Practical Approaches of Integrating HCV into HIV Care David Hachey, Pharm.D., BCPS, AAHIVP Professor Idaho State University

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1 NORTHWEST AIDS EDUCATION AND TRAINING CENTER Practical Approaches of Integrating HCV into HIV Care David Hachey, Pharm.D., BCPS, AAHIVP Professor Idaho State University Presentation prepared by: David Hachey Last Updated: 6/25/14

2 Objectives Understand different models of integrating HCV care into HIV Identify key parallels between HIV and HCV care systems Review a patient case highlighting various challenges

3 Models of HCV Care

4 Models of Care Primary care management with expert back up - Usually includes a primary care HIV provider who manages all aspects of care, but collaborates with specialists Integrated care with HCV management by providers without a designated HCV clinic - There is an established HCV clinic on site of the HIV program Integrated care with a designated HCV clinic - There is a special time in which co-infection clinic is held - Usually involves a team of specialty providers

5 Parallels to HIV Care

6 Parallels to HIV Care Dedicated provider for treatment and monitoring - Program Champion Ongoing evaluation of treatment candidacy - Screening program - how does your program ensure all HIV patients are screened for HCV at least once, or ongoing for high risk patients - Once identified as positive, how are patients deemed to be eligible for treatment (barriers to care) Treatment protocols - EMR Templates - Paper flow charts - Treatment calendars - Dosing protocols (including length of therapy)

7 Parallels to HIV Care Patient education - Adherence counseling, side effect management, dosing, etc Client support groups Access to psychiatry and mental health services Access to substance abuse counseling Medication access and payment/coverage - Patient assistance programs - Prior authorization paper work Disease state monitoring - Lab work and follow up

8 Patient Case

9 MP 34 yo Caucasian male diagnosed with HIV in 2007 just transferred to your clinic - History of KS, syphilis, mild depression and hepatitis C (admits to 500+ lifetime partners) - States a biopsy revealed scarring but no prior records - History of Methamphetamine addiction and completed 30 day inpatient treatment program in spring subsequent relapses because of boredom and loneliness Most recent use is within past 30 days - Has a BS in Molecular Biology, two Masters degrees, Theology and Psychology and has been admitted to a PhD program - Uninsured, unemployed, and lives at home currently

10 MP HIV regimen - Was started on Atripla in 2007 but switched to his current regimen of Kaletra, Truvada and Isentress by his previous provider in preparation of treatment for HCV - States impeccable adherence even when he was using with continuous viral suppression Labs - CD4 500 and VL <20 copies - GT 1a and VL 1,500,000 - HBsAg negative, HBsAb positive, total-hav negative - AST 90, ALT 131, Albumin 4.0, Total bili 1.5, H/H 17/50, Platelets 163, INR 1.02 and TSH 0.967

11 This patient is requesting therapy for his HCV. Which of the following would you do: A. Ini&ate therapy ASAP B. Wait un&l he is abs&nent from Meth for 6 months C. Repeat biopsy D. Refer to mental health and substance abuse while working up his HCV

12 HCV Clinic Flow Box A Pre-treatment Screening (For all initial encounters)! PT and INR! CBC! CMP fasting for glucose! HIV Ab test! Hepatitis A and B screening! Hepatitis A and B vaccines (if indicated)! HCV genotype (if not done)! HCV viral load (For patients be worked up for treatment)! TSH (for interferon patients only)! Urinalysis! Ferritin, iron and TIBC (if clinically indicated)! Pregnancy test x 2! Repeat HCV viral load if last test > 1year old! EKG! Eye exam! Liver biopsy or Ultrasound! HCV Ab test Positive HCV viral load reflex to GT to determine active infection Positive Negative Negative Re-check as needed OR HCV viral load if elevated LFTS HCV VL Undetectable - infection cleared, recheck annually as indicated Pretreatment Screening (See Box A) Not a Treatment Candidate HCV VL Undetectable - infection cleared, recheck annually as indicated Box B Pharmacotherapy Clinic Routine! Complete initial Project ECHO form! Stablize patient (vitals/weight loss/smoking, etc )! Medication management (adherence counseling, drug interaction verification, PHQ9 )! Manage comorbid disease states Patient Education! Disease state education and HCV med education! Completion of labs and vaccines! Insurance review / Pt Assistance / PA Starting Therapy! Injection teaching (nursing?)! Side effect management! Treatment calendar! Informed consent Treatment Candidate Appointment Pharmacotherapy Clinic (See Box B) Present patient to Project ECHO Box C Interferon Ineligible Patients! Intolerance to IFN! Autoimmune hepatitis or other autoimmune disorders! Hypersensitivity to PEG, IFN or any of it s components! Decompensated disease! History of depression, or clinical features consistent w/ depression! Baseline neutrophil count less than 1,500, platelet count less than 90,000 or hemoglobin less than 10! Pre-existing cardiac disease

13 Name: Treatment Calendar Hepatitis C Labs and Medication Information Lab Draw Day: Injection Day: Therapy Start Date Length of Therapy Therapy Finish Date Pharmacy Name: Lab Name: Pharmacy Phone: Lab Phone: Medication Pegasys Peg-Intron Ribavirin Sovaldi Olysio Dose / Instruction Baseline Labs Genotype Viral load (w/ date) Platelets H/H ANC Weeks of Therapy Date of lab Date of Appt Interferon Free Patients 2 CBC, CMP Patients on Interferon 4 CBC CMP, TSH 8 CBC CMP 12 CBC CMP, TSH Ultrasensitive HCV VL Ultrasensitive HCV VL 16 CBC 20 CBC 24 CBC Ultrasensitive HCV VL How long was patient treated for:! 12 Weeks: / / 12 week post therapy VL, CBC and CMP! 24 Weeks: / / 12 week post therapy VL, CBC and CMP ISU Family Medicine 465 Memorial Drive Pocatello, ID Shane Ames, LPN (P) (F) Dave Hachey, Pharm.D (P) (F)

14 MP Outcomes - Patient presented to ECHO and there was a relative split decision on whether or not to treat this patient because of active substance abuse - Patient agreed to following terms of his treatment Start Mirtazipine for depression and potentially reduce meth use Come to clinic weekly for his injections to reduce risk of relapse with exposure to needles, complete weekly PHQ-9 and get labs (if needed) Random drug screening and if positive, potential withholding of therapy Continued weekly counseling - Needed patient assistance to get meds - Complications from IFN with ANC dropping to Total bilirubin elevation - Mild drop in CD4 count on therapy, but no viral break through

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