CARE FOR PATIENTS WITH CHRONIC HCV/HIV COINFECTIONS JOHN I. MCNEIL, - - PDF document

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CARE FOR PATIENTS WITH CHRONIC HCV/HIV COINFECTIONS JOHN I. MCNEIL, - - PDF document

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6/23/17 CARE FOR PATIENTS WITH CHRONIC HCV/HIV COINFECTIONS JOHN I. MCNEIL, MD, FACP MAXIMED ASSOCIATES MARYLAND JUNE 8, 2017 CME Disclosures: Planning Committee And Speaker Speaker: The following speaker has nothing to disclose in

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CARE FOR PATIENTS WITH CHRONIC HCV/HIV COINFECTIONS

JOHN I. MCNEIL, MD, FACP MAXIMED ASSOCIATES MARYLAND JUNE 8, 2017

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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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

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 Jean Davis, PHD,DC, PA, MSCR Denise Bailey, MED

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

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Howard University CME Accreditation Requirements For Internet Viewers

Intended Audience: Health service providers: Physicians, Physician Assistants, Nurse Practitioners, Pharmacists, Dentists, Nurses, Social Workers, Case Managers and other Clinical Personnel. Webinar Requirements: A computer, phone, etc., with internet accessibility and a telephone line.

ØYour presence on the call must be acknowledged at the start of each session. Please log in for the session announce

your name loud and clear at the beginning of the session.

ØYou will not be able to receive CME credits if you leave the session early. ØAt the end of the Webinar our Training Coordinator will email a CME Evaluation Survey. ØAll participants are required to complete and return the CME Evaluation Survey at the end of each

  • 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.

6

TEST YOUR KNOWLEDGE

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TestYour Knowledge Question #1 HIV Accelerates HCV related Fibrosis:

A.True

  • B. False

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

  • A. True

B.

False 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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CARE FOR PATIENTS WITH CHRONIC HCV/HIV COINFECTIONS

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. Identify currently available antiviral regimens
  • 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

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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RISK FACTORS FOR ACQUIRING HCV

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

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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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

CARE CASCADE IN HCV

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PROGRESSION OF FIBROSIS IN HCV

www.hcvonline.org

IMPACT OF HIV COINFECTION

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

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HIV ACCELERATES HCV RELATED FIBROSIS

Kim and Chung Gastroenterology 2009

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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MODIFIABLE RISK FACTORS FOR DISEASE PROGRESSION

¡ Diabetes/ insulin resistance ¡ Coinfection with HBV ¡ Marijuana

HCV THERAPY

1986 1998 2016

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IMPACT OF HCV CURE CURRENTLY AVAILABLE HCV MEDICATIONS

DAA Class Sofosbuvir/ Ledipasvir Paritaprevir/r Ombitasvir Dasabuvir Daclatasvir/ Sofosbuvir Elbasvir/ grazoprevir Sofosbuvir/ Simeprevir Protease Inhibitor X X X NS5A inhibitor X X X X Nucleoside Polymerase Inhibitor X X X Non-Nucleoside Polymerase Inhibitor X Ribavirin X

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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

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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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.

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

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

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

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

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?

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

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

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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DRUG-DRUG INTERACTIONS

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

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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WHAT’S NEW IN HIV/HCV

Wyles et al EASL 2016

ASTRAL 5 VELPATASVIR/ SOFOSBUVIR IN HIV/HCV COINFECTED

Wyles et al EASL 2016

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ASTRAL 5 VELPATASVIR/ SOFOSBUVIR IN HIV/HCV COINFECTED

Wyles et al EASL 2016

ACUTE HCV IN HIV INFECTED PATIENTS

Rockstroh CROI 2016

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LEDIPASVIR/ SOFOSBUVIR IN ACUTE HCV IN PATIENTS WITH HIV

Rockstroh CROI 2016

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TEST YOUR KNOWLEDGE

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TestYour Knowledge Question #5 HIV Accelerates HCV related Fibrosis:

A.True

  • B. False

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

  • A. True

B.

False 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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As a Reminder: At the end of the Webinar, All participants are required to complete and return the CME Evaluation Survey. It may be scanned and emailed back to den_bailey@howard.edu, or faxed to: AETC-Capitol Region T elehealth Center (FAX#: 202.667.1382) ATTN: Training Coordinator.

Please indicate in your email or FAX if you would like to receive CMEs.

www.capitolregiontelehealth.org www.aetcnmc.org