Trial Outcomes & Findings for Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics (NCT NCT02759861)

NCT ID: NCT02759861

Last Updated: 2023-12-29

Results Overview

Sustained viral response in treatment -naive heavy alcohol drinking patients.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 16 participants
• Primary outcome timeframe: 12 weeks after the end of Harvoni therapy
• Results posted on: 2023-12-29

Participant Flow

Participant milestones

Measure	Harvoni x 8 or 12 Weeks patient will receive 8 or 12 weeks depending on clinical data harvoni: 8 or 12 weeks of harvoni therapy with monthly nursing visit to monitor alcohol and adherence of harvoni therapy
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Harvoni x 8 or 12 Weeks patient will receive 8 or 12 weeks depending on clinical data harvoni: 8 or 12 weeks of harvoni therapy with monthly nursing visit to monitor alcohol and adherence of harvoni therapy
Overall Study Death	1

Baseline Characteristics

Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics

Baseline characteristics by cohort

Measure	Harvoni x 8 or 12 Weeks n=16 Participants patient will receive 8 or 12 weeks depending on clinical data harvoni: 8 or 12 weeks of harvoni therapy with monthly nursing visiting to monitor alcohol and adherence of harvoni therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	14 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants
Region of Enrollment United States	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after the end of Harvoni therapy

Sustained viral response in treatment -naive heavy alcohol drinking patients.

Outcome measures

Measure	Harvoni x 8 or 12 Weeks n=15 Participants patient will receive 8 or 12 weeks depending on clinical data harvoni: 8 or 12 weeks of harvoni therapy with monthly nursing visit to monitor alcohol and adherence of harvoni therapy
The Number of Subjects Who Achieve Negative RNA in Alcoholics	14 Participants

SECONDARY outcome

Timeframe: 12 weeks after the end of Harvoni therapy

Population: Had fibrosis F3/F4

Number of alcoholics with HCV type 1 genotype who had advanced fibrosis F3/F4 who achieve SVR

Outcome measures

Measure	Harvoni x 8 or 12 Weeks n=9 Participants patient will receive 8 or 12 weeks depending on clinical data harvoni: 8 or 12 weeks of harvoni therapy with monthly nursing visit to monitor alcohol and adherence of harvoni therapy
Number of Subjects With Advanced Fibrosis Score of F3/F4 Who Achieve SVR	8 Participants

Adverse Events

Harvoni x 8 or 12 Weeks

Serious events: 0 serious events

Other events: 13 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Harvoni x 8 or 12 Weeks n=15 participants at risk patient will receive 8 or 12 weeks depending on clinical data harvoni: 8 or 12 weeks of harvoni therapy with monthly nursing visit to monitor alcohol and adherence of harvoni therapy
General disorders Fatigue	46.7% 7/15 • Number of events 7 • 24 weeks All-Cause Mortality was assessed in the total enrolled population while the Serious and Other (Not including Serious) adverse events were assessed in the completed population.
General disorders Headache	20.0% 3/15 • Number of events 3 • 24 weeks All-Cause Mortality was assessed in the total enrolled population while the Serious and Other (Not including Serious) adverse events were assessed in the completed population.
Gastrointestinal disorders Nausea	6.7% 1/15 • Number of events 1 • 24 weeks All-Cause Mortality was assessed in the total enrolled population while the Serious and Other (Not including Serious) adverse events were assessed in the completed population.
Nervous system disorders Agitation	6.7% 1/15 • Number of events 1 • 24 weeks All-Cause Mortality was assessed in the total enrolled population while the Serious and Other (Not including Serious) adverse events were assessed in the completed population.
Gastrointestinal disorders Diarrhea	6.7% 1/15 • Number of events 1 • 24 weeks All-Cause Mortality was assessed in the total enrolled population while the Serious and Other (Not including Serious) adverse events were assessed in the completed population.

Additional Information

Mark Mailliard

University of Nebraska Medical Center

Phone: 402-559-8126

Email: mark.mailliard@unmc.edu

Results disclosure agreements

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