Trial Outcomes & Findings for Dutch Acute HCV in HIV Study (DAHHS-2): Grazoprevir/Elbasvir for Acute HCV (NCT NCT02600325)

NCT ID: NCT02600325

Last Updated: 2019-07-08

Results Overview

Sustained viral response (SVR) 12 weeks after the end of therapy in all patients who started treatment in which reinfections are not considered failure

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 80 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2019-07-08

Participant Flow

Participant milestones

Measure	Grazoprevir/Elbasvir 100mg/50mg Grazoprevir/elbasvir single tablet regimen (100/50mg) Grazoprevir/Elbasvir 100mg/50mg: Grazoprevir/Elbasvir 100mg/50mg
Overall Study STARTED	80
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dutch Acute HCV in HIV Study (DAHHS-2): Grazoprevir/Elbasvir for Acute HCV

Baseline characteristics by cohort

Measure	Treatment Arm n=80 Participants G/E 8 weeks
Age, Continuous	47 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	72 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Sustained viral response (SVR) 12 weeks after the end of therapy in all patients who started treatment in which reinfections are not considered failure

Outcome measures

Measure	Treatment Group n=80 Participants Grazoprevir/elbasvir single tablet regimen (100/50mg) Grazoprevir/Elbasvir 100mg/50mg: Grazoprevir/Elbasvir 100mg/50mg
SVR12 (Reinfection Not Considered Failure)	79 participants

SECONDARY outcome

Timeframe: week 12

Sustained viral response (SVR) 12 weeks after the end of therapy in all patients who started treatment in which reinfections are considered failure

Outcome measures

Measure	Treatment Group n=80 Participants Grazoprevir/elbasvir single tablet regimen (100/50mg) Grazoprevir/Elbasvir 100mg/50mg: Grazoprevir/Elbasvir 100mg/50mg
SVR12 (Reinfection Equals Failure)	75 Participants

Adverse Events

Treatment Group

Serious events: 2 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Group n=80 participants at risk Grazoprevir/elbasvir single tablet regimen (100/50mg) Grazoprevir/Elbasvir 100mg/50mg: Grazoprevir/Elbasvir 100mg/50mg
Gastrointestinal disorders traumatic rectal bleeding	1.2% 1/80 • Number of events 1 • 20 weeks
Musculoskeletal and connective tissue disorders Elective low back surgery	1.2% 1/80 • Number of events 1 • 20 weeks

Other adverse events

Measure	Treatment Group n=80 participants at risk Grazoprevir/elbasvir single tablet regimen (100/50mg) Grazoprevir/Elbasvir 100mg/50mg: Grazoprevir/Elbasvir 100mg/50mg
General disorders Fatique	13.8% 11/80 • Number of events 11 • 20 weeks
General disorders headache	8.8% 7/80 • Number of events 7 • 20 weeks
General disorders insomnia	8.8% 7/80 • Number of events 7 • 20 weeks
General disorders mood changes	6.2% 5/80 • Number of events 5 • 20 weeks
Gastrointestinal disorders dyspepsia	6.2% 5/80 • Number of events 5 • 20 weeks
General disorders concentration impairment	5.0% 4/80 • Number of events 4 • 20 weeks
General disorders dizziness	5.0% 4/80 • Number of events 4 • 20 weeks

Additional Information

Dr. B. J. A. Rijnders

Erasmus MC

Phone: 0

Email: b.rijnders@erasmusmc.nl

Results disclosure agreements

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