High rates of early treatment discontinuation in hepatitis C-infected US veterans

Abstract

BackgroundPatients with chronic hepatitis C (HCV) frequently discontinued dual therapy with pegylated interferon alfa (Peg-IFN) plus ribavirin (RBV) before reaching the recommended duration of 48 or 24 weeks for genotypes (G) 1/4 or 2/3, respectively. We quantified rates of discontinuation despite efficacy (non-LOE) versus lack of efficacy (LOE) versus discontinuation for unknown reasons in a national database of United States veterans.MethodsWe identified a population-based cohort of U.S. veterans with encounters from 2004 through 2009 who had lab-confirmed HCV infection and initiated therapy with Peg-IFN plus RBV in Veterans Health Administration medical centers. Pharmacy data were used to determine therapy duration, defined as the sum of Peg-IFN days supplied. Patients “discontinued” if they failed to receive at least 44 (G1/4) or 20 weeks (G2/3) of therapy. We classified discontinuations as due to non-LOE, LOE, or unknown reasons using a classification rule based on treatment duration and laboratory confirmed response.ResultsOf 321,238 diagnosed HCV patients during the evaluation period, 9.7% initiated therapy and 6.4% met all other inclusion criteria. 54.9% of patients discontinued early; of these, 41.2% discontinued due to non-LOE reasons, 12.5% discontinued for LOE reasons, and 46.3% discontinued for unknown reasons. Among non-LOE discontinuers, most (60.1%) discontinued in the first 4 weeks of therapy, which constitutes 13.6% of all treated patients.ConclusionsWe observed a high proportion of early discontinuations with dual-therapy regimens in a national cohort of HCV-infected veterans. If this trend persists in the triple-therapy era, then efforts must be undertaken to improve adherence.

Impact of All‐Oral Direct‐Acting Antivirals on Clinical and Economic Outcomes in Patients With Chronic Hepatitis C in the United States

“…Our results are very encouraging, as DAA therapy is associated with high cure rates, few side effects, and a decrease in adverse liver‐related outcomes, unlike earlier HCV interferon‐based therapies, which carried lower cure rates probably as a result of the high side‐effect profile of interferon leading to high discontinuance of treatment prior to cure . Interestingly, unlike our results, a recent report indicated that DAA treatment was associated with an unexpected high rate of HCC .…”

Systematic review: patient-reported outcomes in chronic hepatitis C - the impact of liver disease and new treatment regimens

“…Another commonly used definition for adherence was to achieve >80% rate of treatment completion and >80% receipt of the prescribed treatment regimens. Despite which definition used while treating patients with CH‐C, adherence to the full regimen is important to optimise the efficacy of anti‐viral therapy . Furthermore, adherence to the treatment regimen will become even more important when drugs are approved and are utilised in the “real world” setting.…”

“…Other drivers of non‐adherence that are specific to patients include less than 12 years of education, history of incarceration, current alcohol and drug use, and failure to show for follow‐up appointments . In addition, treatment‐associated fatigue and impairment of HRQOL during treatment can predict non‐adherence .…”

Sustained virological response to ombitasvir/paritaprevir/ritonavir and dasabuvir treatment for hepatitis C: Real‐world data from a large healthcare provider

“…Achieving a sustained virological response with antiviral therapy (SVR, defined as undetected HCV RNA measured at 12‐ or 24‐week post‐treatment) is associated with lower risk of developing hepatocellular cancer (HCC) and lower all‐cause mortality in patients with advanced fibrosis . With the prior standard of care HCV therapy of pegylated interferon combined with ribavirin, however, less than half of GT1 patients achieved SVR, and real‐world evidence underscores the suboptimal adherence to this regimen …”