Outcomes in Liver Disease Patient With and Without HIV Co-infection-Sub Study 2: HCV Treatment: Health Related Quality
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Gastrointestinal, Hepatitis |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/28/2019 |
| Start Date: | June 2015 |
| End Date: | January 18, 2018 |
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.
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.
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.
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
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