 |
|
Pegylated Interferon Alfa-2b vs Standard Interferon Alfa-2b, Plus Ribavirin, for Chronic Hepatitis C in HIV-Infected Patients
A Randomized Controlled Trial
Fabrice Carrat, MD, PhD;
Firouzé Bani-Sadr, MD;
Stanislas Pol, MD, PhD;
Eric Rosenthal, MD;
Françoise Lunel-Fabiani, MD, PhD;
Asmae Benzekri, MD;
Patrice Morand, MD, PhD;
Cécile Goujard, MD;
Gilles Pialoux, MD, PhD;
Lionel Piroth, MD, PhD;
Dominique Salmon-Céron, MD, PhD;
Claude Degott, MD;
Patrice Cacoub, MD;
Christian Perronne, MD, PhD; for the ANRS HCO2 RIBAVIC Study Team
JAMA. 2004;292:2839-2848.
Context Treatment of chronic hepatitis C virus (HCV) infection in human immunodeficiency virus (HIV)–infected patients is a growing concern. Most data on the virologic efficacy and safety of the combination of peginterferon alfa-2b and ribavirin in coinfected patients come from uncontrolled studies.
Objective To study the safety and efficacy of peginterferon alfa-2b plus ribavirin vs standard interferon alfa-2b plus ribavirin in HIV-HCV coinfected patients.
Design and Settings A multicenter, randomized, parallel-group, open-label trial. Patients were enrolled from February 2000 to February 2002 and followed up for 72 weeks.
Patients Four hundred twelve HIV-HCV coinfected patients with detectable serum HCV-RNA, abnormal liver histology, a CD4 cell count of at least 200 x 106/L, and stable plasma HIV-RNA.
Intervention Treatment with ribavirin 400 mg twice a day, orally, plus either peginterferon alfa-2b (1.5 µg/kg subcutaneous injection once a week) or standard interferon alfa-2b (3 million units of subcutaneous injection 3 times a week) for 48 weeks.
Main Outcome Measures Sustained virologic response, defined by undetectable serum HCV-RNA at week 72.
Results More patients had sustained virologic responses in the peginterferon group than in the standard interferon group (27% vs 20%, P = .047). This difference between the treatments was found in patients with HCV genotype 1 or 4 infection (17% for peginterferon vs 6% for standard interferon, P = .006) but was not found in patients with HCV genotype 2, 3, or 5 (44% for peginterferon vs 43% for standard interferon, P = .88). Together, a decline in HCV-RNA of less than 2 log10 from baseline and detectable serum HCV-RNA at week 12 predicted 99% of treatment failures. Histologic activity diminished and fibrosis stabilized in virologic responders. The 2 regimens showed similar tolerability although dose modifications for clinical and biological events were more frequent with peginterferon. Eleven cases of pancreatitis or symptomatic hyperlactatemia were observed, all in patients receiving didanosine-containing antiretroviral regimens.
Conclusion In combination with ribavirin, treatment with peginterferon alfa-2b is more effective than standard interferon alfa-2b for HCV infection in HIV-infected patients.
Author Affiliations: Groupe Hospitalier Universitaire Est, Université Paris 6, INSERM U444 (Drs Carrat and Bani-Sadr) and Groupe Hospitalier Universitaire Ouest, Université Paris 5, INSERM U370 (Dr Pol), Paris; Hôpital de l’Archet, Faculté de médecine, Nice (Dr Rosenthal); Groupe Hospitalier, Faculté de médecine, Angers (Dr Lunel-Fabiani); Groupe Hospitalier Universitaire Nord, Université Paris 7, (Drs Benzeckri and Degott), Centre Hospitalier Universitaire, Grenoble (Dr Morand), Groupe Hospitalier Universitaire Sud, Université Paris 11 (Dr Goujard), and Groupe Hospitalier Universitaire Est, Université Paris 6, (Drs Pialoux and Cacoub) Paris; Centre Hospitalier Universitaire, Dijon (Dr Piroth); and Groupe Hospitalier Universitaire Ouest, Université Paris 5, (Dr Salmon-Céron), Centre Hospitalier Universitaire Raymond Poincaré, Université de Versailles, Garches (Dr Perronne), France.
RELATED LETTERS
Pegylated Interferon vs Standard Interferon for Chronic Hepatitis C
Daniel L. Menkes
JAMA. 2005;293(11):1323.
EXTRACT
| FULL TEXT
Pegylated Interferon vs Standard Interferon for Chronic Hepatitis C—Reply
Fabrice Carrat, Firouzé Bani-Sadr, Patrice Cacoub, Stanislas Pol, Christian Perronne, and for the ANRS HC02-RIBAVIC Study Team
JAMA. 2005;293(11):1323-1324.
EXTRACT
| FULL TEXT
RELATED ARTICLE
Treatment of Hepatitis C in HIV-Infected Patients: Significant Progress But Not the Final Step
Michael P. Manns and Heiner Wedemeyer
JAMA. 2004;292(23):2909-2913.
EXTRACT
| FULL TEXT
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
Efficacy of pegylated interferon and ribavirin for retreatment of chronic HCV infection in HIV co-infected patients failing a previous standard interferon-based regimen
Crespo et al.
J Antimicrob Chemother 2008;62:793-796.
ABSTRACT
| FULL TEXT
Genotypic distribution of hepatitis C among hepatitis C and HIV co-infected patients in Brazil
Mendes-Correa et al.
Int J STD AIDS 2008;19:595-599.
ABSTRACT
| FULL TEXT
The use of trough ribavirin concentration to predict sustained virological response and haematological toxicity in HIV/HCV-co-infected patients treated with ribavirin and pegylated interferon
Aguilar Marucco et al.
J Antimicrob Chemother 2008;61:919-924.
ABSTRACT
| FULL TEXT
Fulminant autoimmune hepatitis after successful interferon treatment in an HIV-HCV co-infected patient
Coriat and Podevin
Int J STD AIDS 2008;19:208-210.
ABSTRACT
| FULL TEXT
Influence of concomitant antiretroviral therapy on the rate of sustained virological response to pegylated interferon plus ribavirin in hepatitis C virus/HIV-coinfected patients
Pineda et al.
J Antimicrob Chemother 2007;60:1347-1354.
ABSTRACT
| FULL TEXT
Rapid and early virological response to chronic hepatitis C treatment with IFN {alpha}2b or PEG-IFN {alpha}2b plus ribavirin in HIV/HCV co-infected patients
Payan et al.
Gut 2007;56:1111-1116.
ABSTRACT
| FULL TEXT
Viral Hepatitis in HIV Infection
Koziel and Peters
NEJM 2007;356:1445-1454.
FULL TEXT
Antiretroviral activity of pegylated interferon alfa-2a in patients co-infected with HIV/hepatitis C virus
Marucco et al.
J Antimicrob Chemother 2007;59:565-568.
ABSTRACT
| FULL TEXT
Increase in hepatitis C virus incidence in HIV-1-infected patients followed up since primary infection
Ghosn et al.
Sex. Transm. Infect. 2006;82:458-460.
ABSTRACT
| FULL TEXT
HAART attenuates liver fibrosis in patients with HIV/HCV co-infection: fact or fiction?
Verma
J Antimicrob Chemother 2006;58:496-501.
ABSTRACT
| FULL TEXT
Treating viral hepatitis C: efficacy, side effects, and complications.
Manns et al.
Gut 2006;55:1350-1359.
FULL TEXT
Management of chronic hepatitis B and C in HIV-coinfected patients
Soriano et al.
J Antimicrob Chemother 2006;57:815-818.
ABSTRACT
| FULL TEXT
Absence of clinically relevant pharmacokinetic interaction between ribavirin and tenofovir in healthy subjects.
Ramanathan et al.
J Clin Pharmacol 2006;46:559-566.
ABSTRACT
| FULL TEXT
Treatment of Hepatitis C in HIV-Coinfected Patients
Hughes and Shafran
The Annals of Pharmacotherapy 2006;40:479-489.
ABSTRACT
| FULL TEXT
Hepatitis C: a review for primary care physicians
Wong and Lee
CMAJ 2006;174:649-659.
ABSTRACT
| FULL TEXT
Comparison of Serum Hepatitis C Virus (HCV) RNA and Core Antigen Levels in Patients Coinfected with Human Immunodeficiency Virus and HCV and Treated with Interferon plus Ribavirin
Pivert et al.
J. Clin. Microbiol. 2006;44:417-422.
ABSTRACT
| FULL TEXT
Management of Hepatitis C Infection in the HIV-Infected Patient
McNelis
Journal of Pharmacy Practice 2006;19:37-52.
ABSTRACT
Chronic hepatitis C in patients with HIV/AIDS: a new challenge in antiviral therapy
Brau
J Antimicrob Chemother 2005;56:991-995.
ABSTRACT
| FULL TEXT
HCV/HIV-coinfection--is there a state of the art after APRICOT and RIBAVIC?
Mauss and Rockstroh
J Antimicrob Chemother 2005;56:615-618.
ABSTRACT
| FULL TEXT
Update in Gastroenterology and Hepatology
Koretz and Lipman
ANN INTERN MED 2005;143:347-354.
FULL TEXT
Pegylated Interferon vs Standard Interferon for Chronic Hepatitis C
Menkes
JAMA 2005;293:1323-1323.
FULL TEXT
Pegylated Interferon vs. Standard Interferon for HCV/HIV Coinfection
JWatch General 2005;2005:4-4.
FULL TEXT
Treatment of Hepatitis C in HIV-Infected Patients: Significant Progress But Not the Final Step
Manns and Wedemeyer
JAMA 2004;292:2909-2913.
FULL TEXT
|
