الفهرس 
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Abstract
Summary
Chronic HCV is the main cause of liver cirrhosis and liver cancer
in Egypt and, indeed, one of the top five leading causes of death
(Mohamed MK 2004).
The current standard of care for treating previously untreated
patients with chronic hepatitis C virus infection is combination
pegylated interferon alfa by subcutaneous injection once weekly and
oral ribavirin daily (Patel K et al. 2006). The results of clinical trials
support a recommendation that patients with genotype 1 require 48
weeks of pegylated interferon therapy with daily ribavirin (1000-1200
mg dosed according to weight). Patients with the more treatment
favorable genotypes 2 and 3 need to be treated for only 24 weeks with
800 mg of ribavirin daily (Manns MP et al. 2001, FriedMW et al.,
2002 and Hadziyannis SJ et al. 2004). Given that many of the large
clinical trials have been based in Europe or North America, data on
treatment efficacy for genotypes 4-6 are limited. As a result, these
patients are treated as for genotype 1 infection (Patel K et al. 2006).
Retrospective analysis of three randomized trials demonstrated a
rapid virologic response (RVR) to be superior to HCV genotype at
predicting sustained virologic response. By varying the treatment
duration based on an individual’s early response, unnecessary side
effects and costs of interferon and ribavirin can be spared. As factors
other than genotype emerge as predictive of future treatment success,
clinicians gain more insight into guiding their patients toward a
customized, best possible outcome (Fried MW et al. 2008).
111
Summary
The aim of current study was to determine if a shorter course of
Peginterferon and ribavirin therapy will be sufficient in carefully
selected patients with chronic hepatitis C virus genotype 4 infections,
as compared to the standard 48 weeks duration.
This prospective study was planned and supervised by National
Liver Institute (NLI) Menoufiya University and was conducted at Kafr
El-Sheikh Liver Research Center. During study period extended from
September 2008 to June 2011. Carefully selected 150 patients (109
adult men and 41 non pregnant women, mean age 38.6±9.4 (21-58),
with documented chronic hepatitis C infection were enrolled in the
study.
The 150 selected patients were randomized given Pegylatedinterferon
alfa-2a at a fixed dose of 180 μg/week subcutaneously
together with ribavirin 1,000 to 1,200 mg daily (1,000 mg for those
who weight 75 kg and 1,200 mg for those who weight >75 kg) , or
Pegylated-interferon alfa-2b ;1.5 μg/kg/week given subcutaneously
dosed according to body weight, together with weight-based oral
ribavirin (800 mg for patients 65 kg; 1,000 mg for patients
weighing 65 to 85 kg; 1,200 mg for patients weighing 85 to 105 kg)
for either fixed duration of 48 weeks (control group) or a variable
duration of 28, 36 weeks.
All of 150 selected patients enrolled in the study should have
undetectable HCV RNA at the end of week 4 and week 12 of
treatment and categorized as super-responders, having attained RVR
(Rapid Virologic Response)
Patients had been classified according to the course of treatment
into three groups; the first group with course of treatment for 28
weeks; the second group with course of treatment for 36 weeks and
112
Summary
the third group with standard course of treatment for 48 weeks. Each
group had been followed for 24 weeks after completion of treatment.
Histopathological evaluation of pre-treatment liver biopsies was
performed. Serial quantitative HCV RNA will be done at week 0, 4,
12, 24 and at the end of assigned course of treatment and at 24 weeks
after completion of treatment for all groups.
A total of 133 patients (40 in group I, 43 in group II, and 50 in
group III) completed the proposed therapy protocol.
Results:
- End of treatment Response (ETR)
In the variable-duration treatment group, viral clearance at the
end of treatment (ETR) was achieved in 39/40 (97.5 %) of patients
treated for 28 weeks in group I, versus 41/43 (95.3 %) of patients
treated for 36 weeks in group II, while in standard treatment group for
48 weeks; viral clearance at the end of treatment (ETR) was achieved
in 49/50 (98 %) of patients treated for 48 weeks in group III. So No
significant difference at end of treatment response (ETR) between
variable-duration treatment groups and standard treatment group had
been noted (p=0.738).
- Sustained Virologic Response (SVR)
In the variable-duration treatment group sustained virologic
response (SVR) was achieved in 34/40 (85%) patients treated for 28
weeks in group I , versus 38/43(88.4%) patients treated for 36 weeks
in group II, while in standard treatment group; 46/50 (92%) patients
treated for 48 weeks in group III. So No significant difference of
sustained virologic response (SVR) between variable-duration
113
Summary
treatment groups and standard treatment group had been noted (p=
0.578).