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EASL RECOMMENDATIONS ON THE 
TREATMENT OF HEPATITIS C
PAKISTAN HAS 2ND HIGHEST PREVALENCE 
OF HCV IN THE WORLD 
4.4%- 9% POPULATION SUFFERS FROM 
HCV
ANTI-HCV BY ELISA …..BEST INITIAL TEST 
EXCEPTIONS 
SUSPECTED ACUTE HEP C 
I IMMUNOCOMPROMISED PT. 
HCV RNA BY PCR IF ELISA POSITIVE 
IF ANTI-HCV POSITIVE AND PCR NEGATIVE 
THEN REPEAT PCR AFTER THREE MONTHS TO 
CONFIRM CONVALESCENCE
ATTAINING SVR
DEFINITION: 
SUSTAINED VIROLOGICAL RESPONSE 
IS UNDETECTABLE HCV RNA AT 12 WKS 
(SVR 12) OR 24 WKS (SVR24)AT THE END 
OF THERAPY , AS ASSESSED BY SENSITIVE 
MOLECULAR METHOD LIKE PCR (THE 
LOWER LIMIT BEING <15 IU/ML.)
SEARCH FOR OTHER CAUSES OF LIVER DISEASE 
ASSESSMENT OF LIVER DISEASE SEVERITY 
HCV RNA LEVEL AND GENOTYPE 
DETERMINATION 
DETERMINATION OF HOST GENETICS
UNCONTROLLED PSYCHOSIS/ DEPRESSION/ EPILEPSY 
PREGNANCY 
RETINAL DISEASE 
AUTOIMMUNE THYROID DISEASE 
FOR PEGYLATED INTERFERON -ALPHA 
ABSOLUTE NEUTROPHIL COUNT <1500/mm 
PLATELET COUNT < 90,000/mm
ALL TREATMENT- NAÏVE AND –EXPERIENCED PTs WITH 
COMPENSATED CLD DUE TO HCV 
TREATMENT SHOULD BE PRIORTIZED IN PTs WITH 
SEVERE FIBROSIS (METAVIR SCORE F3/F4) 
TREATMENT IS JUSTIFIED IN PTs WITH MODERATE 
FIBROSIS (METAVIR SCORE F2) 
PTs WITH DECOMPENSAATED CLD WHO ARE ON 
TRANSPLANT LIST SHOULD BE TREATED WITH 
INTERFERON FREE AND IDEALLY RIBAVIRIN FREE 
THERAPY
TWO DRUG THERAPY TILL 2009 
> INTERFERON ALPHA 2a 180 ug/wk 
INTERFERON ALPHA 2b 1.5 ug/kg/wk 
> RIBAVIRIN 1000 mg/DAY IF WT <75 kg 
1200mg/DAY IF WT >75 kg
TELAPREVIR 
OR 
BOCEPREVIR
SOFOSBUVIR 
SIMEPREVIR 
DACLATASVIR
1- MONITORING OF EFFICACY 
2- STOPPING/FUTILITY RULES 
3- VIROLOGICAL RESPONSE GUDED TRIPLE 
THERAPY 
4- SIDE EFFECTS MONITORING
PCR DONE AT 
1- BASELINE 
2- 4 WKS 
3- 12 WKS 
4- END OF THERAPY 
5- 12 & 24 WKS AFTER THE END OF 
THERAPY 
FOR THERAPY TO BE EFFECTIVE HCV RNA 
SHOULD BE <15IU/mm
FUTILITY RULES APPLY FOR ONLY TRIPLE 
COMBINATION THERAPY WITH 
IFN- ALPHA, RIBAVIRIN AND SIMEPREVIR 
DISCONTINUE IF HCV RNA AT WKS 4/12/24 
IS >25 IU/mm
TRIPLE THERAPY WITH 
IFN-ALPHA 
RIBAVIRIN 
DECLATASVIR 
IF HCV RNA >25IU/mm AT 4 WKS AND DETECTABLE 
AT 10 WKS GIVE TRIPLE THERAPY FOR 24 WKS 
IF HCV RNA <25 IU/mm AT 4WKS AND 
UNDETECTABLE AT 10 WKS DISCONTINUE 
DECLATASVIR AFTER 12 WKS AND GIVE OTHER 2 
MEDS FOR 24 WKS
>PTs RECEIVING IFN AND RIBAVIRIN 
1- CLINICAL S/Es AT EACH VISIT 
2- HEMATOLOGICAL S/Es AT 2 $ 4 WKS AND 
THEN AT 4 -8 WK INTERVAL 
3- TFTs AT 12 WK INTERVAL 
> RFTs SHOULD BE MONITORED REGULARLY IN PTs RECEIVING 
SOFOSBUVIR 
> PTs RECEIVING SIMEPREVIR SHOULD BE MONITORED FOR 
RASHES AND BILIRUBIN ELEVATION
REPEAT HCV RNA AT 48 WKS IF NEGATIVE 
IT MEANS THAT PT IS HCV FREE 
IN CIRRHOTICS WHO ACHIEVE SVR THE 
RISK OF HCC IS DECREASED BUT WE NEED 
SURVEILLANCE AT 6 MONTHS INTERVAL
DIAGNOSIS OF ACUTE AND CHRONIC 
HCV??
GOALS AND END POINTS OF THERAPY???
PRE-THERAPEUTIC ASSESSMENT???
CONTRAINDICATIONS TO THERAPY???
WHO SHOULD BE TREATED???
MONITORING???
Feelings are much like waves, we cannot 
stop them from coming but wee can always 
choose which one to surf.
THANKYOU!!!

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Easl recommendations on the treatment of Hepatitis C

  • 1. EASL RECOMMENDATIONS ON THE TREATMENT OF HEPATITIS C
  • 2. PAKISTAN HAS 2ND HIGHEST PREVALENCE OF HCV IN THE WORLD 4.4%- 9% POPULATION SUFFERS FROM HCV
  • 3. ANTI-HCV BY ELISA …..BEST INITIAL TEST EXCEPTIONS SUSPECTED ACUTE HEP C I IMMUNOCOMPROMISED PT. HCV RNA BY PCR IF ELISA POSITIVE IF ANTI-HCV POSITIVE AND PCR NEGATIVE THEN REPEAT PCR AFTER THREE MONTHS TO CONFIRM CONVALESCENCE
  • 5. DEFINITION: SUSTAINED VIROLOGICAL RESPONSE IS UNDETECTABLE HCV RNA AT 12 WKS (SVR 12) OR 24 WKS (SVR24)AT THE END OF THERAPY , AS ASSESSED BY SENSITIVE MOLECULAR METHOD LIKE PCR (THE LOWER LIMIT BEING <15 IU/ML.)
  • 6. SEARCH FOR OTHER CAUSES OF LIVER DISEASE ASSESSMENT OF LIVER DISEASE SEVERITY HCV RNA LEVEL AND GENOTYPE DETERMINATION DETERMINATION OF HOST GENETICS
  • 7. UNCONTROLLED PSYCHOSIS/ DEPRESSION/ EPILEPSY PREGNANCY RETINAL DISEASE AUTOIMMUNE THYROID DISEASE FOR PEGYLATED INTERFERON -ALPHA ABSOLUTE NEUTROPHIL COUNT <1500/mm PLATELET COUNT < 90,000/mm
  • 8.
  • 9. ALL TREATMENT- NAÏVE AND –EXPERIENCED PTs WITH COMPENSATED CLD DUE TO HCV TREATMENT SHOULD BE PRIORTIZED IN PTs WITH SEVERE FIBROSIS (METAVIR SCORE F3/F4) TREATMENT IS JUSTIFIED IN PTs WITH MODERATE FIBROSIS (METAVIR SCORE F2) PTs WITH DECOMPENSAATED CLD WHO ARE ON TRANSPLANT LIST SHOULD BE TREATED WITH INTERFERON FREE AND IDEALLY RIBAVIRIN FREE THERAPY
  • 10. TWO DRUG THERAPY TILL 2009 > INTERFERON ALPHA 2a 180 ug/wk INTERFERON ALPHA 2b 1.5 ug/kg/wk > RIBAVIRIN 1000 mg/DAY IF WT <75 kg 1200mg/DAY IF WT >75 kg
  • 13. 1- MONITORING OF EFFICACY 2- STOPPING/FUTILITY RULES 3- VIROLOGICAL RESPONSE GUDED TRIPLE THERAPY 4- SIDE EFFECTS MONITORING
  • 14. PCR DONE AT 1- BASELINE 2- 4 WKS 3- 12 WKS 4- END OF THERAPY 5- 12 & 24 WKS AFTER THE END OF THERAPY FOR THERAPY TO BE EFFECTIVE HCV RNA SHOULD BE <15IU/mm
  • 15. FUTILITY RULES APPLY FOR ONLY TRIPLE COMBINATION THERAPY WITH IFN- ALPHA, RIBAVIRIN AND SIMEPREVIR DISCONTINUE IF HCV RNA AT WKS 4/12/24 IS >25 IU/mm
  • 16. TRIPLE THERAPY WITH IFN-ALPHA RIBAVIRIN DECLATASVIR IF HCV RNA >25IU/mm AT 4 WKS AND DETECTABLE AT 10 WKS GIVE TRIPLE THERAPY FOR 24 WKS IF HCV RNA <25 IU/mm AT 4WKS AND UNDETECTABLE AT 10 WKS DISCONTINUE DECLATASVIR AFTER 12 WKS AND GIVE OTHER 2 MEDS FOR 24 WKS
  • 17. >PTs RECEIVING IFN AND RIBAVIRIN 1- CLINICAL S/Es AT EACH VISIT 2- HEMATOLOGICAL S/Es AT 2 $ 4 WKS AND THEN AT 4 -8 WK INTERVAL 3- TFTs AT 12 WK INTERVAL > RFTs SHOULD BE MONITORED REGULARLY IN PTs RECEIVING SOFOSBUVIR > PTs RECEIVING SIMEPREVIR SHOULD BE MONITORED FOR RASHES AND BILIRUBIN ELEVATION
  • 18. REPEAT HCV RNA AT 48 WKS IF NEGATIVE IT MEANS THAT PT IS HCV FREE IN CIRRHOTICS WHO ACHIEVE SVR THE RISK OF HCC IS DECREASED BUT WE NEED SURVEILLANCE AT 6 MONTHS INTERVAL
  • 19. DIAGNOSIS OF ACUTE AND CHRONIC HCV??
  • 20. GOALS AND END POINTS OF THERAPY???
  • 23. WHO SHOULD BE TREATED???
  • 25. Feelings are much like waves, we cannot stop them from coming but wee can always choose which one to surf.