Outcomes in Liver Disease Patient With and Without HIV Co-infection-Sub Study 2: HCV Treatment: Health Related Quality

Hepatitis C Infection Clinical Trial

Official title:

Outcomes in Liver Disease Patient With and Without HIV Co-infection-Sub Study 2: HCV Treatment: Health Related Quality of Life, Fatigue, Work Productivity, Liver Status and Cost-per-SVR/Health Care Utilization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427204
• Other study ID #: GCO 14-1959
• Status: Completed
• Start date: June 2015
• Est. completion date: January 18, 2018

Study information

• Verified date: February 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main questions being addressed are (1) how patient reported outcomes change during treatment for HCV, (2) how treatment impacts liver function and liver status, and (3) how much treatment costs from the payer's perspective and the patient's perspective. The hypothesis being tested is that treatment has a negative effect on the quality of life during treatment. The negative effect is expected to be temporary. Successful treatment, which is equated with a virological cure of the infection, is expected to result in an improvement in quality of life compared to baseline and to improvement in markers of liver function and liver status. Costs of treatment are expected to be $80,000-$200,000 per virological cure.

Description:

The objectives of the study are to collect information about patient reported outcomes before, during, and after treatment for hepatitis C virus infection, to determine the impact of treatment on liver function and stiffness (an indicator of inflammation and fibrosis), and to determine the cost of treatment.

The main questions being addressed are (1) how patient reported outcomes change during treatment for HCV, (2) how treatment impacts liver function and liver status, and (3) how much treatment costs from the payer's perspective and the patient's perspective. The hypothesis being tested is that treatment has a negative effect on the quality of life during treatment. The negative effect is expected to be temporary. Successful treatment, which is equated with a virological cure of the infection, is expected to result in an improvement in quality of life compared to baseline and to improvement in markers of liver function and liver status. Costs of treatment are expected to be $80,000-$200,000 per virological cure.

The purpose of the study is to give patients and providers information about what to expect while undergoing treatment for HCV and to provide information for future cost-effectiveness studies. Previous studies of liver biopsy and transient elastography demonstrate that liver scarring regresses in a significant percentage of patients who achieve an SVR; however, the majority of patients who had liver cirrhosis at the time they achieved an SVR continued to have portal hepatitis and high levels of alpha smooth muscle actin ( D'Ambrosio R, et al., Hepatology, 2012). Particularly because interferon is known to cause autoimmune disease, it is possible that some residual liver abnormalities are due to interferon exposure. If this is the case, liver abnormalities may regress more rapidly and completely in patients receiving interferon-free regimens. Currently, there are no real-world data about the impact of new regimens on liver status as measured by transient elastography. This project will fill an important gap by providing information about changes in liver stiffness in patients receiving the newest therapies for HCV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 18, 2018
• Est. primary completion date: January 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult

• Positive test for HCV RNA and planning to start HCV treatment soon

• Able to travel to Mount Sinai

• Must understand and speak English

• Planning to initiate treatment for HCV infection in the near future

• Willing to sign informed consent and participate

Exclusion Criteria:

• Pregnant

Related Conditions & MeSH terms

• Coinfection
• Communicable Diseases
• Hepatitis
• Hepatitis C
• Hepatitis C Infection
• HIV Infections
• Infection
• Liver Diseases

Locations

Country	Name	City	State
United States	Icahn School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in vitality score, Short form 36 (SF36)	Change in vitality score at week 24 as compared to baseline	baseline and week 24
Secondary	Change in work productivity and activity impairment (WPAI) questionnaire	Change in activity at week 24 as compared to baseline	baseline and week 24
Secondary	Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)	Change in function at week 24 as compared to baseline	baseline and week 24
Secondary	Change in quality of life symptoms, Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV)	Change in quality of life symptoms at week 24 as compared to baseline	baseline and week 24
Secondary	Change in Medication adherence survey	Change in medication adherence at week 24 as compared to baseline	baseline and week 24
Secondary	Change in Medication and co-morbidities questionnaire	Change in medication and co-morbidities at week 24 as compared to baseline	baseline and week 24
Secondary	Lost wages: Change in work ability	Change in work ability at week 24 as compared to baseline	baseline and week 24