Predictors of early treatment discontinuation in a cohort of patients treated with boceprevir‐based therapy for hepatitis C infection

Abstract

In this real-world cohort, 49% of patients stopped boceprevir-based hepatitis C therapy early, with only 20% stopping due to treatment futility. Having more comorbidities was significantly associated with early discontinuation. Tolerability of boceprevir-based regimens may be substantially worse than reported in clinical trials, particularly for patients with comorbidities.

Treatment Patterns, Health Care Resource Utilization, and Costs in U.S. Patients Diagnosed with Chronic Hepatitis C Infection Who Received Telaprevir or Boceprevir

“…However, this study found that female patients were at an increased risk for therapy noncompletion, and the higher percentage of females in this study relative to studies of the VA population may partially explain the higher discontinuation rate found in this study. [14][15][16][17] Taken holistically, the results from the current study support evidence in the literature that completion rates of DAA therapy regimens in the real-world are lower than in clinical trials, which report 66%-73% completion rates in telaprevir patients 10,11 and 60%-65% completion rates in boceprevir patients. 8,9 The higher completion rates found in clinical trials likely reflect the carefully selected patient populations and additional resources used to encourage patient compliance with medications.…”

“…14,15 In another VA database analysis, Ioannou et al (2014) defined duration of treatment from the first fill of PEG/ RBV to the last day of treatment covered by PEG/RBV and found that approximately 41%-45% of telaprevir patients did not complete at least 24 weeks of therapy, and 40%-55% of boceprevir patients did not complete at least 28 weeks of therapy. 17 Finally, Majid et al (2014) found that 49% of boceprevir patients discontinued therapy prior to 24 weeks. 16 The higher rates of therapy noncompletion found in the current study are likely attributable to a stricter definition of therapy completion and differences in the study populations.…”

“…17 Finally, Majid et al (2014) found that 49% of boceprevir patients discontinued therapy prior to 24 weeks. 16 The higher rates of therapy noncompletion found in the current study are likely attributable to a stricter definition of therapy completion and differences in the study populations. For example, this study required that patients take all 3 drugs for the minimum required duration of triple therapy and that patients take PEG and RBV for the minimum recommended duration of lead-in or dual therapy, whereas other definitions patients were found to have statistically significantly higher total annual drug costs than boceprevir patients (P < 0.001; Table 5).…”

“…13 Existing real-world data on the efficacy, safety, and adherence to DAA regimens in the United States are limited. Previous studies have examined the use of DAAs in specific subpopulations, such as the Veterans Administration (VA) health care system in the United States [14][15][16][17] or in small scale health center-based studies. 18,19 However, few of them investigated the treatment patterns or health care utilization and cost outcomes.…”

Limited Generalizability of Registration Trials in Hepatitis C: A Nationwide Cohort Study

“…[27] This results in an increased proportion of adverse events, dropouts and hence lower effectiveness. [28] Our results support the ‘development paradox’ and provide reasons why real world outcomes do differ from registration trials.…”