Trial Outcomes & Findings for Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants (NCT NCT01215643)
NCT ID: NCT01215643
Last Updated: 2016-08-30
Results Overview
RVR4LOQ was defined as RVR \[serum hepatitis C virus (HCV) ribonucleic acid (RNA) \< the limit of quantification (LOQ), i.e., \< 25 IU/mL\], after 4 weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
340 participants
Primary outcome timeframe
after 4 weeks of treatment
Results posted on
2016-08-30
Participant Flow
Participant milestones
| Measure |
ALV 1000 mg
Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.
|
ALV 600 mg+RBV
ALV 600 mg BID with ribavirin (RBV) for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with peginterferon alfa-2a (PEG) during Weeks 2 to 24.
|
PEG+RBV
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
83
|
84
|
94
|
39
|
40
|
|
Overall Study
COMPLETED
|
74
|
80
|
82
|
35
|
29
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
12
|
4
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
Baseline characteristics by cohort
| Measure |
ALV 1000 mg
n=83 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=84 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=94 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=39 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=40 Participants
PEG and RBV during Weeks 1 to 24.
|
Total
n=340 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 11.27 • n=5 Participants
|
42.8 years
STANDARD_DEVIATION 11.77 • n=7 Participants
|
42.6 years
STANDARD_DEVIATION 11.00 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 10.56 • n=4 Participants
|
39.9 years
STANDARD_DEVIATION 11.20 • n=21 Participants
|
41.8 years
STANDARD_DEVIATION 11.25 • n=8 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
123 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
217 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: after 4 weeks of treatmentPopulation: Full Analysis Set (FAS), defined as all participants to whom study treatment was correctly assigned.
RVR4LOQ was defined as RVR \[serum hepatitis C virus (HCV) ribonucleic acid (RNA) \< the limit of quantification (LOQ), i.e., \< 25 IU/mL\], after 4 weeks of treatment.
Outcome measures
| Measure |
ALV 1000 mg
n=81 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=84 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=93 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=39 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=40 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)
|
28.4 percentage of participants
|
36.9 percentage of participants
|
41.9 percentage of participants
|
84.6 percentage of participants
|
72.5 percentage of participants
|
SECONDARY outcome
Timeframe: after 4 weeks of treatmentPopulation: Full Analysis Set
RVR4LOD was defined as Rapid Viral Response (RVR) \[serum HCV RNA \< the limit of detection (LOD), i.e., \< 10 IU/mL\], after 4 weeks of treatment.
Outcome measures
| Measure |
ALV 1000 mg
n=81 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=84 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=93 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=39 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=40 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)
|
18.5 percentage of participants
|
14.3 percentage of participants
|
23.7 percentage of participants
|
69.2 percentage of participants
|
60.0 percentage of participants
|
SECONDARY outcome
Timeframe: after 4 weeks of treatmentPopulation: Participants in the Full Analysis Set with genotype 2 HCV infection
Outcome measures
| Measure |
ALV 1000 mg
n=23 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=30 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=26 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=11 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=13 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)
RVR4LOQ
|
21.7 percentage of participants
|
23.3 percentage of participants
|
46.2 percentage of participants
|
81.8 percentage of participants
|
76.9 percentage of participants
|
|
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)
RVR4LOD
|
13.0 percentage of participants
|
10.0 percentage of participants
|
26.9 percentage of participants
|
63.6 percentage of participants
|
53.8 percentage of participants
|
SECONDARY outcome
Timeframe: after 4 weeks of treatmentPopulation: Participants in the Full Analysis Set with genotype 3 HCV infection
Outcome measures
| Measure |
ALV 1000 mg
n=58 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=54 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=67 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=28 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=27 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)
RVR4LOQ
|
31.0 percentage of participants
|
44.4 percentage of participants
|
40.3 percentage of participants
|
85.7 percentage of participants
|
70.4 percentage of participants
|
|
Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)
RVR4LOD
|
20.7 percentage of participants
|
16.7 percentage of participants
|
22.4 percentage of participants
|
71.4 percentage of participants
|
63.0 percentage of participants
|
SECONDARY outcome
Timeframe: after 12 weeks of treatmentPopulation: Full Analysis Set
cEVR12LOQ and cEVR12LOD were defined as cEVR \[serum HCV RNA \< LOQ and \< LOD\] after 12 weeks of treatment, respectively.
Outcome measures
| Measure |
ALV 1000 mg
n=81 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=84 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=93 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=39 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=40 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)
cEVR12LOQ
|
93.8 percentage of participants
|
95.2 percentage of participants
|
90.3 percentage of participants
|
94.9 percentage of participants
|
85.0 percentage of participants
|
|
Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)
cEVR12LOD
|
91.4 percentage of participants
|
86.9 percentage of participants
|
90.3 percentage of participants
|
84.6 percentage of participants
|
82.5 percentage of participants
|
SECONDARY outcome
Timeframe: after 12 weeks of treatmentPopulation: Participants in the Full Analysis Set with genotype 2 HCV infection
Outcome measures
| Measure |
ALV 1000 mg
n=23 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=30 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=26 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=11 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=13 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)
cEVR12LOQ
|
100.0 percentage of participants
|
96.7 percentage of participants
|
80.8 percentage of participants
|
100.0 percentage of participants
|
84.6 percentage of participants
|
|
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)
cEVR12LOD
|
100.0 percentage of participants
|
83.3 percentage of participants
|
80.8 percentage of participants
|
90.9 percentage of participants
|
84.6 percentage of participants
|
SECONDARY outcome
Timeframe: after 12 weeks of treatmentPopulation: Participants in the Full Analysis Set with genotype 3 HCV infection
Outcome measures
| Measure |
ALV 1000 mg
n=58 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=54 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=67 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=28 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=27 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)
cEVR12LOQ
|
91.4 percentage of participants
|
94.4 percentage of participants
|
94.0 percentage of participants
|
92.9 percentage of participants
|
85.2 percentage of participants
|
|
Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)
cEVR12LOD
|
87.9 percentage of participants
|
88.9 percentage of participants
|
94.0 percentage of participants
|
82.1 percentage of participants
|
81.5 percentage of participants
|
SECONDARY outcome
Timeframe: at end of treatment, within 24 weeksPopulation: Full Analysis Set
ETR24LOQ and ETR24LOD were defined as ETR \[serum HCV RNA \< LOQ and \< LOD\] after 24 weeks of treatment or when prematurely discontinued.
Outcome measures
| Measure |
ALV 1000 mg
n=81 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=84 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=93 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=39 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=40 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)
ETR24LOQ
|
95.1 percentage of participants
|
96.4 percentage of participants
|
95.7 percentage of participants
|
94.9 percentage of participants
|
87.5 percentage of participants
|
|
Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)
ETR24LOD
|
92.6 percentage of participants
|
94.0 percentage of participants
|
92.5 percentage of participants
|
92.3 percentage of participants
|
82.5 percentage of participants
|
SECONDARY outcome
Timeframe: at end of treatment, within 24 weeksPopulation: Participants in the Full Analysis Set with genotype 2 HCV infection
Outcome measures
| Measure |
ALV 1000 mg
n=23 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=30 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=26 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=11 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=13 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)
ETR24LOQ
|
100.0 percentage of participants
|
96.7 percentage of participants
|
84.6 percentage of participants
|
100.0 percentage of participants
|
92.3 percentage of participants
|
|
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)
ETR24LOD
|
100.0 percentage of participants
|
96.7 percentage of participants
|
76.9 percentage of participants
|
100.0 percentage of participants
|
84.6 percentage of participants
|
SECONDARY outcome
Timeframe: at end of treatment, within 24 weeksPopulation: Participants in the Full Analysis Set with genotype 3 HCV infection
Outcome measures
| Measure |
ALV 1000 mg
n=58 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=54 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=67 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=28 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=27 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)
ETR24LOQ
|
93.1 percentage of participants
|
96.3 percentage of participants
|
100.0 percentage of participants
|
92.9 percentage of participants
|
85.2 percentage of participants
|
|
Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)
ETR24LOD
|
89.7 percentage of participants
|
92.6 percentage of participants
|
98.5 percentage of participants
|
89.3 percentage of participants
|
81.5 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after the end of treatmentPopulation: Full Analysis Set
SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) \[serum HCV RNA \< LOQ and \< LOD\] 12 weeks after treatment, respectively.
Outcome measures
| Measure |
ALV 1000 mg
n=81 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=84 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=93 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=39 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=40 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)
SVR12LOQ
|
81.5 percentage of participants
|
84.5 percentage of participants
|
80.6 percentage of participants
|
76.9 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)
SVR12LOD
|
80.2 percentage of participants
|
84.5 percentage of participants
|
80.6 percentage of participants
|
74.4 percentage of participants
|
60.0 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after the end of treatmentPopulation: Participants in the Full Analysis Set with genotype 2 HCV infection
Outcome measures
| Measure |
ALV 1000 mg
n=23 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=30 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=26 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=11 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=13 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)
SVR12LOQ
|
78.3 percentage of participants
|
76.7 percentage of participants
|
76.9 percentage of participants
|
72.7 percentage of participants
|
61.5 percentage of participants
|
|
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)
SVR12LOD
|
78.3 percentage of participants
|
76.7 percentage of participants
|
76.9 percentage of participants
|
72.7 percentage of participants
|
53.8 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after the end of treatmentPopulation: Participants in the Full Analysis Set with genotype 3 HCV infection
Outcome measures
| Measure |
ALV 1000 mg
n=58 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=54 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=67 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=28 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=27 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)
SVR12LOQ
|
82.8 percentage of participants
|
88.9 percentage of participants
|
82.1 percentage of participants
|
78.6 percentage of participants
|
63.0 percentage of participants
|
|
Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)
SVR12LOD
|
81.0 percentage of participants
|
88.9 percentage of participants
|
82.1 percentage of participants
|
75.0 percentage of participants
|
63.0 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeks after the end of treatmentPopulation: Full Analysis Set
Outcome measures
| Measure |
ALV 1000 mg
n=81 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=84 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=93 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=39 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=40 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)
SVR24LOD
|
80.2 percentage of participants
|
84.5 percentage of participants
|
79.6 percentage of participants
|
79.5 percentage of participants
|
57.5 percentage of participants
|
|
Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)
SVR24LOQ
|
80.2 percentage of participants
|
84.5 percentage of participants
|
80.6 percentage of participants
|
79.5 percentage of participants
|
57.5 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeks after the end of treatmentPopulation: Participants in the Full Analysis Set with genotype 2 HCV infection
Outcome measures
| Measure |
ALV 1000 mg
n=23 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=30 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=26 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=11 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=13 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)
SVR24LOQ
|
78.3 percentage of participants
|
76.7 percentage of participants
|
76.9 percentage of participants
|
72.7 percentage of participants
|
53.8 percentage of participants
|
|
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)
SVR24LOD
|
78.3 percentage of participants
|
76.7 percentage of participants
|
76.9 percentage of participants
|
72.7 percentage of participants
|
53.8 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeks after the end of treatmentPopulation: Participants in the Full Analysis Set with genotype 3 HCV infection
Outcome measures
| Measure |
ALV 1000 mg
n=58 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=54 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=67 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=28 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=27 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)
SVR24LOQ
|
81.0 percentage of participants
|
88.9 percentage of participants
|
82.1 percentage of participants
|
82.1 percentage of participants
|
59.3 percentage of participants
|
|
Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)
SVR24LOD
|
81.0 percentage of participants
|
88.9 percentage of participants
|
80.6 percentage of participants
|
82.1 percentage of participants
|
59.3 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 weeks of treatmentPopulation: Full Analysis Set
Viral breakthrough was defined as either: * Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or * HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (\< LOD) during treatment
Outcome measures
| Measure |
ALV 1000 mg
n=81 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=84 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=93 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=39 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=40 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With On-treatment Viral Breakthrough
|
2.5 percentage of participants
|
3.6 percentage of participants
|
2.2 percentage of participants
|
5.1 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: within 24 weeks after the end of treatmentPopulation: Full Analysis Set
Viral relapse was defined as having reappearance of detectable HCV RNA after previously being undetectable (\< LOD) during treatment.
Outcome measures
| Measure |
ALV 1000 mg
n=81 Participants
ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV
n=84 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV
n=93 Participants
ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG
n=39 Participants
ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV
n=40 Participants
PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Viral Relapse
0 to 12 weeks after the end of treatment
|
9.9 percentage of participants
|
8.3 percentage of participants
|
6.5 percentage of participants
|
10.3 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Viral Relapse
12 to 24 weeks after the end of treatment
|
1.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
5.0 percentage of participants
|
Adverse Events
ALV 1000 mg: On-treatment AEs
Serious events: 4 serious events
Other events: 64 other events
Deaths: 0 deaths
ALV 600 mg+RBV: On-treatment AEs
Serious events: 1 serious events
Other events: 69 other events
Deaths: 0 deaths
ALV 800 mg+RBV: On-treatment AEs
Serious events: 9 serious events
Other events: 76 other events
Deaths: 0 deaths
ALV 600 mg+PEG: On-treatment AEs
Serious events: 4 serious events
Other events: 37 other events
Deaths: 0 deaths
PEG+RBV: On-treatment AEs
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
ALV 1000 mg: Post-treatment AEs
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
ALV 600 mg+RBV: Post-treatment AEs
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
ALV 800 mg+RBV: Post-treatment AEs
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
ALV 600 mg+PEG: Post-treatment AEs
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PEG+RBV: Post-treatment AEs
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ALV 1000 mg: On-treatment AEs
n=82 participants at risk
Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV: On-treatment AEs
n=84 participants at risk
AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV: On-treatment AEs
n=94 participants at risk
AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG: On-treatment AEs
n=39 participants at risk
AEs occurring while on treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV: On-treatment AEs
n=37 participants at risk
AEs occurring while on treatment in participants receiving PEG and RBV during Weeks 1 to 24.
|
ALV 1000 mg: Post-treatment AEs
n=82 participants at risk
AEs occurring after end of treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV: Post-treatment AEs
n=84 participants at risk
AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV: Post-treatment AEs
n=94 participants at risk
AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG: Post-treatment AEs
n=39 participants at risk
AEs occurring after end of treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV: Post-treatment AEs
n=37 participants at risk
AEs occurring after end of treatment in participants receiving PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
1.2%
1/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
1.2%
1/82
|
1.2%
1/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Eye disorders
Retinopathy
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
1/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.2%
1/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Infections and infestations
Cellulitis
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Infections and infestations
Muscle abscess
|
1.2%
1/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Infections and infestations
Pneumonia
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
2.7%
1/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
1.2%
1/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Injury, poisoning and procedural complications
Maternal exposure during pregnancy
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
2.7%
1/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
1.2%
1/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/82
|
1.2%
1/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
1.2%
1/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
1.2%
1/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Psychiatric disorders
Homicidal ideation
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Psychiatric disorders
Major depression
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
1.2%
1/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
1.2%
1/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Vascular disorders
Hypertension
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
Other adverse events
| Measure |
ALV 1000 mg: On-treatment AEs
n=82 participants at risk
Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV: On-treatment AEs
n=84 participants at risk
AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV: On-treatment AEs
n=94 participants at risk
AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG: On-treatment AEs
n=39 participants at risk
AEs occurring while on treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV: On-treatment AEs
n=37 participants at risk
AEs occurring while on treatment in participants receiving PEG and RBV during Weeks 1 to 24.
|
ALV 1000 mg: Post-treatment AEs
n=82 participants at risk
AEs occurring after end of treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
|
ALV 600 mg+RBV: Post-treatment AEs
n=84 participants at risk
AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
|
ALV 800 mg+RBV: Post-treatment AEs
n=94 participants at risk
AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
|
ALV 600 mg+PEG: Post-treatment AEs
n=39 participants at risk
AEs occurring after end of treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
|
PEG+RBV: Post-treatment AEs
n=37 participants at risk
AEs occurring after end of treatment in participants receiving PEG and RBV during Weeks 1 to 24.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.8%
8/82
|
13.1%
11/84
|
10.6%
10/94
|
10.3%
4/39
|
8.1%
3/37
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.7%
3/82
|
2.4%
2/84
|
2.1%
2/94
|
5.1%
2/39
|
8.1%
3/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.0%
9/82
|
9.5%
8/84
|
13.8%
13/94
|
25.6%
10/39
|
10.8%
4/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/82
|
6.0%
5/84
|
3.2%
3/94
|
15.4%
6/39
|
5.4%
2/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Cardiac disorders
Palpitations
|
0.00%
0/82
|
2.4%
2/84
|
6.4%
6/94
|
2.6%
1/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Cardiac disorders
Tachycardia
|
2.4%
2/82
|
2.4%
2/84
|
4.3%
4/94
|
5.1%
2/39
|
5.4%
2/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
5.4%
2/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Ear and labyrinth disorders
Vertigo
|
1.2%
1/82
|
1.2%
1/84
|
1.1%
1/94
|
0.00%
0/39
|
5.4%
2/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
2.6%
1/39
|
0.00%
0/37
|
|
Endocrine disorders
Hyperthyroidism
|
1.2%
1/82
|
2.4%
2/84
|
1.1%
1/94
|
5.1%
2/39
|
0.00%
0/37
|
1.2%
1/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Endocrine disorders
Hypothyroidism
|
2.4%
2/82
|
1.2%
1/84
|
3.2%
3/94
|
10.3%
4/39
|
0.00%
0/37
|
1.2%
1/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
5.1%
2/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Gastrointestinal disorders
Abdominal distension
|
3.7%
3/82
|
6.0%
5/84
|
6.4%
6/94
|
7.7%
3/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
6/82
|
4.8%
4/84
|
7.4%
7/94
|
5.1%
2/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.3%
6/82
|
7.1%
6/84
|
7.4%
7/94
|
5.1%
2/39
|
2.7%
1/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Gastrointestinal disorders
Constipation
|
6.1%
5/82
|
6.0%
5/84
|
8.5%
8/94
|
7.7%
3/39
|
0.00%
0/37
|
2.4%
2/82
|
1.2%
1/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Gastrointestinal disorders
Diarrhoea
|
15.9%
13/82
|
7.1%
6/84
|
10.6%
10/94
|
23.1%
9/39
|
2.7%
1/37
|
1.2%
1/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
3/82
|
2.4%
2/84
|
3.2%
3/94
|
5.1%
2/39
|
2.7%
1/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Gastrointestinal disorders
Dyspepsia
|
8.5%
7/82
|
9.5%
8/84
|
7.4%
7/94
|
0.00%
0/39
|
2.7%
1/37
|
1.2%
1/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/82
|
2.4%
2/84
|
0.00%
0/94
|
5.1%
2/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.1%
5/82
|
0.00%
0/84
|
3.2%
3/94
|
10.3%
4/39
|
5.4%
2/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Gastrointestinal disorders
Nausea
|
20.7%
17/82
|
17.9%
15/84
|
24.5%
23/94
|
23.1%
9/39
|
13.5%
5/37
|
0.00%
0/82
|
1.2%
1/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Gastrointestinal disorders
Vomiting
|
8.5%
7/82
|
8.3%
7/84
|
7.4%
7/94
|
5.1%
2/39
|
5.4%
2/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
General disorders
Asthenia
|
12.2%
10/82
|
8.3%
7/84
|
11.7%
11/94
|
7.7%
3/39
|
21.6%
8/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
General disorders
Chills
|
6.1%
5/82
|
3.6%
3/84
|
5.3%
5/94
|
10.3%
4/39
|
2.7%
1/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
General disorders
Fatigue
|
25.6%
21/82
|
27.4%
23/84
|
31.9%
30/94
|
46.2%
18/39
|
27.0%
10/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
General disorders
Feeling cold
|
0.00%
0/82
|
0.00%
0/84
|
2.1%
2/94
|
0.00%
0/39
|
5.4%
2/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
General disorders
Influenza like illness
|
9.8%
8/82
|
7.1%
6/84
|
9.6%
9/94
|
20.5%
8/39
|
10.8%
4/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
General disorders
Injection site erythema
|
2.4%
2/82
|
0.00%
0/84
|
0.00%
0/94
|
5.1%
2/39
|
5.4%
2/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
General disorders
Irritability
|
2.4%
2/82
|
6.0%
5/84
|
8.5%
8/94
|
5.1%
2/39
|
5.4%
2/37
|
0.00%
0/82
|
1.2%
1/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
General disorders
Malaise
|
2.4%
2/82
|
3.6%
3/84
|
0.00%
0/94
|
5.1%
2/39
|
5.4%
2/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
General disorders
Pain
|
3.7%
3/82
|
3.6%
3/84
|
5.3%
5/94
|
5.1%
2/39
|
2.7%
1/37
|
1.2%
1/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
General disorders
Pyrexia
|
17.1%
14/82
|
19.0%
16/84
|
16.0%
15/94
|
30.8%
12/39
|
24.3%
9/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
3.7%
3/82
|
2.4%
2/84
|
5.3%
5/94
|
0.00%
0/39
|
5.4%
2/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/82
|
0.00%
0/84
|
2.1%
2/94
|
2.6%
1/39
|
5.4%
2/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Infections and infestations
Nasopharyngitis
|
6.1%
5/82
|
4.8%
4/84
|
5.3%
5/94
|
0.00%
0/39
|
0.00%
0/37
|
0.00%
0/82
|
1.2%
1/84
|
1.1%
1/94
|
2.6%
1/39
|
0.00%
0/37
|
|
Infections and infestations
Upper respiratory tract infection
|
2.4%
2/82
|
3.6%
3/84
|
4.3%
4/94
|
10.3%
4/39
|
8.1%
3/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
2.6%
1/39
|
0.00%
0/37
|
|
Infections and infestations
Urinary tract infection
|
6.1%
5/82
|
1.2%
1/84
|
1.1%
1/94
|
0.00%
0/39
|
5.4%
2/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
5.1%
2/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.2%
1/82
|
1.2%
1/84
|
1.1%
1/94
|
5.1%
2/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
5.1%
2/39
|
8.1%
3/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Investigations
Platelet count decreased
|
1.2%
1/82
|
3.6%
3/84
|
2.1%
2/94
|
5.1%
2/39
|
2.7%
1/37
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Investigations
Weight decreased
|
4.9%
4/82
|
2.4%
2/84
|
4.3%
4/94
|
7.7%
3/39
|
10.8%
4/37
|
0.00%
0/82
|
1.2%
1/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.3%
15/82
|
16.7%
14/84
|
14.9%
14/94
|
25.6%
10/39
|
24.3%
9/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.0%
9/82
|
2.4%
2/84
|
16.0%
15/94
|
25.6%
10/39
|
13.5%
5/37
|
2.4%
2/82
|
3.6%
3/84
|
2.1%
2/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
5/82
|
4.8%
4/84
|
10.6%
10/94
|
10.3%
4/39
|
0.00%
0/37
|
1.2%
1/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.9%
4/82
|
3.6%
3/84
|
3.2%
3/94
|
5.1%
2/39
|
2.7%
1/37
|
1.2%
1/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.1%
5/82
|
3.6%
3/84
|
0.00%
0/94
|
0.00%
0/39
|
2.7%
1/37
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.2%
10/82
|
8.3%
7/84
|
13.8%
13/94
|
20.5%
8/39
|
21.6%
8/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
2.7%
1/37
|
|
Nervous system disorders
Disturbance in attention
|
3.7%
3/82
|
1.2%
1/84
|
4.3%
4/94
|
5.1%
2/39
|
2.7%
1/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Nervous system disorders
Dizziness
|
7.3%
6/82
|
13.1%
11/84
|
17.0%
16/94
|
12.8%
5/39
|
10.8%
4/37
|
1.2%
1/82
|
0.00%
0/84
|
1.1%
1/94
|
2.6%
1/39
|
0.00%
0/37
|
|
Nervous system disorders
Dysgeusia
|
4.9%
4/82
|
3.6%
3/84
|
3.2%
3/94
|
5.1%
2/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Nervous system disorders
Headache
|
23.2%
19/82
|
21.4%
18/84
|
28.7%
27/94
|
41.0%
16/39
|
18.9%
7/37
|
0.00%
0/82
|
1.2%
1/84
|
0.00%
0/94
|
0.00%
0/39
|
2.7%
1/37
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/82
|
2.4%
2/84
|
1.1%
1/94
|
5.1%
2/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Nervous system disorders
Memory impairment
|
1.2%
1/82
|
1.2%
1/84
|
2.1%
2/94
|
5.1%
2/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Nervous system disorders
Paraesthesia
|
1.2%
1/82
|
1.2%
1/84
|
3.2%
3/94
|
5.1%
2/39
|
2.7%
1/37
|
0.00%
0/82
|
1.2%
1/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Nervous system disorders
Somnolence
|
2.4%
2/82
|
1.2%
1/84
|
1.1%
1/94
|
10.3%
4/39
|
2.7%
1/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Nervous system disorders
Syncope
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
7.7%
3/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
2.6%
1/39
|
0.00%
0/37
|
|
Psychiatric disorders
Anxiety
|
9.8%
8/82
|
10.7%
9/84
|
5.3%
5/94
|
2.6%
1/39
|
13.5%
5/37
|
1.2%
1/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Psychiatric disorders
Depressed mood
|
2.4%
2/82
|
2.4%
2/84
|
3.2%
3/94
|
5.1%
2/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Psychiatric disorders
Depression
|
14.6%
12/82
|
8.3%
7/84
|
9.6%
9/94
|
7.7%
3/39
|
8.1%
3/37
|
0.00%
0/82
|
0.00%
0/84
|
4.3%
4/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Psychiatric disorders
Insomnia
|
13.4%
11/82
|
14.3%
12/84
|
14.9%
14/94
|
10.3%
4/39
|
16.2%
6/37
|
0.00%
0/82
|
2.4%
2/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Psychiatric disorders
Sleep disorder
|
2.4%
2/82
|
4.8%
4/84
|
3.2%
3/94
|
5.1%
2/39
|
2.7%
1/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.4%
11/82
|
15.5%
13/84
|
12.8%
12/94
|
7.7%
3/39
|
10.8%
4/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
3/82
|
7.1%
6/84
|
3.2%
3/94
|
5.1%
2/39
|
5.4%
2/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.2%
1/82
|
7.1%
6/84
|
4.3%
4/94
|
2.6%
1/39
|
8.1%
3/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
6.1%
5/82
|
2.4%
2/84
|
5.3%
5/94
|
5.1%
2/39
|
2.7%
1/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/82
|
1.2%
1/84
|
1.1%
1/94
|
5.1%
2/39
|
2.7%
1/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.2%
10/82
|
9.5%
8/84
|
4.3%
4/94
|
23.1%
9/39
|
18.9%
7/37
|
0.00%
0/82
|
1.2%
1/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.8%
8/82
|
6.0%
5/84
|
6.4%
6/94
|
7.7%
3/39
|
8.1%
3/37
|
1.2%
1/82
|
1.2%
1/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.4%
2/82
|
0.00%
0/84
|
2.1%
2/94
|
0.00%
0/39
|
8.1%
3/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/82
|
1.2%
1/84
|
2.1%
2/94
|
5.1%
2/39
|
0.00%
0/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
0.00%
0/39
|
0.00%
0/37
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.1%
14/82
|
16.7%
14/84
|
12.8%
12/94
|
17.9%
7/39
|
16.2%
6/37
|
1.2%
1/82
|
0.00%
0/84
|
0.00%
0/94
|
2.6%
1/39
|
0.00%
0/37
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.4%
11/82
|
10.7%
9/84
|
14.9%
14/94
|
5.1%
2/39
|
8.1%
3/37
|
0.00%
0/82
|
0.00%
0/84
|
0.00%
0/94
|
2.6%
1/39
|
0.00%
0/37
|
|
Vascular disorders
Hypertension
|
11.0%
9/82
|
11.9%
10/84
|
8.5%
8/94
|
12.8%
5/39
|
2.7%
1/37
|
0.00%
0/82
|
0.00%
0/84
|
1.1%
1/94
|
0.00%
0/39
|
0.00%
0/37
|
Additional Information
Vice President Clinical Research & Development
Debiopharm International S.A.
Phone: 4121 321 01 11
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER