Management of HIV/HCV Coinfection. Kristen M. Marks, MD Assistant Professor Weill Cornell Medical College New York, NY
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1 Management of HIV/HCV Coinfection Kristen M. Marks, MD Assistant Professor Weill Cornell Medical College New York, NY
2 Disclosure Dr. Marks has received grants and research support from Gilead Sciences and Merck.
3 Learning Objectives Consider HCV management issues unique to HIV coinfection Describe study data of direct-acting antivirals (DAAs) used in the treatment of HIV/HCV coinfection Describe post-treatment monitoring in HIV/HCV coinfected peersons
4 CASE 62 y.o. African American M with HIV & HCV Geno 1b and cirrhosis, HCV RNA 1.8 million IU/mL HCV Hx: Treatment naïve IFN unwilling in past Cirrhotic based on Bx 6 yrs ago No decompensation events EGD no varices MRI no HCC Fibroscan 20 kpa Other med hx includes: HTN, CAD (s/p stents) CRCL 55 HOW DO YOU CHOOSE A REGIMEN?
5 Minimum to Know Pre-Treatment HCV genotype/subtype Stage of fibrosis Cirrhosis - yes/no If yes, compensated? (e.g., ascites, encephalopathy, etc) Method? Liver biopsy Transient elastography Laboratory biomarkers Imaging Prior HCV treatment? Response? DAA used? Medications HIV status Medications To check for drug interactions Interferon eligibility and/or willingness Comorbidities Patient preference Child-bearing potential of patient/partner Ribavirin is a teratogen HIV/Hepatitis C helpline
6 Transient elastography to diagnose cirrhosis and predict liver decompensation Factors that may influence results: Failures Obesity Ascites Operator experience Misinterpretation (stiff but not fibrosed liver) Post-hepatic congestion (e.g Rt heart failure) Meal Inflammation Amyloid Cholestasis Lymphoma Merchante et al. Hepatolgy 2012, BMC ID 2015
7 IDSA/AASLD/IAS-USA Easl
8 Hcvguidelines.org
9 Newer strategy for HCV therapy: Direct acting antivirals target life cycle ---PREVIR Protease inhibitors e.g. telaprevir, boceprevir, faldaprevir, simeprevir, danoprevir, asunaprevir, paritaprevir, grazoprevir ---BUVIR Polymerase inhibitors Nucleos(t)ide analogs: e.g. tegobuvir, sofosbuvir, Non-nucs: e.g. deleobuvir, dasabuvir ---ASVIR NS5A inhibitors e.g. daclatasvir, ledipasvir, ombitasvir, elbasvir
10 Currently used combinations of DAA classes NUC + PI +/- RBV NUC + NS5A +/- RBV PI PI + NS5A + NS5A + nonnuc +/- RBV NUC-SPARING HIV Toxicity Resistance Renal insufficiency Drug-drug interactions Affordability NUC-SPARING HCV Affordability Provider preference Renal insufficiency Drug-drug interactions Toxicity Resistance
11 Approved Drug Regimens Interferon PEG RBV SOF PegIFN RBV SOF RBV SMV SOF +/- LDV SOF DAC SOF RBV +/- PTV/r OMV DAS Ribavirin ribavirin ribavirin +/-ribavirin +/-ribavirin Nucs sofosbuvir sofosbuvir sofosbuvir sofosbuvir sofosbuvir +/- GZR EBV Protease inhibitors simeprevir Paritaprevir /ritonavir grazoprevir NS5A ledipasvir daclatasvir ombitasvir elbasvir Non-Nucs dasabuvir G1 x x X X X X X G2 x X x G3 X x X G4 x X x X x X X
12 G1B Initial Treatment Recommended Regimens (including for coinfected) IDSA/AASLD/IAS-USA NO CIRRHOSIS: Elbasvir/grazoprevir x 12 w Ledipasvir/sofosbuvir x 12w Paritaprevir /ritonavir/ombitasvir + dasabuvir x 12w Simperevir x sofosbuvir 12w Daclatasvir + sofosbuvir x 12w CIRRHOSIS: Elbasvir/grazoprevir x 12 w Ledipasvir/sofosbuvir x 12w Paritaprevir /ritonavir/ombitasvir + dasabuvir x 12w* *Based on TURQUOISE-3 study results of PrOD w/o RBV - 100% SVR12 in G1b + cirrhosis
13 G1A Initial Treatment Recommended Regimens (including for coinfected) IDSA/AASLD/IAS-USA NO CIRRHOSIS: Elbasvir/grazoprevir x 12 w if no hi level NS5A resistance Ledipasvir/sofosbuvir x 12w Paritaprevir /ritonavir/ombitasvir + dasabuvir x 12w Simperevir x sofosbuvir 12w Daclatasvir + sofosbuvir x 12w CIRRHOSIS: Elbasvir/grazoprevir x 12 w if no hi level NS5A resistance Ledipasvir/sofosbuvir x 12w *Based on TURQUOISE-3 study results of PrOD w/o RBV - 100% SVR12 in G1b + cirrhosis
14 Grazoprevir/elbasvir x 12w in HIV/HCV Rx Naive ARVs: NUCS + RAL, DOL OR RIL EASL, 2015
15 Ledipasvir/sofosbuvir x 12w in HIV/HCV Rx Naive Failures: 10 relapses 2 on-treatment 1 lost to f/u 1 death Safety and tolerability: 2% Serious AEs No discontinuations due to AEs 1 death ARVs: TDF/FTC + EFV, RAL, OR RIL Naggie, NEJM 2015
16 Retreatment of HCV/HIV-Coinfected Patients Who Failed LDV/SOF x 12 w with LDV/SOF + RBV x 24 w 8/9 (89%) SVR Including 6/7 with NS5A RAVs Naggie et al, CROI 2016
17 PROD + RBV x 12w or 24w in HIV/HCV Rx Naive ARVs Part 1: Nucs + ATZ/r or Dol ARVs Part 2: Nucs + DRV QD or BID Wyles AASLD 2015
18 Daclatasvir + Sofosbuvir x 8 or 12 wks Wyles, EASL, 2015
19 Drug-Drug Interactions with DAAS Acid-reducing drugs Anti-epileptics Antiretrovirals Amiodarone Lipid-lowering drugs #727 Friday
20 Kis er-gram Hcvguidelines.org
21 Take-Home Points: Similarities between HIV and HCV Drug Interactions Drug interactions are common and can be clinically significant. Nucleoside analogs have a lower potential for drug interactions. Protease inhibitors have a higher potential for drug interactions. HIV drug interactions are for life; HCV drug interactions are for 8-12 weeks!
22 Pan-genotypic Sofosbuvir/velpatasvir Study Population N Treatment Duration SVR12 Rates ASTRAL patients received placebo (SVR12=0%) Genotypes 1,2,4,5,6 ASTRAL-2 Genotype 2 ASTRAL-3 Genotype 3 19%(121/624) with cirrhosis 14% (38/266) with cirrhosis 30% (163/552) with cirrhosis ASTRAL-4 Genotypes 1-6 All with Child-Pugh class B (decompensated) cirrhosis 624 SOF/VEL 12 weeks Overall: 99% (618/624) GT1: 98% (323/328) GT2: 100% (104/104) GT4: 100% (116/116) GT5: 97% (34/35) GT6: 100% (41/41) 134 SOF/VEL 12 weeks 99% (133/134) 132 SOF+RBV 12 weeks 94% (124/132) 277 SOF/VEL 12 weeks 95% (264/277) 275 SOF+RBV 24 weeks 80% (221/275) 90 SOF/VEL 12 weeks 83% (75/90) 87 SOF/VEL+RBV 12 weeks 94% (82/87) 90 SOF/VEL 24 weeks 86% (77/90) Press release Oct 2015
23 Sofosbuvir/velpatasvir x 12 wks in HIV/HCV G1-6, Naïve + Rx-exp N=106 29% Rx-exp 18% cirrhosis 12% NS5a RAVs Of 2 relapses: 1 rx-exp, 0 cirrhosis, 0 baseline RAVS Renal fxn looked unchanged in pts on boosted TDF Wyles, EASL, 2016
24 Post HCV Treatment Monitoring HIV/HCV Wk 12 labs confirm SVR, liver tests normalized? Cont to manage if abnl liver tests See after Wk 12 labs Inform them of their cure (& provide that info to PMD) Educate will always be Ab+ Review that can be reinfected Harm reduction Rescreen with HCV RNA if risk Say goodbye to F0-F2 Schedule f/u HCC/cirrhosis monitoring for F3-F4 (e.g sono r/o HCC, EGD r/o varices if cirrhosis) HCCs are expected
25 Post treatment: Reinfections expected (e.g. MSM) The MOSAIC (MSM Observational Study of Acute Infection with hepatitis C) trial in Amsterdam showed a high incidence of HCV reinfection in HIV-infected MSM who were previously diagnosed with a sexually transmitted acute HCV infection and who were HCV RNA-seronegative following HCV treatment of the acute primary infection. Reinfection was defined as a new detectable HCV RNA after successful treatment, accompanied by a switch in HCV genotype or clade. The incidence of HCV reinfection in this group was 15.2 per 100 person-years. The cumulative incidence was 33% within 2 years. Lambers AIDS 2011
26 Acute HCV treatment in HIV+ MSM LDV x SOF x 6wks (n-26) 69% 1a, 31% G4 Any ARVs SVR4 85%, SVR12 77% 4 failures, 2 LTFU by wk 12 Relapses with High baseline RNA 1 reinfection by Wk 12 Rockstroh, CROI 2016
27 Summary Remarkable advances in terms of HCV treatment tolerability & efficacy in coinfected Response rates mirror monoinfection Continued need for therapies without significant drug interactions & those that can be used in varied populations (ESRD, G3, etc) Successful treatment prevents cirrhosis, end stage liver disease, and hepatocellular cancer
28 Resources HCVguidelines.org hepatitisc.uw.edu IASUSA.org nynjaetc.org Thank you
29
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