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In advanced
fibrosis
due
to NASH

How close
are
your
patients to
the tipping
pointTM?

 

FIBROSIS STAGE exponentially INCREASES THE RISK OF
LIVER-RELATED MORTALITY

Patients with Advanced Fibrosis are at the greatest risk.1†

MRR (mortality rate ratio)
(95% CI)

50
40
30
20
10
0
REF
1.41
9.57
 
 

F0

F1

F2

F3

F4

95% confidence intervals
(0.17–11.95)
(1.67–54.93)
(2.92–95.36)
(3.51–510.34)
Risk of Liver-
Related Mortality

Increases exponentially
with increasing
fibrosis stage1
17xHigher
Risk
42xHigher
Risk
Liver related mortality increases exponentially by fibrosis stage
Liver related mortality increases exponentially by fibrosis stage

Risk of Liver-Related Mortality Increases exponentially by fibrosis stage4*

Ratio vs F0

Early Fibrosis - F1 1.41X higher risk, F2 9.57X higher risk

Advanced Fibrosis - F3 17X higher risk, F4 42X higher risk

 

FIBROSIS IS ASSOCIATED WITH REDUCED TRANSPLANT-FREE
SURVIVAL

In patients with fibrosis, survival is reduced regardless of the presence or absence of NASH; therefore, when assessing long-term prognosis of patients, the focus should be on fibrosis stage.2‡

chart for cumulative survival(%) vs Years of follow-up chart for cumulative survival(%) vs Years of follow-up
 

IN ADVANCED FIBROSIS DUE TO NASH, SOME PATIENTS MAY
PROGRESS QUICKLY

The natural history of Advanced Fibrosis due to NASH may be more rapid than previously thought. In a study of patients with histologically confirmed NASH, 48 of 217 (22%) patients with stage 3 fibrosis (F3) progressed to cirrhosis at median follow-up of 29 months.

1 IN 5 PATIENTS

May progress from
F3 to cirrhosis in
just ~2.5 years3

 

GIVEN THE INCREASING RISK OF ADVANCED FIBROSIS DUE TO NASH, IT IS IMPORTANT TO IDENTIFY THESE PATIENTS AND TAKE ACTION

At F4/cirrhosis, the disease state may not be fully reversible.4 For patients with F3, mitigating progression to cirrhosis is therefore a principle objective. That’s why identification of these patients is so vital.

Distribution of NASH population by fibrosis stage in the US using a Markov population model5||

Early Fibrosis
Advanced
Fibrosis
 
 
 
 
 
Patients with advanced fibrosis due to NASH have elevated risk and urgent action is needed. Patients with advanced fibrosis due to NASH have elevated risk and urgent action is needed.
liver graphic representing distribution of fibrosis stage in the NASH population using a Markov population model
F3 12%
F4 8%
without cirrhosis
with cirrhosis
Patients with advanced fibrosis due to NASH have elevated risk and urgent action is needed.
Patients with advanced fibrosis due to NASH have elevated risk and urgent action is needed.
 

BIOPSY HAS TRADITIONALLY BEEN USED FOR IDENTIFICATION OF NASH and/or Advanced Fibrosis BUT IS ASSOCIATED WITH NUMEROUS LIMITATIONS6-10

subjective

Only analyzes 1/50,000 of the liver and interpretation may differ between pathologists, therefore serial biopsies may provide inconsistent findings6-8,10

Cost

Costly procedure6 which may require additional cost and time of an interventional radiologist9

Adverse
events

Invasive procedure with a risk of rare but life-threatening complications, not ideal for monitoring patients over time6,10,11

Patient
Reluctance

Patient concerns related to the invasive nature of biopsy, as well as the potential for pain, discomfort, and complications10,11

 

For patients with Advanced Fibrosis without cirrhosis, halting progression is an important goal 12,13

HALT or REVERSE
FIBROSIS

PREVENTPROGRESSION TOCIRRHOSIS

Managing advanced fibrosis due to nonalcoholic steatohepatitis (NASH)
Managing advanced fibrosis due to nonalcoholic steatohepatitis (NASH)
 

With no indicated pharmacological treatments, management options are currently limited14,17

Lifestyle
Modification

  • Lifestyle modification, including changes such as diet, weight loss, and exercise, is recommended as a first-line treatment15
  • Lack of patient compliance may be a key limitation of this approach14

Nonindicated
Pharmacological
Treatments

  • Nonindicated treatments, such as vitamin E or pioglitazone, may be considered in select patients14,17
  • Data are limited and risks and benefits should be discussed with each patient before starting therapy14

There is an urgent need for options for
patients with Advanced Fibrosis due to NASH15

“Currently, there are no approved drugs for the treatment of NASH.”
– FDA-US, 201816

“No specific therapy can be firmly recommended [for NASH].”
– EASL-EASD-EASO, 201617

 

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US-PP-NAS-0679 09/20