Hepatitis C treatment and SVR: the gap between clinical trials and real-world treatment aspirations

Abstract

Objective: Despite the remarkable improvements in pharmacologic treatment efficacy for hepatitis C (HCV) reported in published clinical trials, published research suggests that, in "real-world" patient care, these medical outcomes may be difficult to achieve. This review was undertaken to summarize recent experience in the treatment of HCV in clinical settings, examining the course of patients through the stages of treatment and barriers to treatment encountered.

Method: A comprehensive and representative review of the relevant literature was undertaken to examine HCV treatment experience outside of clinical trials in the last decade. This review found 25 unique studies with data on course of treatment and/or barriers to treatment in samples of patients with HCV not preselected for inclusion in clinical trials.

Results: Results were examined separately for samples selected for HCV infection versus HCV/HIV coinfection. Only 19% of HCV-selected and 16% of HCV/HIV-coinfection selected patients were considered treatment eligible and advanced to treatment; even fewer completed treatment (13% and 11%, respectively) or achieved sustained virologic response (3% and 6%, respectively). Psychiatric and medical ineligibilities were the primary treatment barriers.

Conclusion: Only by systematically observing and addressing potentially solvable medical and psychosocial barriers to treatment will more patients be enrolled in and complete HCV therapy.