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.
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.