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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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 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.
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients initiating treatment for HCV infection are the source of potential subjects.
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| Name | Affiliation | Role |
|---|---|---|
| Andrea D Branch, PhD | Icahn School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine | New York | New York | 10029 | United States |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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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 |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |