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IAA 06-213 – HSR&D Study

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IAA 06-213
Hepatitis C Antiviral Treatment Rates: Understanding Racial Disparities
Michael K. Chapko PhD
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, WA
Funding Period: May 2009 - September 2013

BACKGROUND/RATIONALE:
HCV is an important health problem within the Veterans Administration (VA). Veterans are more than three times more likely to be infected with HCV than the general population, with the prevalence in African American Veterans being three and a half times higher than that of Caucasian Veterans. The disease results in substantial morbidity and mortality, including cirrhosis, hepatocellular carcinoma, liver transplant, and death. The current antiviral therapy can achieve a HCV cure rate of better than 65%, making it the most effective method for reducing the long-term consequences of the disease. Yet despite the higher prevalence, African Americans within the VA have significantly lower treatment rates compared to Caucasians. No study has addressed this difference in treatment rates within or outside the VA.

OBJECTIVE(S):
1) Using audio recorded GI (gastroenterology) provider-patient clinical encounters, determine whether racial differences exist in providers' recommendations for and patients' interest in initiating antiviral therapy.

2) Using in-depth qualitative interviews with the same cohort of patients, determine whether racial differences exist in patient factors related to initiating antiviral therapy.

3) Using in-depth qualitative interviews with the same cohort of providers, determine whether differences exist in provider factors related to African Americans initiating antiviral therapy.


METHODS:
This longitudinal study enrolled 118 patients referred to a Gastroenterology (GI) clinic who were considered eligible for antiviral treatment. African American (n=51) and Caucasians (n=67) at VA Puget Sound (n=52) and VA Pittsburgh (n=66) had their GI provider-patient clinical encounters audio recorded until a decision was made to start or not start antiviral therapy. Patients and providers also participated in a qualitative interview after each clinical encounter. Patient interviews focused on their satisfaction with the clinical encounter, their concerns, their understanding of HCV treatment, and facilitators and barriers to treatment. Provider interviews focused on their recall of patient concerns, their perception of the patient's understanding of HCV treatment, the patient's treatment candidacy, and the perceived level of patient adherence. We used the quasi-statistical qualitative method for analyzing the clinical encounter audio recordings, plus the patient and provider interviews. Each clinical encounter and set of interviews was coded separately. For the purposes of this analysis we aggregated all interviews given by a patient (and aggregated provider interviews by the patients ID). A similar approach was used for clinical encounters based on the patients ID.

The study began data collection on May 26, 2011 and recorded the last clinical encounters and interviews on March 22, 2013. During that time there were 178 clinic visits recorded, 186 provider interviews, and 183 patient interviews.

FINDINGS/RESULTS:
1) Clinical Encounter. A positive decision to start antiviral treatment occurred for 13.7% of African Americans and 26.9% of Caucasians. This difference was not statistically significant.

In the thematic analysis of clinical encounters, the only significant (p<.05) difference we found for providers was a greater likelihood of recommending imaging of the liver for Caucasians (23.9%) compared to African Americans (8.2%). No significant differences were found for providers with regard to any other coded issues such as drug use, treatment efficacy, psychological, social, or travel issues. African American patients (8.2%) did raise drug use issues significantly more frequently than Caucasian patients (1.4%). Otherwise, no significant differences were found between African American and Caucasian patients with regard to other issues such as treatment efficacy, psychological, relationship, social, or travel issues.

2) Patient Interviews. In the thematic analysis, no significant differences were found between African American and Caucasian patients with regard to any expressed concerns, such as treatment eligibility, quality of life, social, or travel issues associated with antiviral therapy.

3) Provider Interviews. In the thematic analysis of the provider interviews no significant differences were found following African American versus Caucasian clinic visits. Examples of coded categories include adherence, efficacy, mental health, and relationships issues.

IMPACT:
Overall a decision was made to start HCV antiviral treatment for 21.2% of patients. This is similar to the historical percent of VA patients with HCV who have received antiviral treatment. Although we did observe a difference in treatment rates between African Americans (13.7%) and Caucasians (26.9%), this almost two to one ratio of Caucasians to African Americans (although not statistically significant) is about half of the previously identified racial disparity. For example, our research team observed in a previous study that only 5.2% of African Americans proceeded to treatment compared (p<.0001) to 20.4% of Caucasians who had discussed treatment with a VA GI provider. More recent VA nationwide data from the HCV Clinical Case Registry also suggests that a higher percent of African Americans are receiving HCV antiviral treatment compared to the past.

Previous studies have shown that traditional treatment consisting of pegylated interferon and ribavirin was far less successful in eliminating HCV in African Americans compared to Caucasians. The triple therapies (pegylated interferon, ribavirin, plus a protease inhibitor) used during the time period of this study have an overall improvement in cure rates plus little or no difference between African American and Caucasian cure rates. This improvement in outcomes for African Americans may account for the increase in the rates at which African Americans start HCV antiviral treatment.

The original intent of this study was to determine why large differences existed between the percent of African American and Caucasian VA patients receiving HCV antiviral treatment and to develop an intervention to reduce or eliminate the disparity. That disparity appears to be narrowing. In addition, we could not find substantive differences between the two groups in the barriers and other reasons for not initiating treatment. Given the relatively low percent of VA patients with HCV who have received antiviral therapy, the improving success rate for the newer therapies, and the serious longer term consequences of HCV, an intervention to increase the percent of all VA patients with HCV receiving antiviral therapy is clearly warranted. Such an intervention could focus on better dissemination to primary care providers and patients regarding the higher success rates from the newer triple therapies for all patients in general and especially for African American patients. In addition, the FDA has recently approved Sovaldi (sofosbuvir) which promises a shorter treatment period and fewer side-effects because it does not need to be used with Interferon. We will develop and evaluate such interventions with Dr Jason Dominitz, VA National Program Director for Gastroenterology and a co-investigator on this study, and Dr David Ross, Director, HIV, HCV and Public Health Pathogens Programs, VA Office of Public Health.

PUBLICATIONS:

Conference Presentations

  1. Zickmund SL, Hanusa BH, Obrosky DS, Chapko MK, Bayliss NK, Switzer GE, Sevick MA, Zook CL, Mrkva A, Arnold RM. Racial disparities in the initiation of hepatitis C antiviral therapy. Poster session presented at: VA HSR&D / QUERI National Meeting; 2012 Jul 17; National Harbor, MD.


DRA: Infectious Diseases
DRE: Treatment - Observational
Keywords: Adherence, Decision-Making, Disparities, Hepatitis C, HIV/AIDS, Hepatitis C, Patient Preferences
MeSH Terms: none

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