Trial Outcomes & Findings for Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care (NCT NCT01359644)
NCT ID: NCT01359644
Last Updated: 2015-10-23
Results Overview
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA \<25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
350 participants
Primary outcome timeframe
Follow-up Week 12
Results posted on
2015-10-23
Participant Flow
The study was conducted at 18 centres in 2 countries.
A total of 350 participants were enrolled, and 211 were randomized and received study drug.
Participant milestones
| Measure |
Treatment A: Sofosbuvir + Daclatasvir
Participants with hepatitis C virus (HCV) genotypes 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment B: Sofosbuvir + Daclatasvir
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment C: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment D: Sofosbuvir + Daclatasvir
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment E: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
Treatment F: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
|
Treatment G: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
|
Treatment H : Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
|
Treatment I: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment J: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period
STARTED
|
15
|
16
|
14
|
14
|
15
|
14
|
41
|
41
|
21
|
20
|
|
Treatment Period
COMPLETED
|
15
|
15
|
13
|
14
|
15
|
12
|
41
|
41
|
21
|
20
|
|
Treatment Period
NOT COMPLETED
|
0
|
1
|
1
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Follow-up Period
STARTED
|
15
|
16
|
14
|
14
|
15
|
13
|
41
|
41
|
21
|
20
|
|
Follow-up Period
COMPLETED
|
15
|
16
|
14
|
14
|
15
|
12
|
40
|
39
|
21
|
20
|
|
Follow-up Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment A: Sofosbuvir + Daclatasvir
Participants with hepatitis C virus (HCV) genotypes 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment B: Sofosbuvir + Daclatasvir
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment C: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment D: Sofosbuvir + Daclatasvir
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment E: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
Treatment F: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
|
Treatment G: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
|
Treatment H : Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
|
Treatment I: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment J: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period
Lack of Efficacy
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Follow-up Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Follow-up Period
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
Baseline Characteristics
Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care
Baseline characteristics by cohort
| Measure |
Treatment A: Sofosbuvir + Daclatasvir
n=15 Participants
Participants with hepatitis C virus genotype 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment: Sofosbuvir + Daclatasvir
n=16 Participants
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment C: Sofosbuvir + Daclatasvir
n=14 Participants
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment D: Sofosbuvir + Daclatasvir
n=14 Participants
Participants with genotype-2 or -3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks..
|
Treatment E: Sofosbuvir +Daclatasvir + Ribavirin
n=15 Participants
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
Treatment F: Sofosbuvir + Daclatasvir + Ribavirin
n=14 Participants
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
|
Treatment G: Sofosbuvir + Daclatasvir
n=41 Participants
Participants with genotype1 a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks..
|
Treatment H: Sofosbuvir +Daclatasvir + Ribavirin
n=41 Participants
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
|
Treatment I: Sofosbuvir + Daclatasvir
n=21 Participants
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg once daily and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment J: Sofosbuvir +Daclatasvir +Ribavirin
n=20 Participants
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavarin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing \<75 kg) and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 10.18 • n=5 Participants
|
50.6 years
STANDARD_DEVIATION 8.53 • n=7 Participants
|
52.7 years
STANDARD_DEVIATION 7.39 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 10.49 • n=4 Participants
|
50.9 years
STANDARD_DEVIATION 11.72 • n=21 Participants
|
48.8 years
STANDARD_DEVIATION 12.27 • n=10 Participants
|
50.9 years
STANDARD_DEVIATION 11.56 • n=115 Participants
|
53.1 years
STANDARD_DEVIATION 9.53 • n=24 Participants
|
56.6 years
STANDARD_DEVIATION 9.89 • n=42 Participants
|
52.6 years
STANDARD_DEVIATION 10.89 • n=42 Participants
|
52.0 years
STANDARD_DEVIATION 10.37 • n=42 Participants
|
|
Age, Customized
<65 years
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
14 participants
n=5 Participants
|
13 participants
n=4 Participants
|
15 participants
n=21 Participants
|
13 participants
n=10 Participants
|
39 participants
n=115 Participants
|
38 participants
n=24 Participants
|
18 participants
n=42 Participants
|
19 participants
n=42 Participants
|
199 participants
n=42 Participants
|
|
Age, Customized
>= 65 years
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
2 participants
n=115 Participants
|
3 participants
n=24 Participants
|
3 participants
n=42 Participants
|
1 participants
n=42 Participants
|
12 participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
20 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
100 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
21 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
111 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Follow-up Week 12Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA \<25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.
Outcome measures
| Measure |
Treatment-naive Participants With Genotype 1
n=126 Participants
Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
|
Treatment-naive Participants With Genotype 2 or 3
n=44 Participants
Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
|
Telaprevir or Boceprevir Failures With Genotype 1
n=41 Participants
Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
|
Treatment D: Sofosbuvir + Daclatasvir
Participants with genotype 2 or 3 received with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment E: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
Treatment F: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
|
Treatment G: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
|
Treatment H: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b received with sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
|
Treatment I: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure were administered with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment J: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets at AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
DCV/SOF with ribavirin (n=56, 14, 20)
|
96.4 Percentage of participants
|
85.7 Percentage of participants
|
95.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
DCV/SOF without ribavirin (n=70, 30, 21)
|
100.0 Percentage of participants
|
93.3 Percentage of participants
|
100.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
DCF/SOF All
|
98.4 Percentage of participants
|
90.9 Percentage of participants
|
97.6 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Follow-up Week 24Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here the 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
SVR24 was defined as participant's hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir.
Outcome measures
| Measure |
Treatment-naive Participants With Genotype 1
n=126 Participants
Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
|
Treatment-naive Participants With Genotype 2 or 3
n=44 Participants
Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
|
Telaprevir or Boceprevir Failures With Genotype 1
n=41 Participants
Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
|
Treatment D: Sofosbuvir + Daclatasvir
Participants with genotype 2 or 3 received with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment E: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
Treatment F: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
|
Treatment G: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
|
Treatment H: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b received with sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
|
Treatment I: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure were administered with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment J: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets at AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
DCV/SOF with ribavirin (n=56, 14, 20)
|
94.6 Percentage of participants
|
92.9 Percentage of participants
|
100.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
DCV/SOF without ribavirin (n=70, 30, 21)
|
95.7 Percentage of participants
|
93.3 Percentage of participants
|
100.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
DCV/SOF All
|
95.2 Percentage of participants
|
93.2 Percentage of participants
|
100.0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8.
Outcome measures
| Measure |
Treatment-naive Participants With Genotype 1
n=126 Participants
Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
|
Treatment-naive Participants With Genotype 2 or 3
n=44 Participants
Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
|
Telaprevir or Boceprevir Failures With Genotype 1
n=41 Participants
Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
|
Treatment D: Sofosbuvir + Daclatasvir
Participants with genotype 2 or 3 received with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment E: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
Treatment F: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
|
Treatment G: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
|
Treatment H: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b received with sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
|
Treatment I: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure were administered with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment J: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets at AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Viral Breakthrough During the Treatment Period
DCV/SOF with ribavirin (n=56, 14, 20)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Viral Breakthrough During the Treatment Period
DCV/SOF without ribavirin (n=70, 30, 21)
|
0 Percentage of participants
|
3.3 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA \<25 IU/mL at the end of treatment.
Outcome measures
| Measure |
Treatment-naive Participants With Genotype 1
n=126 Participants
Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
|
Treatment-naive Participants With Genotype 2 or 3
n=44 Participants
Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
|
Telaprevir or Boceprevir Failures With Genotype 1
n=41 Participants
Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
|
Treatment D: Sofosbuvir + Daclatasvir
Participants with genotype 2 or 3 received with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment E: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
Treatment F: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
|
Treatment G: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
|
Treatment H: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b received with sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
|
Treatment I: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure were administered with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment J: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets at AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced Viral Relapse During Follow-up Period
DCV/SOF with ribavirin (n=56, 14, 20)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Experienced Viral Relapse During Follow-up Period
DCV/SOF without ribavirin (n=70, 30, 21)
|
1.4 Percentage of participants
|
3.3 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Follow-up week 24Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy.
Change from baseline in log10 HCV RNA at scheduled sampling time.
Outcome measures
| Measure |
Treatment-naive Participants With Genotype 1
n=15 Participants
Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
|
Treatment-naive Participants With Genotype 2 or 3
n=15 Participants
Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
|
Telaprevir or Boceprevir Failures With Genotype 1
n=14 Participants
Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
|
Treatment D: Sofosbuvir + Daclatasvir
n=14 Participants
Participants with genotype 2 or 3 received with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment E: Sofosbuvir + Daclatasvir + Ribavirin
n=15 Participants
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
Treatment F: Sofosbuvir + Daclatasvir + Ribavirin
n=13 Participants
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
|
Treatment G: Sofosbuvir + Daclatasvir
n=39 Participants
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
|
Treatment H: Sofosbuvir + Daclatasvir + Ribavirin
n=38 Participants
Participants with genotype 1a or 1b received with sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
|
Treatment I: Sofosbuvir + Daclatasvir
n=21 Participants
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure were administered with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment J: Sofosbuvir + Daclatasvir + Ribavirin
n=20 Participants
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets at AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24
Change at Follow-up week 24
|
-5.19 IU/mL
Standard Deviation 1.478
|
-5.23 IU/mL
Standard Deviation 1.601
|
-5.67 IU/mL
Standard Deviation 0.336
|
-5.83 IU/mL
Standard Deviation 0.509
|
-5.77 IU/mL
Standard Deviation 0.583
|
-5.61 IU/mL
Standard Deviation 0.610
|
-5.19 IU/mL
Standard Deviation 0.490
|
-5.48 IU/mL
Standard Deviation 0.576
|
-5.39 IU/mL
Standard Deviation 0.386
|
-5.36 IU/mL
Standard Deviation 0.380
|
|
Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24
Baseline
|
1.28 IU/mL
Standard Deviation 1.258
|
0.95 IU/mL
Standard Deviation 0.0
|
0.95 IU/mL
Standard Deviation 0.0
|
0.98 IU/mL
Standard Deviation 0.114
|
0.95 IU/mL
Standard Deviation 0.0
|
0.95 IU/mL
Standard Deviation 0.0
|
0.95 IU/mL
Standard Deviation 0.0
|
0.95 IU/mL
Standard Deviation 0.0
|
0.95 IU/mL
Standard Deviation 0.0
|
0.95 IU/mL
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)Population: All participants who received at least 1 dose of study drug.
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe.
Outcome measures
| Measure |
Treatment-naive Participants With Genotype 1
n=41 Participants
Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
|
Treatment-naive Participants With Genotype 2 or 3
n=49 Participants
Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
|
Telaprevir or Boceprevir Failures With Genotype 1
n=41 Participants
Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
|
Treatment D: Sofosbuvir + Daclatasvir
n=80 Participants
Participants with genotype 2 or 3 received with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment E: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
Treatment F: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
|
Treatment G: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
|
Treatment H: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b received with sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
|
Treatment I: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure were administered with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment J: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets at AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
Gr 3 Total cholesterol
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
SAEs
|
1 Participants
|
6 Participants
|
1 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
AEs leading to discontinuation
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
Gr 3 Phosporus
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
Gr 3 Fasting serum glucose
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
Gr 3 Serum glucose
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
Gr 3 Uric acid
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)Population: All participants who received at least 1 dose of study drug and entered follow-up period
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe
Outcome measures
| Measure |
Treatment-naive Participants With Genotype 1
n=41 Participants
Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
|
Treatment-naive Participants With Genotype 2 or 3
n=48 Participants
Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
|
Telaprevir or Boceprevir Failures With Genotype 1
n=41 Participants
Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
|
Treatment D: Sofosbuvir + Daclatasvir
n=80 Participants
Participants with genotype 2 or 3 received with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment E: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
Treatment F: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
|
Treatment G: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
|
Treatment H: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b received with sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
|
Treatment I: Sofosbuvir + Daclatasvir
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure were administered with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment J: Sofosbuvir + Daclatasvir + Ribavirin
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets at AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period
SAEs
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period
Grade 3-4 Lab Abnormalities: Serum glucose
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Treatment A: Sofosbuvir + Daclatasvir
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment B: Sofosbuvir + Daclatasvir
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment C: Sofosbuvir + Daclatasvir
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment D: Sofosbuvir + Daclatasvir
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment E: Sofosbuvir + Daclatasvir + Ribavirin
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment F: Sofosbuvir + Daclatasvir + Ribavirin
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment G: Sofosbuvir + Daclatasvir
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment H : Sofosbuvir + Daclatasvir + Ribavirin
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment I: Sofosbuvir + Daclatasvir
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment J: Sofosbuvir + Daclatasvir + Ribavirin
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment A: Sofosbuvir + Daclatasvir
n=15 participants at risk
Participants with hepatitis C virus (HCV) genotypes 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment B: Sofosbuvir + Daclatasvir
n=16 participants at risk
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks
|
Treatment C: Sofosbuvir + Daclatasvir
n=14 participants at risk
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment D: Sofosbuvir + Daclatasvir
n=14 participants at risk
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment E: Sofosbuvir + Daclatasvir + Ribavirin
n=15 participants at risk
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
|
Treatment F: Sofosbuvir + Daclatasvir + Ribavirin
n=14 participants at risk
Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks
|
Treatment G: Sofosbuvir + Daclatasvir
n=41 participants at risk
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
|
Treatment H : Sofosbuvir + Daclatasvir + Ribavirin
n=41 participants at risk
Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
|
Treatment I: Sofosbuvir + Daclatasvir
n=21 participants at risk
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
|
Treatment J: Sofosbuvir + Daclatasvir + Ribavirin
n=20 participants at risk
Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing \<75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/15
|
7.1%
1/14
|
0.00%
0/41
|
0.00%
0/41
|
0.00%
0/21
|
0.00%
0/20
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/15
|
0.00%
0/16
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/41
|
0.00%
0/41
|
0.00%
0/21
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/41
|
0.00%
0/41
|
0.00%
0/21
|
5.0%
1/20
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15
|
0.00%
0/16
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/41
|
0.00%
0/41
|
0.00%
0/21
|
0.00%
0/20
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/15
|
7.1%
1/14
|
0.00%
0/41
|
0.00%
0/41
|
0.00%
0/21
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/15
|
0.00%
0/14
|
2.4%
1/41
|
0.00%
0/41
|
0.00%
0/21
|
0.00%
0/20
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/41
|
0.00%
0/41
|
0.00%
0/21
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/14
|
7.1%
1/14
|
6.7%
1/15
|
0.00%
0/14
|
0.00%
0/41
|
0.00%
0/41
|
0.00%
0/21
|
0.00%
0/20
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/15
|
0.00%
0/16
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/41
|
0.00%
0/41
|
0.00%
0/21
|
0.00%
0/20
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/41
|
0.00%
0/41
|
0.00%
0/21
|
0.00%
0/20
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/14
|
6.7%
1/15
|
0.00%
0/14
|
0.00%
0/41
|
2.4%
1/41
|
0.00%
0/21
|
5.0%
1/20
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
6.7%
1/15
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/41
|
0.00%
0/41
|
0.00%
0/21
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
6.7%
1/15
|
0.00%
0/16
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/41
|
0.00%
0/41
|
0.00%
0/21
|
0.00%
0/20
|
|
General disorders
Suprapubic pain
|
0.00%
0/15
|
0.00%
0/16
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/41
|
0.00%
0/41
|
0.00%
0/21
|
0.00%
0/20
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER