Having a pretreatment liver biopsy did not predict whether patients completed a full treatment course for hepatitis C, researchers reported. In subsequent analyses, the presence of a psychiatric disorder also did not affect treatment completion.
"Our study showed that liver biopsy within one year of starting therapy did not have an effect on completion rates," study researcher Joseph Kluck, PharmD, BCPS, of the University of Pennsylvania, told Infectious Disease News. "It also showed that mental health disorder diagnosis at baseline should not necessarily be seen as a barrier to treatment, as this also did not seem to have an effect on completion rates. Overall, it is important for patients to receive close monitoring and individualization of care while undergoing HCV treatment, in order to facilitate their completion of therapy."
Using a computerized patient record system, Kluck and colleagues examined the effect of having liver biopsy within 1 year of starting HCV treatment and the presence of psychiatric disorders on the treatment response and completion rates among 375 HCV-infected veterans who were being treated at the Philadelphia VA Medical Center. Treatment included combination pegylated interferon plus ribavirin for 24 weeks for HCV genotypes 2 and 3, or 48 weeks for HCV genotypes 1 and 4.
Sustained virological response (SVR) was achieved in 31% of patients, and 45% completed the full treatment course.
The researchers hypothesized that having an invasive procedure such as a liver biopsy would make patients more aware of their disease and “psychologically” motivate them to complete the extensive HCV treatment. Additionally, HCV treatment has been associated with psychiatric adverse effects — including anxiety, depression and posttraumatic stress disorder — which also may lead to treatment discontinuation.
However, of the patients who received a liver biopsy within 1 year of starting treatment, 44% completed treatment vs. 46% of those with no biopsy or biopsy more than 1 year prior to starting treatment.
Although biopsy status had no effect on treatment completion, the researchers said having a biopsy may be associated with treatment uptake. For example, the biopsy rate among the cohort was 23% vs. the biopsy rate among those at the VA center who were untreated (3.8%).
Psychiatric disorders, which were based on ICD-9 codes, progress notes and prescription records, were common in the cohort (59.7% having at least one disorder), but did not significantly alter the treatment course.
The most common reasons for discontinuation among those with psychiatric disorders were medication-related adverse effects, virological failure and loss to follow-up.
“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,” the researchers wrote.
According to Kluck, the demographics of many HCV clinical studies are not necessarily representative of a typical patient undergoing HCV therapy.
"More specifically, the veteran population is comprised of patients lacking the characteristics shown to be predictors of a positive response to HCV treatment," he said. "While it may not be possible to alter patient characteristics, ensuring that patients complete a full course of therapy can help increase the chance of achieving SVR."
Joseph Kluck, PharmD, BCPS, can be reached at Department of Pharmacy, Hospital of the University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104; email: firstname.lastname@example.org.
Disclosure: Kluck reports no relevant financial disclosures.