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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.

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ClinicalTrials.gov Identifier: NCT01565889
Recruitment Status : Completed
First Posted : March 29, 2012
Results First Posted : October 1, 2014
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatitis C
HIV
Interventions Drug: SOF
Drug: EFV/FTC/TDF
Drug: EFV
Drug: ZDV/3TC
Drug: ATV
Drug: Ritonavir
Drug: FTC/TDF
Drug: DRV
Drug: RAL
Drug: PEG
Drug: RBV
Enrollment 52
Recruitment Details 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.
Pre-assignment Details

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.

Arm/Group Title Part A: SOF+EFV/FTC/TDF (Cohort 1) Part A: SOF+EFV+ZDV/3TC (Cohort 2) Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3) Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) Part A: SOF+RAL+FTC/TDF (Cohort 5) Part B: SOF+PEG+RBV
Hide Arm/Group Description 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. 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. 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. 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. 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. 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.
Period Title: Part A
Started 12 4 8 7 7 0
Completed 11 [1] 4 [2] 8 [1] 7 [3] 7 [4] 0
Not Completed 1 0 0 0 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0             0             0
[1]
3 participants from this group continued in the Part B: SOF+PEG+RBV group.
[2]
No participants from this group continued in the Part B: SOF+PEG+RBV group.
[3]
2 participants from this group continued in the Part B: SOF+PEG+RBV group.
[4]
1 participant from this group continued in the Part B: SOF+PEG+RBV group.
Period Title: Part B
Started 0 0 0 0 0 23 [1]
Completed 0 0 0 0 0 19
Not Completed 0 0 0 0 0 4
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             1
Lack of Efficacy             0             0             0             0             0             2
Lost to Follow-up             0             0             0             0             0             1
[1]
9 participants in this group transferred from a Part A cohort, and 14 participants joined the study.
Arm/Group Title Part A: SOF+EFV/FTC/TDF (Cohort 1) Part A: SOF+EFV+ZDV/3TC (Cohort 2) Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3) Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) Part A: SOF+RAL+FTC/TDF (Cohort 5) Part B: SOF+PEG+RBV Total
Hide Arm/Group Description 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. 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. 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. 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. 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.

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 of all reporting groups
Overall Number of Baseline Participants 12 4 8 7 7 14 52
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who enrolled and received at least one dose of study drug(s)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 4 participants 8 participants 7 participants 7 participants 14 participants 52 participants
54  (10.1) 58  (5.3) 47  (6.4) 47  (3.8) 46  (10.3) 46  (8.7) 47  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 4 participants 8 participants 7 participants 7 participants 14 participants 52 participants
Female
2
  16.7%
0
   0.0%
1
  12.5%
1
  14.3%
1
  14.3%
3
  21.4%
8
  15.4%
Male
10
  83.3%
4
 100.0%
7
  87.5%
6
  85.7%
6
  85.7%
11
  78.6%
44
  84.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 4 participants 8 participants 7 participants 7 participants 14 participants 52 participants
Hispanic or Latino
12
 100.0%
4
 100.0%
7
  87.5%
7
 100.0%
7
 100.0%
14
 100.0%
51
  98.1%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 4 participants 8 participants 7 participants 7 participants 14 participants 52 participants
White 8 2 4 3 7 11 35
Black or African American 4 2 4 4 0 3 17
HCV Genotype   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 12 participants 4 participants 8 participants 7 participants 7 participants 14 participants 52 participants
Genotype 1A 5 1 5 5 6 9 31
Genotype 1B 5 1 1 0 0 2 9
Genotype 2B 1 1 2 0 0 0 4
Genotype 3A 0 1 0 2 1 2 6
Genotype 4 1 0 0 0 0 0 1
Genotype 4A/4C/4D 0 0 0 0 0 1 1
[1]
Measure Description: There are variations of HCV which are all similar enough to be called HCV, but are distinct enough to be referred to as HCV genotypes.
1.Primary Outcome
Title Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7
Hide Description

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.

Time Frame Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Part A: SOF+EFV/FTC/TDF (Cohort 1) Part A: SOF+EFV+ZDV/3TC (Cohort 2) Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3) Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) Part A: SOF+RAL+FTC/TDF (Cohort 5)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 8 4 8 7 7
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Pharmacokinetics of SOF (AUCtau at Day 7) 867.5  (460.34) 627.6  (315.87) 2269.4  (567.58) 1421.5  (415.10) 1687.1  (573.42)
Pharmacokinetics of EFV (AUCtau at Day 7) 95094.4  (71267.91) 53770.7  (39263.90) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
Pharmacokinetics of TFV (AUCtau at Day 7) 2351.2  (960.74) NA [2]   (NA) 3793.0  (835.11) 3996.8  (1665.17) 2657.1  (751.31)
Pharmacokinetics of FTC (AUCtau at Day 7) 10144.8  (2832.23) NA [3]   (NA) 11564.9  (1739.26) 13091.2  (4093.09) 10622.8  (815.24)
[1]
No data: EFV was not administered to this group.
[2]
No data: TFV was not administered to this group.
[3]
No data: FTC was not administered to this group.
2.Primary Outcome
Title Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7
Hide Description

Cmax: maximum observed concentration of drug in plasma.

Data for this outcome measure were collected for participants in Part A only.

Time Frame Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set with available data were included.
Arm/Group Title Part A: SOF+EFV/FTC/TDF (Cohort 1) Part A: SOF+EFV+ZDV/3TC (Cohort 2) Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3) Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) Part A: SOF+RAL+FTC/TDF (Cohort 5)
Hide Arm/Group Description:
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 8 4 8 7 7
Mean (Standard Deviation)
Unit of Measure: ng/mL
Pharmacokinetics of SOF (Cmax at Day 7) 635.0  (344.19) 285.1  (62.28) 1228.9  (474.93) 828.2  (351.41) 1189.2  (483.83)
Pharmacokinetics of EFV (Cmax at Day 7) 5423.8  (3283.86) 3469.5  (1707.54) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
Pharmacokinetics of TFV (Cmax at Day 7) 372.5  (208.71) NA [2]   (NA) 519.8  (119.89) 441.8  (134.13) 388.1  (118.53)
Pharmacokinetics of FTC (Cmax at Day 7) 1533.1  (829.88) NA [3]   (NA) 1797.9  (232.54) 1808.2  (530.10) 2079.5  (434.32)
[1]
No data: EFV was not administered to this group.
[2]
No data: TFV was not administered to this group.
[3]
No data: FTC was not administered to this group.
3.Primary Outcome
Title Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
Hide Description

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.

Time Frame Posttreatment Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part B Full Analysis Set: participants enrolled into Part B of the study and dosed with at least 1 dose of study drug(s)
Arm/Group Title Part B: SOF+PEG+RBV
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: percentage of participants
91.3
4.Primary Outcome
Title Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Hide Description The percentage of participants discontinuing any study drug due to an adverse event was summarized.
Time Frame Up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who received at least 1 dose of study drug(s)
Arm/Group Title Part A: SOF+EFV/FTC/TDF (Cohort 1) Part A: SOF+EFV+ZDV/3TC (Cohort 2) Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3) Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) Part A: SOF+RAL+FTC/TDF (Cohort 5) Part B: SOF+PEG+RBV
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 8 4 8 7 7 23
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 0 0 8.7
5.Secondary Outcome
Title Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Hide Description

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.

Time Frame Posttreatment Weeks 4 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part B Full Analysis Set
Arm/Group Title Part B: SOF+PEG+RBV
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: percentage of participants
SVR4 91.3
SVR24 91.3
6.Secondary Outcome
Title Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse
Hide Description

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.

Time Frame Posttreatment Weeks 4 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part B Full Analysis Set
Arm/Group Title Part B: SOF+PEG+RBV
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: percentage of participants
Viral breakthrough 0
Viral relapse 8.7
7.Other Pre-specified Outcome
Title Part B: On-treatment HCV RNA
Hide Description Data for this outcome measure were collected for participants in Part B only.
Time Frame Up to 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part B Full Analysis Set
Arm/Group Title Part B: SOF+PEG+RBV
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Baseline (n = 23) 6.59  (0.872)
Week 1 (n = 20) 1.65  (0.425)
Week 2 (n = 22) 1.38  (0.000)
Week 4 (n = 23) 1.38  (0.000)
Week 6 (n = 23) 1.38  (0.000)
Week 8 (n = 21) 1.38  (0.000)
8.Other Pre-specified Outcome
Title Part B: On-treatment HIV RNA
Hide Description Data for this outcome measure were collected for participants in Part B only.
Time Frame Up to 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Part B Safety Analysis Set: participants enrolled in Part B and received at least one dose of study drug(s).
Arm/Group Title Part B: SOF+PEG+RBV
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: copies/mL
Baseline (n = 23) 25  (16.4)
Week 1 (n = 20) 20  (4.1)
Week 2 (n = 22) 20  (3.0)
Week 4 (n = 22) 19  (0.0)
Week 6 (n = 22) 19  (0.0)
Week 8 (n = 21) 19  (0.0)
Time Frame Up to 12 weeks plus 30 days
Adverse Event Reporting Description Nine participants from Part A also enrolled into Part B and are included twice for adverse events.
 
Arm/Group Title Part A: SOF+EFV/FTC/TDF (Cohort 1) Part A: SOF+EFV+ZDV/3TC (Cohort 2) Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3) Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) Part A: SOF+RAL+FTC/TDF (Cohort 5) Part B: SOF+PEG+RBV
Hide Arm/Group Description 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. 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. 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. 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. 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. 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.
All-Cause Mortality
Part A: SOF+EFV/FTC/TDF (Cohort 1) Part A: SOF+EFV+ZDV/3TC (Cohort 2) Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3) Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) Part A: SOF+RAL+FTC/TDF (Cohort 5) Part B: SOF+PEG+RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Part A: SOF+EFV/FTC/TDF (Cohort 1) Part A: SOF+EFV+ZDV/3TC (Cohort 2) Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3) Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) Part A: SOF+RAL+FTC/TDF (Cohort 5) Part B: SOF+PEG+RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/4 (0.00%)   0/8 (0.00%)   0/7 (0.00%)   0/7 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part A: SOF+EFV/FTC/TDF (Cohort 1) Part A: SOF+EFV+ZDV/3TC (Cohort 2) Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3) Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4) Part A: SOF+RAL+FTC/TDF (Cohort 5) Part B: SOF+PEG+RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/12 (16.67%)   0/4 (0.00%)   0/8 (0.00%)   2/7 (28.57%)   1/7 (14.29%)   16/23 (69.57%) 
Blood and lymphatic system disorders             
Anaemia  1  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  12/23 (52.17%) 
Neutropenia  1  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  4/23 (17.39%) 
Thrombocytopenia  1  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  4/23 (17.39%) 
Leukopenia  1  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/23 (8.70%) 
Gastrointestinal disorders             
Abdominal Pain  1  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/23 (8.70%) 
Vomiting  1  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/23 (8.70%) 
Dry mouth  2  1/12 (8.33%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/23 (0.00%) 
Haemorrhoids  2  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  1/7 (14.29%)  0/23 (0.00%) 
Nausea  2  1/12 (8.33%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/23 (0.00%) 
General disorders             
Fatigue  1  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  8/23 (34.78%) 
Chills  2  1/12 (8.33%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/23 (0.00%) 
Pyrexia  2  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/23 (0.00%) 
Hepatobiliary disorders             
Hyperbilirubinaemia  1  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  4/23 (17.39%) 
Infections and infestations             
Herpes zoster  1  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/23 (8.70%) 
Fungal skin infection  2  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/23 (0.00%) 
Investigations             
Body temperature decreased  1  1/12 (8.33%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/23 (0.00%) 
Musculoskeletal and connective tissue disorders             
Myalgia  1  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  3/23 (13.04%) 
Nervous system disorders             
Dizziness  1  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/23 (8.70%) 
Headache  2  1/12 (8.33%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/23 (0.00%) 
Psychiatric disorders             
Depression  1  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  2/23 (8.70%) 
Agitation  2  1/12 (8.33%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/23 (0.00%) 
Mood swings  2  1/12 (8.33%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/23 (0.00%) 
Thinking abnormal  2  1/12 (8.33%)  0/4 (0.00%)  0/8 (0.00%)  0/7 (0.00%)  0/7 (0.00%)  0/23 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough  2  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/23 (0.00%) 
Nasal congestion  2  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/23 (0.00%) 
Oropharyngeal pain  2  0/12 (0.00%)  0/4 (0.00%)  0/8 (0.00%)  1/7 (14.29%)  0/7 (0.00%)  0/23 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 16.1
2
Term from vocabulary, MedDRA Version 16
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01565889     History of Changes
Other Study ID Numbers: P7977-1910
First Submitted: March 27, 2012
First Posted: March 29, 2012
Results First Submitted: August 28, 2014
Results First Posted: October 1, 2014
Last Update Posted: October 1, 2014