Samuela Manages, MD, FAAFP Family Medicine Pines Health Services-FQHC February 9, 2018

Transcription

1 Samuela Manages, MD, FAAFP Family Medicine Pines Health Services-FQHC February 9, 2018

2 None

3 Be familiar with guidelines for Hepatitis C Screening Understand basic workup for patients with Hepatitis C Introduce ECHO Project and how it can guide primary care providers in treating and managing patient with Hepatitis C

4 1970 s: Known as Non-A, Non-B Hepatitis 1989: HCV Identified 1992: Blood supply screened cdc.gov, Ly et al. Ann Intern Med 2012

5 2007: Surpass HIV deaths 2011: FDA approved first Direct Acting Antiviral (DAA) Boceprevir and Telaprevir for Genotype 1 to be administered with PegINF/RBV 2012: CDC recommend testing of baby boomers 2014: First once daily pill for treatment of HCV that did not require PegINF/Ribavirin

6 Annual incidence has declined significantly since the mid-1980 s In 2010, approximately 17,000 new cases of hepatitis have occurred 4.2 to 5.1 million persons are HCV antibody positive Prevalence in pregnant women 0.1%-2.4%, although higher in endemic areas

7 3.2 to 4.1 million persons are living with chronic hepatitis C HCV prevalence is highest among persons born during 1945 to 1965 Although about 25% will clear without treatment, approximately 50% are unaware they have it

8 Cirrhosis occur in 20% of those who are chronically infected with HCV over years. Decompensated Cirrhosis - high risk of mortality from ruptured esophageal varices, bacterial peritonitis, hepatorenal syndrome/renal failure and encephalopathy. Hepatocellular Carcinoma - fastest growing cancer in the US, where 76% associated with chronic HCV infection. 4% annual incidence of HCC in those with cirrhosis.

9 HEALTHY LIVER FIBROTIC LIVER CIRRHOTIC LIVER Few or no symptoms; can progress without signs for decades [1] Most pts asymptomatic until serious liver complications arise [2] 1. CDC. MMWR Morb Mortal Wkly Rep. 1998;47(RR-19): Heidelbaugh JJ, et al. Am Fam Physician. 2006;74: Slide credit: clinicaloptions.com

10 Liver Transplantation - HCV responsible for 65% of liver transplants worldwide. HCV Mortality - estimated at 16,000/year, likely to peak ~2030. Burden of Liver disease expected to triple in next yrs.

11 WHO Vision - A world where viral hepatitis transmission is stopped and everyone has access to safe, affordable and effective treatment and care. 9 countries are currently on track to achieve 2030 HCV elimination goals: Australia, Brazil, Egypt, Georgia, Germany, Iceland, Japan, the Netherlands, and Qatar The United States is NOT among them

12 US Progress Toward HCV Elimination Goals: US HBV/HCV Elimination Strategy developed by National Academies of Sciences, Engineering, and Medicine: elimination = 90% reduction in incidence by Goal: 90% Diagnosed 80% Treated 65% Reduced mortality

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14 Small size Single-stranded enveloved RNA virus 6 Strains: Genotypes 1-6 Most prevalent genotypes in US - 1/2/3 Part of Flavivirdae family Responsible for HCC and Lymphoma

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16 Hepatitis C is and will be a major health problem in United States. Testing can identify persons before onset of HCV complications. Hepatitis C infection can be CURED with treatment. Most of HCV problem in US involves persons born (this is changing 20-50y/o). Approximately 50% of persons with HCV remain unaware of HCV status

17 Individuals born between (USPSTF Grade B recommendation) Any persons who have ever injected illegal drugs (IDUs), including those who injected only once at any time. Non injectable (intranasal cocaine). Recipients (eg., Hemophilia )of clotting factor concentration made before Current sexual partners of individuals with hepatitis C.

18 Recipients of blood transfusion or solid organ transplant before July Patient who have ever received long-term dialysis treatment. Persons with known exposure to hepatitis C such as healthcare workers after needle stick exposure, recipient of blood or organ from a donor who later tested hepatitis C positive.

19 All persons with HIV infection. Patient with signs and symptoms of liver disease (eg., abnormal LFT). Children born to hepatitis C positive mothers. To avoid detecting maternal antibody, children should be tested after 18 months of age. Men having sex with men (MSM). Prison/Incarceration.

20 Hepatitis B and C are tested during pregnancy Mother-to-infant transmission 4%-7% in mothers with active infection with viremia HCV treatment contraindicated during pregnancy C-sec only if indicated Monitor/avoid PROM HCV testing for baby after 18mos No contraindication to breastfeeding, its safe unless nipples cracked/bleeding.

21 Qualitative: HCV Ab or Anti-HCV Uses PCR or TMA (transcription mediated amplification) Reactive vs. Nonreactive Quantitative HCV RNA PCR Measures the amount of virus in blood HCV Viral load (eg., 15-6E) Checked prior to starting treatment Monitor response to treatment Sustained Viral Response (SVR)12

22 HCV guidelines. Adapted from CDC 2013

23 History & Physical When contacted? How contacted? History of IVDA? Past/Current Drug Use and Route Alcohol Use type/amount/frequency Transfusion? Prior treatment? Sexual activity? Immunization Hepatitis A & B PMH/Soc Hx/Med list (DDI)

24 HCV Viral Load HCV Genotype AFP CMP CBC TSH HIV PT/INR Urine Toxicology Screen Lipids Fibrosure/Liver Elastography Ferritin/Iron Studies Pregnancy test Hepatitis A Ab Hepatitis Bc Ab Hepatitis Bs Ag/Ab

25 No Need to Refer Refer According to Provider Experience Refer Hepatitis C reinfection Prior treatment with peginterferon/riba virin No advanced fibrosis Renal impairment If required by insurance Active substance use Compensated cirrhosis Recurrent hepatitis C virus infection after liver transplantation Decompensated cirrhosis (eg, ascites, jaundice, encephalopathy, bleeding varices) Slide credit: clinicaloptions.com

26 SVR12 (%) Nonrandomized phase IV trial of HCV treatment outcomes by DAA prescriber type Pts (N = 600) from 13 urban, FQHCs in DC, all treated with LDV/SOF per FDA prescribing info; all providers given 3-hr training in AASLD/IDSA HCV guidance n/n = 0 134/ / / / 600 NP/PA Primary MD Specialist MD Overall Kattakuzhy S, et al. Ann Intern Med. 2017;167: Slide credit: clinicaloptions.com

27 2017 Medicaid FFS Sobriety Restrictions for HCV Treatment No restrictions Screening/counseling Abstain 1 mo Abstain 3 mos Abstain 6 mos Abstain 12 mos NVHR State of Hepatitis C State of Medicaid Access Report. Oct 23, Slide credit: clinicaloptions.com

28 2017 Medicaid FFS Prescriber Restrictions for HCV Treatment No restrictions By or in consultation with specialist Specialist must prescribe Restrictions unknown NVHR State of Hepatitis C State of Medicaid Access Report. Oct 23, Slide credit: clinicaloptions.com

29 Many highly effective, highly tolerable options All-oral therapy for all Most pts receive: 8-12 wks of treatment Once-daily dosing Ribavirin-free therapy, including some of the newest treatments that provide options for all genotypes, cirrhosis, severe renal impairment

30 Inhibitor Class Suffix Targeting HCV Protein Processing NS3/4A protease -PREVIR Targeting HCV Replication NS5B polymerase NS5A -BUVIR -ASVIR McCauley JA, et al. Curr Opin Pharmacol. 2016;30: Eltahla AA, et al. Viruses. 2015;7: Gitto S, et al. J Viral Hepat. 2017;24: Examples Glecaprevir, grazoprevir, paritaprevir, simeprevir, voxilaprevir Nucleos(t)ide: sofosbuvir Nonnucleos(t)ide: dasabuvir Daclatasvir, elbasvir, ledipasvir, ombitasvir, pibrentasvir, velpatasvir Slide credit: clinicaloptions.com

31 Regimen Approved Genotypes Grazoprevir/elbasvir (Zepatier)* 1, 4 Sofosbuvir/ledipasvir (Harvoni) 1, 4, 5, 6 Sofosbuvir/velpatasvir (Epclusa) 1, 2, 3, 4, 5, 6 Sofosbuvir/velpatasvir/voxilaprevir (Vosevi) recently approved 1, 2, 3, 4, 5, 6 Glecaprevir/pibrentasvir (Mavyret)* recently approved 1, 2, 3, 4, 5, 6 *Approved in advanced renal insufficiency and dialysis. AASLD/IDSA. HCV Guidelines. September Slide credit: clinicaloptions.com

32 Recommendations Offer clinic visits or telephone contact to ensure adherence and to monitor for adverse events and potentially serious drug drug interactions CBC, creatinine level, cgfr, hepatic function panel at Wk 4 and as clinically indicated Quantitative HCV RNA at Wk 4 and 12 wks after completion of treatment SVR12: sustained virologic response 12 wks after end of treatment = cure AASLD/IDSA. HCV Guidelines Slide credit: clinicaloptions.com

33 Newer hepatitis C medications are generally well tolerated Headaches: nonpharmacologic management strategies, limits of OTC pain relievers and liver disease Anemia: still a concern when ribavirin needed Other common adverse events: fatigue, nausea, diarrhea

34 Limit/Avoid exposure to protect liver from additional harm Need Hepatitis A and B vaccine Screening and intervention for alcohol/drugs Acetaminophen Alcohol Other Hepatotoxic drugs

35 Counsel obese patients on diet & weight Loss Especially BMI 25kg/m2 Advise on decreasing risk of transmission to others Do not donate blood, tissue or semen Avoid sharing razors, toothbrushes and nail clippers. Clean, disinfect and cover wound immediately.

36 Advise among IDUs who share water, filters and water container. Encourage to refrain from sharing in order to reduce HCV transmission HCV survives for up to 3 weeks in bottled water. Survives for up to 63 days in syringes. Lower survival in insulin syringes than tuberculin syringes.

37 Environmental Surfaces -16 hours to 4 days Liquid Medium - 2 days to 20 weeks depending on temperature Low (or even null) risk of transmission from heterosexual monogamous sexual contact.

38 No general recommendations for condom use for individuals in monogamous relationship with HCVinfected partners Risk increases: Multiple sex partners STI Engage in rough sex HIV

39 No advanced fibrosis (Metavir stage F0-F2) No hepatitis C follow-up Advanced fibrosis (Metavir stage F3 or F4) Twice-yearly ultrasound surveillance for hepatocellular carcinoma If compensated cirrhosis (F4) also test for varices using baseline endoscopy

40 Ongoing hepatitis C risk or unexplained hepatic dysfunction Test for recurrence or reinfection with quantitative hepatitis C RNA assay, counsel on risk of reinfection Persistently abnormal liver tests Test for other causes of liver disease Refer to GI/ID/Hepatologist if needed No virologic cure Test for disease progression every 6-12 mos with hepatic function panel, CBC, and INR Consider retreatment options

41 Created by Dr Sanjeev Arora, MD, Liver specialist in New Mexico out of frustration for the lack of access to specialist for treatment of Hep C Amplify the capacity to provide access to treatment in underserved area all over the world Allow primary care clinicians to treat Hepatitis C in their own communities Launched in 2003, allow access to specialized medical knowledge where ever it is needed to improve and save lives.

42 Weekly Virtual clinics (TeleECHO clinics) Share knowledge and expands treatment capacity Result: better care for more people Study published in the New England Journal of Medicine in 2011 showed that the quality of hepatitis C care provided by Project ECHO-trained clinicians was equal to that of care provided by university-based specialists

43 Expanded across multispecialty Urban/Rural 130 hubs 65 Disease condition (Chronic pain, Suboxone, etc) 23 countries

44 Project ECHO Video

45 Daklinza (Daclatasvir) Zepatier (Elbasvir-Grazoprevir) Mavyret (Glecaprevir-Pibrentasvir) Harvoni (Ledipasvir-Sofosbuvir) Technivie (Ombitasvir-Paritaprevir-Ritonavir) Viekira Pak (Ombitasvir-Paritaprevir-Ritonavir-Dasabuvir) Pegasys (Peginterferon alfa-2a) PegIntron (Peginterferon alfa-2b) Copegus/Rebetol/Ribaspere (Ribavirin) Olysio (Simeprevir) Sovaldi (Sofosbuvir) Epclusa (Sofosbuvir-Velpatasvir) Vosevi (Sofosbuvir-Velpatasvir-Voxilaprevir) Discontinued Victrelis (Boceprevir) Incivek (Telaprevir)

46 University of Washington ( Centers for Disease Control ( AASLD/IDSA ( CHB Treatment Guideline Navigator ( UpToDate Clinical Care Options ( Aidsinfonet.org Fact sheets, hand outs on medication in different languages. Liverpool Drug-Drug interaction checker. Download App HEP ichart at AppStore

47 THANK YOU :O) Samuela Manages, MD, FAAFP Pines Health Services-FQHC 4 Main Street Van Buren, ME Office: (207) Fax: (207) smanages@pineshealth.org