Treatment Outcomes of Conventional Therapies for Hepatitis C Federal Prisons and a Cost Analysis of Newer Therapies Open Access

Ball, Takiyah Asha (2015)

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Objectives: 1. Examine treatment outcomes of using dual treatment of RBV-pegIFN for Hepatitis C in federal inmates in 2011. 2. Estimate improvement of outcomes if LDV-SOF were given to federal inmates from 2011 compared to RBV-pegIFN. 3. Estimate the ICER.

Design: 1. A retrospective review of BEMR of inmates approved for treatment of HCV GT 1 in 2011, by Federal Bureau of Prisons. Demographic, antiviral therapy and dosage, viral loads at each stage of the treatment, and reasons for stopped treatment or treatment failure data were collected. 2.Using a prospective strategy, this study provides a cost-effectiveness simulation using decision tree

Data Sources: FBOP, CDC, NIH, Pharmaceutical companies

Target Population: Federal inmates approved for HCV GT 1 treatment in 2011

Time Horizon: One year

Perspective: Prison

Intervention: A prospective look at potential cost effectiveness of newer agents' LDV-SOF could have on federal inmates approved for HCV treatment in 2011.

Outcome Measures: SVR, QALYs, and ICER.

Results: 1. Total of 422 HCV positive patients were approved for treatment. Of the 422, 177 (41.9%) patients that had HCV genotype 1; 159 actually began treatment; 18 patients never began treatment. After treatment 28.3% received SVR and 71.7% did not receive SVR. 2.Comparing RBV-pegIFN and LDV-SOF, we found with LDV-SOF the incremental cost effectiveness ratio was $742,020.00 per QALY.

Limitations: Medical labs and treatment response was not always obtained or recorded in timely manner causing gaps in data. Data was not complete in some cases due to lost to follow-up patients. The time horizon was not long enough to show the cost effectiveness of the newer agents.

Conclusion: Many patients with HCV GT 1 in this study did not get cured. Data suggested that Black/African Americans and individuals with cirrhosis have lower odds of a cure and as age increases, the cure rate decreases. Data also suggests that in the time frame that the study was conducted, newer agents were not cost effective in the first year of treatment. The horizon would have to be analyzed for the lifetime of the patient to see any cost effectiveness of the newer agents and we assume that LDV-SOF would be more cost effective than RBV-pegIFN.

Table of Contents

Abstract. xi

List of Tables and Figures. 3

Chapter 1: Introduction. 4

Chapter 2: Literature Review. 6

Hepatitis C Virus. 6

Hepatitis. 6

Genotypes. 6

Transmission. 7

Symptoms and Diagnosis. 7

Treatment 8

Antivirals. 8

Side effects. 10

Cure rates. 10

Hepatitis C in Federal Prisons. 11

Co-Morbidities. 11

Criteria for treatment 12

Hepatitis C and HIV Care Continuum. 14

Cost Analysis of Hepatitis C. 16

Summary. 18

Chapter 3: Treatment Outcomes of Using Dual Treatment of Ribavirin and Peginterferon for Hepatitis C in Federal Inmate Cohort 2011: And an Analysis of the Costs of Treating Patients with Newer Direct Acting Agents. 19

Introduction. 19

Methods. 20

Subjects. 20

Data Collection. 20

Antiviral Interventions. 22

Medical Costs. 23

Utility losses. 23

Data Sources. 24

Results. 24

CEA Study Results. 30

Discussion. 31

Limitations. 35

Chapter 5: Conclusion and Public Health Significance. 36

References. 37

Appendices. 41

Appendix A: CEA Decision Tree. 41

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