First Egyptian Italian Meeting

for Liver Diseases

10-11
th
January 2008

Review of Current Status and of
Proposed Guidelines for Management
of HCV

Moderators:
Prof. Gamal Esmat
Prof. Hosam Abd El Latif
Panel
Prof. Abd El Hamid Abaza
Prof. Abul Dahab El Sahly
Prof. Ahmed Medhat Nasr
Prof. Ali Monis
Prof. Asem El Sherif
Prof. Gloria Taliani
Prof. Hany Khattab
Prof. Helmy Abaza
Prof. Mahasen Abdel Rahman
Prof. Marcello Persico
Prof. Mobarak Hussein
Prof. Mohamed Abd El Hamid
Prof. Mohamed El Ateek
Prof. Mohamed Ramadan Baddar
Prof. Mortada El Shabrawy
Prof. Mostafa El Awadi
Prof. Mostafa Kamal
Prof. Nadia El Ansary
Prof. Piero Almasio
Prof. Samir Kabil
Prof. Seham Abd El Rehim
Prof. Sherif Abd El Fattah

FIRST EGYPTIAN-ITALIAN MEETING
Consensus Statements
Cairo 10,11 January, 2008
BACKGROUND: The hepatitis C virus (HCV) is a major public health
problem and a leading cause of chronic liver disease. The purpose of this
meeting is to provide clinicians with approaches to the diagnosis, and
management of HCV infection.
Summary of the current situation in HCV
According to AASLD profile guidelines 2004", patients who are
indicated for treatment are those with persistently elevated ALT, +ve
RNA, and with Liver biopsy (Metavir 62, Ishak63)
Groups to be individualized are those with normal ALT, failed prior
therapy, low HAI, Coinfection with HBV, extremity of age and those
with chronic renal disease.

Contraindications to therapy include those with uncontrolled depression,
organ transplant recipients, those with autoimmune hepatitis,
hyperthyroidism, severe co-morbid condition, and pregnant females.

Steps that are needed before treatment include:
1. Confirm diagnosis by qualitative PCR + quantitative PCR (predict
response and helps assess flow up).
2. HCV genotype to determine duration and likehood of response
3. Liver biopsy :
4. CBC, Autoimmune profile, thyroid function, HBV and HIV.
5. Cardiological (coronary heart diseases) and psychological evaluation
(depression).
6. Pregnancy test.

The optimum regimen for HCV treatment is:

IN GENOTYPE 1, 4:
Peg-inf (weekly, S.C.) > 2b 1.5ug/kg or > 2a 180ug + Ribavirin
(daily,orally)1000mg (<75kg) or 1200mg (>75)kg for 48 weeks.
- Early viral response EVR: If EVR is not achieved by 12 weeks
treatment could discontinue, yet it could be individualized according to
tolerability, severity of liver damage, BP or HR.

IN GENOTYPE 2, 3:
Peg-inf > + ribavirin (800mg) for 24 weeks.
-EVR: not needed.

The "FIRST EGYPTIAN-ITALIAN MEETING" agreed on the
following consensus regarding HCV:

1-As regards pretreatment evaluation the following points were
discussed with the following recommendations given:
There is No need to do genotyping for Egyptian patients pre-
treatment, except for: "those who traveled abroad ,those with
history of risk factors for exposure, Resistant to treat patients &
relapsers, and Immigrants"
Liver biopsy is still highly recommended in diagnosis before
interferon therapy & must be U.S. guided, 1 core, one pass, Core
must be not less than 2 cm length, and containing at least 6 portal
tracts. Also it is better to use Trocut needle with a size not less than
1.4
Lab markers & fibroscan could not be used alone to assess the liver
condition
PCR should be done at 4 weeks but not at weeks 2, 8
2-As regards treatment regimens, dose modification and follow up the
following points were discussed with the following recommendations
given:

In genotype 1 & 4, ribavirin dose can be aimed to reach up to 15
mg/kg (but not up to 20 even if tolerated).
General agreement on the International hematological values for
decreasing the doses OR stoppage of the treatment
Fundus examination is recommended every 6 months for those
who are not diabetics or hypertensive and every 3 months for those
who are diabetics or hypertensive
SVR without cirrhosis will be followed by LFT & PCR annually
Those with cirrhosis will be followed according to the
recommended regimen (6 months) AFP, US, LFT & annual PCR.

Patients with genotype 4 and have RVR with base line viral load <
600,000 IU & low fibrosis will be treated for only 6 months.
Patients with genotype 4 with pEVR will be treated for 18 months.
Our decision for continuing treatment must be based on testing the
virus at weeks (4, 12, 24) BY: Rt-PCR (real time)
3-As regards non responders and relapsers the following
recommendations were given
No re-treatment will be given to Non responders however non
compliant patients could be given another chance.
Relapsers should be re-treated.
On re-treatment there is no need to increase the dose of ribavirin or
the dose of IFN but the duration of treatment should be increased
to 18 months.
4-As regards Patients with compensated cirrhosis the following
recommendations were given
Patients with compensated cirrhosis will be treated the same way
as the patients without cirrhosis but with strict observation.
We did not reach a conclusion whether to treat cirrhotic patients
with esophageal varices or not.
5-As regards children and elderly the following recommendations were
given:
In spite of FDA non approval, Pegylated INF can be used by
experienced pediatricians for children 5 years old
No upper limit of age of patients to be treated according to the
usual standards
6-As regards Patients with persistent normal ALT the following
recommendations were given:
Patients with persistent normal ALT will be treated according to
liver biopsy:
If > F1..Treat
If < F1..No treatment, just follow up
7-In HCV & HBV coinfection we recommend the following:
Treat the active virus
Patients with positive PCR for both HBV & HCV can be treated by
triple therapy (IFN, Ribavirin, & nucleoside/tide analogue)
8-In patients with Chronic renal failure and HCV we recommend the
following:
HCV positive CRF pts are not recommended to do renal
Transplantation except after trial for clearance of the virus by Peg
IFN.
Cirrhotic patients could have renal & liver Transplantation.
9-As regards the impact of metabolic syndromes (DM, Obesity)
on SVR the following recommendations were given:
HbA1c must be less than 7 before starting therapy
Obese patients are encouraged to loose wt & do exercise for 6
months prior to treatment, to reach a BMI < 30, but there is no
limits to start therapy,
10-In patients with SVR, if liver enzymes are still elevated after 6
months after stopping therapy, it is recommended to :
Search for another cause.
Do a sensitive method to detect the virus (TMA)
Do a liver biopsy.

11-The following Points were recommended for future research:
Determinants of disease progression and response to treatment
(Genetic factors, Genotypes and subtypes, Co-morbid conditions)
Management of Non-responders and who needs re-treatment