Trial Outcomes & Findings for The SIM-SOF Trial for Hepatitis C (NCT NCT02168361)
NCT ID: NCT02168361
Last Updated: 2016-03-14
Results Overview
Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
93 participants
Primary outcome timeframe
12 weeks post-therapy
Results posted on
2016-03-14
Participant Flow
Participant milestones
| Measure |
All Oral Therapy
Simeprevir-sofosbuvir
|
Interferon-containing Arm
Peginterferon/ribavirin/sofosbuvir
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
31
|
|
Overall Study
COMPLETED
|
57
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The SIM-SOF Trial for Hepatitis C
Baseline characteristics by cohort
| Measure |
Oral Therapy Arm
n=58 Participants
|
Interferon-containing Arm
n=24 Participants
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Younger than 18 years old
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
18 years or older
|
58 participants
n=5 Participants
|
24 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post-therapyPopulation: All participants that received at least a single dose of medication
Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy
Outcome measures
| Measure |
All Oral Therapy
n=58 Participants
Simeprevir-sofosbuvir
|
Interferon-containing Arm
n=24 Participants
Peginterferon/ribavirin/sofosbuvir
|
|---|---|---|
|
Proportion of Participants With Sustained Virologic Response 12 (SVR-12)
|
54 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 4 and 12 weeks into therapyPopulation: All participants that received at least a single dose of medication
Outcome measures
| Measure |
All Oral Therapy
n=58 Participants
Simeprevir-sofosbuvir
|
Interferon-containing Arm
n=24 Participants
Peginterferon/ribavirin/sofosbuvir
|
|---|---|---|
|
Serum HCV RNA Level
Serum HCV RNA level at 4 weeks
|
154 IU/ml
Interval 0.0 to 3000.0
|
880 IU/ml
Interval 0.0 to 8500.0
|
|
Serum HCV RNA Level
Serum HCV RNA level at 8 weeks
|
31 IU/ml
Interval 0.0 to 112.0
|
740 IU/ml
Interval 0.0 to 6050.0
|
Adverse Events
All Oral
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Interferon-containing
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Oral
n=58 participants at risk
|
Interferon-containing
n=24 participants at risk
|
|---|---|---|
|
Hepatobiliary disorders
liver decompensation
|
0.00%
0/58
|
4.2%
1/24 • Number of events 1
|
Other adverse events
| Measure |
All Oral
n=58 participants at risk
|
Interferon-containing
n=24 participants at risk
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
17.2%
10/58
|
12.5%
3/24
|
|
Skin and subcutaneous tissue disorders
pruritus
|
10.3%
6/58
|
16.7%
4/24
|
|
Nervous system disorders
insomnia
|
5.2%
3/58
|
25.0%
6/24
|
|
Gastrointestinal disorders
nausea
|
10.3%
6/58
|
29.2%
7/24
|
|
General disorders
fatigue
|
13.8%
8/58
|
70.8%
17/24
|
|
Nervous system disorders
headache
|
12.1%
7/58
|
33.3%
8/24
|
|
Gastrointestinal disorders
asthenia
|
0.00%
0/58
|
16.7%
4/24
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/58
|
8.3%
2/24
|
|
General disorders
fever
|
0.00%
0/58
|
20.8%
5/24
|
|
General disorders
flu like illness
|
0.00%
0/58
|
25.0%
6/24
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
3.4%
2/58
|
16.7%
4/24
|
|
Gastrointestinal disorders
diarrhea
|
1.7%
1/58
|
8.3%
2/24
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
irritability
|
1.7%
1/58
|
12.5%
3/24
|
|
Blood and lymphatic system disorders
neutropenia (500-750/mm3)
|
0.00%
0/58
|
16.7%
4/24
|
|
Blood and lymphatic system disorders
anemia
|
1.7%
1/58
|
37.5%
9/24
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/58
|
12.5%
3/24
|
|
Hepatobiliary disorders
high bilirubin
|
6.9%
4/58
|
0.00%
0/24
|
|
Gastrointestinal disorders
high amylase
|
20.7%
12/58
|
0.00%
0/24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place