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 relation to this activity: John I. McNeil, MD 1
6/23/17 Howard University CME Accreditation Sponsor Accreditation: Howard University College of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Credits for Physicians: Howard University College of 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 only 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 2
6/23/17 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. Ø Your 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. Ø You will not be able to receive CME credits if you leave the session early. Ø At the end of the Webinar our Training Coordinator will email a CME Evaluation Survey. Ø All 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. TEST YOUR KNOWLEDGE 6 3
6/23/17 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 4
6/23/17 TestYour Knowledge Question #3 HCV antibody test means the person is still infectious: A. True False B. 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 5
6/23/17 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 6
6/23/17 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? Ø It is typically spread when blood from a person infected with the hepatitis C virus enters the blood stream of a non-infected person. Ø Yes, and sex Ø Transfusions (before 1982) 7
6/23/17 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 o Fever o Fatigue o Jaundice o Dark urine o Grey colored stools o Joint pain 8
6/23/17 HIV/HCV COINFECTION Ø Compared to HCV monoinfection o Higher rates of susceptibility to mucosal transmission o Higher rates of persistence o Faster rates of fibrosis o Higher rate of cirrhosis o Increased liver related mortality CARE CASCADE IN HCV 9
6/23/17 PROGRESSION OF FIBROSIS IN HCV www.hcvonline.org IMPACT OF HIV COINFECTION http://hivinsite.ucsf.edu/InSite?page=kb-05-03-05#S1X 10
6/23/17 HIV ACCELERATES HCV RELATED FIBROSIS Kim and Chung Gastroenterology 2009 FACTORS ASSOCIATED WITH HIV/HCV FIBROSIS PROGRESSION Ø CD4 count less than 200 cells/mm 3 Ø Alcohol consumption Ø Older age at time of HCV acquisition Di Martino et al Hepatology 2001 11
6/23/17 MODIFIABLE RISK FACTORS FOR DISEASE PROGRESSION ¡ Diabetes/ insulin resistance ¡ Coinfection with HBV ¡ Marijuana HCV THERAPY 1986 1998 2016 12
6/23/17 IMPACT OF HCV CURE CURRENTLY AVAILABLE HCV MEDICATIONS Sofosbuvir/ Paritaprevir/r Daclatasvir/ Sofosbuvir Elbasvir/ Sofosbuvir/ Ledipasvir Ombitasvir grazoprevir Simeprevir Dasabuvir DAA Class Protease Inhibitor X X X NS5A inhibitor X X X X Nucleoside X X Polymerase Inhibitor X Non-Nucleoside X Polymerase Inhibitor Ribavirin X 13
6/23/17 THERAPY IN HIV/HCV COINFECTION Ø When compared to HCV monoinfection: o Duration of treatment usually the same o Medication regimens often the same o Adverse events the same (almost none) o OUTCOMES the same o 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. 14
6/23/17 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 15
6/23/17 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 16
6/23/17 TAKE HOME: SOFOSBUVIR/LEDIPASVIR Ø HCV Genotypes 1, 4 Ø Single pill daily usually 12 weeks Ø Effective in treatment naïve, experienced, cirrhotic, non cirrhotic Ø Some Drug-Drug interactions C-EDGE COINFECTION: ELBASVIR/GRAZOPREVIR IN HIV/HCV COINFECTION Rockstroh et al Lancet HIV 2015 http://www.hepatitisc.uw.edu 17
6/23/17 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 18
6/23/17 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 19
6/23/17 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 o No dose adjustment Ø Cost? ALLY -2 DACLATASVIR/ SOFOSBUVIR GENOTYPE IN HIV/HCV COINFECTION Wyles et al NEJM 2015 http://www.hepatitisc.uw.edu 20
6/23/17 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 21
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