hosny salama hepatitis-2015 orlando, usa july 20 - 22 2015
TRANSCRIPT
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Hosny Salama
Hepatitis-2015Orlando, USA
July 20 - 22 2015
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Effect of Sofosbuvir , Brand drug ( Sofaldi )
versus generic ( MPIviropack ) in treating
chronic HCV infection in Egypt .
Prof. Hosny Salama Cairo University, Egypt.
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Chronic HCV infection is high in Egypt with
prevalence of 12-14% .
More that 85% of HCV is Genotype IV .
Response of therapy to SOC therapy was
around 50% with a lot of side effects and
long duration of therapy
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With the introduction of DAAs , a new era of HCV treatment started .
Sofosbuvir is a NS5B polymerase inhibitor .
It has a pan-genotypic coverage and approved for use in genotype IV AASLD 2014, EASL 2015 .
With the availability of both the brand drug ( Sofaldi- Gilead ) and the generic form
( MPI-Viropack- Marcyrl Pharmaceutical Industries ) in the Egypt in 2014- 2015
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we conducted this comparative study to
evaluate and compare the safety and efficacy
of both the Brand and Generic forms.
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In this study we recruited 105 naïve patients with chronic HCV infection.
For all of them the following was done :
-Liver function tests ( S. bilirubin, ALT, AST . Albumin , PT and PC ),-CBS , ECG, fundus examination - Abdominal ultrasound, Fibroscan -and HCV RNA Quantitative by PCR .
Patients were divided into three groups ( 35 patients each )
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According to Fibroscan :
Group I : F2 ( 23 pts ) , F3 (9 pts) and F4 ( 3 pts ).
Group II : F2 ( 22 pts ) , F3 (10 pts ) and F4 ( 3 pts )
Group III : F2 ( 22 pts ), F3 ( 6 pts ) and F4 ( 7 pts ) .
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For the first group, triple therapy was used, Peg Interferon( Peg Intron- MSD according to body weight) , Ribavirin in a weight adjusted dosage and Sofaldi- Gilead 400 mg once daily .
For the second group, triple therapy was also used, Peg Interferon and Ribavirin as in group I and MPIviropack 400 mg once daily .
For the third group, dual therapy was given using Ribavirin in a weight adjusted dosage and either Sofaldi 400 mg once daily (17 patients ) or MPIviropack once daily ( 18 patients )
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Follow – up after one and three months
using liver function tests, CBC and
HCV RNA by PCR was done .
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There was normalization of liver enzymes in 34 ( 97%) patients group I and II, and 35 (100%) patients in the third group.
CBC showed mild decrease in HB level in 18 (51%) , 19 (54%), 15 (43%) patients in
group I, II , III respectively
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HCV RNA was un-detected in 34 (97%)
patients in group I , II and III after
One and 3 months during therapy .
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The side effects were comparable in group I , II and III :
* Nausea and abdominal Pain in 20 (57%) patients in Gr. I versus 21 ( 60%) in Gr. II, III .
•Diarrhea in 3 (8.5%) patients in Gr. I versus 4 ( 11.4%) patients in Gr. II , III .
* Athenia and exhaustion in 23 ( 66%) in all groups
* Headache in 4 (11.4%) patients in all groups .
However in Group III the side effects were mild including asthenia in 23 (66%) patients and mild gastric upset in 15 (43%) patients .
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Follow-up is still going on to assess the SVR 12, 24 after the end of treatment :
Treatment for 3 months in Group I, II and 6 months in group III .
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From this pilot study, we found that both the brand and the generic forms of Sofosbuvir in combination
with Peg/R or with Ribavirin alone :
Proved to be safe and effective in Egyptian patients with naïve chronic HCV – genotype 4 infection with comparable safety and efficacy profile .
The long term follow-up to assess the SVR
in 12, 24 weeks are still going on .
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Acknolgement
Abdel Rahman Zekri 2, Eman Medhat 1 , Mervat Al Ansary,3 and Sherine A. Alim 1
(Hepatology1 , Clinical Pathology2 and Virology Unit at NCI 3, Cairo University, Cairo, Egypt )
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