Trial Outcomes & Findings for Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C (NCT NCT03365635)

NCT ID: NCT03365635

Last Updated: 2021-12-15

Results Overview

Absence of HCV by viral RNA quantitation at 12 weeks post treatment

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

12 weeks after completion of Elbasivir/Grazoprevir treatment

Results posted on

2021-12-15

Participant Flow

Patients from an outpatient hemodialysis unit were recruited between October 2019 and April 2020

There was no wash out or run-in period to this protocol

Participant milestones

Participant milestones
Measure	Genotype 1a -Rx Naive -no NS5A Polymorph Genotype 1a - treatment naive without NS5A polymorphism - Drug Intervention : Oral administration Elbasvir (50mg)/Grazoprevir (100mg) one tablet per day for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description	Genotype 1b - Rx Naive Genotype 1b-treatment naive - Oral administration of Elbasvir/Grazoprevir one daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description
Overall Study STARTED	3	1
Overall Study COMPLETED	3	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Genotype 1a -Rx Naive -no NS5A Polymorph n=3 Participants Genotype 1a - treatment naive without NS5A polymorphism - Drug Intervention : Oral administration Elbasvir (50mg)/Grazoprevir (100mg) one tablet per day for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description	Genotype 1a, Rx Naive + NS5A Polymorph Genotype 1a - treatment naiive with NS5A polymorphism - Oral administration of Elbasvir/Grazoprevir one tablet daily and ribavirin (200 mg) daily for 16 weeks weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description	Genotype 1b - Rx Naive n=1 Participants Genotype 1b-treatment naive - Oral administration of Elbasvir/Grazoprevir one daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description	Genotype 1a/1b -Prior INF or NS3/4A Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - oral administration of Elbasvir/Grazoprevir and ribavirin each once daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description	Genotype4 - Treatment Naive (e) Genotype 4 - treatment naive - oral administration of Elbasvir/Grazoprevir one daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description	Genotype 4- Prior Treatment Genotype 4 -prior treatment - oral administration of Elbasvir/Grazoprevir and ribavirin each once per day for 16 weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	4 Participants n=115 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	0 Participants n=5 Participants	—	—	—	1 Participants n=115 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	—	1 Participants n=5 Participants	—	—	—	3 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	—	—	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	—	—	0 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	—	—	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	—	1 Participants n=5 Participants	—	—	—	4 Participants n=115 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	—	—	0 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	—	—	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants	—	—	—	0 Participants n=115 Participants
Region of Enrollment United States	3 participants n=5 Participants	—	1 participants n=5 Participants	—	—	—	4 participants n=115 Participants

PRIMARY outcome

Timeframe: 12 weeks after completion of Elbasivir/Grazoprevir treatment

Absence of HCV by viral RNA quantitation at 12 weeks post treatment

Outcome measures

Outcome measures
Measure	Genotype 1a -Rx Naive -no NS5A Polymorph n=3 Participants Genotype 1a - treatment naive without NS5A polymorphism - Drug Intervention : Oral administration Elbasvir (50mg)/Grazoprevir (100mg) one tablet per day for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description	Genotype 1a, Rx Naive + NS5A Polymorph Genotype 1a - treatment naiive with NS5A polymorphism - Oral administration of Elbasvir/Grazoprevir one tablet daily and ribavirin (200 mg) daily for 16 weeks weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description	Genotype 1b - Rx Naive n=1 Participants Genotype 1b-treatment naive - Oral administration of Elbasvir/Grazoprevir one daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description	Genotype 1a/1b -Prior INF or NS3/4A Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - oral administration of Elbasvir/Grazoprevir and ribavirin each once daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description	Genotype4 - Treatment Naive (e) Genotype 4 - treatment naive - oral administration of Elbasvir/Grazoprevir one daily for 12 weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description	Genotype 4- Prior Treatment Genotype 4 -prior treatment - oral administration of Elbasvir/Grazoprevir and ribavirin each once per day for 16 weeks Elbasvir 50 MG / Grazoprevir 100 MG \[Zepatier\]: Same as described in arm description
SVR - Sustained Virologic Response	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Within one month of last patient enrolled

Population: No patients were recruited into some of the subgroups and this is noted as 0 participants for these subgroups

The number of participants for whom their third party insurance approved payment of the DAA (study drug)