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May 2014 VA Hep C Treatment Guidelines
UPDATE: Feb 26, 2016-
Funding and Prioritization Status Update

UPDATE: March 2016
VA Hep C Treatment Guidelines
VA to treat all vets in system
 

By Judith Graham
VA Extends New Hepatitis C Drugs to All Veterans in Its Health System

 
Orange Count Registry
Vietnam vets blame 'jet guns' for their hepatitis C
By Lily Leung Feb. 14, 2016 
 
CBS News Investigates
Congress outraged over hepatitis C treatment VA can't afford
Dr. Raymond Schinazi played a leading role developing a drug that cures hepatitis C while working seven-eighths of his time for the VA
 
ibtimes.com| By amynordrum
 


Hepatitis C drug costing VA, DoD millions
By Patricia Kime, Staff writer
We're looking at a company who is milking a cash cow for everything it's worth," Sanders said. 
 


VA to outsource care for 180,000 vets with hepatitis C
Dennis Wagner, The Arizona Republic 12:27 a.m. EDT June 21, 2015
 


VA to outsource care for 180,000 vets with hepatitis C
, The Republic | azcentral.com 11:51 a.m. MST June 19, 2015
Dr. David Ross, the VA's director public-health pathogens programs, resigned from the working group. "I cannot in good conscience continue to work on a plan for rationing care to veterans," he wrote.
 


VA Region Stops Referring Patients To Outside Hospitals Thanks To Budget Shortfall
Michael Volpe Contributor ...According to a memo — the entire region has been forced to stop all “non-VA care” referrals due to a budget shortfall.
 

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OIG INVESTIGATES VA CHOICE PROGRAM PROBLEMS
Sen. Mark Kirk admitted the VA Choice Program is a failed joke in a letter to Secretary Bob McDonald despite attempts to fix it.
 

 
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IIR 07-101

An Integrated Care Model for Improving HCV Patient Outcomes
Samuel B. Ho MD

VA San Diego Healthcare System, San Diego, CA
San Diego, CA
Funding Period: November 2008 - October 2013


BACKGROUND/RATIONALE:
The prevalence of hepatitis C virus (HCV) infection among VA patients is 3x higher than in the general population. Recent VA data indicate that only about 14% of all HCV-infected VA patients have ever received antiviral therapy, which has the potential to reduce complications and sequelae of HCV infection. Barriers to receiving antiviral treatment include factors such as pre-existing psychiatric illness, ongoing substance abuse, and other medical co-morbidity. Clinical protocols are needed that can increase the number of patients with chronic HCV able to receive safe and effective antiviral treatment.


OBJECTIVE(S):
Primary Objective: To determine the effectiveness of a protocol-based integrated care model for increasing treatment rates and the number of patients with successful antiviral treatment as measured by an increase in percentage of all new HCV patients achieving a sustained virologic response (SVR). We hypothesize that this model will increase the proportion of patients who are fully evaluated for treatment, who initiate treatment, and who complete treatment compared with patients that receive usual care. Secondary Objectives: Assess the effects of an integrated care model on patient involvement in care (appointment attendance) and patient questionnaire forms (PQF) (substance abuse, depression, etc). We hypothesize that veterans managed with the integrated care model will have better attendance at HCV clinic appointments, have improved rates of drug and alcohol abstinence, and fewer psychological symptoms.


METHODS:
This study is a prospective patient level randomized design to study the effectiveness of this intervention at 3 major VA medical centers. All clinic patients will be screened for depression, anxiety, PTSD, or recent SUDs and all patients that screen positive on 1 or more of these measures will be asked to participate. Preliminary data suggest that 85% of HCV clinic patients screen positive on at least one measure. Eligible patients will be randomized to either usual or integrated care at each site. The integrated care intervention follows a manulaized protocol consisting of a series of brief intervention tailored to the patients' main barriers to treatment along with a case management approach in which the integrated care mental health provider actively tracks each patients progress through the evaluation and treatment process. The integrated care mental health provider can be a clinical nurse specialist, psychologist, or licensed clinical social worker that has experience and training in the provision of psychiatric and SUD interventions. They will receive additional training on the integrated care protocol. Data will be collected at baseline, pre-treatment, and post-treatment intervals. Clinical data will be obtained from VA medical records by the study coordinator at each site. PQFs will be assessed using validated measures. Data will be analyzed using hierarchicall linear modeling (HLM) techniques.

FINDINGS/RESULTS:
A total of 1752 unique patients were screened at the three HCV clinics. Of these, 763 (43%) were eligible for antiviral treatment and "high risk" screen positive, and 358 patients were randomized to either IC or UC. Overall patient characteristics included 63% non-White (39% African American, 18% Hispanic); 51% homeless in prior 5 years; 80% genotype 1; mean BDI score 15.34; Audit C 4+ =27.7%; PTSD risk =50.4%. Data suggest that patients at the San Diego site were more favorable for treatment initiation than at other sites. With a mean follow-up of about 16 months across all sites, there was a significant increase in the number of high risk HCV patients that initiated antiviral therapy, (25.0% IC vs. 16.6% UC) p=0.049, despite a marked reduction in antiviral therapy use by Dec 2010 due to anticipation of newer therapies. Adverse event data indicate non- significant trends toward fewer hospitalizations, mean hospitalized days, and mean emergency room for IC patients. There were 8 deaths in UC compared to 2 deaths in IC, not related to antiviral treatment. Data for individual sites show sizable significant differences at the San Diego site for antiviral treatment initiation (45% IC vs 24% UC) and deaths (0 in IC vs. 4 in UC). Other sites had no significant differences.

IMPACT:
Results to date suggest that integrated care models may lead to sizable increases in antiviral treatment initiation along with decreased adverse events at certain sites. These rates occurred during a widespread hiatus in initiation of antiviral therapy for hepatitis C genotype 1 patients due to the nearing availability of more effective therapies. The study will continue to collect longer term outcomes and study the implementation science factors that may have limited intervention effects at two of the sites. Continuation of this study will enable us to measure the impact of this intervention on the uptake of the more complicated but more effective new direct acting antiviral treatments.

PUBLICATIONS:

Journal Articles


Calore BL, Cheung RC, Giori NJ. Prevalence of hepatitis C virus infection in the veteran population undergoing total joint arthroplasty. Journal of Arthroplasty. 2012 Dec 1; 27:(10):1772-6.
Yip B, Chaung K, Wong CR, Trinh HN, Nguyen HA, Ahmed A, Cheung R, Nguyen MH. Tenofovir monotherapy and tenofovir plus entecavir combination as rescue therapy for entecavir partial responders. Digestive diseases and sciences. 2012 Nov 1; 57:(11):3011-6.
Ho SB, Groessl EJ, Brau N, Cheung RC, Weingardt KR, Ward MA, Sklar M, Phelps TE, Marcus SG, Wasil MM, Tisi AS, Huynh LK, Robinson SK. Prospective multisite randomized trial of integrated care (IC) vs. usual care (UC) for improving access to antiviral therapy for high risk patients with chronic HCV. Journal of Hepatology. 2012 Apr 1; 2012(56):S386.
Hwang EW, Thomas IC, Cheung R, Backus LI. Implications of rapid virological response in hepatitis C therapy in the US veteran population. Alimentary pharmacology & therapeutics. 2012 Jan 1; 35(1):105-15.
Chapman J, Oser M, Hockemeyer J, Weitlauf J, Jones S, Cheung R. Changes in depressive symptoms and impact on treatment course among hepatitis C patients undergoing interferon-a and ribavirin therapy: a prospective evaluation. The American journal of gastroenterology. 2011 Dec 1; 106(12):2123-32.
Groessl EJ, Weingart KR, Gifford AL, Asch SM, Ho SB. Development of the hepatitis C self-management program. Patient education and counseling. 2011 May 1; 83(2):252-5.
Groessl EJ, Weingart KR, Stepnowsky CJ, Gifford AL, Asch SM, Ho SB. The hepatitis C self-management programme: a randomized controlled trial. Journal of Viral Hepatitis. 2011 May 1; 18:(5):358-68.
Kanwal F, Kramer J, Asch SM, El-Serag H, Spiegel BM, Edmundowicz S, Sanyal AJ, Dominitz JA, McQuaid KR, Martin P, Keeffe EB, Friedman LS, Ho SB, Durazo F, Bacon BR. An explicit quality indicator set for measurement of quality of care in patients with cirrhosis. Clinical Gastroenterology and Hepatology. 2010 Aug 1; 8(8):709-17.
Dieperink E, Ho SB, Heit S, Durfee JM, Thuras P, Willenbring ML. Significant reductions in drinking following brief alcohol treatment provided in a hepatitis C clinic. Psychosomatics. 2010 Mar 1; 51(2):149-56.
Pichetshote N, Groessl E, Yee H, Ho SB. Optimizing the dose and duration of therapy for chronic hepatitis C. Gut and Liver. 2009 Mar 31; 3(1):1-13.
Groessl EJ, Weingart KR, Kaplan RM, Clark JA, Gifford AL, Ho SB. Living with hepatitis C: qualitative interviews with hepatitis C-infected veterans. Journal of general internal medicine. 2008 Dec 1; 23(12):1959-65.



DRA: Health Systems, Substance Abuse and Addiction
DRE: Treatment - Observational
Keywords: Care Management, Clinical practice guidelines, Hepatitis C
MeSH Terms: none