Trial Outcomes & Findings for Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, With Non-severe Fibrosis (NCT NCT02973503)

Results Overview

Blood samples for HCV RNA determination were collected 12 weeks after cessation of treatment and analysed by local laboratories tests

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

117 participants

Primary outcome timeframe

at 12 weeks post-treatment

Results posted on

2020-10-01

Participant Flow

Participant milestones

Participant milestones
Measure	Elbasvir/Grazoprevir Elbasvir/Grazoprevir Fixed Dose Combination: Evaluate the efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12).
Overall Study STARTED	117
Overall Study COMPLETED	117
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Elbasvir/Grazoprevir n=112 Participants Elbasvir/Grazoprevir Fixed Dose Combination: Evaluate the efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12).
Age, Categorical <=18 years	0 Participants n=112 Participants
Age, Categorical Between 18 and 65 years	86 Participants n=112 Participants
Age, Categorical >=65 years	26 Participants n=112 Participants
Age, Continuous	54 YEARS STANDARD_DEVIATION 13 • n=112 Participants
Sex: Female, Male Female	77 Participants n=112 Participants
Sex: Female, Male Male	35 Participants n=112 Participants
Region of Enrollment France	112 Participants n=112 Participants

PRIMARY outcome

Timeframe: at 12 weeks post-treatment

Population: 117 were enrolled. Five patients were excluded from the analysis population because they were non genotype 1b. 112 patients were analysed in modified intention to treat

Blood samples for HCV RNA determination were collected 12 weeks after cessation of treatment and analysed by local laboratories tests

Outcome measures

Outcome measures
Measure	Elbasvir/Grazoprevir n=112 Participants One group, open label study
Evaluation of the Efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve as Measured by the Proportion of Subjects With Sustained Viral Response 12 Weeks After Cessation of Treatment (SVR 12).	109 Participants

SECONDARY outcome

Timeframe: Between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks

Population: 117 patients were included and 5 patients were excluded from the analysis because of non genotype 1b. 112 patients were analysed in modified intention to treat

Asthenia was defined by abnormal physical weakness or lack of energy. Asthenia was monitored throughout the study and up to 24 weeks after planned end of treatment. An investigator who is a qualified physician evaluated all adverse events, causality and severity. Only grade 1 or 2 were reported. No grade 3. Grade was evaluated with table 9 of protocol.

Outcome measures

Outcome measures
Measure	Elbasvir/Grazoprevir n=112 Participants One group, open label study
Evaluation of the Safety and Tolerability of EBV/GZR Treatment by Number of Patients With Treatment-related Asthenia Reported	26 Participants

SECONDARY outcome

Timeframe: between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks

Population: 117 patients were included and 5 patients were excluded from the analysis because of non genotype 1b. 112 patients were analysed in modified intention to treat

Headache is defined by pain felt in the cranial box. Headache was monitored throughout the study and up to 24 weeks after planned end of treatment. An investigator who is a qualified physician evaluated all adverse events, causality and severity. Only grade 1 or 2 were reported. No grade 3. grade was evaluated with table 9 of protocol.

Outcome measures

Outcome measures
Measure	Elbasvir/Grazoprevir n=112 Participants One group, open label study
Evaluation of the Safety and Tolerability of EBV/GZR Treatment by Number of Patients With Treatment-related Headache Reported	25 Participants

SECONDARY outcome

Timeframe: Between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks

Population: 117 patients were included and 5 patients were excluded from the analysis because of non genotype 1b. 112 patients were analysed in modified intention to treat

Digestive disorders is defined by an acceleration, a slowing down or a disturbance of the intestinal transit with or without pain. Digestive disorders were monitored throughout the study and up to 24 weeks after planned end of treatment. An investigator who is a qualified physician evaluated digestive disorders causality and severity. Only grade 1 or 2 were reported. No grade 3. Grade was evaluated with table 9 of protocol.

Outcome measures

Outcome measures
Measure	Elbasvir/Grazoprevir n=112 Participants One group, open label study
Evaluation of the Safety and Tolerability of EBV/GZR Treatment by Number of Patients With Treatment-related Digestive Disorders Reported	16 Participants

SECONDARY outcome

Timeframe: at 4 weeks after cessation of treatment

Population: 117 patients were enrolled. 5 patients were excluded from the analysis because they were non genotype 1b. 112 patients were analysed in modified intention to treat

blood samples were collected at 4 weeks after cessation of treatment and HCV RNA was measured using local laboratories tests

Outcome measures

Outcome measures
Measure	Elbasvir/Grazoprevir n=112 Participants One group, open label study
Percentage of Subjects Who Attain SVR at 4 Weeks After Cessation of Treatment (SVR4)	111 Participants

SECONDARY outcome

Timeframe: at 24 weeks after cessation of treatment

Population: 117 patients were included; 5 patients were excluded from the analysis population because they were non genotype 1b and one patient is lost to follow up 24 weeks after cessation of treatment. 111 patients were analysed in modified intention to treat

blood samples were collected at 24 weeks after cessation of treatment and HCV RNA was measured using local laboratories tests

Outcome measures

Outcome measures
Measure	Elbasvir/Grazoprevir n=111 Participants One group, open label study
Percentage of Subjects Who Attain SVR 24 Weeks After Cessation of Treatment (SVR 24)	106 Participants

SECONDARY outcome

Timeframe: at 12 weeks after cessation of treatment

Population: 117 patients were enrolled. 5 patients were excluded from the analysis because they were non genotype 1b. 112 patients were analysed in modified intention to treat

patient with HCV RNA \> low limit of quantification in two different consecutive blood samples were considered as relapser

Outcome measures

Outcome measures
Measure	Elbasvir/Grazoprevir n=112 Participants One group, open label study
Percentage of Subjects With Virologic Failure	3 Participants

SECONDARY outcome

Timeframe: at 24 weeks after end of treatment

Population: 111 patients were analysed in modified intention to treat (5 were non genotype 1b and one was lost to follow up at week 24 after the end of treatment)

Patients with HCV RNA\> low limit of quantification in two consecutive blood samples were considered as relapsers.

Outcome measures

Outcome measures
Measure	Elbasvir/Grazoprevir n=111 Participants One group, open label study
Evaluation of the Emergence of Viral Resistance to EBV/GZR at 24 Weeks After Cessation of Treatment	5 Participants

Adverse Events

Elbasvir/Grazoprevir

Serious events: 3 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Elbasvir/Grazoprevir n=117 participants at risk Elbasvir/Grazoprevir Fixed Dose Combination: Evaluate the efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12).
Psychiatric disorders MELANCHOLIA	0.85% 1/117 • Number of events 1 • adverse events were collected between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks
Musculoskeletal and connective tissue disorders FRACTURE OF ANATOMICAL NECK OF HUMERUS	0.85% 1/117 • Number of events 1 • adverse events were collected between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks
Psychiatric disorders ATTEMPTED SUICIDE	0.85% 1/117 • Number of events 1 • adverse events were collected between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks

Other adverse events

Other adverse events
Measure	Elbasvir/Grazoprevir n=117 participants at risk Elbasvir/Grazoprevir Fixed Dose Combination: Evaluate the efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12).
General disorders ASTHENIA	21.4% 25/117 • Number of events 25 • adverse events were collected between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks
Gastrointestinal disorders DIGESTIVE DISORDERS	16.2% 19/117 • Number of events 19 • adverse events were collected between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks
General disorders HEADACHE	21.4% 25/117 • Number of events 25 • adverse events were collected between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks

Additional Information

Armand Abergel

CHU Clermont-Ferrand

Phone: +33473750523

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place