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Hepatitis C in HIV
Ronald D. Wilcox MD FAAP
Program 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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www.deltaaetc.org
504-903-0788
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.
– 2.
– 3.
– 4.
– 5.
– 6.
Nurse or Advanced Practice Nurse
Physician or Physician Assistant
Dental professional
Pharmacist
Case Manager / Social Worker
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 75
plts 92,000
HCV 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 5.0
Creat 1.5
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Case
• Two months later, after 9 doses of
cidofovir:
AST 390 ALT 162
AlkPO4 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 C
Family
# Virions/ day
Diversity
Chronicity
Integration
Transmission
Hepatitis C
HIV
Flavivirus
10 (12)
Six genotypes
Retrovirus
10 (10-11)
11+ clades
80%
None
100%
Host DNA
Parenteral > sexual
Sexual > parenteral
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X 100,000
HIV/HCV Co-infection in the
United States
45
40
35
30
25
20
15
10
5
0
Mono-infected
Co-infected
HCV
HIV
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Risk of HIV, HCV, and HBV in IV
Drug Users
Seroprevalence (%)
Baltimore, 1983-1988
100
80
HCV
HBV
HIV
60
40
20
0
6
12
18
24
30
36
42
48
54
60
66
72
Duration of IVDU (Mos)
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 Transmission
Role of HCV/HIV Co-infection
• HIV Co-infection
– HCV only
– HIV/HCV
HCV transmission
5% (3-8%)
17% (7-36%)
• HCV co-infection may
– HIV only
– HIV/HCV
HIV transmission
16.3%
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
100
90
80
70
Prevalence 60
of HIV/HCV 50
40
(%)
30
20
10
N=1742
0
89
45
Co
ho
rt
10
En
tir
e
M
SM
er
os
ex
ua
l
He
t
IV
DU
14
Sulkowski et al. Hepatology. 2000;32:212A.
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Co-infection HIV Risk Factor
Prevalence at the HOP clinic
N = 402
w
n
Un
kn
o
er
os
ex
ua
l
He
m
op
hi
lia
Tr
an
sf
us
io
n
He
t
M
SM
/I
VD
U
M
SM
IV
DU
45
40
35
30
25
20
15
10
5
0
Data abstracted from the ASD database by Kathleen Welch, PhD
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Polling Question
• If someone has chronic hepatitis C, their
chance of developing cirrhosis is
approximately:
– 1.
– 2.
– 3.
– 4.
– 5.
5%
20%
35%
50%
65%
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Fibrosis Grade (METAVIR
Scoring System)
Effect of HCV/HIV Co-infection on Fibrosis
Progression Rate
4.5
4
3.5
3
2.5
2
1.5
1
0.5
0
HIV+, n=122
HIV– matched controls, n=122
Progression rate was
increased in those persons
with CD4 < 200 or
Ongoing EtOH use
10
20
30
40
HCV Duration, years
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
35
30
25
20
1995
1999
15
10
5
0
PCP
BP
SEPSIS CANCER
ESLD
Berggren R. 39th IDSA Conference 2001
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Cause of Death by CD4 count
40
35
30
25
> 200
< 200
20
15
10
5
0
ESLD
P<.0001
PCP
Sepsis
Malig
Pneum
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 HBVcoinfected 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 1012,000
• GI vs. interventional radiology
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Histologic Staging
Stage 0
No Fibrosis
Stage 1
Stage 2
Few septa
Portal Fibrosis
Stage 3
Numerous septa
Stage 4
Cirrhosis
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Progression of Fibrosis on Biopsy
No Fibrosis
Stage 1: Fibrous
expansion of
some portal areas
Stage 3: Fibrous
expansion of
most portal areas
with occasional
portal to portal
bridging
Courtesy of Gregory
MD.
DELTAEverson,
REGION
Stage 4: Fibrous
expansion of portal
areas with marked
bridging (portal to
portal and portal to
central)
Stage 5,6: Cirrhosis,
probable or defined
Cirrhotic liver:
Gross anatomy
of cadaver
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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.
– 2.
– 3.
– 4.
– 5.
none at all
less than 500 mg per day
less than 1000 mg per day
less than 2000 mg per day
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.
– 2.
– 3.
– 4.
– 5.
Herbal medications
Interferon-alpha plus ritonavir
Pegylated-interferon-alpha plus ribavirin
Lamivudine plus entacavir
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 websitewww.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 C
Candidates 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 23 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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How long to treat?
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
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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 coinfected 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
• [email protected]
• Office: 504-903-7301
• Pager: 504-363-1692
• Cell: 504-491-1219
• Delta AETC: www.deltaaetc.org
– 504-903-0788
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