delta region aids education and training center deltaaetc.org hepatitis c in hiv ronald d. wilcox md...
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DELTA REGION AIDS EDUCATION AND TRAINING CENTER • deltaaetc.org
Hepatitis C in HIV
Ronald D. Wilcox MD FAAPProgram Director/PI, Delta AETC
Asst Professor of Internal Medicine and Pediatrics, Section of Infectious Diseases
Louisiana State University Health Sciences Center
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LPS Coordinator: Dana Gray
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Disclosure
• The speaker receives or has received research support from all companies that make HIV medications in the US now or in the past five years
• The speaker is NOT on a speakers bureau for any pharmaceutical company
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Polling Question
• Please choose which category best describes your profession:– 1. Nurse or Advanced Practice Nurse– 2. Physician or Physician Assistant– 3. Dental professional– 4. Pharmacist– 5. Case Manager / Social Worker– 6. Other medical professional or
Administrator
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Polling Question
• My current knowledge/experience of Hepatitis C in the setting of HIV most closely resembles which of the following:– 1. I know basically nothing about hepatitis C– 2. I know hepatitis C infects the liver but that is all– 3. I take care of many patients with hepatitis C for
their HIV but do not do anything with their hepatitis C– 4. I have a good working knowledge of Hepatitis C
and have treated some patients in the past– 5. I am an expert in this field and should actually be
giving this talk
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Case• 37 y/o AA male diagnosed 12 years prior with HIV
when his lover tested +. Lowest CD4 per pt had been 179. Placed on CombivirTM and abacavir.
• Previous meds: indinavir, ddI, AZT, 3TC, nevirapine, and ritonavir.
• PMH: syphilis, pneumonia, and + antibodies for hepatitis C and B (HBsAg neg).
• SH: Denied IVDU or tobacco. Incarcerated x 12 years • Lab values: AST 131 ALT 147
AlkPO4 75plts 92,000HCV RNA PCR 115,000
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Case
• Liver biopsy two months after presentation:mild piecemeal necrosis of the parenchyma as well as moderate portal inflammation and
bridging fibrosis, compatible with moderate chronic active hepatitis.
• 5 months later:acute left hand weakness x 2-3 weeks, facial
droop, slurred speech, left foot weakness. MRI consistent with PML; JC virus PCR +.CD4 328, viral load 495.
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Case
• HAART changed to d4T, ddI, Efavirenz, and Amprenavir.
• Began cidofovir 2 doses one week apart then q3w w/ probenecid .
• 6th dose: worsening renal and liver function:ALT 158 AST 207
AlkPO4 209 TB 5.0Creat 1.5
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Case• Two months later, after 9 doses of
cidofovir: AST 390 ALT 162AlkPO4 193 TB 10.6
PT 14.9– Pt reported anorexia, diarrhea, and pruritus.– Efavirenz held.
• One month later pt died encephalopathic with ESLD 5 days before his parole hearing date. PT one week prior to death 40.9.
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Polling Question
• Hepatitis C differs from HIV in all the following ways EXCEPT:– 1. Likelihood of chronicity– 2. Amount of virus production per day in an
untreated patient– 3. Ability to integrate into host DNA– 4. Likelihood of cure with therapy– 5. Most common means of transmission
when comparing parenteral versus sexual
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HIV versus Hepatitis CHepatitis C HIV
Family Flavivirus Retrovirus# Virions/ day 10 (12) 10 (10-11)Diversity Six genotypes 11+ clades
Chronicity 80% 100%Integration None Host DNA
Transmission Parenteral > sexual Sexual > parenteral
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HIV/HCV Co-infection in the United States
0
5
10
15
20
25
30
35
40
45
HCV HIV
X 1
00,0
00
Mono-infected
Co-infected
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Risk of HIV, HCV, and HBV in IV Drug Users
Baltimore, 1983-1988
0
20
40
60
80
100
6 12 18 24 30 36 42 48 54 60 66 72
Duration of IVDU (Mos)
Ser
op
reva
len
ce (
%)
HCV
HBV
HIV
Garfein et al. Am J Public Health. 1996;86:655-61
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Influence of HIV on Sexual Transmission of HCV
• Multi-center cross-sectional study to look at hepatitis C antibody positivity among female sexual partners of hemophiliac men
• 3% in partners of co-infected men• 0% in partners of HIV negative men
Eyster et al. Ann Inter Med. 1991; 115:764-8
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Perinatal Transmission• Increase risk factors
– Maternal HIV– High maternal HCV viral load– Membrane rupture > 6 hours– Internal fetal monitoring
• No increase in breast feeding• ? C-section role ?• Testing:Ab after 15 months
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Perinatal TransmissionRole of HCV/HIV Co-infection
• HIV Co-infection HCV transmission– HCV only 5% (3-8%)– HIV/HCV 17% (7-36%)
• HCV co-infection may HIV transmission– HIV only 16.3%– HIV/HCV 26.1% (RO 1.82)
Zanetti et al. Lancet. 1995;345:289-91
Hershow et al. J Infect Dis. 1997;176:414-20
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Co-infection HIV Risk Factor Prevalence at Johns Hopkins HIV Clinic
89
14 10
45
0102030405060708090
100
Prevalence of HIV/HCV
(%)
N=1742
Sulkowski et al. Hepatology. 2000;32:212A.
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Co-infection HIV Risk Factor Prevalence at the HOP clinic
05
1015202530354045
Data abstracted from the ASD database by Kathleen Welch, PhD
N = 402
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Polling Question
• If someone has chronic hepatitis C, their chance of developing cirrhosis is approximately:– 1. 5%– 2. 20%– 3. 35%– 4. 50%– 5. 65%
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Effect of HCV/HIV Co-infection on Fibrosis Progression Rate
00.5
11.5
22.5
33.5
44.5
10 20 30 40
HCV Duration, years
Fib
rosi
s G
rad
e (M
ET
AV
IR
Sco
rin
g S
yst
em) HIV+, n=122
HIV– matched controls, n=122
Progression rate was increased in those persons
with CD4 < 200 orOngoing EtOH use
Benhamou et al. Hepatology. 1999;1054-8.
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Wilcox’s Rules of 20
• Applies to mono-infected patients with Hep C
– 15-20% - chronicity– 20% of those with chronic disease develop
cirrhosis– Development of cirrhosis occurs in 20-40 years– Of those with cirrhosis, about 5% (1 in 20)
develop hepatocellular carcinoma– Chance of perinatal transmission – 1 in 20 (5%)
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Causes of death in HIV+ patients
0
5
10
15
20
25
30
35
PCP BP SEPSIS CANCER ESLD
1995
1999
Berggren R. 39th IDSA Conference 2001
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Cause of Death by CD4 count
0
5
10
15
20
25
30
35
40
ESLD PCP Sepsis Malig Pneum
> 200< 200
P<.0001 P=.025
Berggren R. 39th IDSA Conference 2001
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HCV and HAART• NNRTIs
– 20% increase incidence of transaminase elevation– Increased levels of EFV seen with cirrhosis– Once daily nevirapine highest incidence of significant
transaminase elevation in class in co-infected
• NRTIs– Abacavir may influence chance of cure – mixed results
from studies– AZT relatively contra-indicated secondary to anemia– ddI interacts with ribavirin so is absolutely
contraindicated
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HCV and HAART
• PIs– Full dose ritonavir probably worse choice– Tipranavir, darunavir have case reports of
significant toxicity in co-infected patients– Nelfinavir, atazanavir, fos-amprenavir may be
safest choices in co-infected patients
• IIs– Case reports of liver toxicity when raltegravir
added to a tipranavir-based regimen
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HAART and Mortality in HCV
• SMART Study– “Interruption of antiretroviral therapy is
particularly unsafe in persons with hepatitis virus coinfection. Although HCV- and/or HBV-coinfected participants constituted 17% of participants in the SMART study, almost one-half of all non-OD deaths occurred in this population. Viral hepatitis was an unlikely cause of this excess risk”
Tedaldi E, Peters L, Neuhaus J et al. Opportunistic disease and mortality in patients coinfected with hepatitis B or C virus in the strategic management of antiretroviral therapy (SMART) study. Clin Infect Dis. 2008 Dec 1;47(11):1468-75
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Polling Question
• If an HIV+ patient with + hepatitis C antibody has a normal ALT level, the chance of significant liver disease is the same as in the mono-infected HCV+ patient.– 1. True– 2. False
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ALT Levels in Chronic HCV
• Co-infected patients– 7-9% have consistently normal liver enzymes
• 25-40% have significant liver fibrosis on biopsy• 12-14% have cirrhosis
– Mono-infected • 10-30% of those with normal enzymes have significant fibrosis
– Genotype 3 shown to have faster progression to cirrhosis
• Lower ALT– Women– Genotype 4
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Tests to Order Prior to the Liver Biopsy
• ANA• TSH• Alpha-fetoprotein• HCV genotype• HCV Viral load• ART / RPR• Ferritin (plus
transferrin if elevated)• PT/ PTT
• CBC with plts• Chemistry 7• LFTs• Uric Acid• ECG• Stress Test, if indicated• Lipid Profile• Insulin
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Liver Biopsy• Gold standard, especially in those with genotype 1
– Often by-passed for those with genotypes 2 or 3
• Predictive of outcome and prognosis• Low morbidity/mortality : risk of death 1 per 10-
12,000• GI vs. interventional radiology
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Histologic StagingNo Fibrosis Portal Fibrosis Few septa
Stage 0 Stage 1 Stage 2
Numerous septa
Stage 3Cirrhosis
Stage 4
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Progression of Fibrosis on Biopsy
No FibrosisNo Fibrosis
Stage 1: Fibrous Stage 1: Fibrous expansion of expansion of some portal areassome portal areas
Stage 3: Stage 3: Fibrous Fibrous expansion of expansion of most portal most portal areas areas with occasional with occasional portal to portal portal to portal bridgingbridging
Stage 4: Fibrous Stage 4: Fibrous expansion of expansion of portal areas with portal areas with marked bridging marked bridging (portal to portal (portal to portal and portal to and portal to central)central)
Stage 5,6: Cirrhosis, Stage 5,6: Cirrhosis, probable or definedprobable or defined
Cirrhotic liver: Cirrhotic liver: Gross anatomy Gross anatomy of cadaverof cadaver
Courtesy of Gregory Everson, MD.Courtesy of Gregory Everson, MD.
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Non-invasive Procedures to Assess Liver Fibrosis
• Elastrometry (ie FibroScan)
• Serum Biochemical markers (ie Fibrotest, APRI, SHASTA, FIB-4, Forn’s Index, etc.)– Less accurate in co-infected pts
• Good for lack of fibrosis versus advanced disease but less accurate for intermediate stages
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Fig. 1. Main variables to assess in patients considered as candidates for hepatitis C (HCV) therapy. *Low viral load defined as HCV RNA < 500 000–800 000 IU/ml. Ab, antibody.
From: Soriano: AIDS, Volume 21(9).May 31, 2007.1073–1089
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Polling Question
• When patients have chronic hepatitis, they should be advised to limit acetaminophen use to:– 1. none at all– 2. less than 500 mg per day– 3. less than 1000 mg per day– 4. less than 2000 mg per day– 5. less than 4000 mg per day
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Prevention Practices• Hepatic Diet - balanced
• Avoid Alcohol
• Immunizations – hepatitis A & B, Pneumovax, Influenza
• Limit acetaminophen (Tylenol) < 2 gm/day
• Avoid raw seafood, esp from the Gulf
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Nutrition with Hep C
• Avoid alcohol• Avoid crash diets and / or binges• Educate self about food pyramid• Eat a variety of foods• Drink plenty of water• If have cirrhosis, need to decrease protein,
salt, and iron in diet
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Alcohol Use in HCV
• More rapid fibrosis progression • Higher viral loads
• 2 schools of thought– No use acceptable– Minimal or special occasion use accepted
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Baseline Screenings
Ophthalmologic exam in patients with HTN/DM
Alcohol and Depression screen
Consider anti-depressant prophylaxis
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Polling Question
• The standard therapy for treatment of hepatitis C in HIV is:– 1. Herbal medications– 2. Interferon-alpha plus ritonavir– 3. Pegylated-interferon-alpha plus ribavirin– 4. Lamivudine plus entacavir– 5. Tenofovir plus emtricitabine
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Treatment for Hepatitis C co-infection
• Modalities :-- pharmacotherapy :
Peg-Interferon alpha (2 choices of formulation) weekly + Ribavirin weight based (usually 1 gm to 1.2 gm daily)
-- transplant: referral for MELD score above 25 & end-stage liver disease
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MELD Score• Three blood tests:
– Bilirubin– Prothrombin time (PT) - measured as international normalized ratio
(INR)– Creatinine (a measure of kidney function)
• 3.8 x log (e) (bilirubin mg/dL) + 11.2 x log (e) (INR) + 9.6 log (e) (creatinine mg/dL)
• There are many internet websites that have automatic
calculators. All you have to do is to plug in your bilirubin, INR, and creatinine. One such website is the UNOS website- www.unos.org.
• Scores range from 6-40
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Side Effects of Interferon
• Flu-like illness• Fatigue• Alopecia• Weight loss• Emotional lability• Neutropenia• Depression• Thrombocytopenia
• Insomnia• Thyroid dysfunction• Anorexia• Retinopathy• Neuropathy• Diarrhea• Hearing loss• Rash
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Interferon + RBV in HIV/HCV• Special Toxicity Concerns
– Ribavirin• Dose-dependent hemolytic anemia (aggrevated in
HIV)• Potential antagonism between AZT, d4T, ddC• Enhancement of ddI levels• Lactic acidosis?• Teratogenicity
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Contra-indications to Treatment with Interferon or Ribavirin
• Alcoholics or pts with ongoing IV drug use
• Hypersensitivity to either agent
• Autoimmune Disease• Decompensated Liver
Disease• Pregnancy • Creatinine Clearance < 50
• Hemoglobinopathies or severe anemia
• Platelets < 90K (50K)• CD4 < 100• Unstable Angina• Active Opportunistic
Infection• Untreated depression
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Treatment for Hepatitis CCandidates for Treatment
Baseline Histology Initial Therapy Maintenance Therapy
Mild Individualize No
Moderate Yes No
Severe Yes No
Cirrhosis Yes/Individualize No
Decompensated No No
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Sequencing of therapy• If stable on HAART therapy
• In treatment-naïve patients:– Usually HAART first*– If liver disease is severe or prevents use of HAART, treat
liver disease first– If no need for HAART, treat liver disease first but monitor
HIV status closely
• *Do NOT start both therapy in same month; wait 2-3 months to sort out toxicities
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Independent Predictors of Sustained Response
• Genotype 2 or 3• HCV Viral Load < 500,000 –
800,000 IU/ml• Undetectable HCV RNA at
week 4• Gender ( F > M)• White ethnicity• Age < 40 years old• No concurrent ddI or AZT
use
• No fibrosis or portal involvement only
• Low BMI• Higher CD4 counts• No polysubstance abuse or
psychiatric disease• Lack of Insulin Resistance
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Clinical and Laboratory Assessments• 2 week intervals first 2-3 months
– Depression questionnaire– CBC
• 4 week visit– HCV Viral Load*– CBC– Evaluate weight, adverse events– Neurotoxicity rating scale
• 12 week intervals– HIV viral load*, CD4 count, HCV Viral Load– Evaluate for drug-drug interactions– TSH to screen
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Proposed optimal duration of hepatitis C (HCV) therapy in HCV/HIV-coinfected patients. *In patients with baseline low viral load and minimal liver fibrosis. W, week; neg, negative; pos, positive; G, genotype. From: Soriano: AIDS, Volume 21(9).May 31, 2007.1073–1089
How long to treat?
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Response to Therapy in Co-Infected– Infectious Diseases Service, Hospital Clínic, Barcelona, Spain.
[email protected]– A prospective, randomized, multi-center, open-label clinical trial
including 182 human immunodeficiency virus (HIV)-hepatitis C virus (HCV) patients naïve for HCV therapy was performed.
– Patients were assigned to PEG 2b (80-150 mug/week; n = 96) or PEG 2a (180 mug/week; n = 86), plus RBV (800-1200 mg/day) for 48 weeks.
– The primary endpoint was sustained virological response (SVR: negative HCV-RNA 24 weeks after completion of treatment).
– At baseline, both groups were well balanced: 73% male; 63% HCV genotype 1 through 4; 29% had fibrosis index of 3 or greater.
–Laguno M, Cifuentes C, Murillas J et al. Randomized trial comparing pegylated interferon alpha-2b versus pegylated interferon alpha-2a, both plus ribavirin, to treat chronic hepatitis C in human immunodeficiency virus patients.Hepatology. 2009 Jan;49(1):22-31.
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Response to Therapy in Co-Infected– The overall SVR was 44% (42% PEG 2b versus 46% PEG 2a, P = 0.65). – Genotypes 1 and 4, SVRs were 28% versus 32% (P = 0.67) – Genotypes 2 and 3, SVRs were 62% versus 71% (P = 0.6) – Early virological response (EVR; >or=2 log reduction from baseline or
negative HCV-RNA at week 12) was 70% in the PEG 2b group and 80% in the PEG 2a group (P = 0.13), reaching a positive predictive value of SVR of 64% and a negative predictive value of 100% in both arms.
– Side effects were present in 96% of patients but led to treatment discontinuation in 10% of patients (8% on PEG 2b and 13% on PEG 2a, P = 0.47).
– Conclusion: In patients with HIV, HCV therapy with PEG 2b or PEG 2a plus RBV had no significant differences in efficacy and safety
–Laguno M, Cifuentes C, Murillas J et al. Randomized trial comparing pegylated interferon alpha-2b versus pegylated interferon alpha-2a, both plus ribavirin, to treat chronic hepatitis C in human immunodeficiency virus patients.Hepatology. 2009 Jan;49(1):22-31.
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Maintenance therapy: HALT
• HALT-C study: 1050 non-responders to Treatment with chronic HCV, advanced fibrosis.
• Patients randomized to Peg-Ifn versus no treatment for 3.5 years
• Mean ALT, inflammatory changes and HCV RNA levels decreased on treatment .
• However, no significant difference was observed in any of the primary outcomes including fibrosis
Di bisceglie et al. AASLD 2007
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HIV Co-infection with HBV & HCV
• * Epidemiology : up to 9-30 % of HBsAg positive individuals are also HCV seropositive
• Fourfold fibrosis progression compared to HBV mono-infected
• No guidelines. Based on expert opinion, Management is based on virus predominance
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HIV co-infection with HepB & HepC
Management• Because HCV usually predominates over HBV, most pts will
be treated according to HCV recommendations• Individuals with HBV DNA Viral load exceeding 104 IU/ml
and undetectable HCV should be treated for HBV predominance
• When both viruses are detectable, peg-ifn/ribavarin +/- adefovir or entecavir if HBV DNA response is sub-optimal
Cheruvu et al. Clinics in liver disease 2007. 917-43
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Summation
• Hepatitis C co-infection is fairly common, especially in those with a hx of IVDU
• Hepatitis C co-infection should influence choice of HAART
• Co-infection increases the progression to cirrhosis
• Hepatitis C is curable though and all co-infected patients should be evaluated for treatment.
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Polling question
• Compared to your knowledge on this subject before this presentation, your knowledge level now about hepatitis C in HIV is:– 1. Greatly enhanced– 2. Moderately enhanced– 3. Mildly enhanced– 4. I learned nothing new– 5. I am totally confused now and have no
interest in dealing with co-infected patients in the future
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Contact Info
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