Trial Outcomes & Findings for Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection (NCT NCT01641640)
NCT ID: NCT01641640
Last Updated: 2014-05-08
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
328 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2014-05-08
Participant Flow
Subjects were enrolled in a total of 55 study sites in the United States. The first participant was screened on 18 June 2012. The last participant observation was on 16 April 2013.
456 participants were screened and 328 were enrolled; 327 participants were treated, and comprise the Safety Analysis Set and the Full Analysis Set.
Participant milestones
| Measure |
Sofosbuvir+PEG+RBV
Participants received Sofosbuvir+pegylated interferon alfa 2a (PEG)+ribavirin (RBV) for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets.
|
|---|---|
|
Overall Study
STARTED
|
328
|
|
Overall Study
Enrolled and Treated
|
327
|
|
Overall Study
COMPLETED
|
292
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
Sofosbuvir+PEG+RBV
Participants received Sofosbuvir+pegylated interferon alfa 2a (PEG)+ribavirin (RBV) for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets.
|
|---|---|
|
Overall Study
Enrolled but not treated
|
1
|
|
Overall Study
Efficacy failure
|
29
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
Baseline characteristics by cohort
| Measure |
Sofosbuvir+PEG+RBV
n=327 Participants
Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets.
|
|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
209 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
46 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
281 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
54 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
257 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian/ Alaska Native/ First Nations
|
6 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hawaiian or Pacific Islander
|
2 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
|
Hepatitis C Virus (HCV) genotype
Genotype 1a/1b
|
1 participants
n=99 Participants
|
|
Hepatitis C Virus (HCV) genotype
Genotype 1a
|
225 participants
n=99 Participants
|
|
Hepatitis C Virus (HCV) genotype
Genotype 1b
|
66 participants
n=99 Participants
|
|
Hepatitis C Virus (HCV) genotype
Genotype 4
|
28 participants
n=99 Participants
|
|
Hepatitis C Virus (HCV) genotype
Genotype 5
|
1 participants
n=99 Participants
|
|
Hepatitis C Virus (HCV) genotype
Genotype 6
|
6 participants
n=99 Participants
|
|
HCV RNA
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.67 • n=99 Participants
|
|
HCV RNA Category
< 6 log10 IU/mL
|
71 participants
n=99 Participants
|
|
HCV RNA Category
≥ 6 log10 IU/mL
|
256 participants
n=99 Participants
|
|
IL28 Genotype
CC
|
95 participants
n=99 Participants
|
|
IL28 Genotype
CT
|
181 participants
n=99 Participants
|
|
IL28 Genotype
TT
|
51 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.
Outcome measures
| Measure |
Sofosbuvir+PEG+RBV
n=327 Participants
Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets.
|
|---|---|
|
Percentage of Participants Achieving Sustained Virologic Response (SVR)12
|
91 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Safety Analysis Set
The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments.
Outcome measures
| Measure |
Sofosbuvir+PEG+RBV
n=327 Participants
Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets.
|
|---|---|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Anaemia
|
2 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Haemolytic anaemia
|
1 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Neutropenia
|
1 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Vision blurred
|
1 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Blood creatinine increased
|
1 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Haemoglobin abnormal
|
1 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Dermatitis
|
1 participants
|
SECONDARY outcome
Timeframe: Posttreatment Week 4Population: Full Analysis Set
SVR4 was defined as HCV RNA \< LLOQ 4 weeks after cessation of therapy
Outcome measures
| Measure |
Sofosbuvir+PEG+RBV
n=327 Participants
Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets.
|
|---|---|
|
Percentage of Participants Achieving SVR4
|
92.4 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Week 24Population: Full Analysis Set
SVR24 was defined as HCV RNA \< LLOQ 24 weeks after cessation of therapy
Outcome measures
| Measure |
Sofosbuvir+PEG+RBV
n=327 Participants
Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets.
|
|---|---|
|
Percentage of Participants Achieving SVR24
|
90.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Full Analysis Set
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.
Outcome measures
| Measure |
Sofosbuvir+PEG+RBV
n=327 Participants
Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets.
|
|---|---|
|
Percentage of Participants With Viral Breakthrough
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: End of treatment to post-treatment Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
Outcome measures
| Measure |
Sofosbuvir+PEG+RBV
n=326 Participants
Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets.
|
|---|---|
|
Percentage of Participants With Viral Relapse
|
8.6 percentage of participants
|
Adverse Events
Sofosbuvir+PEG+RBV
Serious events: 4 serious events
Other events: 310 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sofosbuvir+PEG+RBV
n=327 participants at risk
Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.31%
1/327 • Baseline to Week 12 plus 30 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.31%
1/327 • Baseline to Week 12 plus 30 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.31%
1/327 • Baseline to Week 12 plus 30 days
|
|
General disorders
Non-cardiac chest pain
|
0.31%
1/327 • Baseline to Week 12 plus 30 days
|
|
General disorders
Pyrexia
|
0.31%
1/327 • Baseline to Week 12 plus 30 days
|
|
Immune system disorders
Cryoglobulonaemia
|
0.31%
1/327 • Baseline to Week 12 plus 30 days
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.31%
1/327 • Baseline to Week 12 plus 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.31%
1/327 • Baseline to Week 12 plus 30 days
|
Other adverse events
| Measure |
Sofosbuvir+PEG+RBV
n=327 participants at risk
Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.
Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.8%
68/327 • Baseline to Week 12 plus 30 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.5%
54/327 • Baseline to Week 12 plus 30 days
|
|
Gastrointestinal disorders
Nausea
|
34.3%
112/327 • Baseline to Week 12 plus 30 days
|
|
Gastrointestinal disorders
Diarrhoea
|
11.9%
39/327 • Baseline to Week 12 plus 30 days
|
|
Gastrointestinal disorders
Vomiting
|
11.9%
39/327 • Baseline to Week 12 plus 30 days
|
|
Gastrointestinal disorders
Constipation
|
6.1%
20/327 • Baseline to Week 12 plus 30 days
|
|
General disorders
Fatigue
|
59.3%
194/327 • Baseline to Week 12 plus 30 days
|
|
General disorders
Pyrexia
|
17.4%
57/327 • Baseline to Week 12 plus 30 days
|
|
General disorders
Chills
|
16.5%
54/327 • Baseline to Week 12 plus 30 days
|
|
General disorders
Influenza like illness
|
15.6%
51/327 • Baseline to Week 12 plus 30 days
|
|
General disorders
Irritability
|
13.1%
43/327 • Baseline to Week 12 plus 30 days
|
|
General disorders
Pain
|
10.1%
33/327 • Baseline to Week 12 plus 30 days
|
|
General disorders
Injection site reaction
|
8.3%
27/327 • Baseline to Week 12 plus 30 days
|
|
General disorders
Injection site erythema
|
6.4%
21/327 • Baseline to Week 12 plus 30 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.7%
58/327 • Baseline to Week 12 plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.4%
47/327 • Baseline to Week 12 plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.8%
45/327 • Baseline to Week 12 plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
19/327 • Baseline to Week 12 plus 30 days
|
|
Nervous system disorders
Headache
|
36.1%
118/327 • Baseline to Week 12 plus 30 days
|
|
Nervous system disorders
Dizziness
|
12.5%
41/327 • Baseline to Week 12 plus 30 days
|
|
Psychiatric disorders
Insomnia
|
24.8%
81/327 • Baseline to Week 12 plus 30 days
|
|
Psychiatric disorders
Depression
|
9.5%
31/327 • Baseline to Week 12 plus 30 days
|
|
Psychiatric disorders
Anxiety
|
8.0%
26/327 • Baseline to Week 12 plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.2%
40/327 • Baseline to Week 12 plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.4%
34/327 • Baseline to Week 12 plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.2%
17/327 • Baseline to Week 12 plus 30 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.3%
60/327 • Baseline to Week 12 plus 30 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.1%
56/327 • Baseline to Week 12 plus 30 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.7%
22/327 • Baseline to Week 12 plus 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER