HIV/HCV Co-Infection
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1 HIV/HCV Co-Infection 2015 Kentucky Conference on Viral Hepatitis Matt Cave, M.D. Associate Professor Department of Medicine Division of Gastroenterology, Hepatology, & Nutrition Department of Pharmacology and Toxicology Department of Biochemistry and Molecular Biology University of Louisville, Robley Rex VAMC, & The Jewish Hospital Liver Transplant Program 505 South Hancock Street Louisville, KY (502) ;
2 Disclosures / Acknowledgment This seminar contains off-label and investigational medications. Industry Relationships: DiaPharma, Conatus, Intercept, Lumena, Zeon Chemicals, Merck, Gilead, Janssen, Genentech, Kadmon, Vertex, Abbvie. Current Government Grants and Contracts: NIH 1R01ES021375, K23AA18399, 1R13ES024661, CDC/ATSDR# M Dr. Cave would like to acknowledge Susanna Naggie, MD, Assistant Professor of Medicine - Infectious Disease, Duke University, for her assistance with this presentation.
3 Learning Objectives After attending this presentation, participants will be able to: Discuss the epidemiology and natural history of HCV in HIV-infected patients Discuss the AASLD/IDSA Guideline recommendations for management and treatment of HIV/HCV Patients Discuss response rates and phase III trials of DAA in HIV/HCV Discuss the drug interactions with antiretrovirals and HCV direct acting antivirals (DAAs)
4 HIV & HCV HIV 40 million Hepatitis C 180 million 10 million people worldwide 30% of US patients with HIV have HCV Epidemic in HIV+ MSM Staples CT. Clin Infect Dis 1999 DAD Study Group, Arch Intern Med 2006
5 Annual HCV screening in high risk HIV+ Patients
6 The Effect of HIV on Development of HCV Cirrhosis Overall RR 2.11 Pre-HAART era RR 2.49 HAART era RR year, 30-year rates 25%, 54% HCV monoinfection HIV/HCV coinfection Thein et al. AIDS 2008; 22:1979
7 Hepatic Decompensation Lo Re et al. Ann Intern Med 2014; 160
8 Delaying HCV Treatment in HIV Co-infection Impacts Survival : Delaying treatment until 1 year after diagnosis or until F2, F3 or F4 led to 14, 43, 142 and 418 additional cases of liver-related deaths per 1000 HCV infections as compared with treating all patients one month after diagnosis Impact of Deferring HCV Treatment on Liver-Related Events in HIV+ Patients. Cindy Zahn et al. CROI 2015#150.
9 When and In Whom to Initiate HCV Therapy
10 HIV/HCV Co-infection (Dec 2014)
11 The new treatment paradigm Nuc-NS5B NS5A NS5A NS3/4A nonnuc- NS5B ±RBV NS5A Nuc-NS5B NS3/4A Nuc-NS5B NS3/4A +RBV
12 Agents and Regimens Antiviral NS3 NS5A Non-Nuc NS5B Nuc NS5B RBV Ledipasvir/sofosbuvir FDC Paritaprevir/r/ombitasvir FDC + dasabuvir 1a only Simeprevir + sofosbuvir Sofosbuvir + ribavirin Daclatasvir* + sofosbuvir *pending FDA approval; approved in EU
13 The State of HIV/HCV data (Geno 1) Regimen Phase Size Design SVR FDA Approved Ledipasvir/sofosbuvir II 50 Single arm: 12 weeks 98% Paritaprevir/r/ombitasvir + dasabuvir + ribavirin III 327 Single arm: 12 weeks 96% II 63 RCT: 12 vs 24 weeks 92% Simeprevir + sofosbuvir N/A 19/31 Observational 95/77% Investigational Daclatasvir + sofosbuvir III 168 RCT: 8 vs 12 (N=127) weeks 97% Grazoprevir + elbasvir III 218 Single arm: 12 weeks 95% Osinusi et al, JAMA 2015; Naggie et al, CROI 2015 LB152; Sulkowski et al, JAMA 2015; Wyles et al, CROI 2015 LB151; Rockstroh et al, EASL 2015 P0887; Grant et al, CROI ; Gilmore et al, CROI
14 Recommended regimens for treatmentnaïve and experienced patients with HIV/HCV genotype 1 infection and without cirrhosis Regimen Weeks Rating Ledipasvir + sofosbuvir 12* I, A Simeprevir + sofosbuvir ± ribavirin (subtype) 12 IIa, B Paritaprevir/r/ombitasvir + dasabuvir + ribavirin, GT 1a 12 I, A Paritaprevir/r/ombitasvir + dasabuvir, GT 1b 12 I, A *8 weeks considered in patients without cirrhosis with HCV RNA <6 million IU/mL although I would not recommend this approach in patient with HIV
15 SVR12, % Question #1: Do GT-1 HIV patients achieve same SVR with 12W of LDV/SOF? HIV/HCV HCV Total naïve experienced no cirrhosis cirrhosis Naggie et al, CROI 2015 LB152; Afdhal et al. NEJM 2014
16 ION-4 LDV/SOF X 12W in HIV/HCV Predictors of relapse Overall Sex Race HCV Genotype Baseline HCV RNA (IU/mL) Baseline BMI (kg/m 2) IL28B Cirrhosis Prior HCV Treatment ARV Regimen Baseline CD4 (cells/μl) Male Female Black Non-Black 1a 1b 4 <800, ,000 <30 30 CC CT TT No Yes No Yes EFV + FTC + TDF RAL + FTC + TDF RPV + FTC + TDF < Naggie et al, CROI 2015 LB152 Lennox et al. AASLD 2014 Oral abstract #237 LDV/SOF 12 Weeks, N= SVR12, % (95% CI) No difference in SVR in HCV mono-infected ION program (12 weeks) for black (89/90, 99%) versus non-black (431/448, 96%) LDV and SOF population PK levels Similar across the different ARV regimens, black and non-black patients, relapse and SVR GWAS and whole genome sequencing analysis underway 16
17 Characteristics of Relapsers HIV-HCV (ION-4) Age Sex Race BMI (kg/m 2 ) HCV GT BL CD4 Count (cells/µl) Cirrhosis IL28B GT BL HCV RNA (log 10 IU/mL) HCV RNA <LLOQ (Wk) Timing of VF (FU wk) Prior HCV Treatment ARV Regimen 35 M Black a 308 No CT N/A EFV+FTC+TDF 58 M Black a 553 No TT PEG+RBV EFV+FTC+TDF 61 M Black a 504 Yes TT N/A EFV+FTC+TDF 61 F Black a 144 Yes CT PEG+RBV RAL+FTC+TDF 51 M Black a 964 No TT NS5A+PEG +RBV* EFV+FTC+TDF 65 F Black b 904 Yes TT N/A EFV+FTC+TDF 60 M Black a 435 No TT N/A RAL+FTC+TDF 63 M Black a 690 No TT PEG+RBV EFV+FTC+TDF 55 M Black a 933 No CT PEG+RBV EFV+FTC+TDF 58 M Black b 2069 No TT PEG+RBV EFV+FTC+TDF *Prohibited regimen (protocol violation). BL, baseline; FU, follow-up; VF, virologic failure. Naggie et al, CROI 2015 LB152 17
18 SVR12, % SVR12, % Question #2: Do GT-1 HIV patients achieve same SVR with P/r/O+D+RBV? Treatment Naïve 12 Weeks Treatment Experienced weeks 100 HIV/HCV HCV HIV/HCV 90 HCV /42 454/473 Overall 0 19/21 286/297 Overall Sulkowski et al, JAMA 2015; Feld et al, NEJM 2014.
19 SVR12, % Question #3: Do GT-1 HIV patients achieve same SVR with 12W of DCV/SOF? HIV/HCV HCV Total naïve experienced Wyles et al, CROI 2015 LB151; Sulkowski et al. NEJM 2014
20 French Compassionate Use Program for HIV/HCV: DCV/SOF SVR4 733 Co-infected 12 vs 24 weeks % 24W 70% cirrhosis 78% Treatment exp W 24W GT1 GT4 Fontaine et al. EASL 2015 LP23
21 SVR % SVR12, % Question #4: Should we use 8 weeks of LDV/SOF in HIV/HCV? HCV MONO Tx Naïve, No cirrhosis: ION HCV RNA <6 million IU/mL -8 weeks 121/123 (98%) -12 weeks 129/131 (98%) -RBV +RBV 8 weeks 20 relapse (4.5%) -RBV 12 weeks 3 relapse (1%) ION-3 Kowdley et al. NEJM; Wyles et al. CROI 2015 LB HIV/HCV COINFECTION Naïve : ALLY-2 (DCV/SOF) /83 12 weeks 1 relapse (1%) /41 8 weeks 10 relapse (25%) Tx
22 Recommended regimens for HCV genotype 1 infection and cirrhosis Regimen Weeks Rating Treatment Naïve or Experienced Simeprevir + sofosbuvir ± ribavirin 24 IIa, B Paritaprevir/r/ombitasvir + dasabuvir + ribavirin, GT 1a 24 I, A Paritaprevir/r/ombitasvir + dasabuvir + ribavirin, GT 1b 12 I, A Treatment Experienced Only Ledipasvir + sofosbuvir + ribavirin 12 I, A Ledipasvir + sofosbuvir 24 I, A
23 SVR % Treating Genotype 2 or HCV HIV/HCV GT 2 naïve GT 2 experienced GT 3 naïve** GT 3 experienced 12 weeks weeks 24 weeks 24 weeks Sulkowski et al. JAMA 2014 (PHOTON-1), Lawitz et al. NEJM April 2013; Zeuzem et al NEJM May 2014, Rockstroh et al, AASLD 2014 (pooled PHOTON 1 and 2)
24 SVR12, % Merck Grazoprevir/Elbasvir 12 Wks NS5A NS3/4A HIV/HCV HCV Total 1a 1b no cirrhosis cirrhosis Rockstroh et al. EASL 2015 Abstract P0887, Zeuzem et al. EASL 2015
25 Slide courtesy of Jennifer Kiser DDI Simeprevir Sofosbuvir Ledipasvir Daclatasvir P/r/O + D Substrate of CYP3A4, OATP1B1/3 Substrate of P-gp and BCRP Inhibitor/ Substrate of P-gp and BCRP Inhibitor of OATP1B1/3, BCRP, Substrate of P-gp and CYP3A4 Inhibit/Sub of UGT1A1,OATP1B1/ 3, BCRP, CYP3A4, CYP2C8, P-gp ATV/r No data No data LDV ; ATV DCV * ATV ; ABT450 DRV/r SIM ; DRV SOF ; DRV LDV ; DRV ALLY-2 DRV ; 3D LPV/r No data No data No data ALLY-2 LPV ; ABT450 TPV/r No data No data No data No data No data EFV SIM ; EFV SOF ; EFV ION-4 DCV * No PK data** RPV SIM ; RPV SOF ; RPV LDV ; RPV ALLY-2 ABT450 ; RPV ETV No data No data No data No data No data RAL SIM ; RAL SOF ; RAL LDV ; RAL ALLY-2 3D ; RAL ELV/cobi No data No data No data No data No data DLG No data No data No data ALLY-2 No data MVC No data No data No data No data No data TDF SIM ; TFV SOF ; TFV LDV ; TFV DCV ; TFV 3D ; TFV * Decrease DCV dose to 30mg QD, Increase DCV dose to 90mg QD, ** 3D + EFV led to premature study discontinuation/toxicities
26 Allowed HIV Meds in Clinical Trials Harvoni (ION-4): tenofovir/emtricitabine (Truvada) plus either efavirenz (Sustiva), raltegravir (Isentress), or rilpivirine (Edurant). Viekira Pak (Turquoise I): atazanavir (Reyataz) or raltegravir plus 2 nucleos(t)ide RTI (e.g. Truvada). Sofosbuvir/Daclatasvir (Ally-2): Only exclusion was ritonavirboosted PI Plus NNRTI (e.g. efavirenz/sustiva, nevirapine/viramune, delavirdine/resriptor, etravirine/intelence. Rilpivirine OK. Grazoprevir/elbasvir (C-EDGE): Truvada or abacavir/emtricitabine or abacavir/lamivudine plus either raltegravir, dolutegravir, rilpivirine. Comon Regimen Cheat Sheet Truvada+Isentress: anything (harvoni, sim/sof, dca/sof, Merck) Truvada+Reyataz/r: Viekira Pak (hold r) or sofosbuvir/daclatasvir (90mg) Atripla: Harvoni or sofosbuvir/daclatasvir (30mg)
27 The real challenge isn t the HIV
28 Conclusions Co-infection is common and the natural history of HCV is aggressive in HIV. Discussed the AASLD/IDSA Guideline recommendations for management and treatment of HIV/HCV Patients. Discussed response rates and phase III trials of DAA in HIV/HCV including investigational agents awaiting FDA approval in Discussed the drug interactions with antiretrovirals and HCV direct acting antivirals (DAAs)
29 Questions
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