Hepatitis C Infection
Conditions
Keywords
Hepatitis C infection, Hepatitis C treatment
Brief 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.
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.
Interventions
None listed
Sponsors
Gilead Sciences
Icahn School of Medicine at Mount Sinai
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in vitality score, Short form 36 (SF36) | baseline and week 24 | Change in vitality score at week 24 as compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | baseline and week 24 | Change in function at week 24 as compared to baseline |
| Change in quality of life symptoms, Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV) | baseline and week 24 | Change in quality of life symptoms at week 24 as compared to baseline |
| Change in work productivity and activity impairment (WPAI) questionnaire | baseline and week 24 | Change in activity at week 24 as compared to baseline |
| Change in Medication and co-morbidities questionnaire | baseline and week 24 | Change in medication and co-morbidities at week 24 as compared to baseline |
| Lost wages: Change in work ability | baseline and week 24 | Change in work ability at week 24 as compared to baseline |
| Change in Medication adherence survey | baseline and week 24 | Change in medication adherence at week 24 as compared to baseline |
Countries
United States
Outcome results
None listed