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CCO HCV NOW Downloadable 3
CCO HCV NOW Downloadable 3
Stacey Trooskin, MD, PhD, MPH, has disclosed that she has received consulting
fees and funds for research support from Gilead Sciences.
Faculty
Nancy Reau, MD
Professor of Medicine
Richard B. Capps Chair of Hepatology
Chief, Section of Hepatology
Associate Director, Solid Organ Transplantation
Rush University Medical Center
Chicago, Illinois
Nancy Reau, MD, has disclosed that she has received consulting fees from
Abbvie, Gilead Sciences, and Intercept and funds for research support from
Abbott.
Program Overview
Epidemiology of HCV
Simplified HCV screening, diagnosis, and treatment
Efficacy and safety of pangenotypic treatment regimens in persons who
inject drugs and persons receiving opioid substitution therapy
Expansion of the HCV provider pool
Question and Answer Session
WHO Vision: Eliminate Viral Hepatitis as a Major Health
Threat by 2030
“A world where viral hepatitis transmission is halted and everyone
living with hepatitis has access to safe, affordable and effective
care and treatment services”
~ 2.4 million
Americans living
with HCV in
2013-2016[1] Persons with
HCV per 100,00
Nearly 50% population
unaware of their 0-650
651-850
infection[1] 851-1000
1001-1200
1251+
1. Ryerson. MMWR Morb Mortal Wkly Rep. 2020;69:399. 2. HepVu. https://map.hepvu.org/map. Accessed November 17, 2020. Slide credit: clinicaloptions.com
HCV Epidemic Among Young PWIDs in Rural Settings
US cases increased from Acute HCV Incidence in People ≤ 30 Years of Age:
Kentucky, Tennessee, Virginia, West Virginia, 2006-2012[2]
850 in 2010 to 2436 in 4.5
50,300 On track
50,000 5.00 5.03 5.01 4.91
44,700 4.42
41,200 4.13
40,000 4.00 3.72
33,900 35,000
30,500 3.00
29,700
30,000 Not on track 3.00
20,000
ₓ 2.00
10,000 1.00
0 0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023
Yr Yr
*By multiplying the no. of reported cases by a factor to adjust for under-reporting. †
Age-adjusted to the 2000 US standard population.
CDC. National Viral Hepatitis Progress Report 2025. https://www.cdc.gov/hepatitis/policy/NationalProgressReport.htm. Slide credit: clinicaloptions.com
How Can We Achieve WHO HCV 2030 Elimination Goal?
Enable Enable Need
Conceptual slides based on Hellard. J Hepatol. 2018;68:383. Cooke. Lancet Gastroenterol Hepatol. 2019;4:135. Slide credit: clinicaloptions.com
Initial HCV Testing and Pre-Treatment Assessment
Quantitative Assessment
HCV- Liver HAV, HBV,
HCV RNA HCV of potential
antibody fibrosis HIV
genotype DDIs;
test (VL) assessment testing
Treatment
? ? ?
Pangenotypic Therapy
GLE/PIB 8 weeks or SOF/VEL 12 weeks
Minimal Monitoring
(No HCV-related laboratory monitoring required)
139
‒ Community events, 19% 150
Participants (n)
128 42% with
venipuncture
‒ Methadone clinic, 16% 100 were HCV RNA+
54
50
0
FibroScan HCV Venipuncture HCV RNA+
Performed Antibody Performed
Positive
Price. AASLD 2019. Abstr 594. https://www.gastroendonews.com/Article/PrintArticle?articleID=57472. Slide credit: clinicaloptions.com
Drug-Drug Interactions With HCV Treatments
No clinically significant interaction expected
Illicit/Recreational Drug SOF SOF/VEL SOF/VEL/VOX GLE/PIB GZR/EBR
Potential interaction that may require dose adjustment, Amphetamine
altered administration timing, or additional monitoring Cannabis
Should not be coadministered Cocaine
Diamorphine
Lipid-Lowering Drug SOF SOF/VEL SOF/VEL/VOX GLE/PIB GZR/EBR
Diazepam
Atorvastatin
Fentanyl
Bezafibrate γ-hydroxybutyrate
Ezetimibe Ketamine
Fenofibrate MDMA
Fluvastatin Mephedrone
Gemfibrozil Methadone
Methamphetamine
Lovastatin
Oxycodone
Pitavastatin
Phencyclidine
Pravastatin
Temazepam
Rosuvastatin
Simvastatin
Feld. NEJM. 2015;373:2599. Foster. NEJM. 2015:373;2608. Zeuzem. NEJM 2018;378:354. Puoti. J Hepatol. 2018;69:293. 5.
Bourliere. NEJM. 2017;376:2134. Bourliere. Lancet Gastroenterol Hepatol. 2018;3:559. Wyles. J Hepatol. 2018;68:S23. Slide credit: clinicaloptions.com
SIMPLIFY: SOF/VEL for 12 Wks in PWID
Characteristics Participants (N = 103)
Single-arm, multicenter trial Median age, yrs (SD) 48 (41-53)
Mar-Oct 2016 Male sex, n (%) 74 (72)
HCV GT 1/2/3/4, n 36/5/60/2
N = 103 participants with chronic Cirrhosis (Fib-4), n (%) 9 (9)
HCV (GT 1-6) treated with 12 Unstable housing, n (%) 24 (23)
wks SOF/VEL provided in Any IVDU in past 6 mos, n (%) 103 (100)
electronic blister packs Any IVDU in past 30 days, n (%) 76 (74)
At least daily IVDU in past 30 days, n (%) 27 (26)
‒ Recruited from hospital- and Alcohol use in past 30 days, n (%) 62 (60)
community-based clinics History of OST use, n (%) 84 (82)
Current OST, n (%)
‒ Excluded HIV coinfection and/or Methadone 45 (44)
decompensated liver disease Buprenorphine 4 (4)
Buprenorphine-naloxone 12 (12)
Grebely. Lancet Gastroenterol Hepatol. 2018;3:153. Grebely. Clin Infect Dis. 2016;63:1479. Slide credit: clinicaloptions.com
SIMPLIFY: Injection Drug Use and Treatment Adherence
Self-Reported Injection Overall Treatment Adherence[2]a
Drug Use During Therapy[1],a
100 100 94 98 99
80 80
Adherence (%)
IVDU (%)
60 60
40 40
20 20
0 0
Baseline Week 4 Week 8 Week 12 Daily Blister Weekly Self-
Pack Blister Pack reported
Any Other opioids Cocaine
Heroin Methamphetamine
1. Gilead Sciences. EPCLUSA US full Prescribing Information. 2. Cunningham. Int J Drug Policy. 2018;62:14. Slide credit: clinicaloptions.com
SIMPLIFY: Efficacy of SOF/VEL in PWID With Chronic HCV
6/103 patients did not have SVR12 (4 LTFU, 1 drug overdose death, 1
reinfection) SVR12: Overall and By Baseline Drug Use
(Intention-to-Treat Analysis)
94 95 96 94 96
100
80
SVR12 (%)
60
40
20
0
SOF/VEL Recent ≥ Daily < Daily Recent
12 Wks Injecting at Injecting
Baseline Frequency of Injecting During Therapy
Drugs at Baseline
Grebely. Lancet Gastroenterol Hepatol. 2018;3:153. Grebely. Clin Infect Dis. 2016;63:1479. Slide credit: clinicaloptions.com
Safety and Efficacy of GLE/PIB in PWID With Hepatitis C
Infection
Analysis of pooled data from 8 Outcomes
Receiving OST
(n = 157)
Not receiving
OST (n = 2099)
international Phase 2 and 3 trials of Completion, n/N (%) 154/157 (98) 2070/2099 (99)
GLE/PIB; N = 2256 patients, including Adherence, n/N* (%) 121/123 (98) 1884/1905 (99)
157 (7%) receiving OST SVR12 n/N (%) 151/157 (96) 2055/2099 (98)
GT 1 40/41 (98) 841/848 (99)
Patients received GLE (300 mg)/PIB GT2 17/17 (100) 443/449 (99)
GT3 89/94 (95) 523/549 (95)
(120 mg) QD for 8, 12, or 16 wks GT4 4/4 (100) 170/174 (98)
GT5 0 (0) 32/32 (100)
GT6 1/1 (100) 46/46 (98)
Outcomes: treatment completion and
DAA-related serious AE, n (%) 0 (0) 1 (< 1)
adherence; SVR12; and safety
DAA-related AE leading to
0 (0) 5 (< 1)†
discontinuation, n (%)
GLE/PIB demonstrated high efficacy
*Patients with missing drug accountability records not assessed for adherence
across HCV genotypes regardless of (therefore, total adherence N is lower than total patients enrolled).
†
Diarrhea; abdominal pain; dizziness; dyspepsia; fatigue; headache; malaise;
OST use nausea; pruritus; transient ischemic attack in a patient with high-risk CVD.
SVR (%)
Randomized groups
40
‒ Individual treatment (n = 51): self-
administer all HCV medications 20
Litwin. Contemp Clin Trials. 2019;87:105859. Litwin. AASLD 2020. Abstr LO10. Slide credit: clinicaloptions.com
HERO: Initial Virologic Results
No difference between care models: mDOT vs PN
Cascade of HCV Care
100
100 100 P = .414
80 83.6 P = .392
81.4 P = .543
Participants (%)
0
mDOT PN mDOT PN mDOT PN mDOT PN
Enrolled With HCV Initiated Treatment Completed Achieved SVR
Infection With SOF/VEL Treatment
Litwin. Contemp Clin Trials. 2019;87:105859. Litwin. AASLD 2020. Abstr LO10. Slide credit: clinicaloptions.com
MINMON: The Keep it Simple and Safe Approach to HCV
Treatment
Single-arm, open-label, October Patients with HCV from 38 sites in
2018 to July 2019 5 countries, 400 persons (limit 132
from US) enrolled; 399 treated
Included: treatment-naive persons
with HCV and no evidence of ‒ Median age: 47 yrs
decompensated cirrhosis by FIB-4 ‒ 34/399 (9%) with compensated
Participants received SOF/VEL QD cirrhosis defined as FIB-4 ≥ 3.25
for 12 wks ‒ 166 (42%) with HIV coinfection
Primary outcomes SVR data available for 396/399
‒ SVR between 22 and 76 wks post- (99%)
initiation of treatment 355/399 (89%) self-reported taking
‒ Serious adverse events to Wk 28 all medication in 12 wks
Sunil. AASLD 2020. Abstr LO7. Slide credit: clinicaloptions.com
MINMON: Minimal Monitoring Approach
No genotyping
All 84 tablets dispensed at outset
No on-treatment lab visits
Two remote contacts scheduled
‒ Wk 4: adherence assessment
‒ Wk 22: schedule SVR assessment
‒ Unplanned visits for patient concerns were permitted
No. → 379 20
%→ 0 10 20 30 40 50 60 70 80 90 100
SVR Non-SVR
HCV
Effective Test-and-treat Micro-
treatments approaches elimination
achieving considered by strategies
cure in the national and for the
majority of international hardest to
patients[1] guidelines[1,2] treat[3]
1. WHO. Guidelines for the care and treatment of persons diagnosed with chronic hepatitis C virus infection. Accessed
November 17, 2020. 2. Kattakuzhy. Ann Intern Med. 2017;167:311. 3. Lazarus. Semin Liver Dis. 2018;38:181. Slide credit: clinicaloptions.com
Engagement of Non-HCV Specialists Is Critical to Close
Gaps in the Care Cascade
Data from Jan 2013 to Dec 2016
Care Cascade by Physician Specialty*
100
19 26 21 28 20 24
33 32
Proportion of Tests (%)
80 Nonspecialist†
30 26 23 HCV specialist‡
60 28 18 23
21 20 0.6 OB/GYN
2 0.3 0.3
11 3 13 2 1 Other§
40 3 6 19 29 30 Missing specialty
17 37
20 37 38 38 28 28 25 27
15
0
Screening Detection Confirmatory Awareness Diagnosis Genotype Liver Function Treatment
test Test Test
*Percentages rounded so may add up to > 100; †Includes primary care, family practice, and internal medicine; ‡Includes
hepatologists, gastroenterologists, and infectious diseases specialists; §Includes all other physicians and specialties.
Downloadable slidesets with key data and considerations for streamlining HCV treatment and
improving access to care during the COVID-19 pandemic
clinicaloptions.com/hepatitis