HCV Case Study. Optimizing Outcomes with Current Therapies

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1 HCV Case Study Optimizing Outcomes with Current Therapies

2 This program is supported by educational grants from Kadmon and Merck Pharmaceuticals. Program Disclosure This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the sponsorship of Annenberg Center for Health Sciences at Eisenhower and the Chronic Liver Disease Foundation. Annenberg Center for Health Sciences at Eisenhower is accredited by the ACCME to provide continuing medical education for physicians.

3 Learning Objectives Describe current approaches to managing adverse events associated with current chronic hepatitis C treatments Optimize treatment results for patients with chronic hepatitis C utilizing current therapies

4 Jackie: Patient Characteristics 45 year old African American female History/risk factors BMI=32 CHC diagnosed in 2002 Treated with Peg-IFN/RBV in 2007 Tolerability issues: fatigue, anemia, neutropenia, alopecia, anxiety, depression after 6 months (treated with paroxetine)

5 Jackie: Disease Characteristics Prior relapser (early virologic response) Genotype 1a IL28B CT METAVIR F1 in 2007 BL viral load 18,000,000 IU/mL

6 Jackie: Baseline Labs Hemoglobin 12.1 g/dl Neutrophils 1300 cells/mm 3 Platelets 200,000 cells/mm 3 Serum creatinine 0.9 mg/dl AST/ALT 73/56 IU/L Albumin 4.1 g/dl Bilirubin 0.8 mg/dl INR 0.9

7 Clinical Decision #1 Would you reassess stage of fibrosis before retreatment and, if so, how? 1. No, I don t believe it is necessary 2. Yes, I would re-biopsy the patient 3. Yes, I would use non-invasive test

8 Clinical Question Which of the following statements is most accurate? 1. Jackie has a low likelihood of success because she is African American and IL28B CT. 2. Jackie has a very high likelihood of success because she is a prior relapser. 3. If restaging shows cirrhosis, Jackie has a very low chance of success. 4. Treatment is contraindicated for Jackie since she developed depression while on PEG/RBV.

9 %SVR REALIZE: SVR by Response to Previous Peg-IFN/RBV Therapy % All Patients 59% All T12/PR48 Placebo/PR % 15% 32% 5% 0 Relapsers Partial Responders Null Responders Telaprevir (INCIVEK ) Prescribing Information. Vertex Pharmaceuticals Incorporated, Cambridge, MA. October, 2012.

10 %SVR RESPOND 2: SVR by Response to Previous Peg-IFN/RBV Therapy % BOC* PR 60 46% % 7% 150/208 16/51 53/115 2/29 Prior Relapsers Partial Responders *Response Guided Therapy and 48 Week Arms Combined Boceprevir (VICTRELIS ) Prescribing Information. Merck Sharp & Dohme Corp., Whitehouse Station, NJ, November 2012.

11 Prior Response Trumps Other Pretreatment Baseline Factors Ethnicity IL28B Genotype Baseline Viral Load Fibrosis Score G1 Subtype

12 Jackie: On Treatment Labs Hemoglobin (g/dl) Neutrophil Count (cells/mm 3 ) HCV RNA (IU/mL) Baseline ,000,000 TW ,300 TW Undetectable

13 Clinical Decision #2 How would you manage Jackie s anemia? 1. No change to treatment 2. Add EPO 3. Reduce RBV from 1200 mg to 1000 mg 4. Reduce RBV from 1200 mg to 600 mg 5. Add EPO and reduce RBV (1200 to 600 mg)

14 Boceprevir: No Difference in SVR Rate in Anemic Patients Undergoing RBV DR vs EPO Use % of Patients RBV DR Arm EPO Arm Patients Randomized When Hb <10 g/dl / / / / / 196 EOT Response SVR Relapse Adapted from Poordad F et al. Abstract Poster presented at the 47th Annual Meeting of the European Association for the Study of the Liver. April 2012, Barcelona, Spain. 19/ 197

15 SVR (%; 95% CI) SVR Rates Did Not Vary with the Start Time of Anemia Management / 54 RBV DR 71 39/ 55 Poordad F et al, Abstract 154, AASLD 2012 EPO Use 64 58/ / / 62 4 Wks >4-8 Wks >8-12 Wks >12-16Wks >16 Wks Timing of the Start of Anemia Management 70 47/ / / / / 24

16 SVR, n/n(%) SVR Rates in Treatment Naïve Patients by RBV Dose/Day % 74% 75% 329/ % 29/ / % Any Dose reduction Received 600 mg/day Received mg/day 16/ 38 RBV Dose Reductions Never reduced Adapted from Sulkowski MS et al. Abstract Poster presented at the 47th Annual Meeting of the European Association for the Study of the Liver. April 21, 2012, Barcelona, Spain. 38/ 51 54% 13/ 24 79% 346/ % 134/ 292 T12PR PR

17 Jackie: On Treatment Labs Hemoglobin (g/dl) Neutrophil Count (cells/mm 3 ) HCV RNA (IU/mL) Action Baseline ,000,000 TW ,300 TW Undetectable Decreased RBV (1200 to 600 mg/day) TW Undetectable TW Undetectable TW Undetectable TW Undetectable Increased RBV (600 to 800 mg/day) Increased RBV (800 to 1000 mg/day)

18 Conclusions Many chronic hepatitis c patients are good candidates for treatment today Treatment outcomes with current treatments can be optimized with appropriate management/interventions

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