Trial Outcomes & Findings for Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV (NCT NCT02032901)
NCT ID: NCT02032901
Last Updated: 2015-10-01
Results Overview
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
173 participants
Primary outcome timeframe
Week 12 (Follow-up period)
Results posted on
2015-10-01
Participant Flow
The study was conducted at 31 sites in 2 countries.
A total of 173 participants were enrolled in the study. 152 were treated. 21 participants were not treated as they no longer met the study criteria.
Participant milestones
| Measure |
Daclatasvir + Sofosbuvir in Treatment-naive Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Treatment Period (12 Weeks)
STARTED
|
101
|
51
|
|
Treatment Period (12 Weeks)
COMPLETED
|
100
|
51
|
|
Treatment Period (12 Weeks)
NOT COMPLETED
|
1
|
0
|
|
Follow-Up Period (24 Weeks)
STARTED
|
101
|
51
|
|
Follow-Up Period (24 Weeks)
COMPLETED
|
101
|
50
|
|
Follow-Up Period (24 Weeks)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Daclatasvir + Sofosbuvir in Treatment-naive Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Treatment Period (12 Weeks)
Pregnancy
|
1
|
0
|
|
Follow-Up Period (24 Weeks)
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV
Baseline characteristics by cohort
| Measure |
Daclatasvir + Sofosbuvir in Treatment-naive Participants
n=101 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants
n=51 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.3 years
STANDARD_DEVIATION 10.73 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 6.64 • n=7 Participants
|
52.3 years
STANDARD_DEVIATION 9.94 • n=5 Participants
|
|
Age, Customized
<65 years
|
95 participants
n=5 Participants
|
47 participants
n=7 Participants
|
142 participants
n=5 Participants
|
|
Age, Customized
>= 65 years
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12 (Follow-up period)Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy.
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir + Sofosbuvir in Treatment-naive Participants
n=101 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
|
90.1 Percentage of participants
Interval 82.5 to 95.1
|
—
|
PRIMARY outcome
Timeframe: Week 12 (Follow-up period)Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy.
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir + Sofosbuvir in Treatment-naive Participants
n=51 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
|
86.3 percentage of participants
Interval 73.7 to 94.3
|
—
|
SECONDARY outcome
Timeframe: Week 4Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy.
RVR was defined as hepatitis C virus RNA levels to be \< lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir + Sofosbuvir in Treatment-naive Participants
n=101 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants
n=51 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)
|
63.4 Percentage of participants
Interval 53.2 to 72.7
|
72.5 Percentage of participants
Interval 58.3 to 84.1
|
SECONDARY outcome
Timeframe: Week 12Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy.
cEVR was defined as hepatitis C virus RNA levels to be \< lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir + Sofosbuvir in Treatment-naive Participants
n=101 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants
n=51 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)
|
98.0 Percentage of participants
Interval 93.0 to 99.8
|
100.0 Percentage of participants
Interval 93.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to the end of treatment (up to 24 weeks)Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy.
EOTR were defined as hepatitis C virus RNA levels to be \< lower limit of quantitation ie, 25 IU/mL TND at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir + Sofosbuvir in Treatment-naive Participants
n=101 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants
n=51 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)
|
99.0 percentage of participants
Interval 94.6 to 100.0
|
100.0 percentage of participants
Interval 93.0 to 100.0
|
SECONDARY outcome
Timeframe: Week 1, 2, 6, 8 (treatment period)Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy.
Percentage of participants who achieved HCV RNA \<LLOQ, TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir + Sofosbuvir in Treatment-naive Participants
n=101 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants
n=51 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)
Week 1
|
11.9 Percentage of participants
Interval 6.3 to 19.8
|
2.0 Percentage of participants
Interval 0.0 to 10.4
|
|
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)
Week 2
|
34.7 Percentage of participants
Interval 25.5 to 44.8
|
29.4 Percentage of participants
Interval 17.5 to 43.8
|
|
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)
Week 6
|
86.1 Percentage of participants
Interval 77.8 to 92.2
|
90.2 Percentage of participants
Interval 78.6 to 96.7
|
|
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)
Week 8
|
95.0 Percentage of participants
Interval 88.8 to 98.4
|
98.0 Percentage of participants
Interval 89.6 to 100.0
|
SECONDARY outcome
Timeframe: Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy.
Percentage of participants who achieved HCV RNA \<LLOQ,TD or TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir + Sofosbuvir in Treatment-naive Participants
n=101 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants
n=51 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)
Week 1
|
39.6 Percentage of participants
Interval 30.0 to 49.8
|
23.5 Percentage of participants
Interval 12.8 to 37.5
|
|
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)
Week 2
|
77.2 Percentage of participants
Interval 67.8 to 85.0
|
68.6 Percentage of participants
Interval 54.1 to 80.9
|
|
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)
Week 4
|
94.1 Percentage of participants
Interval 87.5 to 97.8
|
98.0 Percentage of participants
Interval 89.6 to 100.0
|
|
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)
Week 6
|
100.0 Percentage of participants
Interval 96.4 to 100.0
|
98.0 Percentage of participants
Interval 89.6 to 100.0
|
|
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)
Week 8
|
100.0 Percentage of participants
Interval 96.4 to 100.0
|
100.0 Percentage of participants
Interval 93.0 to 100.0
|
|
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)
Week 12
|
98.0 Percentage of participants
Interval 93.0 to 99.8
|
100.0 Percentage of participants
Interval 93.0 to 100.0
|
|
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)
End of treatment
|
99.0 Percentage of participants
Interval 94.6 to 100.0
|
100.0 Percentage of participants
Interval 93.0 to 100.0
|
|
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)
Follow-up Week 4
|
91.1 Percentage of participants
Interval 83.8 to 95.8
|
86.3 Percentage of participants
Interval 73.7 to 94.3
|
|
Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)
Follow-up Week 24
|
89.1 Percentage of participants
Interval 81.3 to 94.4
|
82.4 Percentage of participants
Interval 69.1 to 91.6
|
SECONDARY outcome
Timeframe: Baseline, Week 12 (Follow-up period)Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The 'n' signifies the number of evaluable participants with or without cirrhosis in the reporting arm and time point, respectively.
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin. Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse.
Outcome measures
| Measure |
Daclatasvir + Sofosbuvir in Treatment-naive Participants
n=101 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants
n=51 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)
With cirrhosis (n= 19, 13)
|
57.9 Percentage of participants
Interval 33.5 to 79.7
|
69.2 Percentage of participants
Interval 38.6 to 90.9
|
|
Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)
Without cirrhosis (n= 75, 34)
|
97.3 Percentage of participants
Interval 90.7 to 99.7
|
94.1 Percentage of participants
Interval 80.3 to 99.3
|
SECONDARY outcome
Timeframe: Week 12 (Follow-up period)Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, ''n'' signifies number of participants evaluable for the specified category.
Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Outcome measures
| Measure |
Daclatasvir + Sofosbuvir in Treatment-naive Participants
n=101 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants
n=51 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12)
Genotype: CC (n=40, 20)
|
90.0 Percentage of participants
Interval 76.3 to 97.2
|
95.0 Percentage of participants
Interval 75.1 to 99.9
|
|
Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12)
Genotype: Non-CC (n=61, 31)
|
90.2 Percentage of participants
Interval 79.8 to 96.3
|
80.6 Percentage of participants
Interval 62.5 to 92.5
|
SECONDARY outcome
Timeframe: From Day 1 first dose to last dose plus 7 daysPopulation: The analysis was performed in all treated participants who received at least 1 dose of active study therapy.
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Outcome measures
| Measure |
Daclatasvir + Sofosbuvir in Treatment-naive Participants
n=101 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
Daclatasvir + Sofosbuvir in Treatment-experienced Participants
n=51 Participants
Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)
Discontinuations Due to AEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)
SAEs
|
1 Participants
|
0 Participants
|
Adverse Events
Daclatasvir + Sofosbuvir
Serious events: 1 serious events
Other events: 73 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daclatasvir + Sofosbuvir
n=152 participants at risk
All participants infected with hepatitis C virus (HCV) genotype-3 received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks during the study.
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.66%
1/152 • From Day 1 first dose to last dose plus 7 days
On-treatment period.
|
Other adverse events
| Measure |
Daclatasvir + Sofosbuvir
n=152 participants at risk
All participants infected with hepatitis C virus (HCV) genotype-3 received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks during the study.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
8/152 • From Day 1 first dose to last dose plus 7 days
On-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
8/152 • From Day 1 first dose to last dose plus 7 days
On-treatment period.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.6%
13/152 • From Day 1 first dose to last dose plus 7 days
On-treatment period.
|
|
General disorders
Fatigue
|
19.1%
29/152 • From Day 1 first dose to last dose plus 7 days
On-treatment period.
|
|
Nervous system disorders
Headache
|
19.7%
30/152 • From Day 1 first dose to last dose plus 7 days
On-treatment period.
|
|
Psychiatric disorders
Insomnia
|
5.9%
9/152 • From Day 1 first dose to last dose plus 7 days
On-treatment period.
|
|
Gastrointestinal disorders
Nausea
|
11.8%
18/152 • From Day 1 first dose to last dose plus 7 days
On-treatment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER