Patient-reported Outcomes in Chronic Hepatitis C
The early pioneers of PRO work during this treatment period of time determined that patients reported a significant decrease in their HRQOL even prior to the treatment. One of the initial studies of HRQOL in CH-C reported that five of the eight domains of the SF-36 (RP, GH and SF) were significantly impaired before anti-HCV therapy even began. However, even more significant was that the investigators found patient scores fell even further during treatment. The vitality parameter of the SF-36 was identified as the area most affected. Following further studies, researchers have deemed vitality as the most comprehensive well-being measure for a patient who suffers from HCV (Table 2).
Other studies have investigated the impact of IFN/RBV induced anaemia and depression on HRQOL. In one such study, investigators found that treatment-induced depression which increased for the first 20 weeks of treatment as well as the presence of anaemia both negatively affected HRQOL scores. From the results of their multivariate analysis, the researchers found that the impact of depression on a patient's HRQOL was so strong that many variables that were initially found to be significant were no longer significant once depression was introduced into the multivariate model. Therefore, the authors concluded that treatment for depression and anaemia must be addressed carefully when treating patients with PEG/INF.
There have also been a number of studies investigating the impact of IFN/RBV therapy on health utilities. In one such study, investigators used several measures of health utilities (HUI2, HUI3, SF-6D and Time trade off) to assess patients' preferences. After adjusting for known confounders (age, sex, ethnicity, marital status, comorbidity and severity of impairment), the main utility outcome of HUI-3 (levels of functioning on vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain) was effected by viral factors not by the host factors. Using the same measurement tools, other investigators determined that CH-C patients who had developed sustained viral clearance had the highest utility scores while those with late advanced stage liver disease (cirrhosis and liver cancer) had the lowest utility scores. In contrast, these investigators found that host factors such as age, lower income, unattached marital status and high comorbidity were strongly associated with impairment in health utilities.
Despite the significant reduction in patient's HRQOL and worker productivity during IFN/RBV treatment, PRO scores and worker productivity both improved after treatment discontinuation. Furthermore, those who achieved SVR, had further improvement of their HRQOL, health utility scores and worker productivity.
Summary of Historical Data Related to PRO Impairment in Patients With CH-C
The early pioneers of PRO work during this treatment period of time determined that patients reported a significant decrease in their HRQOL even prior to the treatment. One of the initial studies of HRQOL in CH-C reported that five of the eight domains of the SF-36 (RP, GH and SF) were significantly impaired before anti-HCV therapy even began. However, even more significant was that the investigators found patient scores fell even further during treatment. The vitality parameter of the SF-36 was identified as the area most affected. Following further studies, researchers have deemed vitality as the most comprehensive well-being measure for a patient who suffers from HCV (Table 2).
Other studies have investigated the impact of IFN/RBV induced anaemia and depression on HRQOL. In one such study, investigators found that treatment-induced depression which increased for the first 20 weeks of treatment as well as the presence of anaemia both negatively affected HRQOL scores. From the results of their multivariate analysis, the researchers found that the impact of depression on a patient's HRQOL was so strong that many variables that were initially found to be significant were no longer significant once depression was introduced into the multivariate model. Therefore, the authors concluded that treatment for depression and anaemia must be addressed carefully when treating patients with PEG/INF.
There have also been a number of studies investigating the impact of IFN/RBV therapy on health utilities. In one such study, investigators used several measures of health utilities (HUI2, HUI3, SF-6D and Time trade off) to assess patients' preferences. After adjusting for known confounders (age, sex, ethnicity, marital status, comorbidity and severity of impairment), the main utility outcome of HUI-3 (levels of functioning on vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain) was effected by viral factors not by the host factors. Using the same measurement tools, other investigators determined that CH-C patients who had developed sustained viral clearance had the highest utility scores while those with late advanced stage liver disease (cirrhosis and liver cancer) had the lowest utility scores. In contrast, these investigators found that host factors such as age, lower income, unattached marital status and high comorbidity were strongly associated with impairment in health utilities.
Despite the significant reduction in patient's HRQOL and worker productivity during IFN/RBV treatment, PRO scores and worker productivity both improved after treatment discontinuation. Furthermore, those who achieved SVR, had further improvement of their HRQOL, health utility scores and worker productivity.
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