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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C Infection

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients initiating treatment for HCV infection are the source of potential subjects.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vitality score, Short form 36 (SF36)	Change in vitality score at week 24 as compared to baseline	baseline and week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in work productivity and activity impairment (WPAI) questionnaire	Change in activity at week 24 as compared to baseline	baseline and week 24
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
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
Change in Medication adherence survey	Change in medication adherence at week 24 as compared to baseline	baseline and week 24
Change in Medication and co-morbidities questionnaire	Change in medication and co-morbidities at week 24 as compared to baseline	baseline and week 24
Lost wages: Change in work ability	Change in work ability at week 24 as compared to baseline	baseline and week 24

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Andrea D Branch, PhD, Icahn School of Medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): January 18, 2018
• Study Completion (Actual): January 18, 2018

Study Registration Dates

• First Submitted: April 22, 2015
• First Submitted That Met QC Criteria: April 24, 2015
• First Posted (Estimate): April 27, 2015

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Hepatitis C infection; Hepatitis C treatment
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Flaviviridae Infections; Hepatitis, Viral, Human; Liver Diseases; HIV Infections; Infections; Communicable Diseases; Hepatitis; Hepatitis C; Coinfection
• Other Study ID Numbers: GCO 14-1959