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Trial Outcomes & Findings for SMV + SOF With/Without RBV for IFN-II Patients With CHC (NCT NCT02214420)

NCT ID: NCT02214420

Last Updated: 2018-06-19

Results Overview

Comparison of sustained virologic response at 12 weeks post-treatment (SVR12) in 2 arms of IFN-II patients: one receiving 12 weeks of simeprevir (SMV) (150mg QD)+ sofosbuvir (SOF) (400mg QD) and the second receiving to SMV (150mg QD)+SOF (400mg QD)+weight-based ribavirin (RBV) 1000-1200 mg/day. SVR12 is defined as a patient having undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks post-treatment. Achieving SVR12 is generally indicative of hepatitis C infection being cured.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-06-19

Participant Flow

Participant milestones

Participant milestones
Measure
SMV+SOF
Interferon (IFN)-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) Simeprevir Sofosbuvir
SMV+SOF+RBV
Interferon (IFN)-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day Simeprevir Sofosbuvir Ribavirin
Overall Study
STARTED
14
10
Overall Study
COMPLETED
13
10
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SMV + SOF With/Without RBV for IFN-II Patients With CHC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
SMV+SOF
n=14 Participants
IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) Simeprevir Sofosbuvir
SMV+SOF+RBV
n=10 Participants
IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day Simeprevir Sofosbuvir Ribavirin
Total
n=24 Participants
Total of all reporting groups
Age, Continuous
50.84 years
n=5 Participants
58.31 years
n=7 Participants
53.95 years
n=5 Participants
Sex: Female, Male
Female
9 Participants
n=5 Participants
3 Participants
n=7 Participants
12 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
7 Participants
n=7 Participants
12 Participants
n=5 Participants
BMI
29.47 kg/m^2
n=5 Participants
27.56 kg/m^2
n=7 Participants
28.67 kg/m^2
n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Comparison of sustained virologic response at 12 weeks post-treatment (SVR12) in 2 arms of IFN-II patients: one receiving 12 weeks of simeprevir (SMV) (150mg QD)+ sofosbuvir (SOF) (400mg QD) and the second receiving to SMV (150mg QD)+SOF (400mg QD)+weight-based ribavirin (RBV) 1000-1200 mg/day. SVR12 is defined as a patient having undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks post-treatment. Achieving SVR12 is generally indicative of hepatitis C infection being cured.

Outcome measures

Outcome measures
Measure
SMV+SOF
n=14 Participants
IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) Simeprevir Sofosbuvir
SMV+SOF+RBV
n=10 Participants
IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day Simeprevir Sofosbuvir Ribavirin
Sustained Viral Response
13 Participants
8 Participants

Adverse Events

SMV+SOF

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

SMV+SOF+RBV

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
SMV+SOF
n=14 participants at risk
IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) Simeprevir Sofosbuvir
SMV+SOF+RBV
n=10 participants at risk
IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day Simeprevir Sofosbuvir Ribavirin
Gastrointestinal disorders
Nausea or other GI discomfort
71.4%
10/14
30.0%
3/10
Nervous system disorders
Fatigue
35.7%
5/14
40.0%
4/10
Nervous system disorders
Headache
21.4%
3/14
0.00%
0/10
Respiratory, thoracic and mediastinal disorders
Cough and cold symptoms
21.4%
3/14
30.0%
3/10
Skin and subcutaneous tissue disorders
Photosensitivity
14.3%
2/14
0.00%
0/10
Ear and labyrinth disorders
Dizziness
7.1%
1/14
20.0%
2/10
Musculoskeletal and connective tissue disorders
Myalgia
14.3%
2/14
0.00%
0/10
Skin and subcutaneous tissue disorders
Pruritis or rash
14.3%
2/14
10.0%
1/10

Additional Information

Dr. Paul Pockros

Scripps Clinic

Phone: (858) 554-8879

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place