Pegylated Interferon plus Ribavirin in the Treatment of Chronic Hepatitis C Geno

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Pegylated Interferon plus Ribavirin in the Treatment of Chronic

Hepatitis C Genotype 4

By Liz Highleyman

Genotype 4 is the most prevalent form of hepatitis C virus (HCV) in

parts of the Middle East and North Africa, including Egypt. Studies

have produced conflicting data about whether this genotype is " hard

to treat, " like genotype 1, or easier to treat, like genotypes 2 and

3.

Genotype 4 has been less widely studied than genotypes 1, 2, and 3,

which are more common in North America and Europe, and the optimum

duration of interferon-based therapy and predictors of sustained

virological response (SVR) have not yet been determined.

As reported in the December 2007 issue of Hepatology, S.M. Kamal and

colleagues from Ain Shams University in Cairo, Egypt, conducted a

study in which 358 patients with chronic genotype 4 HCV were treated

with 1.5 mug/kg/week pegylated interferon alpha-2b (PegIntron) plus

10.6 mg/kg/day oral ribavirin.

Participants were randomly assigned to received treatment either for

the standard fixed duration of 48 weeks (control group, n = 50) or

for a variable duration based on interim viral load:

• Undetectable HCV RNA at week 4: treated for 24 weeks (Group A, n =

69);

• Undetectable HCV RNA at week 12: treated for 36 weeks (Group B, n =

79);

• Continued detectable HCV RNA at week 12: treated for 48 weeks

(Group C, n = 160).

The primary endpoint was SVR, defined as undetectable HCV RNA 24

weeks after completion of treatment.

Results

• SVR rates were as follows:

- Group A (24-week treatment): 86%;

- Group B (36-week treatment): 76%;

- Group C (variable duration 48 weeks): 56%;

- Control group (fixed duration 48 weeks): 58%.

• After controlling for predictors of response, milder liver damage

(low baseline histological grade and stage) was associated with SVR

(P < 0.029) in all groups.

• Among patients in Group C, older age (P = 0.04), higher baseline

body mass index (P = 0.013), and low baseline HCV RNA (P < 0.001)

were also associated with SVR.

• The incidence of adverse events and the rate of treatment

discontinuation were higher for patients in the variable duration and

fixed duration groups treated for 48 weeks.

Conclusion

Based on these findings, the authors concluded, " In patients with

chronic hepatitis C genotype 4 and undetectable HCV RNA at weeks 4

and 12, treatment with [pegylated interferon] alpha-2b and ribavirin

for 24 weeks and 36 weeks, respectively, is sufficient. "

01/08/08

Reference