Trial Outcomes & Findings for Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients. (NCT NCT01565889)
NCT ID: NCT01565889
Last Updated: 2014-10-01
Results Overview
AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Data for this outcome measure were collected for participants in Part A only.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose
Results posted on
2014-10-01
Participant Flow
52 participants were enrolled at one study site in Puerto Rico, a commonwealth of the United States (US). The first participant was screened on 27 February 2012. The last participant observation occurred on 10 December 2013.
Part A: 52 participants were screened; 38 were enrolled and treated, and comprise the Part A Safety Analysis Set (SAS) and Part A Full Analysis Set (FAS). Part B: 42 participants were screened; 23 were enrolled and treated (9 from Part A and 14 who joined the study), and comprise the Part B SAS and Part B FAS.
Participant milestones
| Measure |
Part A: SOF+EFV/FTC/TDF (Cohort 1)
Sofosbuvir (SOF; 1 × 400 mg tablet or 2 × 200 mg tablets) + efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
|
Part A: SOF+EFV+ZDV/3TC (Cohort 2)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
|
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + atazanavir (ATV) 400 mg tablet boosted with ritonavir (RTV) 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + darunavir (DRV; 800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RAL+FTC/TDF (Cohort 5)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + raltegravir (RAL) 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
|
Part B: SOF+PEG+RBV
SOF 400 mg tablet once daily + pegylated interferon alpha (PEG) 180 μg subcutaneous injection once weekly + weight-based ribavirin (RBV; 1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Part A
STARTED
|
12
|
4
|
8
|
7
|
7
|
0
|
|
Part A
COMPLETED
|
11
|
4
|
8
|
7
|
7
|
0
|
|
Part A
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
0
|
0
|
0
|
23
|
|
Part B
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
19
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
4
|
Reasons for withdrawal
| Measure |
Part A: SOF+EFV/FTC/TDF (Cohort 1)
Sofosbuvir (SOF; 1 × 400 mg tablet or 2 × 200 mg tablets) + efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
|
Part A: SOF+EFV+ZDV/3TC (Cohort 2)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
|
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + atazanavir (ATV) 400 mg tablet boosted with ritonavir (RTV) 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + darunavir (DRV; 800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RAL+FTC/TDF (Cohort 5)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + raltegravir (RAL) 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
|
Part B: SOF+PEG+RBV
SOF 400 mg tablet once daily + pegylated interferon alpha (PEG) 180 μg subcutaneous injection once weekly + weight-based ribavirin (RBV; 1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Part A
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part B
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part B
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Part B
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.
Baseline characteristics by cohort
| Measure |
Part A: SOF+EFV/FTC/TDF (Cohort 1)
n=12 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
|
Part A: SOF+EFV+ZDV/3TC (Cohort 2)
n=4 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
|
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)
n=8 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
n=7 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RAL+FTC/TDF (Cohort 5)
n=7 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
|
Part B: SOF+PEG+RBV
n=14 Participants
SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
This reporting group presents data for those participants who joined the study for Part B only.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
58 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
47 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
47 years
STANDARD_DEVIATION 3.8 • n=4 Participants
|
46 years
STANDARD_DEVIATION 10.3 • n=21 Participants
|
46 years
STANDARD_DEVIATION 8.7 • n=10 Participants
|
47 years
STANDARD_DEVIATION 7.2 • n=115 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
44 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
51 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
8 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
7 participants
n=21 Participants
|
11 participants
n=10 Participants
|
35 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=10 Participants
|
17 participants
n=115 Participants
|
|
HCV Genotype
Genotype 1A
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
6 participants
n=21 Participants
|
9 participants
n=10 Participants
|
31 participants
n=115 Participants
|
|
HCV Genotype
Genotype 1B
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=10 Participants
|
9 participants
n=115 Participants
|
|
HCV Genotype
Genotype 2B
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
4 participants
n=115 Participants
|
|
HCV Genotype
Genotype 3A
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
1 participants
n=21 Participants
|
2 participants
n=10 Participants
|
6 participants
n=115 Participants
|
|
HCV Genotype
Genotype 4
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
|
HCV Genotype
Genotype 4A/4C/4D
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
1 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdosePopulation: Pharmacokinetics (PK) Analysis Set: participants with evaluable PK profiles who enrolled into Part A of the study and received study drug. Participants in the PK Analysis Set with available data were included.
AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Data for this outcome measure were collected for participants in Part A only.
Outcome measures
| Measure |
Part A: SOF+EFV/FTC/TDF (Cohort 1)
n=8 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
|
Part A: SOF+EFV+ZDV/3TC (Cohort 2)
n=4 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
|
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)
n=8 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
n=7 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RAL+FTC/TDF (Cohort 5)
n=7 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
|
Part B: SOF+PEG+RBV
SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7
Pharmacokinetics of SOF (AUCtau at Day 7)
|
867.5 h*ng/mL
Standard Deviation 460.34
|
627.6 h*ng/mL
Standard Deviation 315.87
|
2269.4 h*ng/mL
Standard Deviation 567.58
|
1421.5 h*ng/mL
Standard Deviation 415.10
|
1687.1 h*ng/mL
Standard Deviation 573.42
|
—
|
|
Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7
Pharmacokinetics of EFV (AUCtau at Day 7)
|
95094.4 h*ng/mL
Standard Deviation 71267.91
|
53770.7 h*ng/mL
Standard Deviation 39263.90
|
NA h*ng/mL
Standard Deviation NA
No data: EFV was not administered to this group.
|
NA h*ng/mL
Standard Deviation NA
No data: EFV was not administered to this group.
|
NA h*ng/mL
Standard Deviation NA
No data: EFV was not administered to this group.
|
—
|
|
Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7
Pharmacokinetics of TFV (AUCtau at Day 7)
|
2351.2 h*ng/mL
Standard Deviation 960.74
|
NA h*ng/mL
Standard Deviation NA
No data: TFV was not administered to this group.
|
3793.0 h*ng/mL
Standard Deviation 835.11
|
3996.8 h*ng/mL
Standard Deviation 1665.17
|
2657.1 h*ng/mL
Standard Deviation 751.31
|
—
|
|
Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7
Pharmacokinetics of FTC (AUCtau at Day 7)
|
10144.8 h*ng/mL
Standard Deviation 2832.23
|
NA h*ng/mL
Standard Deviation NA
No data: FTC was not administered to this group.
|
11564.9 h*ng/mL
Standard Deviation 1739.26
|
13091.2 h*ng/mL
Standard Deviation 4093.09
|
10622.8 h*ng/mL
Standard Deviation 815.24
|
—
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdosePopulation: Participants in the PK Analysis Set with available data were included.
Cmax: maximum observed concentration of drug in plasma. Data for this outcome measure were collected for participants in Part A only.
Outcome measures
| Measure |
Part A: SOF+EFV/FTC/TDF (Cohort 1)
n=8 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
|
Part A: SOF+EFV+ZDV/3TC (Cohort 2)
n=4 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
|
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)
n=8 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
n=7 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RAL+FTC/TDF (Cohort 5)
n=7 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
|
Part B: SOF+PEG+RBV
SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7
Pharmacokinetics of SOF (Cmax at Day 7)
|
635.0 ng/mL
Standard Deviation 344.19
|
285.1 ng/mL
Standard Deviation 62.28
|
1228.9 ng/mL
Standard Deviation 474.93
|
828.2 ng/mL
Standard Deviation 351.41
|
1189.2 ng/mL
Standard Deviation 483.83
|
—
|
|
Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7
Pharmacokinetics of EFV (Cmax at Day 7)
|
5423.8 ng/mL
Standard Deviation 3283.86
|
3469.5 ng/mL
Standard Deviation 1707.54
|
NA ng/mL
Standard Deviation NA
No data: EFV was not administered to this group.
|
NA ng/mL
Standard Deviation NA
No data: EFV was not administered to this group.
|
NA ng/mL
Standard Deviation NA
No data: EFV was not administered to this group.
|
—
|
|
Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7
Pharmacokinetics of TFV (Cmax at Day 7)
|
372.5 ng/mL
Standard Deviation 208.71
|
NA ng/mL
Standard Deviation NA
No data: TFV was not administered to this group.
|
519.8 ng/mL
Standard Deviation 119.89
|
441.8 ng/mL
Standard Deviation 134.13
|
388.1 ng/mL
Standard Deviation 118.53
|
—
|
|
Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7
Pharmacokinetics of FTC (Cmax at Day 7)
|
1533.1 ng/mL
Standard Deviation 829.88
|
NA ng/mL
Standard Deviation NA
No data: FTC was not administered to this group.
|
1797.9 ng/mL
Standard Deviation 232.54
|
1808.2 ng/mL
Standard Deviation 530.10
|
2079.5 ng/mL
Standard Deviation 434.32
|
—
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Part B Full Analysis Set: participants enrolled into Part B of the study and dosed with at least 1 dose of study drug(s)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. Data for this outcome measure were collected for participants in Part B only.
Outcome measures
| Measure |
Part A: SOF+EFV/FTC/TDF (Cohort 1)
n=23 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
|
Part A: SOF+EFV+ZDV/3TC (Cohort 2)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
|
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RAL+FTC/TDF (Cohort 5)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
|
Part B: SOF+PEG+RBV
SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
|
91.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Analysis Set: participants who received at least 1 dose of study drug(s)
The percentage of participants discontinuing any study drug due to an adverse event was summarized.
Outcome measures
| Measure |
Part A: SOF+EFV/FTC/TDF (Cohort 1)
n=8 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
|
Part A: SOF+EFV+ZDV/3TC (Cohort 2)
n=4 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
|
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)
n=8 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
n=7 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RAL+FTC/TDF (Cohort 5)
n=7 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
|
Part B: SOF+PEG+RBV
n=23 Participants
SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
8.7 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Part B Full Analysis Set
SVR4 and SVR24 was defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure were collected for participants in Part B only.
Outcome measures
| Measure |
Part A: SOF+EFV/FTC/TDF (Cohort 1)
n=23 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
|
Part A: SOF+EFV+ZDV/3TC (Cohort 2)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
|
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RAL+FTC/TDF (Cohort 5)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
|
Part B: SOF+PEG+RBV
SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
91.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
91.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Part B Full Analysis Set
Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA \> LLOQ) on treatment after having previously had undetectable HCV RNA levels (HCV RNA \< LLOQ) while on treatment. Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) at end of treatment, but did not achieve an SVR. Data for this outcome measure were collected for participants in Part B only.
Outcome measures
| Measure |
Part A: SOF+EFV/FTC/TDF (Cohort 1)
n=23 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
|
Part A: SOF+EFV+ZDV/3TC (Cohort 2)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
|
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RAL+FTC/TDF (Cohort 5)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
|
Part B: SOF+PEG+RBV
SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
Viral breakthrough
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
Viral relapse
|
8.7 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 8 weeksPopulation: Part B Full Analysis Set
Data for this outcome measure were collected for participants in Part B only.
Outcome measures
| Measure |
Part A: SOF+EFV/FTC/TDF (Cohort 1)
n=23 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
|
Part A: SOF+EFV+ZDV/3TC (Cohort 2)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
|
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RAL+FTC/TDF (Cohort 5)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
|
Part B: SOF+PEG+RBV
SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Part B: On-treatment HCV RNA
Baseline (n = 23)
|
6.59 log10 IU/mL
Standard Deviation 0.872
|
—
|
—
|
—
|
—
|
—
|
|
Part B: On-treatment HCV RNA
Week 1 (n = 20)
|
1.65 log10 IU/mL
Standard Deviation 0.425
|
—
|
—
|
—
|
—
|
—
|
|
Part B: On-treatment HCV RNA
Week 2 (n = 22)
|
1.38 log10 IU/mL
Standard Deviation 0.000
|
—
|
—
|
—
|
—
|
—
|
|
Part B: On-treatment HCV RNA
Week 4 (n = 23)
|
1.38 log10 IU/mL
Standard Deviation 0.000
|
—
|
—
|
—
|
—
|
—
|
|
Part B: On-treatment HCV RNA
Week 6 (n = 23)
|
1.38 log10 IU/mL
Standard Deviation 0.000
|
—
|
—
|
—
|
—
|
—
|
|
Part B: On-treatment HCV RNA
Week 8 (n = 21)
|
1.38 log10 IU/mL
Standard Deviation 0.000
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 8 weeksPopulation: Part B Safety Analysis Set: participants enrolled in Part B and received at least one dose of study drug(s).
Data for this outcome measure were collected for participants in Part B only.
Outcome measures
| Measure |
Part A: SOF+EFV/FTC/TDF (Cohort 1)
n=23 Participants
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
|
Part A: SOF+EFV+ZDV/3TC (Cohort 2)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
|
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RAL+FTC/TDF (Cohort 5)
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
|
Part B: SOF+PEG+RBV
SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Part B: On-treatment HIV RNA
Baseline (n = 23)
|
25 copies/mL
Standard Deviation 16.4
|
—
|
—
|
—
|
—
|
—
|
|
Part B: On-treatment HIV RNA
Week 1 (n = 20)
|
20 copies/mL
Standard Deviation 4.1
|
—
|
—
|
—
|
—
|
—
|
|
Part B: On-treatment HIV RNA
Week 2 (n = 22)
|
20 copies/mL
Standard Deviation 3.0
|
—
|
—
|
—
|
—
|
—
|
|
Part B: On-treatment HIV RNA
Week 4 (n = 22)
|
19 copies/mL
Standard Deviation 0.0
|
—
|
—
|
—
|
—
|
—
|
|
Part B: On-treatment HIV RNA
Week 6 (n = 22)
|
19 copies/mL
Standard Deviation 0.0
|
—
|
—
|
—
|
—
|
—
|
|
Part B: On-treatment HIV RNA
Week 8 (n = 21)
|
19 copies/mL
Standard Deviation 0.0
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A: SOF+EFV/FTC/TDF (Cohort 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: SOF+EFV+ZDV/3TC (Cohort 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: SOF+RAL+FTC/TDF (Cohort 5)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B: SOF+PEG+RBV
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: SOF+EFV/FTC/TDF (Cohort 1)
n=12 participants at risk
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
|
Part A: SOF+EFV+ZDV/3TC (Cohort 2)
n=4 participants at risk
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
|
Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)
n=8 participants at risk
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)
n=7 participants at risk
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
|
Part A: SOF+RAL+FTC/TDF (Cohort 5)
n=7 participants at risk
SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
|
Part B: SOF+PEG+RBV
n=23 participants at risk
SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
52.2%
12/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
17.4%
4/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
17.4%
4/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
8.7%
2/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
8.7%
2/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
8.7%
2/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
General disorders
Fatigue
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
34.8%
8/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
17.4%
4/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
8.7%
2/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
13.0%
3/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
8.7%
2/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Psychiatric disorders
Depression
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
8.7%
2/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
1/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
14.3%
1/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
14.3%
1/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
General disorders
Chills
|
8.3%
1/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
14.3%
1/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
14.3%
1/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Investigations
Body temperature decreased
|
8.3%
1/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Psychiatric disorders
Agitation
|
8.3%
1/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Psychiatric disorders
Mood swings
|
8.3%
1/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Psychiatric disorders
Thinking abnormal
|
8.3%
1/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
14.3%
1/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
14.3%
1/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/4 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/8 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
14.3%
1/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/7 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
0.00%
0/23 • Up to 12 weeks plus 30 days
Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER