Pegasys
plus Ribavirin for 16 versus 24 Weeks in Patients with HCV Genotype 2
The
current standard recommendation for treatment of HCV patients with HCV genotype
2 peginterferon alfa plus ribavirin for 24 weeks. However, SVR rates of >80%
with peginterferon alfa-2a (Pegasys) plus ribavirin in genotype 2/3 patients have
stirred interest in whether even shorter treatment duration will yield comparably
high SVR rates.
In the current Taiwanese study, investigators sought to
determine whether the effectiveness of 16 weeks of therapy was comparable to the
standard 24-week treatment course in HCV genotype 2 patients.
In
a controlled, multicenter, open-label study in Taiwan, 150 treatment-naïve
patients with HCV genotype 2 infection were randomized (1:2) to 16 weeks (n=50)
or 24 weeks (n=100) Pegasys 180 ?g/week plus ribavirin 1000/1200 mg/day, with
a follow-up period of 24 weeks.
The primary endpoint was sustained virological
response (SVR; undetectable HCV RNA [<50 IU/mL] after 24 weeks' untreated follow-up).
SVR was also determined in patients with and without a rapid virological response
(RVR; undetectable HCV RNA after 4 weeks).
Results
Baseline characteristics
were similar in the two groups (see Table).
Overall, an SVR was achieved in 94% and 95% of patients receiving 16 and 24 weeks'
treatment (see Table).
Patients with an RVR had a significantly higher SVR rate than patients without
an RVR in both the 16- and 24-week treatment arms.
For patients without RVR, the mean dose of ribavirin from week 5 to 16 of treatment
was significantly lower in non-responders than in responders.
Multivariate logistic regression analysis in all patients showed that an RVR and
age were independently associated with an SVR.
Both treatment arms were equally well tolerated. The incidence of alopecia was
significantly higher in the 24-week group (49%) than in the 16-week group (20%,
p=0.001).
The
authors conclude, "In this study, high SVR rates (>94%) were seen with
both 16 and 24 weeks' of peginterferon alfa-2a (40KD) plus ribavirin 1000/1200
mg/day in genotype 2 patients from Taiwan. This probably reflects the absence
of negative prognostic factors in this patient population and the rapid rate with
which patients responded (>86% RVR rate in both arms)."
"We
were unable to detect a difference in SVR rates with 16 and 24 weeks' treatment
among the 150 patients included in our trial."
Baseline characteristics
16 wks (n=50)
24 wks (n=100)
Male, n (%) Age, yrs BMI, kg/m2 HCV RNA, log IU/mL Advanced hepatic fibrosis, F3/4, n (%)
32 (64) 50.8 25.1 4.98 11 (22)
58 (58) 49.9 24.8 4.88 20 (20)
Efficacy, n (%; 95% CI)
RVR
43 (86; 76–96)
87 (87; 80–94)
SVR - overall SVR - Pts with an RVR, n (%) SVR - Pts
without an RVR, n (%)
47 (94; 87–100) 43/43 (100)a 4/7 (57)
95 (95; 91–99) 85/87 (98))b 10/13 (77)
Faculty
of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung,
Taiwan; Department of Internal Medicine, Kaohsiung Medical University, Chung-Ho
Memorial Hospital, Kaohsiung, Taiwan; Department of Internal Medicine, Kaohsiung
Medical University, Hsiao-Kang Hospital, Kaohsiung, Taiwan; Department of Internal
Medicine, Foo Yin Hospital, Pintung, Taiwan.
11/03/06
Reference M
Yu, C Dai, J Huang, and others. A randomized, controlled, open-label study of
peginterferon alfa-2a (40KD) (PEGASYS®) plus ribavirin (COPEGUS®) for
16 vs. 24 weeks in patients with genotype 2 hepatitis C infection. 57th AASLD.
October 27-31, 2006. Boston, MA. Abstract 208.
Baseline characteristics
were similar in the two groups (see Table). 
