CASE STUDY. Adverse Events in treatment chronic hepatitis C patients with PegInterferon and Ribavirin What would your management decision be?

Transcription

1 Adverse Events in treatment chronic hepatitis C patients with PegInterferon and Ribavirin What would your management decision be? CASE STUDY Pham Thi Thu Thuy MD, PhD Ho Chi Minh City Vietnam

2 Serious Adverse Events and Adverse Events Asian Caucasian n = 86 % n = 63 % Serious Adverse Events % % -Death 0 0% 0 0% -Sepsis 0 0% 3 4.8% -Decompensation 1 1.2% 3 4.8% -Blood transfusions % 5 7.9% Adverse Events -Anemia (<10g/dl) % % -Neutropenia (<500 cells/dl) 1 1.2% % -Thrombocytopenia(<30,000/dl) 2 2.3% 5 7.9% -Skin Rashes 8 9.3% % -Weight loss % % -Dysgusia % % -Diarrhea 1 1.2% 5 7.9% -Nausea % % Discontinuations - Due to AEs 4 4.6% % - Fulfilled stopping rules % %

3 Case history 54 year old Vietnamese woman She lives in HCM city and works as a teacher The patient presented in December 2012 with fatigue and anorexia 48 kg (BMI: 20.5) Diagnosed with HCV in 2008 Negative for both HBV and HIV antibodies No prior HCV treatment Physical examination unremarkable Single

4 Family and other history Parents alive, HBV and HCV status unknown Operation for appendicitis in 2002 No alcohol, non-smoker Hypertension for 4 years Treated with Adalate LA 30mg, 1 tablet/day

5 Laboratory investigations HCV RNA:7.35 x 10 6 copies/ml HCV genotype 6b- IL28B: CT AST: 44 IU/L; ALT: 65 IU/L GGT: 45 IU/mL Total bilirubin: 0.8mg/100mL WBC: 6.55 x 10 9 /L; neutrophils: 61% Haematocrit: 43.6%; haemoglobin: 14.2 g/dl Platelets: 259 x 10 9 /L Thyroid stimulating hormone: 1.75 miu/l Antinuclear antibody test: negative Glycemia: 5.65 mmol/l Creatinin:0.8mg% Albumin:3.9g% Alpha-fetoprotein: 5 ng/ml FibroScan: F3 (Fs=12.7 Kpa) Abdomen US: chronic hepatitis

6 Treatment regimen for this patient Peginterferon alfa-2a 180 mg/week and ribavirin 800 mg/day

7 Week 4 follow-up Fatigue and headache 47kg HCV RNA: negative AST: 32 IU/L; ALT: 35 IU/L GGT: 37 IU/mL WBC: /L; neutrophils: 42% Haematocrit: 31.7%; haemoglobin : 10.6 g/dl Platelets: 189 x 10 9 /L Thyroid stimulating hormone: 2.15 miu/l

8 Week 8 follow-up Fatigue 44kg Insomnia (from 1am to 4 am) AST: 28 IU/L; ALT: 30 IU/L WBC: /L; neutrophils: 41% Haematocrit: 30.1%; haemoglobin : 10.2 g/dl Platelets: 135 x 10 9 /L Thyroid stimulating hormone: 1.56 miu/l

9 What would your management decision be now? 1 Work with the psychologist 2 Medicines 3 Doing exercise

10 Week 12: follow-up Fatigue, myalgia HCV RNA: negative Weight: 42 kg AST: 26 IU/L; ALT: 28 IU/L GGT:32 IU/ml WBC:3.2 x 10 9 /L; neutrophils: 38% Haematocrit: 28.4%; haemoglobin: 8.9 g/dl Platelets: 115 x 10 9 /L Thyroid stimulating hormone: 1.48 miu/l

11 What would your management decision MEDIC CENTER be now? 1 Reduce peginterferon dose 2 Reduce ribavirin dose 3 continue treatment, plus Erythropoietin and control Hb level

12 % of Patients ( 95 % CL ) MEDIC CENTER Primary Efficacy Results* RBV DR EPO EOT Response SVR Relapse *Presented at EASL, 2012

13 Week 16: follow-up Chest pain Cardioechography: ischemic heart disease Weight: 39 kg WBC: 2.9 x 10 9 /L; neutrophils: 36% Haematocrit: 25.7%; haemoglobin: 8.3 g/dl Platelets: 103 x 10 9 /L Thyroid stimulating hormone: 3.6 miu/l

14 What would your management decision MEDIC CENTER be now? 1 Reduce peginterferon and/or ribavirin dose 2 Stop treatment until heart disease is well-controlled 3 Work with the cardiologist and continue treatment

15 Treatment decision Continue with current HCV treatment regimen plus erythropoietin and medication for heart disease

16 FibroScan: F2 (Fs=8.6 Kpa) MEDIC CENTER Week 24: follow-up Patient feels well HCV RNA: negative AST: 24 IU/L; ALT: 26 IU/L GGT:35 IU/mL Creatinin:0.8mg% WBC: /L; N: 45% Hct: 26.5%; Hb: 8.9 g/dl Platelets: /L TSH: 1.17 miu/l Abdomen US: normal

17 What would be your next treatment MEDIC CENTER decision for this patient? 1 Stop treatment at 24 weeks 2 Continue treatment until 48 weeks

18 Virolgoic response rate (%) MEDIC CENTER Similar SVR rates with 24 or 48 weeks treatment in HCV genotype 6 patients in Vietnam 48 weeks Peg-IFN ɑ-2a 180 g/wk plus RBV 15 mg/kg/day 24 weeks Peg-IFN ɑ-2a 180 g/wk plus RBV 15 mg/kg/day P>0.05 -P>0.05- P> P> RVR cevr ETR SVR Thu Thuy, Hepatology, May 2012 V56

19 Rapid virological response is a good predictor of SVR Yes n=51 (80.95%) SVR 49/51 (96.07%) Group I n=63 Week 4 RVR? No n=12 (19.05%) SVR 1/12 (8.33%) Yes n=23 (79.31%) SVR 21/23 (91.3%) Group II n=29 Week 4 RVR? No n=6 (20.69%) SVR 0/6 (0%) Thu Thuy, Hepatology May 2012, V 56

20 SVR rate (%) MEDIC CENTER RVR may be predictive of achieving an SVR in genotype 6 patients Peg-IFN α-2a 180 µg/week plus weight-based RBV mg/day weeks 48 weeks n= Patients with RVR Patients without RVR Lam KD et al. Hepatology 2010; 52:

21 24 weeks after stopping treatment Patient feels well Weight: 44 kg HCV RNA: negative AST: 22 IU/L; ALT: 26 IU/L WBC: /L Hct: 36.3% Hb: 12.2 g/dl Platelets: /L TSH: 1.45 miu/l Abdomen US: normal FibroScan: F1 (Fs=6.7 Kpa)