Randomized trial comparing pegylated interferon alpha-2b versus pegylated interferon alpha-2a, both plus ribavirin, to treat chronic hepatitis C in human immunodeficiency virus patients

December 22, 2008

Hepatology. 2008 Sep 9. [Epub ahead of print]

Randomized trial comparing pegylated interferon alpha-2b versus pegylated

interferon alpha-2a, both plus ribavirin, to treat chronic hepatitis C in human

immunodeficiency virus patients.

Laguno M, Cifuentes C, Murillas J, Veloso S, Larrousse M, Payeras A, Bonet L,

Vidal F, Milinkovic A, Bassa A, Villalonga C, Pérez I, Tural C,

Martínez-Rebollar M, Calvo M, Blanco JL, Martínez E, Sánchez-Tapias JM, Gatell

JM, Mallolas J.

Infectious Diseases Service. Hospital Clínic, Barcelona, Spain.

Although two pegylated interferons (Peg-IFN) are available to treat chronic

hepatitis C virus (HCV) infection, no head-to-head comparative studies have been

published. We aim to compare the efficacy and safety of PEG IFN alfa-2b (PEG 2b)

versus PEG IFN alfa-2a (PEG 2a), plus ribavirin (RBV). A prospective,

randomized, multi-center, open-label clinical trial including 182 human

immunodeficiency virus (HIV)-hepatitis C virus (HCV) patients naïve for HCV

therapy was performed. Patients were assigned to PEG 2b (80-150 mug/week; n =

96) or PEG 2a (180 mug/week; n = 86), plus RBV (800-1200 mg/day) for 48 weeks.

The primary endpoint was sustained virological response (SVR: negative HCV-RNA

24 weeks after completion of treatment). At baseline, both groups were well

balanced: 73% male; 63% HCV genotype 1 through 4; 29% had fibrosis index of 3 or

greater. The overall SVR was 44% (42% PEG 2b versus 46% PEG 2a, P = 0.65). Among

genotypes 1 through 4, SVRs were 28% versus 32% (P = 0.67) and 62% versus 71% (P

= 0.6) in genotypes 2 through 3 for PEG 2b and PEG 2a, respectively. Early

virological response (EVR;>/=2 log reduction from baseline or negative HCV-RNA

at week 12) was 70% in the PEG 2b group and 80% in the PEG 2a group (P = 0.13),

reaching a positive predictive value of SVR of 64% and a negative predictive

value of 100% in both arms. Side effects were present in 96% of patients but led

to treatment discontinuation in 10% of patients (8% on PEG 2b and 13% on PEG 2a,

P = 0.47). Conclusion: In patients with HIV, HCV therapy with PEG 2b or PEG 2a

plus RBV had no significant differences in efficacy and safety. (HEPATOLOGY

2008.).

PMID: 19085908 [PubMed - as supplied by publisher]

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