 |
 Duration
of Pegylated Interferon plus Ribavirin May Be Tailored Based on Early Patient
Response
In the first
study, researchers assessed whether a longer course of therapy would lead to a
higher sustained virological response (SVR) rate in
patients classified as “slow responders.” Results were published in the December
2007 issue of Hepatology and presented at the
58th Annual Meeting
of the American Association for the Study of Liver Diseases in Boston (November
2-6, 2007). Study
participants were treatment-naive slow responder U.S. patients with chronic genotype
1 hepatitis C. Slow response was defined as achieving at least a 2-log reduction
in HCV RNA from baseline, still having detectable HCV viral load at week 12, but
undetectable HCV RNA at week 24 (limit of detection 10 IU/mL). About half the participants were African-American. All
participants were treated with 1.5 mcg/kg/week pegylated
interferon alpha-2b (PegIntron) plus 800-1400
mg/day ribavirin. They were randomly assigned in
a 1:1 manner to Results •
End-of-treatment
response rates were similar in the 48-week and 72-week groups (45% versus 48%;
P = non-significant). •
The
overall SVR rate was greater in patients treated for 72 weeks versus 48 weeks
(38% versus 18%, respectively; P = 0.026). •
Dose
reductions and treatment discontinuations due to adverse events or laboratory
abnormalities were similar in the 2 treatment arms. “Extending
the treatment duration from 48 weeks to 72 weeks in genotype 1-infected patients
with slow virologic response to peginterferon alpha-2b and weight-based ribavirin
significantly improves SVR rates,” the researchers concluded. “Treatment extension
does not seem to increase the rate of dose reduction or therapy discontinuation.” While
the end-of-treatment response rates were In
the second study, Italian researchers tested the hypothesis that variable treatment
duration individualized on the basis of first undetectable HCV RNA is as effective
as standard 48-week treatment. This
study included 696 genotype 1 chronic hepatitis C patients
treatment with either 180 mcg/week pegylated
interferon alfa-2a (Pegasys) or 1.5 mcg/kg/week
PegIntron plus 1000-1200 mg/day ribavirin. One group (n = 237) was treated for the standard
48-week duration. The other group (n = 459) received variable durations of treatment
based on early response: •
24
weeks if HCV RNA became undetectable at 4 weeks; •
48
weeks if HCV RNA became undetectable at 8 weeks; •
72
weeks if HCV RNA became undetectable at 12 weeks. Results •
45%
of patients in the standard duration group and 49% in the variable duration group
achieved SVR (P = 0.37). •
27%
first achieved undetectable HCV RNA at 4 weeks, 28% at 8 weeks, and 11% at 12
weeks. •
In
the standard duration group, 87%, 70%, and 38% of patients who first achieved
undetectable HCV RNA at 4, 8, and 12 weeks, respectively, achieved SVR. •
In
the variable duration arm, the corresponding SVR rates were 77%, 72%, and 64%.
•
Low
baseline HCV RNA levels and younger age were independent predictors of rapid virological response (RVR) at week 4. •
Patients
with RVR who had a high baseline viral load ≥ 400,000 IU/mL had a higher SVR rate when treated for 48 rather than 24
weeks (87% vs 73%; P = 0.14). •
The
only predictive factor for SVR in patients with RVR was advanced liver fibrosis.
In
conclusion, the authors wrote, “Variable treatment duration ensures SVR rates
similar to those of standard treatment duration, sparing unnecessary side effects
and costs.” 01/04/08 References A Mangia, N Minerva, D Bacca, and others. Individualized treatment duration
for hepatitis C genotype 1 patients: A randomized controlled trial. Hepatology 47(1):
43-50. January 2008. |
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