5/2/2016. Andrew I. Aronsohn, MD Associate Professor of Medicine University of Chicago Chicago, Illinois. Learning Objectives
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1 Challenges in the Management and Treatment of HIV/Hepatitis C Virus Coinfection Andrew I. Aronsohn, MD Associate Professor of Medicine University of Chicago Chicago, Illinois FORMATTED: 05/02/2016 Chicago, Illinois: May 9, 2016 Learning Objectives After attending this presentation, participants will be able to: Describe progression of liver disease in the setting of HIV/hepatitis C virus (HCV) coinfection List currently available antiviral regimens Describe barriers to treatment, including drugdrug interactions Slide 3 of 42 Compared to HCV monoinfection HIV/HCV Coinfection Higher rates of susceptibility to mucosal transmission Higher rates of persistence Faster rates of fibrosis Higher rate of cirrhosis Increased liver related mortality Slide 4 of 42 1
2 Care Cascade in HCV Slide 5 of 42 Yehia et al PLoS ONE 2014 Progression of Fibrosis in HCV Slide 6 of 42 Impact of HIV Coinfection Slide 7 of 42 Di Martino et al Hepatology
3 HIV Accelerates HCV related Fibrosis Slide 8 of 42 Kim and Chung Gastroenterology 2009 Factors Associated with HIV/HCV Fibrosis Progression CD4 count less than 200 cells/mm 3 Alcohol consumption Older age at time of HCV acquisition Slide 9 of 42 Di Martino et al Hepatology 2001 Modifiable Risk Factors for Disease Progression Diabetes/ insulin resistance Coinfection with HBV? Marijuana Slide 10 of 42 Freedman et al Hepatology
4 HCV Therapy Slide 11 of 42 Impact of HCV Cure Slide 12 of 42 DAA Class Currently Available HCV Medications 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 Non-Nucleoside Polymerase Inhibitor X X X X Ribavirin X Slide 13 of 42 4
5 Structure of HCV Genome : Protease Inhibitors Ex: Simeprevir, Paritaprevir, Grazoprevir Slide 14 of 42 Nucleoside/ Nucleoside/tide Polymerase Polymerase Inhibitors Mechanism Inhibitors of Ac on Ex: Ex: Sofosbuvir Nucleoside/ de Inhibitor (NI) Chain-terminator Primer strand 5ʹ G C C A NI U RNA chain cannot be elongated 3ʹ C G G U G A C G 5ʹ Template strand Slide 15 of 42 NS5a Inhibitors Ex: Ledipasvir, Daclatasvir, Elbasvir Large phosphoprotein Associatesatleastasa dimer BindsRNA Amphipathic helix(h) atamino terminus promotesmembrane association Essential componentofhcvrna ER-membrane associated replication complex Modulatescellularsystemsinvolved in IFNresistance Slide 16 of 42 5
6 Therapy in HIV/HCV Coinfection 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. Drug-drug interactions may be significant Slide 17 of 42 Poor Historical Response in HIV/HCV coinfection with IFN Poordad F et al, NEJM 2011; 364: vs. Sulkowski et al. Lancet Infect Dis 2013; 13(7): Jacobson I et al, NEJM 2011; 364: vs. Sulkowski et al. Ann Intern Med 2013; 159(2): 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): versus Sulkowski et al. JAMA 2014;312(4): Slide 18 of 42 Equivalent HIV/HCV response to DAAs WylesDL, Ruane PJ, Sulkowski MS, etal. DaclatasvirplussofosbuvirforHCVin patientscoinfected with HIV-1. NEngl JMed. 2015;373: Sulkowski MS, GardinerDF, Rodriguez-TorresM, etal. Daclatasvirplussofosbuvirforpreviously treated oruntreated chronic HCVinfection. NEngl JMed. 2014;370: Naggie S, CooperC, Saag M, etal. Ledipasvirand sofosbuvirforhcvin patients coinfected with HIV-1. NEngl JMed. 2015;373: Afdhal N, Zeuzem S, Kwo P, etal. Ledipasvirand sofosbuvirforuntreated HCVgenotype 1 infection. NEngl JMed. 2014;370: Sulkowski MS, Eron JJ, WylesD, etal. Ombitasvir, paritaprevirco-dosed with ritonavir, dasabuvir, and ribavirin forhepatitisc in patientsco-infected with HIV-1: a randomized trial. JAMA. 2015;313: Ferenci P, Bernstein D, Lalezari J, etal. ABT-450/r-ombitasvirand dasabuvirwith orwithoutribavirin forhcv. NEngl JMed. 2014;370: Dieterich D, Rockstroh JK, Orkin C, etal. 7. Rockstroh JK, Nelson M, Katlama C, etal. E ficacy and safety ofgrazoprevir(mk-5172) and elbasvir(mk-8742) in patientswith hepatitisc virusand HIVco-infection (C-EDGE CO-INFECTION): a non-randomized, open-label trial. LancetHIV. 2015;2:e Zeuzem S, Ghalib R, Reddy KR, etal. Grazoprevir-ElbasvirCombination Therapy fortreatment-naive Cirrhotic and Noncirrhotic PatientsWith Chronic HepatitisC Virus Genotype 1, 4, or6 Infection: A Randomized Trial. Ann Intern Med. 2015;163:1-13. Slide 19 of 42 6
7 ION 4: Sofosbuvir/ Ledipasvir in HIV/HCV coinfection Slide 20 of 42 Naggie et al NEJM 2014 ION 4: Sofosbuvir/ Ledipasvir in HIV/HCV coinfection Slide 21 of 42 Naggie et al NEJM 2014 ION 4: Sofosbuvir/ Ledipasvir in HIV/HCV coinfection Slide 22 of 42 Naggie et al NEJM
8 HCV Genotypes 1, 4 Take Home Sofosbuvir/Ledipasvir Single pill daily usually 12 weeks Effective in treatment naïve, experienced, cirrhotic, non cirrhotic Some Drug-Drug interactions Slide 23 of 42 C-EDGE Coinfection: Elbasvir/Grazoprevir In HIV/HCV Coinfection Slide 24 of 42 Rockstroh et al Lancet HIV 2015 C-EDGE Coinfection Elbasvir/Grazoprevir In HIV/HCV Coinfection Slide 25 of 42 Rockstroh et al Lancet HIV
9 Elbasvir/Grazoprevir Effect of Baseline RAVs Zeuzem et al Ann Int Med 2015 Slide 26 of 42 Elbasvir/Grazoprevir Baseline NS5a RAVs Zeuzem et al Ann Int Med 2015 Slide 27 of 42 Elbasvir/ Grazoprevir in Renal Disease Roth et al Lancet 2015 Slide 28 of 42 9
10 Genotype 1 and 4 Single pill daily Take Home: Grazoprevir Elbasvir Effective in treatment naïve, experienced, cirrhotic, non cirrhotic Some Drug-Drug Interactions Need to check baseline RAVs in 1a Useful in Renal disease, including ESRD No dose adjustment Cost? Slide 29 of 42 ALLY -2 Daclatasvir/ Sofosbuvir Genotype in HIV/HCV coinfection 1 4 Slide 30 of 42 Wyles et al NEJM 2015 ALLY-2 Daclatasvir/Sofosbuvir Genotype 1 HIV/HCV Coinfection Slide 31 of 42 Wyles et al NEJM
11 Comparison of ART Allowed in Phase 3 Clinical Trials Slide 32 of 42 Genotypes 1 through 4 2 pills a day Take Home Daclatasvir/ Sofosbuvir Some Drug-Drug interactions but can adjust dose of DCV May be expensive 2 separate manufacturers Slide 33 of 42 Drug-Drug Interactions Simeprevir Sofosbuvir Ledipasvir Daclatasvir Paritaprevir, Paritaprevir, Grazoprevir/ ritonavir, ritonavir, Elbasvir ombitasvir ombitasvir plus dasabuvir (PrO) (PrOD) Raltegravir Simeprevir ; raltegravir Ritonavirboosted atazanavir a (okay atazanavir atazanavir elbasvir; No data No data Ledipasvir ; Daclatasvir b Paritaprevir; Paritaprevir; Grazoprevir; atazanavir with TAF nottdf) atazanavir Ritonavirboosted darunavir darunavir darunavir a (okay darunavir darunavir darunavir elbasvir; Simeprevir ; Sofosbuvir ; Ledipasvir, Daclatasvir; Paritaprevir/; Paritaprevir; Grazoprevir; darunavir with TAF nottdf) darunavir Ritonavirboosted lopinavir lopinavir lopinavir elbasvir; No data No data No data a Daclatasvir; Paritaprevir; Paritaprevir; Grazoprevir; lopinavir lopinavir Ritonavirboosted No data No data No data No data No data No data No data tipranavir Efavirenz Simeprevir ; Sofosbuvir ; Ledipasvir ; efavirenz efavirenz efavirenz a Daclatasvirb No No data Grazoprevir; pharmacokinetic elbasvir; data c efavirenz Rilpivirine Simeprevir ; Sofosbuvir ; Ledipasvir ; No data Paritaprevir; No data Grazoprevir; rilpivirine rilpivirine rilpivirine rilpivirine elbasvir; rilpivirine Etravirine No data No data No data Daclatasvir b No data No data No data Cobicistatboosted elvitegravir Sofosbuvir ; raltegravir No data Cobicistat a ; sofosbuvir (okay with TAF nottdf) Ledipasvir ; raltegravir Cobicistat; ledipasvir a (okay with TAF nottdf) No data PrOD ; PrO ; Grazoprevir; raltegravir raltegravir elbasvir; raltegravir No data No data No data No data Dolutegravir No data No data Ledipasvir ; Daclatasvir; Paritaprevir; No data Grazoprevir; dolutegravir dolutegravir dolutegravir elbasvir; dolutegravir Maraviroc No data No data No data No data No data No data No data Tenofovir Simeprevir ; disoproxil tenofovir fumarate Sofosbuvir ; tenofovir Ledipasvir ; tenofovir Daclatasvir; tenofovir PrOD ; tenofovir Pro ; tenofovir Grazoprevir; elbasvir; tenofovir Slide 34 of 42 11
12 Drug-Drug Interactions Slide 35 of 42 Key Points in Treating HCV in HIV/HCV Coinfection 1. High priority due to faster progression to cirrhosis 2. DAA therapy is highly effective Drug-Drug Interactions may guide therapy Cost will guide therapy 3. Many HCV regimens will NOT require alteration in HIV therapy 4. 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 3-6 months before treating HCV Slide 36 of 42 What s New in HIV/HCV Wyles et al EASL 2016 Slide 37 of 42 12
13 ASTRAL 5 Velpatasvir/ Sofosbuvir in HIV/HCV coinfected Wyles et al EASL 2016 Slide 38 of 42 ASTRAL 5 Velpatasvir/ Sofosbuvir in HIV/HCV coinfected 101/ / 104* Wyles et al EASL 2016 Slide 39 of 42 Acute HCV in HIV infected Patients Many Coinfected with HCV Rockstroh CROI 2016 Slide 40 of 42 13
14 Ledipasvir/ Sofosbuvir in Acute HCV in Patients with HIV Rockstroh CROI 2016 Slide 41 of 42 Thank you Slide 42 of 42 14
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