For patients with hepatitis C virus (HCV), poor adherence to antiviral therapy is a common barrier to treatment success. Challenges associated with administration and tolerability make this issue especially true of pegylated interferons + ribavirin. The Be In Charge® program (BIC) is a comprehensive patient support program for HCV patients.

BIC encourages adherence by providing 24-hour inbound and proactive outbound on-call nursing support and mailings of HCV educational materials throughout therapy.

The purpose of the current study was to determine the effect of BIC on patient adherence to combination therapy with PegIntron and ribavirin.

A retrospective cohort analysis comparing BIC enrollees to a matched control group was conducted. Subjects were included if they were ≥18 years of age; started peg-2b on or after 1/1/2004; and could be followed for at least 12 weeks after treatment initiation.

To reduce potential selection bias from self-enrollment in the program, BIC enrollees were propensity score-matched to peg-2b starters not enrolled in BIC (controls), based on clinical and demographic characteristics.

Filled prescription records were used to measure adherence based on the number of injections dispensed and proportion of patients who received an average of ≥1 injection per week during follow-up.

Adherence was compared using paired chi-square and t-test.

Results

• The BIC group consisted of 780 eligible subjects who were observable for ≥12 weeks, including 638 and 333 subjects observable for 24 and 48 weeks, respectively.
• Of control subjects, 8572, 7014, and 4071 subjects were observable for 12, 24, and 48 weeks, respectively.
• Compared to non-BIC subjects, BIC enrollees were more likely to be female (53% vs. 41%, P<0.0001) and to use injection delivery devices vs. vials (74.0% vs. 56.7%, P<0.0001).
• In the matched analysis, BIC subjects refilled 1.2 more injections (P<0.0001) than the control cohort within 12 weeks, 2.7 more (P<0.0001) within 24 weeks, and 6.7 more (P<0.0001) within 48 weeks.

• Compared to matched controls, BIC enrollees were more likely to refill ≥12 injections within 12 weeks of initiation (72% vs. 64%, P=0.0005), ≥24 injections within 24 weeks (52% vs. 41%, P<0.0001), and ≥48 injections within 48 weeks (22% vs. 13%, P=0.0020).

According to the authors, “These findings suggest the BIC program significantly improves adherence to PegIntron. Additional research is needed to ascertain which aspects of the program are most effective and which patients are most likely to benefit from this intervention.”

ValueMedics Research, LLC, Falls Church, VA, USA, NDC Health Research & Consulting, Deerfield, IL, USA.

05/23/06

Reference
M. Hussein, J. S. Benner, D. Lee, and others. Evaluation of a HCV Patient Support Program’s Impact on Patient Adherence. Abstract 200. (Oral Presentation). Digestive Disease Week 2006 (DDW 2006). May 20-25, 2006. Los Angeles, CA.