | Seoul | Korea, Republic of | 06273 | |
| 11 | Catholic University of Korea, Seoul Saint Mary's Hospital | Seoul | Korea, Republic of | 06591 | |
| 12 | SMG-SNU Boramae Medical Center | Seoul | Korea, Republic of | 07061 | |
| 13 | Korea University Guro Hospital | Seoul | Korea, Republic of | 08308 |
Sponsors and Collaborators
- Gilead Sciences
- F-star Therapeutics, Inc.
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT03434353
Other Study ID Numbers:
- GS-US-464-4437
First Posted:
Feb 15, 2018
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled at study sites in Hong Kong and South Korea. The first participant was screened on 28 February 2018. The last study visit occurred on 26 January 2021. |
|---|---|
| Pre-assignment Detail | 161 participants were screened. |
| Arm/Group Title | Group 1: Inarigivir Soproxil 50 mg + TAF | Group 2: TAF | Group 3: Inarigivir Soproxil 200 mg + TAF | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) | Group 5: Inarigivir Soproxil 400 mg + TAF |
|---|---|---|---|---|---|
| Arm/Group Description | Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus tenofovir alafenamide (TAF) 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks. | Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Virally suppressed participants who were receiving commercially available nucleoside/nucleotide (NUC[s]) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks. | Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks. |
| Period Title: Overall Study | |||||
| STARTED | 30 | 12 | 30 | 21 | 30 |
| COMPLETED | 16 | 9 | 16 | 18 | 12 |
| NOT COMPLETED | 14 | 3 | 14 | 3 | 18 |
Baseline Characteristics
| Arm/Group Title | Group 1: Inarigivir Soproxil 50 mg + TAF | Group 2: TAF | Group 3: Inarigivir Soproxil 200 mg + TAF | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) | Group 5: Inarigivir Soproxil 400 mg + TAF | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks. | Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Virally suppressed participants who were receiving NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks. | Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks. | Total of all reporting groups |
| Overall Participants | 30 | 12 | 30 | 21 | 30 | 123 |
| Age, Customized (Count of Participants) | ||||||
| <50 years |
23
76.7%
|
5
41.7%
|
19
63.3%
|
11
52.4%
|
13
43.3%
|
71
57.7%
|
| ≥50 years |
7
23.3%
|
7
58.3%
|
11
36.7%
|
10
47.6%
|
17
56.7%
|
52
42.3%
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
12
40%
|
3
25%
|
11
36.7%
|
9
42.9%
|
11
36.7%
|
46
37.4%
|
| Male |
18
60%
|
9
75%
|
19
63.3%
|
12
57.1%
|
19
63.3%
|
77
62.6%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
30
100%
|
12
100%
|
30
100%
|
21
100%
|
30
100%
|
123
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
30
100%
|
12
100%
|
30
100%
|
21
100%
|
30
100%
|
123
100%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||||
| Hong Kong |
8
26.7%
|
5
41.7%
|
22
73.3%
|
11
52.4%
|
30
100%
|
76
61.8%
|
| South Korea |
22
73.3%
|
7
58.3%
|
8
26.7%
|
10
47.6%
|
0
0%
|
47
38.2%
|
| Hepatitis B Surface Antigen (HBsAg) Category (Count of Participants) | ||||||
| ≤ 4 log10 IU/mL |
16
53.3%
|
4
33.3%
|
23
76.7%
|
19
90.5%
|
21
70%
|
83
67.5%
|
| > 4 log10 IU/mL |
14
46.7%
|
8
66.7%
|
7
23.3%
|
2
9.5%
|
9
30%
|
40
32.5%
|
Outcome Measures
| Title | Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1-3 and 5) |
|---|---|
| Description | |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set included all participants who were randomized to Groups 1 or 2, or enrolled in Group 3 and 5, and who took at least 1 dose of any study drug. |
| Arm/Group Title | Group 1: Inarigivir Soproxil 50 mg + TAF | Group 2: TAF | Group 3: Inarigivir Soproxil 200 mg + TAF | Group 5: Inarigivir Soproxil 400 mg + TAF |
|---|---|---|---|---|
| Arm/Group Description | Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks. | Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks. |
| Measure Participants | 30 | 12 | 30 | 30 |
| Number (95% Confidence Interval) [percentage of participants] |
23.3
77.7%
|
25.0
208.3%
|
0
0%
|
6.7
31.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Inarigivir Soproxil 50 mg + TAF, Group 2: TAF |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | -2.0 | |
| Confidence Interval |
(2-Sided) 95% -30.4 to 26.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The percentage difference (Group 1 - Group 2) & corresponding 2-sided 95% confidence interval (CI) were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline hepatitis B e antigen (HBeAg) status (positive,negative). | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 2: TAF, Group 3: Inarigivir Soproxil 200 mg + TAF |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | -24.7 | |
| Confidence Interval |
(2-Sided) 95% -49.2 to -0.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The percentage difference (Group 3 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative). | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group 2: TAF, Group 5: Inarigivir Soproxil 400 mg + TAF |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | -17.8 | |
| Confidence Interval |
(2-Sided) 95% -43.7 to 8.2 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The percentage difference (Group 5 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative). | |
| Title | Percentage of Participants With ≥ 0.5 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4) |
|---|---|
| Description | |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Full Analysis Set (Group 4) included all participants who were enrolled in Group 4, and who took at least 1 dose of any study drug. |
| Arm/Group Title | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) |
|---|---|
| Arm/Group Description | Virally suppressed participants who were receiving commercially available NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks. |
| Measure Participants | 21 |
| Number (95% Confidence Interval) [percentage of participants] |
0
0%
|
| Title | Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Groups 1 Through 3 and 5) |
|---|---|
| Description | |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set (Group 1-3 and 5) were analyzed. |
| Arm/Group Title | Group 1: Inarigivir Soproxil 50 mg + TAF | Group 2: TAF | Group 3: Inarigivir Soproxil 200 mg + TAF | Group 5: Inarigivir Soproxil 400 mg + TAF |
|---|---|---|---|---|
| Arm/Group Description | Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks. | Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks. |
| Measure Participants | 30 | 12 | 30 | 30 |
| Number (95% Confidence Interval) [percentage of participants] |
0
0%
|
16.7
139.2%
|
0
0%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Inarigivir Soproxil 50 mg + TAF, Group 2: TAF |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | -16.6 | |
| Confidence Interval |
(2-Sided) 95% -37.7 to 4.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The percentage difference (Group 1 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative). | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 2: TAF, Group 3: Inarigivir Soproxil 200 mg + TAF |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | -16.9 | |
| Confidence Interval |
(2-Sided) 95% -38.1 to 4.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The percentage difference (Group 3 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative). | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group 2: TAF, Group 5: Inarigivir Soproxil 400 mg + TAF |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Percentage Difference |
| Estimated Value | -16.7 | |
| Confidence Interval |
(2-Sided) 95% -37.9 to 4.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The percentage difference (Group 5 - Group 2) and the corresponding 2-sided 95% CI were calculated by using stratum-adjusted Mantel-Haenszel proportions, stratified by baseline HBeAg status (positive, negative). | |
| Title | Percentage of Participants With ≥ 1 log10 IU/mL Decline in HBsAg From Baseline at Week 12 (Group 4) |
|---|---|
| Description | |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set (Group 4) were analyzed. |
| Arm/Group Title | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) |
|---|---|
| Arm/Group Description | Virally suppressed participants who were receiving commercially available NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks. |
| Measure Participants | 21 |
| Number (95% Confidence Interval) [percentage of participants] |
0
0%
|
| Title | Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5) |
|---|---|
| Description | HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. HBeAg seroconversion was defined as HBeAb changing from negative or missing at baseline to positive at any postbaseline visit. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion. |
| Time Frame | Baseline, Weeks 12, 24, 36, and 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set (Group 1-3 and 5) with HBeAg-positive status at baseline were analyzed. |
| Arm/Group Title | Group 1: Inarigivir Soproxil 50 mg + TAF | Group 2: TAF | Group 3: Inarigivir Soproxil 200 mg + TAF | Group 5: Inarigivir Soproxil 400 mg + TAF |
|---|---|---|---|---|
| Arm/Group Description | Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks. | Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks. |
| Measure Participants | 18 | 7 | 14 | 16 |
| Week 12 |
5.6
18.7%
|
0
0%
|
0
0%
|
0
0%
|
| Week 24 |
5.6
18.7%
|
0
0%
|
0
0%
|
0
0%
|
| Week 36 |
5.6
18.7%
|
0
0%
|
0
0%
|
0
0%
|
| Week 48 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Percentage of HBeAg-positive Participants Who Achieved HBeAg Loss and Seroconversion at Weeks 12, 24, 36, and 48 (Group 4) |
|---|---|
| Description | HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. HBeAg seroconversion was defined as HBeAb changing from negative or missing at baseline to positive at any postbaseline visit. Participants who had missing information were assumed to have no HBeAg loss and no HBeAg seroconversion. |
| Time Frame | Baseline, Weeks 12, 24, 36, and 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set (Group 4) with HBeAg-positive status at baseline were analyzed. |
| Arm/Group Title | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) |
|---|---|
| Arm/Group Description | Virally suppressed participants who were receiving commercially available NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks. |
| Measure Participants | 7 |
| Week 12 |
14.3
47.7%
|
| Week 24 |
14.3
47.7%
|
| Week 36 |
14.3
47.7%
|
| Week 48 |
14.3
47.7%
|
| Title | Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Groups 1 Through 3 and 5) |
|---|---|
| Description | HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. Participants who had missing information were assumed to have no HBeAg loss. |
| Time Frame | Baseline, Weeks 12, 24, 36, and 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set (Groups 1 through 3 and 5) were analyzed. |
| Arm/Group Title | Group 1: Inarigivir Soproxil 50 mg + TAF | Group 2: TAF | Group 3: Inarigivir Soproxil 200 mg + TAF | Group 5: Inarigivir Soproxil 400 mg + TAF |
|---|---|---|---|---|
| Arm/Group Description | Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks. | Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks. |
| Measure Participants | 30 | 12 | 30 | 30 |
| Week 12 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 24 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 36 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Week 48 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Percentage of Participants Who Achieved HBsAg Loss at Weeks 12, 24, 36, and 48 (Group 4) |
|---|---|
| Description | HBeAg loss was defined as qualitative HBeAg result changing from positive at baseline to negative at post-baseline visit. |
| Time Frame | Baseline, Weeks 12, 24, 36, and 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set (Group 4) were analyzed. |
| Arm/Group Title | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) |
|---|---|
| Arm/Group Description | Virally suppressed participants who were receiving commercially available NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks. |
| Measure Participants | 21 |
| Week 12 |
0
0%
|
| Week 24 |
0
0%
|
| Week 36 |
0
0%
|
| Week 48 |
0
0%
|
| Title | Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Had HBV DNA ≥ 69 IU/mL (Groups 1 Through 3 and 5) |
|---|---|
| Description | |
| Time Frame | Baseline, Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with at least 12 weeks and 48 weeks of exposure to inarigivir soproxil and TAF, respectively, and with HBV DNA ≥ 69 IU/mL at Week 48 or Early Discontinuation were analyzed. |
| Arm/Group Title | Group 1: Inarigivir Soproxil 50 mg + TAF | Group 2: TAF | Group 3: Inarigivir Soproxil 200 mg + TAF | Group 5: Inarigivir Soproxil 400 mg + TAF |
|---|---|---|---|---|
| Arm/Group Description | Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks. | Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks. |
| Measure Participants | 6 | 3 | 5 | 9 |
| Count of Participants [Participants] |
4
13.3%
|
0
0%
|
0
0%
|
4
19%
|
| Title | Percentage of Participants Experiencing Hepatitis B Virus (HBV) Virologic Breakthrough During 12 Weeks of Inarigivir Soproxil Treatment (Group 4) |
|---|---|
| Description | Virologic breakthrough was defined as HBV deoxyribonucleic acid (DNA) ≥69 IU/mL for 2 consecutive visits |
| Time Frame | Baseline up to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set (Group 4) were analyzed. |
| Arm/Group Title | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) |
|---|---|
| Arm/Group Description | Virally suppressed participants who were receiving commercially available NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks. |
| Measure Participants | 21 |
| Number [percentage of participants] |
0
0%
|
| Title | Change From Baseline in HBV DNA at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5) |
|---|---|
| Description | |
| Time Frame | Baseline, Weeks 12, 16, 24, 36, and 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set (Groups 1-3 and 5) with available data were analyzed. |
| Arm/Group Title | Group 1: Inarigivir Soproxil 50 mg + TAF | Group 2: TAF | Group 3: Inarigivir Soproxil 200 mg + TAF | Group 5: Inarigivir Soproxil 400 mg + TAF |
|---|---|---|---|---|
| Arm/Group Description | Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks. | Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks. |
| Measure Participants | 30 | 12 | 30 | 30 |
| Baseline |
7.06
(1.530)
|
7.06
(1.757)
|
6.30
(1.365)
|
6.61
(1.479)
|
| Change at Week 12 |
-4.18
(0.959)
|
-4.24
(1.340)
|
-4.02
(0.854)
|
-3.93
(0.817)
|
| Change at Week 16 |
-4.58
(1.023)
|
-4.65
(1.326)
|
-4.29
(0.946)
|
-4.23
(0.869)
|
| Change at Week 24 |
-5.02
(1.101)
|
-5.25
(1.510)
|
-4.67
(1.049)
|
-4.76
(1.013)
|
| Change at Week 36 |
-5.27
(1.194)
|
-5.53
(1.610)
|
-4.78
(1.207)
|
-4.92
(1.129)
|
| Change at Week 48 |
-5.36
(1.225)
|
-5.25
(1.839)
|
-4.83
(1.162)
|
-4.93
(1.370)
|
| Title | Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Groups 1 Through 3 and 5) |
|---|---|
| Description | |
| Time Frame | Baseline, Weeks 12, 16, 24, 36, and 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set (Groups 1-3 and 5) with available data were analyzed. |
| Arm/Group Title | Group 1: Inarigivir Soproxil 50 mg + TAF | Group 2: TAF | Group 3: Inarigivir Soproxil 200 mg + TAF | Group 5: Inarigivir Soproxil 400 mg + TAF |
|---|---|---|---|---|
| Arm/Group Description | Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks. | Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks. |
| Measure Participants | 30 | 12 | 30 | 30 |
| Baseline |
3.933
(0.8058)
|
4.118
(0.6543)
|
3.529
(0.8835)
|
3.418
(0.8075)
|
| Change at Week 12 |
-0.244
(0.3443)
|
-0.435
(0.5320)
|
0.016
(0.2850)
|
-0.026
(0.3805)
|
| Change at Week 16 |
-0.282
(0.3954)
|
-0.479
(0.5429)
|
0.014
(0.2916)
|
-0.082
(0.4262)
|
| Change at Week 24 |
-0.310
(0.4303)
|
-0.482
(0.5119)
|
-0.021
(0.3171)
|
-0.104
(0.5000)
|
| Change at Week 36 |
-0.330
(0.4363)
|
-0.524
(0.5430)
|
-0.055
(0.4213)
|
-0.209
(0.5319)
|
| Change at Week 48 |
-0.322
(0.4311)
|
-0.517
(0.5617)
|
-0.045
(0.4778)
|
-0.235
(0.5429)
|
| Title | Change From Baseline in HBsAg at Weeks 12, 16, 24, 36, and 48 (Group 4) |
|---|---|
| Description | |
| Time Frame | Baseline, Weeks 12, 16, 24, 36, and 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set (Group 4) were analyzed. |
| Arm/Group Title | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) |
|---|---|
| Arm/Group Description | Virally suppressed participants who were receiving commercially available NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks. |
| Measure Participants | 21 |
| Baseline |
3.211
(0.5536)
|
| Change at Week 12 |
-0.017
(0.0417)
|
| Change at Week 16 |
-0.010
(0.0645)
|
| Change at Week 24 |
-0.039
(0.0925)
|
| Change at Week 36 |
-0.037
(0.0939)
|
| Change at Week 48 |
-0.073
(0.1120)
|
Adverse Events
| Time Frame | All-cause mortality: From randomization/enrollment up to Week 48 + 3 days Adverse events: Groups 1, 2, 3, 5: From first dose up to Week 48 + 3 days Group 4: From first dose up to Week 12 + 30 days (for Group 4, adverse events were planned to be collected only up to Week 12 + 30 days) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All cause mortality: The All Randomized/Enrolled Analysis Set included all participants who were randomized (Group 1 and 2) or enrolled (Group 3-5) in the study. Adverse events: The Safety Analysis Set included all participants who took at least 1 dose of any study drug. | |||||||||
| Arm/Group Title | Group 1: Inarigivir Soproxil 50 mg + TAF | Group 2: TAF | Group 3: Inarigivir Soproxil 200 mg + TAF | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) | Group 5: Inarigivir Soproxil 400 mg + TAF | |||||
| Arm/Group Description | Viremic participants were administered inarigivir soproxil 50 mg (2 x 25 mg capsules) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Viremic participants were administered TAF 25 mg tablet once daily orally with food for 48 weeks. | Viremic participants were administered inarigivir soproxil 200 mg (2 x 100 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed by TAF 25 mg tablet once daily orally with food for 36 weeks. | Virally suppressed participants who were receiving NUC(s) were administered inarigivir soproxil 100 mg tablet once daily orally 1 hour before or 1 hour after a meal for 12 weeks. Participants continued commercially available NUC(s) for 48 weeks. | Viremic participants were administered inarigivir soproxil 400 mg (2 x 200 mg tablets) once daily orally 1 hour before or 1 hour after a meal plus TAF 25 mg tablet once daily orally with food for 12 weeks followed TAF 25 mg tablet once daily orally with food for 36 weeks. | |||||
All Cause Mortality |
||||||||||
| Group 1: Inarigivir Soproxil 50 mg + TAF | Group 2: TAF | Group 3: Inarigivir Soproxil 200 mg + TAF | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) | Group 5: Inarigivir Soproxil 400 mg + TAF | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | 0/12 (0%) | 0/30 (0%) | 0/21 (0%) | 0/30 (0%) | |||||
Serious Adverse Events |
||||||||||
| Group 1: Inarigivir Soproxil 50 mg + TAF | Group 2: TAF | Group 3: Inarigivir Soproxil 200 mg + TAF | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) | Group 5: Inarigivir Soproxil 400 mg + TAF | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/30 (3.3%) | 1/12 (8.3%) | 1/30 (3.3%) | 0/21 (0%) | 1/30 (3.3%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal pain upper | 0/30 (0%) | 0/12 (0%) | 1/30 (3.3%) | 0/21 (0%) | 0/30 (0%) | |||||
| Infections and infestations | ||||||||||
| Campylobacter gastroenteritis | 1/30 (3.3%) | 0/12 (0%) | 0/30 (0%) | 0/21 (0%) | 0/30 (0%) | |||||
| Investigations | ||||||||||
| Alanine aminotransferase increased | 0/30 (0%) | 0/12 (0%) | 0/30 (0%) | 0/21 (0%) | 1/30 (3.3%) | |||||
| Nervous system disorders | ||||||||||
| Carpal tunnel syndrome | 0/30 (0%) | 1/12 (8.3%) | 0/30 (0%) | 0/21 (0%) | 0/30 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Group 1: Inarigivir Soproxil 50 mg + TAF | Group 2: TAF | Group 3: Inarigivir Soproxil 200 mg + TAF | Group 4: Inarigivir Soproxil 100 mg + Commercially Available NUC(s) | Group 5: Inarigivir Soproxil 400 mg + TAF | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/30 (26.7%) | 7/12 (58.3%) | 15/30 (50%) | 9/21 (42.9%) | 9/30 (30%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Vertigo | 0/30 (0%) | 1/12 (8.3%) | 0/30 (0%) | 0/21 (0%) | 0/30 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Diarrhoea | 0/30 (0%) | 0/12 (0%) | 2/30 (6.7%) | 1/21 (4.8%) | 1/30 (3.3%) | |||||
| General disorders | ||||||||||
| Influenza like illness | 0/30 (0%) | 0/12 (0%) | 2/30 (6.7%) | 6/21 (28.6%) | 1/30 (3.3%) | |||||
| Hepatobiliary disorders | ||||||||||
| Hepatic steatosis | 0/30 (0%) | 1/12 (8.3%) | 0/30 (0%) | 0/21 (0%) | 0/30 (0%) | |||||
| Infections and infestations | ||||||||||
| Influenza | 1/30 (3.3%) | 0/12 (0%) | 0/30 (0%) | 2/21 (9.5%) | 0/30 (0%) | |||||
| Nasopharyngitis | 2/30 (6.7%) | 0/12 (0%) | 0/30 (0%) | 0/21 (0%) | 0/30 (0%) | |||||
| Upper respiratory tract infection | 1/30 (3.3%) | 3/12 (25%) | 6/30 (20%) | 1/21 (4.8%) | 3/30 (10%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Tooth fracture | 0/30 (0%) | 1/12 (8.3%) | 0/30 (0%) | 0/21 (0%) | 0/30 (0%) | |||||
| Investigations | ||||||||||
| Alanine aminotransferase increased | 4/30 (13.3%) | 1/12 (8.3%) | 1/30 (3.3%) | 1/21 (4.8%) | 0/30 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Myalgia | 0/30 (0%) | 1/12 (8.3%) | 0/30 (0%) | 0/21 (0%) | 0/30 (0%) | |||||
| Nervous system disorders | ||||||||||
| Dizziness | 0/30 (0%) | 0/12 (0%) | 2/30 (6.7%) | 1/21 (4.8%) | 2/30 (6.7%) | |||||
| Headache | 1/30 (3.3%) | 0/12 (0%) | 3/30 (10%) | 0/21 (0%) | 2/30 (6.7%) | |||||
| Sciatica | 0/30 (0%) | 1/12 (8.3%) | 1/30 (3.3%) | 0/21 (0%) | 0/30 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Hiccups | 0/30 (0%) | 1/12 (8.3%) | 0/30 (0%) | 0/21 (0%) | 0/30 (0%) | |||||
| Productive cough | 0/30 (0%) | 0/12 (0%) | 1/30 (3.3%) | 0/21 (0%) | 3/30 (10%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Acne | 0/30 (0%) | 1/12 (8.3%) | 0/30 (0%) | 0/21 (0%) | 0/30 (0%) | |||||
| Dry skin | 0/30 (0%) | 1/12 (8.3%) | 0/30 (0%) | 0/21 (0%) | 0/30 (0%) | |||||
| Vascular disorders | ||||||||||
| Hypertension | 0/30 (0%) | 1/12 (8.3%) | 1/30 (3.3%) | 0/21 (0%) | 0/30 (0%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Results Point of Contact
| Name/Title | Gilead Clinical Study Information Center |
|---|---|
| Organization | Gilead Sciences |
| Phone | 1-833-445-3230 (GILEAD-0) |
| GileadClinicalTrials@gilead.com |
Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT03434353
Other Study ID Numbers:
- GS-US-464-4437
First Posted:
Feb 15, 2018
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022