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Adherence to HCV Therapy: Relation with Virologic Outcomes and Changes in Adherence Over Time

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Adherence to HCV Therapy: Relation with Virologic Outcomes and Changes in Adherence Over Time

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    1. Adherence to HCV Therapy: Relation with Virologic Outcomes and Changes in Adherence Over Time Vincent Lo Re, MD, MSCE V. Teal, R. Localio, V. Amorosa, D. Kaplan, R. Gross Division of Infectious Diseases Center for Clinical Epidemiology and Biostatistics University of Pennsylvania School of Medicine

    2. Hepatitis C Virus (HCV) Therapy Pegylated interferon (PEG-IFN) + ribavirin Complex treatment regimen Frequent monitoring of laboratory results Office visits to evaluate for adverse effects Suboptimal adherence ? ? response

    3. Adherence to HCV Therapy Prior data: ? drug exposure from dosage reductions: ? SVR Few data: ? drug exposure from missed doses =85% adherence: ? wk 12 HCV RNA declines* Unanswered questions: Differences between PEG-IFN, ribavirin Levels of adherence for virologic response Changes in antiviral adherence over time

    4. Specific Aims Aim 1: Evaluate relation between adherence to PEG-IFN, ribavirin and virologic response Hypothesis: ? adherence ? ? HCV response Aim 2: Assess changes in adherence over course of HCV treatment Hypothesis: Adherence ? with time

    5. Study Design / Setting Retrospective cohort study Setting: U.S. VA Hepatitis C Case Registry Extract of VA records from HCV+ veterans Demographic, administrative, lab data Dispensing data on meds Advantages: Majority receive meds through VA* Initiate contact for refills (not automatic) Dispensing of antivirals not linked

    6. Study Subjects Inclusion criteria: HCV RNA+, HCV genotype 1 – 4 PEG-IFN + ribavirin rx: Jan 2003 ? Dec 2006 HCV viral load prior to, after treatment start Exclusion criteria: Clinical trial, switched IFN formulation, HIV Selection: first treatment course

    7. Adherence: Pharmacy Refills Calculated over 12-wk intervals: 0 – 12 wks 13 – 24 wks 25 – 36 wks 37 – 48 wks Initial fills: closest to wks 13, 25, 37 Included in analyses: fill during interval

    8. Data Analysis: Calculation of Adherence

    9. Study Outcomes Early virologic response (EVR) =2 log ? in HCV RNA copies/ml at 12 wks Defined wk 12 HCV RNA: wks 9 – 15 Sustained virologic response (SVR) Undetectable HCV RNA in all follow-up viral load tests 24 wks after treatment end date Collected HCV viral loads ? Dec. 2008

    10. Data Analysis Calculated adherence separately Adherence categorized into 4 strata Examined virologic response in each stratum Chi-square tests for trend Mixed effects regression models Changes in adherence (each med) over time

    11. Results: Subject Selection

    12. Results: Patient Characteristics

    13. Ribavirin Adherence and EVR: Genotypes 1 / 4

    14. Ribavirin Adherence and EVR: Genotypes 2 / 3

    15. Ribavirin Adherence and SVR: Genotypes 1 / 4, EVR+

    16. Adherence Over Time

    17. Potential Limitations Overestimate actual adherence Patients may not take meds after refill Assoc. with biological surrogate that only responds to antiviral therapy Retrospective design No standardized HCV RNA testing Generalizability

    18. Conclusions ? EVR and SVR with higher levels of adherence to PEG-IFN and ribavirin PEG-IFN adherence higher than ribavirin Adherence to both anti-HCV drugs ? over time Greater decline in ribavirin adherence

    19. Implications / Future Directions Addition of direct acting antivirals: Increase complexity ? adherence ? antiviral resistance Methods to measure adherence in real time Identify non-adherence as soon as it occurs Future research emphasis: Identify risk factors for non-adherence Develop interventions

    20. Acknowledgements Center for Clinical Epi: Robert Gross, MD, MSCE Russell Localio, PhD Valerie Teal, MS Infectious Diseases: Valerianna Amorosa, MD Gastroenterology: David E. Kaplan, MD

    22. Results: Virologic Response

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