Trial Outcomes & Findings for Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon (NCT NCT01542788)
NCT ID: NCT01542788
Last Updated: 2014-05-19
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
278 participants
Primary outcome timeframe
Post-treatment Week 12
Results posted on
2014-05-19
Participant Flow
Participants were enrolled at 54 sites in the North America, Australia, and New Zealand. The first participant was screened on 07 March 2012. The last participant observation was on 04 February 2013.
410 participants were screened and 280 were randomized. Of those participants randomized, 278 received at least one dose of study drug, and comprise the Safety Analysis Set and the Full Analysis Set.
Participant milestones
| Measure |
SOF+RBV
Participants were randomized to receive sofosbuvir (SOF)+ribavirin (RBV) for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
|
Placebo
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
|
|---|---|---|
|
Overall Study
STARTED
|
209
|
71
|
|
Overall Study
Randomized and Treated
|
207
|
71
|
|
Overall Study
COMPLETED
|
154
|
0
|
|
Overall Study
NOT COMPLETED
|
55
|
71
|
Reasons for withdrawal
| Measure |
SOF+RBV
Participants were randomized to receive sofosbuvir (SOF)+ribavirin (RBV) for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
|
Placebo
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
|
|---|---|---|
|
Overall Study
Randomized but Not Treated
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
41
|
71
|
|
Overall Study
Lost to Follow-up
|
5
|
0
|
|
Overall Study
Death
|
3
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon
Baseline characteristics by cohort
| Measure |
SOF+RBV
n=207 Participants
Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
|
Placebo
n=71 Participants
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
|
Total
n=278 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
52 years
STANDARD_DEVIATION 8.2 • n=107 Participants
|
52 years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
151 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
188 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
248 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
188 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
254 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
168 participants
n=99 Participants
|
60 participants
n=107 Participants
|
228 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
15 participants
n=99 Participants
|
8 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
18 participants
n=99 Participants
|
3 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Region of Enrollment
New Zealand
|
6 participants
n=99 Participants
|
0 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Cirrhosis
No
|
176 participants
n=99 Participants
|
58 participants
n=107 Participants
|
234 participants
n=206 Participants
|
|
Cirrhosis
Yes
|
31 participants
n=99 Participants
|
13 participants
n=107 Participants
|
44 participants
n=206 Participants
|
|
HCV Genotype
Genotype 2
|
109 participants
n=99 Participants
|
34 participants
n=107 Participants
|
143 participants
n=206 Participants
|
|
HCV Genotype
Genotype 3
|
98 participants
n=99 Participants
|
37 participants
n=107 Participants
|
135 participants
n=206 Participants
|
|
IL28 Genotype
CC
|
97 participants
n=99 Participants
|
29 participants
n=107 Participants
|
126 participants
n=206 Participants
|
|
IL28 Genotype
CT
|
84 participants
n=99 Participants
|
36 participants
n=107 Participants
|
120 participants
n=206 Participants
|
|
IL28 Genotype
TT
|
26 participants
n=99 Participants
|
6 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
HCV RNA
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.77 • n=99 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.76 • n=107 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.77 • n=206 Participants
|
|
HCV RNA Category
< 6 log10 IU/mL
|
67 participants
n=99 Participants
|
17 participants
n=107 Participants
|
84 participants
n=206 Participants
|
|
HCV RNA Category
≥ 6 log10 IU/mL
|
140 participants
n=99 Participants
|
54 participants
n=107 Participants
|
194 participants
n=206 Participants
|
|
Interferon Classification
Ineligible
|
88 participants
n=99 Participants
|
33 participants
n=107 Participants
|
121 participants
n=206 Participants
|
|
Interferon Classification
Intolerant
|
17 participants
n=99 Participants
|
8 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Interferon Classification
Unwilling
|
102 participants
n=99 Participants
|
30 participants
n=107 Participants
|
132 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Post-treatment Week 12Population: Full Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized into the study and received at least 1 dose of study drug
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 |
SOF+RBV
n=207 Participants
Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
|
Placebo
n=71 Participants
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
|
|---|---|---|
|
Percentage of Participants Achieving SVR12
|
78 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: Safety Analysis Set: participants were randomized and received at least 1 dose of study drug
The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment.
Outcome measures
| Measure |
SOF+RBV
n=207 Participants
Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
|
Placebo
n=71 Participants
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
|
|---|---|---|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Anaemia
|
1 participants
|
0 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Anxiety
|
1 participants
|
0 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Chest discomfort
|
1 participants
|
0 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Injury
|
1 participants
|
0 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Muscle spasms
|
1 participants
|
0 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Oedema peripheral
|
0 participants
|
1 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
No adverse event leading to discontinuation
|
202 participants
|
68 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Abdominal pain upper
|
1 participants
|
0 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Alanine aminotransferase increased
|
0 participants
|
1 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Insomnia
|
1 participants
|
0 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Pancreatitis
|
0 participants
|
1 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Rash
|
0 participants
|
1 participants
|
|
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Road traffic accident
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Post-treatment Week 4Population: Full Analysis Set
SVR4 was defined as HCV RNA \< LLOQ 4 weeks after cessation of therapy
Outcome measures
| Measure |
SOF+RBV
n=207 Participants
Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
|
Placebo
n=71 Participants
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
|
|---|---|---|
|
Percentage of Participants Achieving SVR4
|
83.1 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Post-treatment Week 24Population: Full Analysis Set
SVR24 was defined as HCV RNA \< LLOQ 24 weeks after cessation of therapy
Outcome measures
| Measure |
SOF+RBV
n=207 Participants
Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
|
Placebo
n=71 Participants
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
|
|---|---|---|
|
Percentage of Participants Achieving SVR24
|
77.8 percentage of participants
|
0.0 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 |
SOF+RBV
n=207 Participants
Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
|
Placebo
n=71 Participants
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
|
|---|---|---|
|
Percentage of Participants Experiencing Viral Breakthrough
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: End of treatment to post-treatment Week 24Population: Participants in the Full Analysis Set who had an end-of-treatment response (HCV RNA \< LLOQ as the last observed on-treatment value) 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 |
SOF+RBV
n=205 Participants
Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
|
Placebo
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
|
|---|---|---|
|
Percentage of Participants Experiencing Viral Relapse
|
20.5 percentage of participants
|
—
|
Adverse Events
SOF+RBV
Serious events: 11 serious events
Other events: 184 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF+RBV
n=207 participants at risk
Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
|
Placebo
n=71 participants at risk
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/207 • Baseline to last dose date of study regimen + 30 days
|
1.4%
1/71 • Baseline to last dose date of study regimen + 30 days
|
|
General disorders
Drug withdrawal syndrome
|
0.48%
1/207 • Baseline to last dose date of study regimen + 30 days
|
0.00%
0/71 • Baseline to last dose date of study regimen + 30 days
|
|
General disorders
Non-cardiac chest pain
|
0.48%
1/207 • Baseline to last dose date of study regimen + 30 days
|
0.00%
0/71 • Baseline to last dose date of study regimen + 30 days
|
|
General disorders
Oedema peripheral
|
0.48%
1/207 • Baseline to last dose date of study regimen + 30 days
|
0.00%
0/71 • Baseline to last dose date of study regimen + 30 days
|
|
General disorders
Pyrexia
|
0.48%
1/207 • Baseline to last dose date of study regimen + 30 days
|
0.00%
0/71 • Baseline to last dose date of study regimen + 30 days
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/207 • Baseline to last dose date of study regimen + 30 days
|
1.4%
1/71 • Baseline to last dose date of study regimen + 30 days
|
|
Immune system disorders
Hypersensitivity
|
0.48%
1/207 • Baseline to last dose date of study regimen + 30 days
|
0.00%
0/71 • Baseline to last dose date of study regimen + 30 days
|
|
Infections and infestations
Abdominal abscess
|
0.48%
1/207 • Baseline to last dose date of study regimen + 30 days
|
0.00%
0/71 • Baseline to last dose date of study regimen + 30 days
|
|
Infections and infestations
Bronchitis
|
0.00%
0/207 • Baseline to last dose date of study regimen + 30 days
|
1.4%
1/71 • Baseline to last dose date of study regimen + 30 days
|
|
Infections and infestations
Cellulitis
|
0.48%
1/207 • Baseline to last dose date of study regimen + 30 days
|
0.00%
0/71 • Baseline to last dose date of study regimen + 30 days
|
|
Injury, poisoning and procedural complications
Overdose
|
0.97%
2/207 • Baseline to last dose date of study regimen + 30 days
|
0.00%
0/71 • Baseline to last dose date of study regimen + 30 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.48%
1/207 • Baseline to last dose date of study regimen + 30 days
|
0.00%
0/71 • Baseline to last dose date of study regimen + 30 days
|
|
Injury, poisoning and procedural complications
Injury
|
0.48%
1/207 • Baseline to last dose date of study regimen + 30 days
|
0.00%
0/71 • Baseline to last dose date of study regimen + 30 days
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.48%
1/207 • Baseline to last dose date of study regimen + 30 days
|
0.00%
0/71 • Baseline to last dose date of study regimen + 30 days
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.48%
1/207 • Baseline to last dose date of study regimen + 30 days
|
0.00%
0/71 • Baseline to last dose date of study regimen + 30 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.48%
1/207 • Baseline to last dose date of study regimen + 30 days
|
0.00%
0/71 • Baseline to last dose date of study regimen + 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.48%
1/207 • Baseline to last dose date of study regimen + 30 days
|
0.00%
0/71 • Baseline to last dose date of study regimen + 30 days
|
|
Psychiatric disorders
Abnormal behaviour
|
0.48%
1/207 • Baseline to last dose date of study regimen + 30 days
|
0.00%
0/71 • Baseline to last dose date of study regimen + 30 days
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.48%
1/207 • Baseline to last dose date of study regimen + 30 days
|
0.00%
0/71 • Baseline to last dose date of study regimen + 30 days
|
Other adverse events
| Measure |
SOF+RBV
n=207 participants at risk
Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
|
Placebo
n=71 participants at risk
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.0%
27/207 • Baseline to last dose date of study regimen + 30 days
|
0.00%
0/71 • Baseline to last dose date of study regimen + 30 days
|
|
Gastrointestinal disorders
Nausea
|
22.2%
46/207 • Baseline to last dose date of study regimen + 30 days
|
18.3%
13/71 • Baseline to last dose date of study regimen + 30 days
|
|
Gastrointestinal disorders
Diarrhoea
|
9.2%
19/207 • Baseline to last dose date of study regimen + 30 days
|
5.6%
4/71 • Baseline to last dose date of study regimen + 30 days
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
12/207 • Baseline to last dose date of study regimen + 30 days
|
7.0%
5/71 • Baseline to last dose date of study regimen + 30 days
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
6/207 • Baseline to last dose date of study regimen + 30 days
|
5.6%
4/71 • Baseline to last dose date of study regimen + 30 days
|
|
General disorders
Fatigue
|
44.0%
91/207 • Baseline to last dose date of study regimen + 30 days
|
23.9%
17/71 • Baseline to last dose date of study regimen + 30 days
|
|
General disorders
Irritability
|
9.2%
19/207 • Baseline to last dose date of study regimen + 30 days
|
1.4%
1/71 • Baseline to last dose date of study regimen + 30 days
|
|
General disorders
Oedema peripheral
|
1.9%
4/207 • Baseline to last dose date of study regimen + 30 days
|
5.6%
4/71 • Baseline to last dose date of study regimen + 30 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.4%
7/207 • Baseline to last dose date of study regimen + 30 days
|
9.9%
7/71 • Baseline to last dose date of study regimen + 30 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
16/207 • Baseline to last dose date of study regimen + 30 days
|
1.4%
1/71 • Baseline to last dose date of study regimen + 30 days
|
|
Nervous system disorders
Headache
|
20.8%
43/207 • Baseline to last dose date of study regimen + 30 days
|
19.7%
14/71 • Baseline to last dose date of study regimen + 30 days
|
|
Nervous system disorders
Dizziness
|
9.2%
19/207 • Baseline to last dose date of study regimen + 30 days
|
7.0%
5/71 • Baseline to last dose date of study regimen + 30 days
|
|
Psychiatric disorders
Insomnia
|
18.8%
39/207 • Baseline to last dose date of study regimen + 30 days
|
4.2%
3/71 • Baseline to last dose date of study regimen + 30 days
|
|
Psychiatric disorders
Anxiety
|
6.3%
13/207 • Baseline to last dose date of study regimen + 30 days
|
5.6%
4/71 • Baseline to last dose date of study regimen + 30 days
|
|
Psychiatric disorders
Depression
|
7.2%
15/207 • Baseline to last dose date of study regimen + 30 days
|
1.4%
1/71 • Baseline to last dose date of study regimen + 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.2%
19/207 • Baseline to last dose date of study regimen + 30 days
|
1.4%
1/71 • Baseline to last dose date of study regimen + 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
11/207 • Baseline to last dose date of study regimen + 30 days
|
2.8%
2/71 • Baseline to last dose date of study regimen + 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.4%
5/207 • Baseline to last dose date of study regimen + 30 days
|
5.6%
4/71 • Baseline to last dose date of study regimen + 30 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
23/207 • Baseline to last dose date of study regimen + 30 days
|
8.5%
6/71 • Baseline to last dose date of study regimen + 30 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.7%
18/207 • Baseline to last dose date of study regimen + 30 days
|
8.5%
6/71 • Baseline to last dose date of study regimen + 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