African Americans and African Americans and Hepatitis CHepatitis C

Marlene Taylor PA-CMarlene Taylor PA-C

HIV/HCV Primary Care ProviderHIV/HCV Primary Care Provider

Montefiore Medical CenterMontefiore Medical Center

• African Americans are African Americans are twicetwice as likely to be as likely to be infected with the hepatitis C virus (HCV) infected with the hepatitis C virus (HCV) compared to the general U.S. population, compared to the general U.S. population, according to the according to the CDC. While African . While African Americans represent only Americans represent only 12 percent12 percent of of the U.S. population, they make up roughly the U.S. population, they make up roughly 22 percent22 percent of the estimated of the estimated 3.2 million 3.2 million personspersons with chronic HCV infection. with chronic HCV infection. Moreover, chronic liver disease, often Moreover, chronic liver disease, often hepatitis C-related, is a leading cause of hepatitis C-related, is a leading cause of death among death among African Americans ages African Americans ages 45-64.45-64.

Hepatitis C FactsHepatitis C Facts

• Hepatitis C is a liver disease caused by a virus. Hepatitis C is a liver disease caused by a virus.

• Hepatitis C is usually spread when blood from a Hepatitis C is usually spread when blood from a person infected with the hepatitis C virus enters the person infected with the hepatitis C virus enters the body of someone who is not infected. This can happen body of someone who is not infected. This can happen from sharing equipment for injecting drugs, receiving from sharing equipment for injecting drugs, receiving blood transfusions or organ transplants before 1992, blood transfusions or organ transplants before 1992, getting a needlestick injury in health care settings, getting a needlestick injury in health care settings, and even being born to a mother who has Hepatitis C. and even being born to a mother who has Hepatitis C. And some people don’t know how they got infected. And some people don’t know how they got infected. Hepatitis C can spread through sexual intercourse, Hepatitis C can spread through sexual intercourse, but it’s rare. but it’s rare.

• Anyone can get hepatitis C, but African Anyone can get hepatitis C, but African Americans – as well as people born between Americans – as well as people born between 1945-1965, (“babyboomers” )– bear a 1945-1965, (“babyboomers” )– bear a disproportionate burden of diseasedisproportionate burden of disease. .

Hepatitis C FactsHepatitis C Facts

• Most people living with hepatitis C do not know they Most people living with hepatitis C do not know they are infected. are infected.

• The hepatitis C virus (HCV) can cause chronic The hepatitis C virus (HCV) can cause chronic hepatitis, in which the infection is prolonged, hepatitis, in which the infection is prolonged, sometimes lifelong. Chronic hepatitis can lead to sometimes lifelong. Chronic hepatitis can lead to cirrhosis, liver failure, and liver cancer.  In fact, viral cirrhosis, liver failure, and liver cancer.  In fact, viral hepatitis is the leading cause of liver cancer and the hepatitis is the leading cause of liver cancer and the most common reason for liver transplantation. most common reason for liver transplantation.

• Most people living with HCV infection often have no Most people living with HCV infection often have no symptoms until significant damage has been done. symptoms until significant damage has been done.

• There is no vaccine to prevent hepatitis C infection. There is no vaccine to prevent hepatitis C infection. • Getting tested is the only way to know if you have Getting tested is the only way to know if you have

been exposed to hepatitis C. been exposed to hepatitis C. • There are new and improved treatments exists for There are new and improved treatments exists for

hepatitis C. hepatitis C.

Features of Hepatitis C Features of Hepatitis C Virus InfectionVirus Infection

Incubation periodIncubation period Average 6-7 Average 6-7 weeksweeksRange 2-26 weeksRange 2-26 weeks

Acute illness (jaundice)Acute illness (jaundice) Mild (Mild (<<20%)20%)

Chronic infectionChronic infection 75%-85%75%-85%

CirrhosisCirrhosis 10%-20%10%-20%

Mortality from CLDMortality from CLD 1%-5%1%-5%

Liver Cancer 1%Liver Cancer 1%

Serologic Pattern of Acute HCV Infection with Progression to

Chronic Infection

Symptoms +/-

Time after Exposure

Tit

eranti-HCV

ALT

Normal

0 1 2 3 4 5 6 1 2 3 4YearsMonths

HCV RNA

Transmission of HCVTransmission of HCV

– Injecting drug useInjecting drug use– Blood Transfusion, transplant from infected Blood Transfusion, transplant from infected

donor,(before screening available in 1992 )donor,(before screening available in 1992 )– Therapeutic (contaminated equipment, Therapeutic (contaminated equipment,

unsafe injection practices)unsafe injection practices)– Occupational (needlestick)Occupational (needlestick)– Perinatal (mother to child)Perinatal (mother to child)– SexualSexual– Sharing Contaminated items with infected Sharing Contaminated items with infected

blood( ie toothbrush, razor, )blood( ie toothbrush, razor, )

Signs and SymptomsSigns and Symptoms

• Persons with newly acquired HCV infection Persons with newly acquired HCV infection usually are asymptomatic or have mild symptoms usually are asymptomatic or have mild symptoms that are unlikely to prompt a visit to a health care that are unlikely to prompt a visit to a health care professional. When symptoms occur, they can professional. When symptoms occur, they can includeinclude

• Fever Fever • Fatigue Fatigue • Dark urine Dark urine • Clay-colored stool Clay-colored stool • Abdominal pain Abdominal pain • Loss of appetite Loss of appetite • Nausea Nausea • Vomiting Vomiting • Joint pain Joint pain • Jaundice Jaundice

Signs and SymptomsSigns and Symptoms

Most persons with chronic HCV infection are Most persons with chronic HCV infection are asymptomatic. However, many have chronic liver asymptomatic. However, many have chronic liver disease, which can range from mild to severe, disease, which can range from mild to severe, including cirrhosis and liver cancer. Chronic liver including cirrhosis and liver cancer. Chronic liver disease in HCV-infected persons is usually insidious, disease in HCV-infected persons is usually insidious, progressing slowly without any signs or symptoms for progressing slowly without any signs or symptoms for several decades. In fact, HCV infection is often not several decades. In fact, HCV infection is often not recognized until asymptomatic persons are identified recognized until asymptomatic persons are identified as HCV-positive when screened for blood donation or as HCV-positive when screened for blood donation or when elevated alanine aminotransferase (ALT, a liver when elevated alanine aminotransferase (ALT, a liver enzyme) levels are detected during routine enzyme) levels are detected during routine examinations.examinations.

  

Medical Work upMedical Work up

• History and PhysicalHistory and Physical

• HCV antibody resultHCV antibody result• Hepatitis C Viral RNA if HCVab +Hepatitis C Viral RNA if HCVab +• Check HIV statusCheck HIV status• HepA ab /HepBsab status – vaccinate if negHepA ab /HepBsab status – vaccinate if neg• Liver enzymes(ALT/AST SGOT/SGPT)Liver enzymes(ALT/AST SGOT/SGPT)• Metabolic panel (check glucose, kidney fct)Metabolic panel (check glucose, kidney fct)• Genotype Genotype • Abdominal ultrasoundAbdominal ultrasound• Liver Biopsy +/-Liver Biopsy +/-

Progression of Fibrosis on Progression of Fibrosis on BiopsyBiopsy

No Fibrosis

Stage 1: Fibrous Stage 1: Fibrous expansion of expansion of some portal areassome portal areas

Stage 3: Fibrous expansion of most portal areas with occasional portal to portal bridging

Stage 4: Fibrous expansion of portal areas with marked bridging (portal to portal and portal to central)

Stage 5,6: Cirrhosis, probable or defined

Cirrhotic liver: Gross anatomy of cadaver

Courtesy of Gregory Everson, MD.

ChallengesChallenges

• GenotypeGenotype• Fewer Blacks in Clinical trialsFewer Blacks in Clinical trials• StigmaStigma• Co morbid conditionsCo morbid conditions• NeutropeniaNeutropenia• Disease progression (Fibrosis)Disease progression (Fibrosis)• Treatment ResponseTreatment Response• IL28BIL28B• Access to care/ Insurance/Access to care/ Insurance/

TreatmentTreatment

• Important to understand that currently available treatment must be Important to understand that currently available treatment must be individualized –(treatment experienced or naïve, genotype, liver bx etc) individualized –(treatment experienced or naïve, genotype, liver bx etc)

• Early 2000-Combination therapy Pegylated interferon, and ribavirin,Early 2000-Combination therapy Pegylated interferon, and ribavirin,• 2011 in addition to the above two protease drugs (Bocepravir or 2011 in addition to the above two protease drugs (Bocepravir or

Telapravir FDA approved and one combined with peg and riba for Telapravir FDA approved and one combined with peg and riba for treatment, treatment,

• Studies show that currently available treatment improved because of Studies show that currently available treatment improved because of shorter durationshorter duration

• Better clincal outcomes (SVR’s)Better clincal outcomes (SVR’s)• Improved tolerability, less side effectsImproved tolerability, less side effects• Treatment is defined as undetectable HCV RNA in the patient's blood 24 Treatment is defined as undetectable HCV RNA in the patient's blood 24

weeks after the end of treatmentweeks after the end of treatment• At least six distinct HCV genotypes (genotypes 1–6) and more than 50 At least six distinct HCV genotypes (genotypes 1–6) and more than 50

subtypes have been identified. Genotype 1 is the most common HCV subtypes have been identified. Genotype 1 is the most common HCV genotype in the United States and the most common in African genotype in the United States and the most common in African Americans.Americans.

• Patients with genotypes 2 and 3 are almost three times more likely than Patients with genotypes 2 and 3 are almost three times more likely than patients with genotype 1 to respond to therapypatients with genotype 1 to respond to therapy

http://effectivehealthcare.ahrq.gov/slides/?pageaction=displaySlides&tk=68&pg=1

http://effectivehealthcare.ahrq.gov/slides/?pageaction=displaySlides&tk=68&pg=1

DAA Combinations Phase III (without DAA Combinations Phase III (without interferoninterferon Drug Name/Drug Name/

Category Drug Name/ Category Drug Name/

Category CompanyVerifiedABT-450/rCategory CompanyVerifiedABT-450/r(Protease Inhibitor)ABT-267 (Protease Inhibitor)ABT-267 (NS5A Inhibitor) and/or (NS5A Inhibitor) and/or ABT-333 ABT-333 (Polymerase Inhibitor)(Polymerase Inhibitor)Abbott / EnantaJuly 3, 2013 Daclatasvir / EnantaJuly 3, 2013 Daclatasvir (BMS-790052)(BMS-790052)(NS5A Inhibitor)Asunaprevir(NS5A Inhibitor)Asunaprevir(BMS-650032)(BMS-650032)(Protease Inhibitor)Bristol-Myers SquibbJuly 3, 2013 Faldaprevir(Protease Inhibitor)Bristol-Myers SquibbJuly 3, 2013 Faldaprevir(BI 201335)(BI 201335)Protease InhibitorDeleobuvirProtease InhibitorDeleobuvirBI 207127 Polymerase Inhibitor Boehringer IngelheimJuly 3, 2013 BI 207127 Polymerase Inhibitor Boehringer IngelheimJuly 3, 2013 Sofosbuvir Sofosbuvir (GS-7977) (GS-7977) (Polymerase Inhibitor)Ledipasvir(Polymerase Inhibitor)Ledipasvir(GS-5885)(GS-5885)(NS5A Inhibitor)GileadJuly 3, 2013 (NS5A Inhibitor)GileadJuly 3, 2013

Phase III (with PegINF plus RBVPhase III (with PegINF plus RBV

• Phase III (with PegINF plus RBV)Phase III (with PegINF plus RBV)Drug Name Drug Name Drug Category Drug Category CompanyVerifiedCompanyVerifiedDaclatasvir Daclatasvir (BMS-790052)NS5A Inhibitor (BMS-790052)NS5A Inhibitor Bristol-Myers Bristol-Myers SquibbSquibbJuly 3, 2013 Faldaprevir July 3, 2013 Faldaprevir (BI 201335)Protease Inhibitor Boehringer (BI 201335)Protease Inhibitor Boehringer IngelheimJuly 3, 2013 SimeprevirIngelheimJuly 3, 2013 Simeprevir(TMC435)Protease Inhibitor JanssenJuly 3, 2013 (TMC435)Protease Inhibitor JanssenJuly 3, 2013 Sofosbuvir Sofosbuvir (GS-7977)Polymerase Inhibitor GileadJuly 3, 2013 (GS-7977)Polymerase Inhibitor GileadJuly 3, 2013

   

CaseCase

• RT is a 26 yo AA female who presented to the local medical RT is a 26 yo AA female who presented to the local medical clinic for a routine physical . Her previous clinic “closed down “ clinic for a routine physical . Her previous clinic “closed down “ and she needs an exam to return to school and work.and she needs an exam to return to school and work.

• PMHPMH- Denies DM, HTN, CVS Ds, Pneumnia, Asthma or TB, - Denies DM, HTN, CVS Ds, Pneumnia, Asthma or TB, last PPD 2011 negative, last PPD 2011 negative,

• Gyn Hx-Gyn Hx- G0 P0 – last pap neg, Neg HPV 2012 ,sexually active G0 P0 – last pap neg, Neg HPV 2012 ,sexually active , heterosexual with 2 partners, uses condoms ‘”most of the , heterosexual with 2 partners, uses condoms ‘”most of the time” No h/o GC, Chlamydia or HSV, tested HIV negative 2010time” No h/o GC, Chlamydia or HSV, tested HIV negative 2010

• ROSROS- tired most of the time for past 3- 4 yrs , generalized - tired most of the time for past 3- 4 yrs , generalized itching on and off, occ nausea , no fevers diarrhea or wgt loss, itching on and off, occ nausea , no fevers diarrhea or wgt loss, has good appetite despite intermittent nausea is able to go to has good appetite despite intermittent nausea is able to go to school and work.school and work.

AllergiesAllergies- NKA - NKA MedsMeds- Multivitamin daily- Multivitamin daily• Social Hx-Social Hx- single, P/T college student x 2 yrs, F/T work as unit single, P/T college student x 2 yrs, F/T work as unit

clerk in local hospital x 5 years, no h/o smoking , +Social clerk in local hospital x 5 years, no h/o smoking , +Social drinker once a moth with the girls” few glasses wine” , no h/o drinker once a moth with the girls” few glasses wine” , no h/o IVDA or illicit drug use. Hobbies include being a Big Sister to a IVDA or illicit drug use. Hobbies include being a Big Sister to a 9 yo girl twice a month who sleeps over “sometimes she forgets 9 yo girl twice a month who sleeps over “sometimes she forgets to bring toiletries but I keep a supply of mine for her”to bring toiletries but I keep a supply of mine for her”

• Family Hx-Family Hx- Mother and Father both deceased AIDS related Mother and Father both deceased AIDS related complications 1992, 5 siblings 1 she recalls with “yellow complications 1992, 5 siblings 1 she recalls with “yellow jaundice” as a childjaundice” as a child

CaseCase

• PE : Thin AA female in NAD vital signs stablePE : Thin AA female in NAD vital signs stable• HEENT- anicteric, throat clear no lymph node HEENT- anicteric, throat clear no lymph node

enlargementenlargement• Lungs- clearLungs- clear• CVS- S1 S2CVS- S1 S2• Abdomen- soft + BS, slight RUQ tenderness, no Abdomen- soft + BS, slight RUQ tenderness, no

hepatomegaly hepatomegaly • no spleenomegaly, no fluid waveno spleenomegaly, no fluid wave• Extremity- no clubbing cyanosis or edema, no palmar Extremity- no clubbing cyanosis or edema, no palmar

erythemaerythema• Neuro- no deficitsNeuro- no deficits• Skin- no rashes or petichiae no spider angiomasSkin- no rashes or petichiae no spider angiomas• Mental status- pleasant, alert, oriented , appropriateMental status- pleasant, alert, oriented , appropriate• Genitalia- wnl no lesions or rashesGenitalia- wnl no lesions or rashes• Pelvic –no d/c , no cmt, no lesions or adnexal tendernessPelvic –no d/c , no cmt, no lesions or adnexal tenderness• Ut antverted nl size Ut antverted nl size

LabsLabs

• CBC and PLT’s - wnlCBC and PLT’s - wnl• Metabolic Panel-wnlMetabolic Panel-wnl• LFT- elevated ALT (83), AST (37) LFT- elevated ALT (83), AST (37) • alk phos112alk phos112• HepAsab-NegativeHepAsab-Negative• HepBsag- Negative/ HepBsab- PositiveHepBsag- Negative/ HepBsab- Positive• HCV Ab- positiveHCV Ab- positive• RPR- Non reactiveRPR- Non reactive• Urine GC and Chlamydia - negativeUrine GC and Chlamydia - negative• Urinalysis – wnlUrinalysis – wnl• Quantiferon – negativeQuantiferon – negative• Pap- negative malignant cells , negative HPVPap- negative malignant cells , negative HPV

QuestionsQuestions

• What is the diagnosis in this patient?What is the diagnosis in this patient?

• What was the most likely mode of transmission?What was the most likely mode of transmission?

• What are the next diagnostic steps in her medical What are the next diagnostic steps in her medical work up?work up?

• Is she cleared to go to return to school? to work?Is she cleared to go to return to school? to work?

• What would you advise this patient to do What would you advise this patient to do immediately?immediately?

• Would you refer this patient to a specialist for Would you refer this patient to a specialist for treatment ? Why or why not?treatment ? Why or why not?

• What important information is missing in the What important information is missing in the history essential for the management of this history essential for the management of this patient?patient?

Despite the seriousness of this health problem Despite the seriousness of this health problem in the African American community, too few in the African American community, too few African Americans know about the disease African Americans know about the disease

or get tested for it. Early detection of or get tested for it. Early detection of chronic viral hepatitis infection can save chronic viral hepatitis infection can save

lives,” observes Dr. Ronald Valdiserri, MD, lives,” observes Dr. Ronald Valdiserri, MD, MPH, Deputy Assistant Secretary for Health, MPH, Deputy Assistant Secretary for Health, Infectious Diseases and Director, Office of Infectious Diseases and Director, Office of HIV/AIDS and Infectious Disease Policy at HIV/AIDS and Infectious Disease Policy at the U.S. Department of Health and Human the U.S. Department of Health and Human

ServicesServices

Thank You!Thank You! Marlene Taylor PA-CMarlene Taylor PA-C

mataylor@montefiore.orgmataylor@montefiore.org

718 920-8542718 920-8542