hcv 2014 and beyond the interferon era patrick m. horne, msn, arnp, fnp-bc assistant director of...
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HCV 2014 and beyond the interferon era
Patrick M. Horne, MSN, ARNP, FNP-BCAssistant Director of Hepatology Clinical Research
Division of Gastroenterology, Hepatology and NutritionUniversity of Florida Health
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Disclosures and Off-label Discussion• Financial relationships to disclose within
the past 12 months:• Scientific consultant for Gilead Sciences
• Off-label discussion:• Combination sofosbuvir + simeprevir
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Objectives• Discuss the history and worldwide
prevalence of hepatitis C• Review the current approved therapeutic
options for HCV therapy based on genotype• Discuss some future treatment options in
development
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6%
16%
34%42%
55%
>70%
>90%
Developments in Treatment and Cure RatesS
VR
(%
)
1991
1998
2001
2011
StandardInterferon
Ribavirin
Peginterferon
Direct Acting Antivirals
2013Protease inhibitor
Nucleoside inhibitor
SVR%
TIME
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Seroprevalence of Hepatitis C: 170 to 200 Million Worldwide
Americas12-15 M
Africa 30-40M Australia
.2 M
Western Pacific60 MWestern
Europe 5 M
Eastern Europe
10 M
Southeast Asia
30-35 M
1. World Health Organization. Wkly Epidemiol Rec. 2000;75:17-28.
2. Edlin B et al. AASLD; November 11-15; 2005 San Francisco, California. Oral Presentation #44.
United States5M
Highest Prevalence:
Egypt-4M(45% adults
>40y)
P-DS-D-159
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SVR is Associated with Reduced Mortality Among HCV-infected Persons
Van der Meer, et al. JAMA 2012:308:2584-2593.
• 530 adults in Europe prospectively followed for median 8.4 years after HCV treatment
• 192 (36%) achieved SVR
No. at risk Without SVR 405 393 382 363 344 317 295 250
207 164 135
With SVR 192 181 168 162 156 144 125 88 56 40 28
30
20
10
0
All-cause mortality
All-c
ause
mor
talit
y,
%
P<0.001
Time, y0 1 2 3 4 5 6 7 8 9 10
Without SVR With SVR
No. at risk Without SVR 405 392 380 358 334 305 277 229 187 146 119 With SVR 192 181 168 162 156 144 125 88 56 40 28
30
20
10
0
Liver-related mortality or liver transplantation
Live
r-re
late
d m
orta
lity
or li
ver
tran
spla
ntati
on, %
P<0.001
Time, y0 1 2 3 4 5 6 7 8 9 10
Without SVR
With SVR
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75% of Infected Individuals Are Not Aware of Their HCV Status
1. Institute of Medicine. Hepatitis and Liver Cancer, A National Strategy for Prevention and Control of Hepatitis B and C. Washington, DC. The National Academies Press, 2010; 2.United States Department of Health and Human Services. Combating the Silent Epidemic of Viral Hepatitis, Action Plan for the Prevention, Care & Treatment of Viral Hepatitis. 2011
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CDC Releases Birth Cohort Screening Guidelines
• Adults born during 1945–1965 should receive one-time testing for HCV without prior ascertainment of HCV risk
• All persons identified with HCV infection should receive a brief alcohol screening and intervention as clinically indicated, followed by referral to appropriate care and treatment services
Smith BD, et al. MMWR Recomm Rep. 2012;61(RR-4):1-32.
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Case 1• 60 year old Caucasian male presents
recently found to be HCV Ab positive.– Confirmatory testing confirms genotype 1a with
a viral load of 1,245,300 IU/mL.
• Hx of illicit drug use in the 1960s• Medical hx includes
– Hypertension-well controlled– GERD-well controlled with PPI
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Case 1• Naïve to treatment• Baseline labs:
– AST 66, ALT 70– Total bilirubin 0.5– Hemoglobin 14.0– Platelet count 175,000– Fibrotest=F2 disease
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Case 1• What do you do?
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Current options• Approved options
– Pegylated interferon (Peg-INF) and ribavirin (RBV), weight based times 48 weeks
– Peg-INF, RBV plus either telaprevir (TVR) or bocepravir (BOC) for 24-48 weeks
– Peg-INF, RBV plus simeprevir (SIM) for 24-48 weeks
– Peg-INF, RBV plus sofosbuvir (SOF) times 12 weeks or SOF and RBV for 24 weeks
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Current options• Not approved option but with good data
– SOF + SIM with or without ribavirin for 12 weeks- COSMOS study
• Wait for something else
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Peg-INF/RBV PEG-INF/RBV/TVR or BOC
Peg-INF/RBV/SIM Peg-INF/RBV/SOF SOF/RBV0
10
20
30
40
50
60
70
80
90
100
50%
75% 80%
90%
76%
Package inserts
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Recommendations for HCV Genotype 1 Treatment-Naïve
Population Recommended Regimen Duration
Treatment-naïve genotype 1 Sofosbuvir (400 mg) + PEG-INF + RBV (1000-1200 mg/d)
12 weeks
• Alternative regimens:• Simeprevir + PEG-INF+ RBV x 12 wks• SIM + SOF+/- RBV x 12 wks• SOF + RBV x24 wks
• Regimens specifically not recommended:• Peg-INF/RBV x 48 wks with or without TVR or
BOC• Monotherapy with PEG, RBV, or DAA
AASLD/IDSA Treatment Recommendations.www.hcvguidelines.org. Accessed January 31, 2014.
Peg-INF = pegylated interferon; RBV=ribavirin; DAA = direct acting antiviral
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Neutrino Study
Overall
HCV GT
1 (1a, 1b, 1a/b)
1a
1b
4, 5, 6
Cirrhosis No
Yes
Race Black
Non-black
HCV RNA level <6 log10 IU/mL
≥6 log10 IU/mL
IL28BCC
Non-CC
60 70 80 90 100
SVR %
Lawitz E, et al. EASL 2013, Abstract 1411; Lawitz E, et al. N Engl J Med. 2013;368:1878-1887.
SOF + PEG-IFN + RBV
SVR by Subgroups
SVR
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Genotype 1 Treatment OptionsPhase 3 Landscape
2014 (now)
PEG/RBV + SOF
DCV + ASU (1b)
SOF + LPV + RBV
SVR (est)
ABT-450+ 333 + 267 + RBV
2014-201500 1212
90%
> 94%
90%
SOF + SMV (off-label) > 90%
SOF + DCV > 94%
weeks
SOF + RBV (select populations) 60-70%
>94%
0 24-4812
Courtesy of David Nelson, M.D.
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Case 2• 55 year old African-American female with
HCV genotype 2b who was a prior relapser to Peg-INF + RBV times 24 weeks.
• Liver biopsy in 2013-F3 fibrosis• Other medical hx:
– Diabetes– Hyperlipidemia– Anxiety
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Case 2• Labs:
– HCV RNA 550,000 IU/mL– AST 100, ALT 98– Total bilirubin 1.0– Hemoglobin 12.5– Platelet count 110,000
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Case 2• What do you do?
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Options• Re-treat with Peg-INF + RBV for 48 weeks
– Prior treatment she required multiple dose reductions of Peg-INF due to side effects
• SOF + RBV for 12 weeks• Wait
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Recommendations for HCV Genotype 2 Treatment-Experienced
Population Recommended Regimen Duration
Previous treatment with PEG/RBV
Sofosbuvir (400 mg) + RBV (1000-1200 mg/d)
12 weeks*
AASLD/IDSA Treatment Recommendations.www.hcvguidelines.org. Accessed January 31, 2014.
*Patients with cirrhosis may benefit by extension of therapy to 16 weeks
Population Alternative Regimen Duration
Previous treatment with PEG/RBV
Sofosbuvir (400 mg) + PEG-IFN + RBV (1000-1200 mg/d)
12 weeks
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23
GT-2 GT-3
SVR12 rate (%)
FISSION
POSITRON
FUSIONFUSION
16 week
16 week
62%
12 week
12 Week
5656%%
12 week
12 week
12 week
12 week
0 10 20 30 40 50 60 70 80 90 100
Sofosbuvir + RBV in HCV GT 2/3Genotype 2 = 3
Lawitz E, et al. N Engl J Med 2013;368:1878-87. Jacobson IM, et al. N Engl J Med 2013;368:1867-77.
24 weekVALENCE
12 week
FUSION
97%
93%
61%
86%
30%
94%
62%
93%
84%
GT-2
GT-3
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Case 3• 54 year old Hispanic male with HCV
genotype 3.– Diagnosed 5 years ago– Relapser to Peg-INF and RBV– Liver biopsy 2013-F1 fibrosis
• Other medical history:– Bipolar disorder– GERD– Arthritis
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Case 3• Labs:
– HCV RNA 1,200,000 IU/mL– AST 55, ALT 80– Total bilirubin 0.6– Hemoglobin 13.4– Platelet count 200,000
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Treatment options• Peg-INF + RBV for 24 weeks• SOF + RBV for 24 weeks• Peg-INF + RBV + SOF for 12 weeks
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Recommendations for HCV Genotype 3, Treatment – Naïve/Experienced
Population Recommended Regimen Duration
Regardless of IFN eligibility Sofosbuvir (400 mg) + RBV (1000-1200 mg/d)
24 weeks
AASLD/IDSA Treatment Recommendations.www.hcvguidelines.org. Accessed January 31, 2014.
Population Alternative Regimen Duration
Consider only if eligible for IFN
Sofosbuvir (400 mg) + Peginterferon + RBV (1000-1200 mg/d)
12 weeks
Not recommended:• PEG/RBV• Telaprevir, boceprevir, simeprevir
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28
GT-2 GT-3
SVR12 rate (%)
FISSION
POSITRON
FUSIONFUSION
16 week
16 week
62%
12 week
12 Week
5656%%
12 week
12 week
12 week
12 week
0 10 20 30 40 50 60 70 80 90 100
Sofosbuvir + RBV in HCV GT 2/3Genotype 2 = 3
Lawitz E, et al. N Engl J Med 2013;368:1878-87. Jacobson IM, et al. N Engl J Med 2013;368:1867-77.
24 weekVALENCE
12 week
FUSION
97%
93%
61%
86%
30%
94%
62%
93%
84%
GT-2
GT-3
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VALENCE: Sofosbuvir + RBVGenotype 3 IFN naïve, ineligible or treatment failures
SOF+RBV (n=250)G3
Series10
102030405060708090
100
93 9285
60
Naïve Treatment-experienced
Noncirrhotic Cirrhotic Noncirrhotic Cirrhotic
SVR 12 (%)
86/92 12/13 85/100 27/45
Zeuzem S et al, AASLD 2013, #1085
12 240 weeks
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100
80
60
40
20
0
37
63
85
19
61 60
No Cirrhosis Cirrhosis
Impact of Duration on Efficacy of SOF in Tx-experienced GT 3
FUSION: 12 Weeks SOF/RBVFUSION: 16 Weeks SOF/RBV
VALENCE: 24 Weeks SOF/RBV
Lawitz E, et al. AASLD 2013. Zeuzem, et al. AASLD 2013.
SV
R12
(%
)
14/38
25/40
85/100
5/26
14/23
27/45
Genotype 3
n/N =
SOF = sofosbuvir; RBV=ribavirin
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Lonestar-2
Peg-INF + RBV + SOF times 12 weeks
Lawitz E AASLD 2013
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What about waiting?• What may be coming?
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• Sulkowski MS, et al. N Engl J Med. 2014;370:211-21.; Clinical Trials.gov
Daclatasvir + Sofosbuvir +/- Ribavirin for HCV GT 2-3Treatment-Naïve 24 Week Rx
SOF × 7 days, then DCV + SOF SVR12 = 88%
Week 0 24 36
Rx NaïveGT 2 or 3
n = 44
n = 14
n = 16
12
DCV + SOF
n = 14 DCV + SOF + RBV
SVR12 = 93%
SVR12 = 86%
Drug DosingDaclatasvir (DCV): 60 mg once dailySofosbuvir (SOF): 400 mg once daily
Phase 3 Trial (NCT02032901): ongoing, but closed to enrollment
DCV + SOF
Genotype 3 (n= 150) - naïve - experienced
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The New Era of HCV TherapyMultiple Direct Acting Antivirals
3’UTR5’UTR Core E1 E2 NS2 NS4BNS3 NS5A NS5Bp7 4A
HCV PIs
NS5A
Inhibitors
NS5B
Nucs
NS5B
Non-nucs
Protease
Viral enzyme
Active site
Telaprevir
Boceprevir
Simeprevir
Faldaprevir
Asunaprevir
ABT-450
MK-5172
Sovaprevir
ACH-2684
Non-enzyme
Replication complex
Daclatasvir
Ledipasvir
ABT-267
GS-5816
ACH-3102
PPI-668
GSK2336805
Samatasvir
MK-8742
Viral enzyme
Active site
Sofosbuvir
VX-135
IDX20963
ACH-3422
Viral enzyme
Allosteric site
ABT-333
Deleobuvir
BMS-791325
PPI-383
GS-9669
TMC647055
Polymerase
Courtsey of David Nelson, M.D.
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HCV Future Treatment ParadigmMany Options to Choose From
NS5A + PI
+ NNI + RBVSOF + RBV
PEG-IFN + RBV
+ DAA
SOF + NS5A
+ RBV
NI: nucleotide polymerase inhibitor (SOF), NNI: non-nucleotide polymerase inhibitorPI: protease inhibitor, NS5A: NS5A replication complex inhibitor
SOF + PI
+ RBV
Direct Acting Antivirals
IL28B CC
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Summary• Large cohort of patients that have yet to be
diagnosed.• Treatment options are becoming better and
short and more individualized.• More patients will have access to
medications options as we will no longer be limited by contraindications to treatment due to medical co-morbidities or side effects
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Thank you!