GUIDELINES FOR INCORPORATING HIV/HCV PREVENTION INTO MEDICAL CARE - - PowerPoint PPT Presentation

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GUIDELINES FOR INCORPORATING HIV/HCV PREVENTION INTO MEDICAL CARE - - PowerPoint PPT Presentation

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GUIDELINES FOR INCORPORATING HIV/HCV PREVENTION INTO MEDICAL CARE JOHN I. MCNEIL, MD, FACP MAXIMED ASSOCIATES MARYLAND JANUARY 25, 2018 CME Disclosures: Planning Committee And Speaker Speaker: The following speaker has nothing to disclose in

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GUIDELINES FOR INCORPORATING HIV/HCV PREVENTION INTO MEDICAL CARE

JOHN I. MCNEIL, MD, FACP MAXIMED ASSOCIATES MARYLAND JANUARY 25, 2018

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SLIDE 2

CME Disclosures: Planning Committee And Speaker

Speaker: The following speaker has nothing to disclose in relation to this activity: John I. McNeil, MD

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SLIDE 3

Howard University CME Accreditation

Sponsor Accreditation: Howard University College

  • f Medicine is accredited by the Accreditation Council

for Continuing Medical Education to provide continuing medical education for physicians. Credits for Physicians: Howard University College

  • f Medicine, Office of Continuing Medical Education,

designates this live activity for a maximum of 1.0 AMA PRA Category I Credit(s)TM . Physicians should claim

  • nly the credit commensurate with the extent of their

participation in the activity. Goulda A. Downer, PHD, RD, LN, CNS – Principal Investigator/Project Director

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SLIDE 4

CME Disclosures: Planning Committee And Speaker

AETC-Capitol Region Telehealth Project Planning Committee: The following committee members have nothing to disclose in relation to this activity:

Goulda A. Downer, PhD, RD, LN, CNS John I. McNeil, MD John Richards, MA-AITP Denise Bailey, MED

Speaker: The following speaker has nothing to disclose in relation to this activity: John I. McNeil, MD

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SLIDE 5

Howard University CME Accreditation Requirements For Internet Viewers

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  • session. It may be scanned and emailed back to den_bailey@howard.edu, or faxed to: AETC-Capitol Region T

elehealth Project (FAX#: 202.667.1382) ATTN: Project Coordinator. Please indicate in your email or FAX if you would like to receive CMEs.

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6

TEST YOUR KNOWLEDGE

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SLIDE 7

TestYour Knowledge Question #1 HIV Accelerates HCV related Fibrosis:

A.True

  • B. False
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SLIDE 8

TestYour Knowledge Question #2 The following factors are associated with HIV/HCV Fibrosis Progression:

  • A. Alcohol Consumption
  • B. Male Gender
  • C. Age
  • D. Multiple Transfusions
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SLIDE 9

TestYour Knowledge Question #3 HCV antibody test means the person is still infectious:

  • A. True

B.

False

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SLIDE 10

TestYour Knowledge Question #4 Which of the following is true about Hepatitis C?

  • A. Cure protects for a life time
  • B. Cannot be treated while treating HIV
  • C. Cannot be treated in someone with cirrhosis
  • D. Can be cured in as little as 8 weeks
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SLIDE 11

CARE FOR PATIENTS WITH CHRONIC HCV/HIV COINFECTIONS

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LEARNING OBJECTIVES

  • 1. Describe the epidemiology of HCV
  • 2. Describe progression of liver disease in the setting of HIV/hepatitis C

virus (HCV) coinfection

  • 3. Understand treatment objectives
  • 4. Describe barriers to treatment, including drug-drug interactions
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EPIDEMIOLOGY

Ø Five major types, maybe six minor types Ø Estimated 3.5 million people in the US have chronic HCV Ø Yearly, 17,000 get infected Ø Long-term incubation can eventually result in liver failure, liver cancer Ø Every year approximately 12, 000 die from HCV related liver disease

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SLIDE 14

WHERE DOES IT COME FROM?

ØIt is typically spread when blood from a person infected with the hepatitis

C virus enters the blood stream of a non-infected person.

ØYes, and sex ØTransfusions (before 1982)

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SLIDE 15

RISK FACTORS FOR ACQUIRING HCV

http://www.healthline.com/health/hepatitis-c/facts-statistics-infographic

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SYMPTOMS

Ø Silent for years Ø Signs of eventual liver damage

  • Fever
  • Fatigue
  • Jaundice
  • Dark urine
  • Grey colored stools
  • Joint pain
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SLIDE 17

HIV/HCV COINFECTION

ØCompared to HCV monoinfection

  • Higher rates of susceptibility to mucosal transmission
  • Higher rates of persistence
  • Faster rates of fibrosis
  • Higher rate of cirrhosis
  • Increased liver related mortality
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SLIDE 18

CARE CASCADE IN HCV

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SLIDE 19

PROGRESSION OF FIBROSIS IN HCV

www.hcvonline.org

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IMPACT OF HIV COINFECTION

http://hivinsite.ucsf.edu/InSite?page=kb-05-03-05#S1X

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SLIDE 21

HIV ACCELERATES HCV RELATED FIBROSIS

Kim and Chung Gastroenterology 2009

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FACTORS ASSOCIATED WITH HIV/HCV FIBROSIS PROGRESSION

ØCD4 count less than 200 cells/mm3 ØAlcohol consumption ØOlder age at time of HCV acquisition

Di Martino et al Hepatology 2001

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SLIDE 23

MODIFIABLE RISK FACTORS FOR DISEASE PROGRESSION

¡ Diabetes/ insulin resistance ¡ Coinfection with HBV ¡ Marijuana

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SLIDE 24

IMPACT OF HCV CURE

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54 Y.O. WITH HCV ANTIBODIES

¡ 54 year old man was anti-HCV positive after elevated ALT was noted by

the Primary Care Provider. He had a brief history of IDU when in his 20’s, and was now currently a moderate ETOH user, otherwise healthy.

¡ HCV RNA was 4 million IU/L; Genotype 1a, ALT 42 IU/ml, AST 65 IU/ml,

TB 1.6 mg/dl, Alb 3.9 mg/dl, Hgb 13.4 mg/dl, PLT 110,000, Creatinine 1.2 mg/dl

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54 Y.O. WITH HCV ANTIBODIES

¡ Which of the following is the net appropriate step:

  • 1. Treat with oral regimen for 12 weeks
  • 2. Check HCV 1a resistance test
  • 3. Elastography
  • 4. Confirm HCV antibody test
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SLIDE 27

STAGING IS NEEDED FOR CHRONIC HCV

¡ Accepted Staging Methods 1.

Liver biopsy

2.

Blood markers

3.

Elastography

4.

Combination of 1-3

¡ Not for Staging 1.

Viral Load

2.

HCV genotype

3.

Ultrasound

4.

CT scan or MRI

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VALIDITY OF NONINVASIVE TESTS FOR DETECTING CIRRHOSIS

T est % Sens %Spec AUROC Pos LR Neg LR Fibrotest >.56 85 74 .86 3.3 0.2 Fibrotest>.73 56 81

  • 2.9

0.54 FIB4>1.45 90 58 .87 2.1 0.17 APRI 51 91 0.73 3.1 0.31 Elastography 12.5 87 91 0.95

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54 Y.O. WITH HCV ANTIBODIES

¡ Elastography is 16.4 kPa ¡ FIB 4 = (Age x AST)/(PLT x √ALT) ¡ FIB 4 = (54 x 65)/(110 x √42) = 4.92 ¡ What is the next step?

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MANAGEMENT OF HCV WITH F3-4

  • 1. Need US (or CT/MRI) to rule out Hepatocellular Carcinoma
  • 2. Need UGI to assess for Esophageal Varicies
  • 3. Need to assess if compensated – CPT: no encephalopathy or ascites;

bilirubin <2 mg/dl, albumin >3.5 g/dl, and INR<1.7

  • 4. Treat

MELD = 3.8*log(serum bilirubin[mg/dL]) + 11.2*log(INR) + 9.6log(serum creatinine [mg/dL]) + 6.4

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SLIDE 31

DOES HIV CHANGE THINGS?

¡ You are called back and told the patient is HIV coinfected and on

TDF/FTC and darunavir/retonavir. What does that change?

  • 1. Treat for 24 weeks vs 12 weeks
  • 2. Use SOF/LDV to avoid drug interactions
  • 3. Notify the patient treatment is the same, but chances of SVR is 85%

instead of 95%

  • 4. Treat with elbasvir/grazoprevir if no resistance
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SLIDE 32

HCV AND HIV

¡ Treatment responses are the same ¡ Drug interaction often define treatment

  • 1. HIV integrase inhibitors generally ok
  • 2. HCV SOF Ok
  • 3. HCV PI – avoid HIV PI, efavirenz and cobistat
  • 4. HCV LDV and VEL – PPI reduces absorption
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SLIDE 33

HCV GUIDELINES

¡ Test all born 1945-1965 and with risk ¡ For positives

¡ Vaccinate HAV and HBV ¡ Counsel regarding alcohol and transmission ¡ Stage ¡ Treat

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SLIDE 34

54 YEAR OLD WITH HCV AND HIV

¡ Ultrasound and UGI are ok and you recommend treatment but he wants

to know why. Which of the following is not true?

  • 1. Successful treatment reduces the risk of reinfection
  • 2. Successful treatment reduces the risk of death
  • 3. Successful treatment reduces the risk of Hepatocellular Carcinoma
  • 4. Successful treatment reduces the risk of lever failure
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SLIDE 35

THERAPY IN HIV/HCV COINFECTION

Ø When compared to HCV monoinfection:

  • Duration of treatment usually the same
  • Medication regimens often the same
  • Adverse events the same (almost none)
  • OUTCOMES the same
  • But….

Ø Drug-drug interactions may be significant

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SLIDE 36

POOR HISTORICAL RESPONSE IN HIV/HCV

Poordad F et al, NEJM 2011; 364:1195-1206 vs. Sulkowski et al. Lancet Infect Dis 2013; 13(7):597-605. Jacobson I et al, NEJM 2011; 364:2405-2416 vs. Sulkowski et al. Ann Intern Med 2013; 159(2): 86-96. Antiviral Drugs Advisory Committee Meeting, FDA review, 10/24/13 C208, C216, C206, C212, HPC3007, Dieterich et al. Clin Infect Disease 2014 (epub ahead of print) Lawitz et al. NEJM 2013 versus Torres-Rodriguez et al., IDSA 2013 Osinusi et al., JAMA 2013;310(8):804-11 versus Sulkowski et al. JAMA 2014;312(4):353-61.

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SLIDE 37

EQUIVALENT HIV/HCV RESPONSE TO DAAS

Wyles DL, Ruane PJ, Sulkowski MS, et al. Daclatasvir plus sofosbuvir for HCV in patients coinfected with HIV-1. N Engl J Med. 2015;373:714-25. 2. Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014;370:211-21 3. Naggie S, Cooper C, Saag M, et al. Ledipasvir and sofosbuvir for HCV in patients coinfected with HIV-1. N Engl J Med. 2015;373:705-13. 4. Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370:1889-98. 5. Sulkowski MS, Eron JJ, Wyles D, et al. Ombitasvir, paritaprevir co- dosed with ritonavir, dasabuvir, and ribavirin for hepatitis C in patients co-infected with HIV-1: a randomized trial. JAMA. 2015;313:1223-31. 6. Ferenci P, Bernstein D, Lalezari J, et al. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med. 2014;370:1983-92.1. Dieterich D, Rockstroh JK, Orkin C, et al. 7. Rockstroh JK, Nelson M, Katlama C, et al. Efficacy and safety of grazoprevir (MK-5172) and elbasvir (MK-8742) in patients with hepatitis C virus and HIV co-infection (C-EDGE CO-INFECTION): a non-randomized, open-label trial. Lancet HIV. 2015;2:e319-27. 8. Zeuzem S, Ghalib R, Reddy KR, et al. Grazoprevir-Elbasvir Combination Therapy for Treatment-Naive Cirrhotic and Noncirrhotic Patients With Chronic Hepatitis C Virus Genotype 1, 4, or 6 Infection: A Randomized Trial. Ann Intern Med. 2015;163:1-13.

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ION 4: SOFOSBUVIR/ LEDIPASVIR IN HIV/HCV COINFECTION

Naggie et al NEJM 2014 http://www.hepatitisc.uw.edu

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ION 4: SOFOSBUVIR/ LEDIPASVIR IN HIV/HCV COINFECTION

Naggie et al NEJM 2014 http://www.hepatitisc.uw.edu

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ION 4: SOFOSBUVIR/ LEDIPASVIR IN HIV/HCV COINFECTION

Naggie et al NEJM 2014 http://www.hepatitisc.uw.edu

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TAKE HOME: SOFOSBUVIR/LEDIPASVIR

ØHCV Genotypes 1, 4 ØSingle pill daily usually 12 weeks ØEffective in treatment naïve, experienced, cirrhotic, non cirrhotic ØSome Drug-Drug interactions

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C-EDGE COINFECTION: ELBASVIR/GRAZOPREVIR IN HIV/HCV COINFECTION

Rockstroh et al Lancet HIV 2015 http://www.hepatitisc.uw.edu

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C-EDGE COINFECTION ELBASVIR/GRAZOPREVIR IN HIV/HCV COINFECTION

Rockstroh et al Lancet HIV 2015 http://www.hepatitisc.uw.edu

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ELBASVIR/GRAZOPREVIR EFFECT OF BASELINE RAVS

Zeuzem et al Ann Int Med 2015 http://www.hepatitisc.uw.edu

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ELBASVIR/GRAZOPREVIR BASELINE NS5A RAVS

Zeuzem et al Ann Int Med 2015 http://www.hepatitisc.uw.edu

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ELBASVIR/ GRAZOPREVIR IN RENAL DISEASE

Roth et al Lancet 2015 http://www.hepatitisc.uw.edu

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TAKE HOME: GRAZOPREVIR ELBASVIR

Ø Genotype 1 and 4 Ø Single pill daily Ø Effective in treatment naïve, experienced, cirrhotic, non cirrhotic Ø Some Drug-Drug Interactions Ø Need to check baseline RAVs in 1a Ø Useful in Renal disease, including ESRD

  • No dose adjustment

Ø Cost?

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ALLY -2 DACLATASVIR/ SOFOSBUVIR GENOTYPE IN HIV/HCV COINFECTION

Wyles et al NEJM 2015 http://www.hepatitisc.uw.edu

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ALLY-2 DACLATASVIR/SOFOSBUVIR GENOTYPE 1 HIV/HCV COINFECTION

Wyles et al NEJM 2015 http://www.hepatitisc.uw.edu

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COMPARISON OF ART ALLOWED IN PHASE 3 CLINICAL TRIALS

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TAKE HOME: DACLATASVIR/ SOFOSBUVIR

ØGenotypes 1 through 4 Ø2 pills a day ØSome Drug-Drug interactions but can adjust dose of DCV ØMay be expensive

  • 2 separate manufacturers
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DRUG-DRUG INTERACTIONS

Simeprevir Sofosbuvir Ledipasvir Daclatasvir Paritaprevir, ritonavir,

  • mbitasvir plus

dasabuvir (PrOD) Paritaprevir, ritonavir,

  • mbitasvir (PrO)

Grazoprevir/ Elbasvir Ritonavir-boosted atazanavir No data No data Ledipasvir ; atazanavir

a (okay with TAF not

TDF) Daclatasvir

b

Paritaprevir ; atazanavir Paritaprevir ; atazanavir Grazoprevir ; elbasvir ; atazanavir Ritonavir- boosted darunavir Simeprevir ; darunavir Sofosbuvir ; darunavir Ledipasvir , darunavir

a (okay with TAF not

TDF) Daclatasvir ; darunavir Paritaprevir /; darunavir Paritaprevir ; darunavir Grazoprevir ; elbasvir ; darunavir Ritonavir-boosted lopinavir No data No data No data

a

Daclatasvir ; lopinavir Paritaprevir ; lopinavir Paritaprevir ; lopinavir Grazoprevir ; elbasvir ; lopinavir Ritonavir-boosted tipranavir No data No data No data No data No data No data No data Efavirenz Simeprevir ; efavirenz Sofosbuvir ; efavirenz Ledipasvir ; efavirenz

a

Daclatasvir

b

No pharmacokinetic data

c

No data Grazoprevir ; elbasvir ; efavirenz Rilpivirine Simeprevir ; rilpivirine Sofosbuvir ; rilpivirine Ledipasvir ; rilpivirine No data Paritaprevir ; rilpivirine No data Grazoprevir ; elbasvir ; rilpivirine Etravirine No data No data No data Daclatasvir

b

No data No data No data Raltegravir Simeprevir ; raltegravir Sofosbuvir ; raltegravir Ledipasvir ; raltegravir No data PrOD ; raltegravir PrO ; raltegravir Grazoprevir ; elbasvir ; raltegravir Cobicistat-boosted elvitegravir No data Cobicistat

a;

sofosbuvir (okay with TAF not TDF) Cobicistat ; ledipasvir

a (okay with TAF not

TDF) No data No data No data No data Dolutegravir No data No data Ledipasvir ; dolutegravir Daclatasvir ; dolutegravir Paritaprevir ; dolutegravir No data Grazoprevir ; elbasvir ; dolutegravir Maraviroc No data No data No data No data No data No data No data Tenofovir disoproxil fumarate Simeprevir ; tenofovir Sofosbuvir ; tenofovir Ledipasvir ; tenofovir Daclatasvir ; tenofovir PrOD ; tenofovir Pro ; tenofovir Grazoprevir ; elbasvir ; tenofovir

www.hcvguidelines.org

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SLIDE 53

DRUG-DRUG INTERACTIONS

http://www.hep-druginteractions.org/checker

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KEY POINTS IN TREATING HCV IN HIV/HCV COINFECTION

Ø High priority due to faster progression to cirrhosis Ø DAA therapy is highly effective

  • Drug-Drug Interactions may guide therapy
  • Cost will guide therapy

Ø Many HCV regimens will NOT require alteration in HIV therapy Ø If change in HIV regimen is needed remember:

  • HCV therapy is short, HIV is very long
  • Ensure patient is stable on new HIV regimen x three-six months before treating HCV
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TEST YOUR KNOWLEDGE

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SLIDE 56

TestYour Knowledge Question #5 HIV Accelerates HCV related Fibrosis:

A.True

  • B. False
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SLIDE 57

TestYour Knowledge Question #6 The following factors are associated with HIV/HCV Fibrosis Progression:

  • A. Alcohol Consumption
  • B. Male Gender
  • C. Age
  • D. Multiple Transfusions
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SLIDE 58

TestYour Knowledge Question #7 HCV antibody test means the person is still infectious:

  • A. True

B.

False

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SLIDE 59

TestYour Knowledge Question #8 Which of the following is true about Hepatitis C?

  • A. Cure protects for a life time
  • B. Cannot be treated while treating HIV
  • C. Cannot be treated in someone with cirrhosis
  • D. Can be cured in as little as 8 weeks
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SLIDE 60

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