Treatment of chronic hepatitis C with pegylated interferon and ribavirin in treatment-naive patients in 'true life': a plea in favor of independent postmarketing evaluations

November 2, 2010

Eur J Gastroenterol Hepatol. 2010 Nov;22(11):1297-302.

Treatment of chronic hepatitis C with pegylated interferon and ribavirin in

treatment-naive patients in 'true life': a plea in favor of independent

postmarketing evaluations.

Pariente A, Lahmek P, Duprat C, Denis J, Faroux R, Renou C, Nalet B, Morin T,

Cadranel JF; Investigator Group belonging to Association Nationale des

Gastroentérologues des Hôpitaux Généraux (ANGH).

Collaborators (43)

Wartelle-Bladou C, Bellaïche G, Tordjman G, Lapoile E, Slama JL, Goulu LD,

Arpurt JP, Bories C, Pillon D, Denis J, Chapat O, Constantini D, Listrat D,

Riera JC, Barjonet, Cadranel JF, Jouannaud V, Dumouchel P, I, Lons T,

Ratel-Saby, Labayle D, Drouhin F, Lambare B, Wisniewski B, Danis J, Renou C,

Gatineau-Saillant G, Nalet B, Lesgourgues B, Ahmed SN, Causse X, Arotçarena R,

Berthelémy P, Bouet C, Pariente A, Seyrig JA, Faroux R, Schne M, Lafargue JP,

Ink O, Morin T, Cassan P.

Unité d'hépatogastroentérologie, Centre Hospitalier, Pau Cedex, France.

alex.pariente@...

Abstract

BACKGROUND: Results of treatments for chronic hepatitis C virus are only

estimated and disclosed from pivotal trials.

AIM: To report the 'true life' results of pegylated interferon and ribavirin in

treatment-naive patients.

METHODS: A prospective, multicenter observatory in 22 general hospitals.

RESULTS: Five-hundred and one patients were included, with 309 men (62%), aged

46 ± 11 years, weighting 70 ± 13 kg, infected with the following hepatitis C

virus genotypes: 1 (50%), 2 (12%), 3 (28%), 4 (7.5%), 5 (0.6%). Liver biopsy,

available in 436 patients showed stage F3 fibrosis in 24% and F4 in 13%.

Two-hundred and seven patients had a comorbid condition. Treatment consisted of

interferon alpha 2b in 340 patients and interferon alpha 2a in 161 patients.

Dose reductions were necessary in 145 patients (29%). Treatment was prematurely

interrupted in 145 patients (29%) owing to lack of efficacy (n =72) or

side-effects (n =73). Sustained virological response (SVR) rates were 50% for

all patients, and 37.1, 70.5, and 71% for patients with genotype 1, 2 and 3,

respectively. At multivariate analysis, age, genotype, and fibrosis severity

were the only independent factors of SVR.

CONCLUSION: In true life, patients are older and more severe, and SVR is about

10% lower than in pivotal trials.

PMID: 20964260 [PubMed - in process]

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