Our results indicate that there is no difference in rates of completion when considering biopsy status within one year of starting HCV treatment. While biopsy status had no impact on treatment completion rates, it is likely that biopsy status correlated with treatment uptake as the biopsy rate of this cohort (23%) was significantly greater than the rate of liver biopsy in the untreated chronic hepatitis C population at our center (3.8%). We did not collect provider level information in this analysis, but it is also highly likely that provider practice style might strongly influence patient persistence during therapy.
In theory, patients with mental health disorders, at baseline, would seem less likely to tolerate and complete a full course of HCV treatment, as they may be more sensitive to the psychiatric adverse effect profile of interferon-alpha. To assess the impact of a mental health disorder at baseline on HCV therapy completion rates, we assessed whether the number of mental health disorders at baseline affected rates of HCV therapy completion and rates of therapy discontinuation related to psychiatric adverse effects for patients with relative to those without mental health disorders. Pegylated interferon and ribavirin can cause symptoms of anxiety and depression at an incidence of 20–30% [26
]. Some studies have shown that almost 50% of patients undergoing antiviral treatment can experience symptoms of anxiety, depression, or irritability [29
]. Additional studies have shown that interferon induced depression significantly contributes to early discontinuation of treatment and subsequently lower incidence of SVR [30
]. Interestingly, our study showed that the rates of HCV therapy discontinuation due to psychiatric-related adverse drug effects were similar between patients with a mental health disorder at baseline and with no mental health disorder at baseline.
Since complete information on patients lost to follow-up was not available, it is possible that psychiatric adverse effects contributed to these discontinuations. Therefore, we determined that it was necessary to evaluate overall completion rates for patients with mental health disorders at baseline. We also intended to determine if there was any difference in completion rates among patients with different numbers of mental health diagnoses at baseline. Liu et al. evaluated a random sample of patients treated in the HCV clinic and noted that patients with a diagnosis of depression at baseline had lower rates of completion than patients without preexisting depression [33
]. Previous studies have also shown that patients with schizophrenia have similar completion rates as patients without schizophrenia [34
]. Our study revealed that patients with one or more mental health disorders at baseline had similar rates of completion when compared to patients without any diagnosed mental health disorder.
Our study found that discontinuation of treatment due to psychiatric related adverse drug effects was similar among all patients, regardless of mental health disorder diagnosis at baseline. Additionally, patients with any number of mental health disorders at baseline have similar rates of completion as patients without a mental health disorder. With this being said, it is difficult to ignore the role that mental health plays with HCV treatment. Mental health disorders should not necessarily be seen as a barrier to HCV treatment. It may be more important for all patients, regardless of psychiatric history, to have close monitoring and individualization of their care, as supported by a recent study and treatment guidelines [7
Several quality improvement measures were identified for our HCV clinic, as a result of this evaluation. This study did indicate that it is necessary to standardize the monitoring and followup of HCV-treated patients at our institution, so that 100% of patients are consistently assessed for adverse drug effects, HIV-status, reason for early discontinuation of treatment, and viral load at appropriate time points.
There were several potential limitations of our study. Our study contained many variables over a large span in time. Specific changes in HCV therapy identified between the study dates included adherence to checking viral load, aggressiveness in management of adverse effects, practice styles, treatment guidelines, and the actual viral assay. In addition, data was not collected regarding patients' mental health stability or use of psychiatric medications at baseline. This potential for bias was known prior to preparation of the study, as this was a retrospective analysis. Some data was self-reported by patients, such as concomitant alcohol and substance abuse during the treatment course, and this information is potentially biased to underreporting. Another limitation was also attributed to the study design. Incomplete data was occasionally observed, due to lack of documentation and patients lost to follow-up.
In conclusion, in this retrospective analysis, liver biopsy within one year of starting HCV therapy was not associated with increased rates of therapy completion. Similar completion rates were found between patients without a mental health disorder at baseline, with one mental health disorder prior to treatment, and with two or more mental health disorders at baseline. Treatment discontinuation due to psychiatric-related adverse drug effects was found to be similar among patients, regardless of psychiatric history.