A Randomized, Controlled Trial of Triple Antiviral Therapy As Initial Treatment of Chronic Hepatitis C in HIV-infected Patients

Overview

Journal J Hepatol

Publisher Elsevier

Specialty Gastroenterology

Date 2004 Aug 4

PMID 15288482

Citations 2

Authors

Massimo Puoti

Barbara Zanini

Gian Paolo Quinzan

Laura Ravasio

Giuseppe Paraninfo

Teresa Santantonio

Adriano Rollo

Stefania Artioli

Franco Maggiolo

Serena Zaltron

Enzo Raise

Ermenegildo Mignani

Francesco Resta

Gabriella Verucchi

Giuseppe Pastore

Fredy Suter

Giampiero Carosi

Affiliations

Soon will be listed here.

Abstract

Background/aims: Interferon and ribavirin combination therapy for chronic hepatitis C induces a low response rate in human immunodeficiency virus (HIV) infected patients. To assess the impact of intensification of interferon administration and of the addition of amantadine on the efficacy and safety of standard anti-hepatitis C virus (HCV) treatment in HIV-infected patients.

Methods: Multicentre, prospective, open-label, randomized, phase III clinical trial. Eighty co-infected patients were randomized to receive ribavirin 800-1,000 mg/day in combination with, group A: interferon alpha 2a 3MIU thrice weekly; group B: IFN alpha 2a 3MIU daily, plus amantadine 200 mg/day; treatment duration was 24-48 weeks according to HCV genotype.

Results: Forty-one patients were randomized in group A and 39 in group B. Intention-to-treat analysis showed a sustained virological response, defined as HCV-RNA negativization, 6 months after stopping treatment in 22% of patients from group A and 13% from group B (P>0.05). The lack of a 2-log drop in HCV-RNA levels after 12 weeks of treatment showed a 100% predictive value of lack of sustained response.

Conclusions: Amantadine addition and interferon intensification do not improve the low efficacy of combination of interferon alfa plus ribavirin in HIV/HCV co-infected patients. Patients with no early virologic response did not have any probability of sustained response.

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