Treatment Outcomes among HCV Patients on Novel Direct Acting Antiviral Therapies in a Primary Care-Based Hepatitis C Clinic Público

Kim, Frances (2015)

Permanent URL: https://etd.library.emory.edu/concern/etds/d504rm22v?locale=es
Published

Abstract

Background: The introduction of direct acting antiviral agents (DAA) represents a new era in Hepatitis C (HCV) treatment, leading to significant improvements in efficacy, as well as a shorter and more tolerable treatment process.

Purpose: Despite advances in HCV therapies, successful treatment outcomes have been difficult to observe in primary care-based HCV clinics. The aim of this study is to evaluate whether largely uninsured, underserved, and minority patients of the Grady Liver Clinic (GLC) have better treatment outcomes on newer, interferon (IFN)-free DAA regimens compared to earlier patients on IFN-containing regimens.

Methods: A retrospective chart review of patients started on HCV treatment in the first IFN-containing triple therapy era (2011-2013) and the newer IFN-free DAA era (2013-2015) was performed (n=112). Various demographic, HCV-specific, and co-morbidity factors were also analyzed to determine whether patients with certain characteristics were more likely to successfully complete treatment and achieve SVR after 12 weeks of treatment.

Results: Out of the patients with complete outcome data, there were 61 patients on IFN-containing DAAs, and 51 patients on IFN-free DAAs. A higher percentage of patients on newer DAA regimens achieved SVR (94%) compared to patients on older DAA regimens (79%) (p=0.0659). The average age of the study population was 58 years, 82% were black, and half had public health insurance. More than a quarter of patients (29%) had a prior history of IFN-containing HCV treatment, and patients on newer regimen had more comorbidities than patients on older regimens. Continuous age was found to be associated with successful treatment outcome at the p<0.1 level (p=0.0889), as well as HIV and diabetes comorbidities at the p<0.2 level. However, no significant predictors of achieving SVR were found in models with the exposure of DAA regimen type.

Conclusions: Despite the challenges of this population, patients on newer, IFN-free DAA regimens have better treatment outcomes and SVR rates compared to those on older, IFN-containing regimens. These findings indicate that as improved and more effective IFN-free treatments become available, the GLC is a successful model for treating underserved, racial minorities with HCV, while reducing significant barriers to treatment that patients typically face.

Table of Contents

INTRODUCTION ………………………………………………………………………………………………..........…1 CHC treatment ……………………………………………………………………………........…........…… 1 New DAA regimens .…………………………………………………………........…….……........……. 2

PART I ……………………………………………………………………………………………………………..........…. 5

LITERATURE REVIEW: Factors Associated with CHC Treatment Uptake …....… 5

Barriers to Treatment Access ………………………………………………………………...…............ 5

I. Demographic variables ……………………………………………………………………….............…. 8

Race/Ethnicity …………………………………………………………………………....................…… 8

Black race ……………......................………………….…………………..............……. 9

Hispanic race …………………………........……….………………..........................… 11

Asian race ……......………………………...…………………………………...................… 11 Age ………………………………………………………………………………..……………..................... 12 Gender …………………………………………………………………………….….….......................… 14

II. Clinical stage variables ………………………………………………..……………….....….........… 15

Fibrosis stage and cirrhosis ………………………………………………………….................… 15

III. Comorbidity conditions …………………………………………………………………..............… 16

HIV/HCV co-infection ………………………………………………………….……...................…. 16 Psychiatric comorbidities ………………………………………….……………........…............… 18 Substance and drug use ………………………………….……………………......…...........….… 19

Other medical comorbidities ………………….………………………………........…..........….. 20

IV. Socioeconomic status ………………………………………………..………………........….....…… 21

Income ………………………………………………………………………………………....................… 21 Education …………………………………………………………………………………….......….........… 22 Health insurance status ………………………………………………….…………..................... 23

V. Stigmatization …………………………………………………………………………………........…......… 24

PART II………………………………………………………………………………….….…….........……..…....…. 26

INTRODUCTION…………………………………………………………………........………………………...…. 26

CHC Treatment at the Grady Liver Clinic (GLC)…………….....……………….…………... 26

METHODS…………………………………………………………………………..........………………………..…... 27

Data sources……………………………………………………………….........………………….........… 27 Variables used in analysis………………………………………….........…………………….......… 28 Statistical analysis……………………………………………………..……………………………........… 29

RESULTS…………………………………………………………………………..........………………………….….… 31

Descriptive statistics…………………………………………….......………………………………….......… 31

Treatment outcomes……………………………………....………………………………............…… 33

Univariate analyses………………………………………..........…………………………………..…........ 34

Treatment regimen………………………..………........………………………………….............… 34

Other variables…………………………………………......……………………………...…............... 34

Multivariate analyses……………………………………………......………………………….....….......… 35

DISCUSSION…………………………………………………………………........……………………….……….... 36

General findings……….……………………………………….......……………………...…............… 36

Associations between race and treatment outcome…………....……………….........… 37

Associations between DAA regimen type and treatment outcome………............ 38

Study limitations…………………………………………………………………………..………................… 39

Study design…………………………………………………………………………..……..................... 39

Data limitations………………………………………………………………………….......…............… 39

Other variable definitions……………………………………………………………...…..............… 41

CONCLUSION…………………………………………………………………………………………………............ 41

Next steps……………………………………………..………………………………....…................… 43

TABLES……………………………………………………………………………………………………...........…….… 44

REFERENCES………………………………………………………………………………………………..........……. 48

APPENDIX………………………………………………………………………………………………............……… 60

IRB Acceptance Letter………………………………………………………………………….........……......…. 61

GROC Acceptance Letter…………………………………………………................................…….… 63

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