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
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