Ari Bunim, M.D. Director of Hepatology New York Hospital Queens Assistant Professor of Clinical Medicine Weill Cornell Medical College

Transcription

1 Ari Bunim, M.D. Director of Hepatology New York Hospital Queens Assistant Professor of Clinical Medicine Weill Cornell Medical College

2 New York State Law Goes into Effect January 1, 2014 Hepatitis C Virus Testing (Chapter 425 of the Laws of 2013) This new law requires a hepatitis C virus screening test to be offered to all patients born between 1945 and 1965 who are receiving health services as a hospital inpatient or receiving primary care services and applies to physician, physician assistant, or nurse practitioner. The law further requires that the health care provider refer a patient who receives a positive screening test to another provider to receive confirmatory testing and follow-up care.

3 Number infected Hepatitis C is Under Diagnosed in the United States 4,000,000 3,000,000 Undiagnosed Diagnosed ~75% 2,000,000 1,000,000 ~21% ~65% 0 HIV HBV HCV HBV=hepatitis B virus; HCV=hepatitis C virus; HIV=human immunodeficiency virus. Institute of Medicine. Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C; 2010.

4 X1000 persons HCV-Infected Persons in the US: Estimated Rates of Detection, Referral to Care and Cure CDC & USPSTF recommend 1-time testing of baby boomers (born ) % % 20-23% 7-11% 5-6% 0 Infected Diagnosed Referred HCV RNA Treated Cure to care test Holmberg S, N Engl J Med 2013; 368: 1859

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6 Number Burden of Hepatitis C Related Morbidity and Mortality in the US Markov model of health outcomes Of 2.7 M HCV infected persons in primary care 1.47 M will develop cirrhosis 350,000 will develop liver cancer 897,000 will die from HCV-related complications Deaths Decompensated cirrhosis HCC Transplants Rein et al. Dig Liver Dis Year

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8 Cumulative Incidence (%) Cumulative Incidence (%) SVR Reduced HCC and Liver-Related Complications in Patients With Bridging Fibrosis or Cirrhosis HCC (n=307) Liver-Related Complications* (n=307) Follow-Up (years) Follow-Up (years) *Ascites, variceal bleeding. 307 HCV patients with bridging fibrosis (n=127) or cirrhosis (n=180) were evaluated by Cox regression analysis. Non-SVR in 67% of patients treated with pegylated interferon plus ribavirin. Median follow-up: 3.5 years. Cardoso A-C, et al. J Hepatol. 2010;52:

9 % patients after 5 years 5-year risk of death (all-cause) by SVR General: 18 studies n=29,269 Avg. FU=4.6 years 4.5% 10.5% Cirrhotic: 9 studies n=2,734 Avg. FU=6.6 years 3.6% 11.3% HIV/HCV: 5 studies n=2,560 Avg. FU=5.1 years 1.3% 10.0% General Cirrhotic Co-infected Hill et al AASLD 2014 Abstract 44 SVR No SVR

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11 Simeprevir (Olysio ) 2 nd generation NS 3/4a protease inhibitor Approved for use in patients with genotype 1 HCV with Peg/Riba or with Sofosbuvir Metabolized in the liver and cleared via the biliary system

12 Sofosbuvir (Sovaldi ) HCV-specific NS5B polymerase inhibitor Approved for Genotypes 1,2,3, and 4 Geno 1 12 weeks with P/R or Simeprevir (non-cirrhotics) 24 weeks with riba if cannot tolerate IFN Geno 2: 12 weeks with riba Geno 3: 24 weeks with riba Geno 4: 12 weeks with P/R Renally Cleared

13 SVR12 (%) SOF + SMV + RBV for 12 vs 24 Weeks: SVR12 in F0-F2 Patients With Prior Null Response to PEG/RBV (COSMOS) 24 Weeks 12 Weeks /24 14/ /27 13/14 SMV/SOF + RBV SMV/SOF SMV/SOF + RBV SMV/SOF Lawitz E et al., Lancet, July 28, 2014, epub (

14 SVR12 (%) SOF + SMV + RBV for 12 vs 24 Weeks: SVR12 in F3-F4 Treatment-naïve Patients (COSMOS) Weeks 12 Weeks /13 8/8 11/12 6/7 0 SMV/SOF + RBV SMV/SOF SMV/SOF + RBV SMV/SOF Lawitz E et al., Lancet, July 28, 2014, epub (

15 SVR12 (%) SOF + SMV + RBV for 12 vs 24 Weeks: SVR12 in F3-F4 Patients With Prior Null Response to PEG/RBV (COSMOS) Weeks 12 Weeks /17 8/8 14/15 7/7 0 SMV/SOF + RBV SMV/SOF SMV/SOF + RBV SMV/SOF Lawitz E et al., Lancet, July 28, 2014, epub (

16 Sofosbuvir/Ledipasvir (Harvoni ) Recently approved for genotype 1 chronic HCV infection Most patients treated 8-12 weeks Once daily, oral fixed-dose (90/400 mg) combination tablet No food effect >2000 patients treated

17 SVR12 (%) SVR12 (%) LDV/SOF + RBV for 12 vs 24 Weeks: SVR12 in GT 1 Treatment-naïve Patients (ION-1) Non-cirrhotic Cirrhotic 179/ / / / / 33 33/ 33 31/ 32 36/ 36 LDV/S OF LDV/SOF + RBV LDV/S OF LDV/SOF + RBV LDV/S OF LDV/SOF + RBV LDV/S OF LDV/SOF + RBV 12 Weeks 24 Weeks Afdhal et al. N Eng J Med 2014;370: Weeks 24 Weeks

18 SVR12 (%) LDV/SOF + RBV for 8 vs 12 Weeks: SVR12 in GT 1 Treatment-naïve Non-cirrhotic Patients (ION-3) p= / / /216 LDV/SOF LDV/SOF + RBV LDV/SOF 8 Weeks 12 Weeks Error bars represent 95% confidence intervals. Kowdley KV et al. N Eng J Med 2014; 370:

19 SVR12 (%) Ion 2: Ledipasvir + Sofosbuvir ± RBV Genotype 1 Treatment Experienced / / / /111 SOF/LDV SOF/LDV+RBV SOF/LDV SOF/LDV+RBV 12 weeks 24 weeks Afdhal N et al, epub April 17, 2014 at NEJM.org

20 Abbvie 3D (Viekira Pak ) Recently approved for treatment of genotype 1 chronic HCV Including those with compensated cirrhosis, HIV, and post-liver transplant Consists of 4 different drugs Ribavirin also used in geno 1a and those with compensated cirrhosis

21 SVR12 (%) 3D + RBV for 12 Weeks: SVR12 in GT1a and GT1b Treatment-naïve Noncirrhotic Patients (PEARL-III and PEARL-IV) GT 1a GT 1b / / / /209 3D Regimen + RBV 3D Regimen 0 3D Regimen + RBV 3D Regimen Ferenci P et al. N Engl J Med 2014;370:

22 SVR12 (%) SAPPHIRE-2 (Placebo-Controlled) Paritaprevir/r-Ombitasvir + Dasabuvir + RBV Genotype 1, treatment experienced, noncirrhotic, 12 weeks, n= Overall G1a G1b Zeuzem S et al, N Engl J Med 2014;

23 Patients (%) with SVR 12 TURQUOISE II: Paritaprevir/r-Ombitasvir + Dasabuvir ± RBV D + RBV x 12 Weeks D + RBV x 24 Weeks P= Overall GT1a GT1b Relapse/viral breakthrough in 6% (12 wks) and 2% (24 wks) Poordad F et al. N Engl J Med; 2014;370:

24 Hepatitis B 800, million cases in the United States Should screen anyone born from an endemic area Asia, Africa, South America, Russia Up to 25% of people with hepatitis B will die prematurely from cirrhosis of liver cancer Not curable Very effective oral medications available to treat with few side effects

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26 New York Hospital Queens

27 NYHQ 519-bed acute, tertiary care facility Opened in 1957 as Booth Memorial Medical Center Has 1,500 doctors, podiatrists, and dentists on staff Member of New York Presbyterian Healthcare System Affiliate Weill Cornell Medical College

28 NYHQ Liver Center Provide in-patient and out-patient care for a variety of liver diseases, including decompensated cirrhosis Comprehensive management of hepatocellular carcinoma Drainage of ascites Liver biopsies Liver transplant evaluations and post-transplant care in conjunction with Columbia University Medical Center

29 Abnormal liver tests Hepatitis B and C Liver lesion or mass Anyone with cirrhosis Portal hypertension Varices Ascites Encephalopathy Who to Refer?

30 How to Refer Ari Bunim, M.D Main Street Flushing, New York (718)