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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
SM Kamal, SS El Kamary, MD Shardell, and others. Pegylated interferon alpha-2b plus ribavirin in patients with genotype 4 chronic hepatitis C: The role of rapid and early virologic response. Hepatology 46(6):1732-40. December 2007.

Hepatitis C Main Section
FDA-approved Treatments for HCV

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FDA-approved
Monotherapies
Intron A
Roferon

Infergen

Pegasys
PEG-Intron
FDA-approved
Combination Therapies
Pegasys + Copegus
PEG-Intron + Rebetol
Intron A + Rebetol
Roferon A + Ribavirin