Body weight and dietary intake in adults undergoing HCV treatment v1.0
Research type
Research Study
Full title
The impact of a Telaprevir-based treatment regime on body weight and dietary intake in adults with chronic hepatitis C: a pilot study.
IRAS ID
127498
Contact name
Sue Green
Contact email
Sponsor organisation
University Hospital Southampton
Research summary
This study will examine the effect of two different medication regimes for hepatitis C on nutritional status and dietary intake. The normal medication regime for adults with genotype (or variation) one hepatitis C is three medications called Telaprevir, Ribavirin and Pegylated Interferon. The normal medication regime for genotypes 2 to 6 hepatitis C is the medications Ribavirin and Pegylated Interferon. People who take the medications Ribavirin and Pegylated Interferon have been known to lose weight. However, people prescribed Telaprevir as part of their medication regime may not lose weight because they have to eat a high calorie diet to increase gut absorption of Telaprevir. This study aims to investigate if people who are prescribed the medication Telaprevir for the treatment of their hepatitis C are less likely to lose weight than those who are not prescribed it as part of their treatment.
The study will involve people attending for treatment of hepatitis C at Southampton General Hospital. People aged between 18 to 80 years with no other issues that could affect their weight will be asked if they would like to participate. People who agree to participate will be asked to attend two study visits; one on the day of starting their prescribed medication regime and the other 12 weeks later. Participants will be asked to answer questions about their dietary intake, and nutritional status will be assessed by measuring body weight, thickness of fat deposits and hand grip strength. This may cause participants inconvenience but the tests are not invasive so should not cause distress.
There is minimal risk for participants. Their normal clinical care will not be altered. If there are any concerns about a participant’s weight or any other issue, their clinical care team will be informed. This study is being conducted for a masters dissertation.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
13/EM/0279
Date of REC Opinion
4 Jul 2013
REC opinion
Favourable Opinion