1081b 
A Randomized Trial to Compare the Efficacy and Safety of PEG-interferon alfa-2b plus Ribavirin versus PEG-interferon alfa-2a plus Rivabirin for Treatment of Chronic Hepatitis C in HIV Co-infected Patients.
M Laguno1, C Cifuentes2, J Murillas3, F Vidal4, L Bonet3, S Veloso4, C Tural5, I Perez1, J Gatell1, and Josep Mallolas*1
1Hosp Clin Barcelona, Spain; 2Hosp Son Llatzer, Palma de Mallorca, Spain; 3Hosp Son Dureta, Palma de Mallorca, Spain; 4Hosp Joan XXIII, Tarragona, Spain; and 5Hosp Univ Germans Trias i Pujol, Badalona, Spain
Background: The “gold standard” of chronic
hepatitis C virus (HCV) therapy is pegylated interferon (peg-INF) plus
ribavirin (RBV). Despite the availability of 2 peg-INF, so far no head-to-head
comparisons have been reported. The aim of the present study was to compare the
efficacy and safety of peg-INF-alfa-2b (PEG 2b) + RBV vs peg-INF-alfa-2a (PEG
2a) + RBV.
Methods: Randomized, multi-center,
open-label clinical trial including patients with: detectable HCV RNA, alanine
aminotransferase >1.5-fold upper normal limit, abnormal liver histology, CD4
counts >250 cells/mL, and HIV RNA <50000 copies/mL. Patients were
assigned to PEG 2b (80 to 150 µg/week adjusted to body weight) or PEG 2a (180 µg/week)
plus RBV (800 to 1200 mg/day adjusted to body weight). Duration of treatment
was 48 weeks. The primary endpoint was the sustained virological response (SVR =
HCV RNA negative at week 72). Sample size was calculated to detect, with 80%
power, differences above 20 percentage points if they exist.
Results: We randomized 182 patients (86
PEG 2b, 96 PEG 2a). At baseline both groups were well balanced and 73% were
males, 76% former drug users; 63% had HCV genotype 1 or 4; 29% had bridging fibrosis
or cirrhosis, and in 56% HCV viral load was higher than 800,000 IU/mL. Overall,
SVR was achieved in 44% (42% PEG 2b vs 46% PEG 2a, p = 0.65). SVR was
achieved in genotype 1 or 4 in 28% vs 32% (p = 0.67) and, in genotypes 2
or 3, in 62% vs 71% (p = 0.6) in patients receiving PEG 2b vs PEG 2a
respectively. Rapid virological response (HCV RNA negative at week 4) was
similar in both arms (35%) and reached a positive predictive value of SVR of
88% in PEG 2b and 74% in PEG 2a group. Early virological response (HCV RNA
negative or a drop ≥2 log of HCV RNA from baseline at week 12) was
obtained in 70% in the PEG 2b arm and 80% in PEG 2a (p = 0.13) with a positive
predictive value of SVR of 64% and a negative predictive value of 100% in both arms.
Using a multivariate approach, independent factors related with SVR were HCV
genotype 2 or 3, male gender and age ≤40 years. Side effects were very
frequent (96% of patients); they lead to treatment discontinuation in 10% of patients
(8% in PEG 2b and 13% in PEG 2a arm, p = 0.56).
Conclusions: In HIV patients, treatment of
chronic HCV with RBV plus PEG 2b or PEG 2a had no statistically significant
differences in tolerance and efficacy.
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