Details

Autor(en) / Beteiligte

• Sánchez–Tapias, José M.
• Diago, Moisés
• Escartín, Pedro
• Enríquez, Jaime
• Romero–Gómez, Manuel
• Bárcena, Rafael
• Crespo, Javier
• Andrade, Raúl
• Martínez–Bauer, Eva
• Pérez, Ramón
• Testillano, Milagros
• Planas, Ramón
• Solá, Ricard
• García–Bengoechea, Manuel
• Garcia–Samaniego, Javier
• Muñoz–Sánchez, Miguel
• Moreno–Otero, Ricardo

Titel

Peginterferon-Alfa2a Plus Ribavirin for 48 Versus 72 Weeks in Patients With Detectable Hepatitis C Virus RNA at Week 4 of Treatment

Ist Teil von

• Gastroenterology (New York, N.Y. 1943), 2006-08, Vol.131 (2), p.451-460

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2006

Quelle

ScienceDirect

Beschreibungen/Notizen

• Background & Aims: Patients with chronic hepatitis C who do not respond rapidly to therapy have a low chance of developing a sustained virologic response (SVR) when treated for 48 weeks. This study investigated whether treatment for 72 weeks increases the rate of SVR in patients with detectable hepatitis C virus (HCV)-RNA levels at week 4 of treatment. Methods: A total of 510 treatment-naive patients were treated with peginterferon-alfa2a (180 μg/wk) plus ribavirin (800 mg/day). Patients with detectable HCV-RNA levels at week 4 (n = 326) were randomized to complete 48 (group A, n = 165) or 72 weeks (group B, n = 161) of treatment. Patients with undetectable HCV-RNA levels at week 4 (n = 184) were allocated into group C (n = 148) or group D (n = 36), according to HCV genotype and baseline viremia, and treated for 24 or 48 weeks, respectively. All patients were followed-up for 24 weeks after the end of treatment. Results: The end-of-treatment response rate (61%) was similar in groups A and B, but the SVR rate was higher in group B (45% vs 32% in A; P = .01). In genotype 1–infected patients randomized to group A (n = 149) or B (n = 142), SVR rates were 28% and 44%, respectively ( P = .003). The incidence of adverse events was similar in all groups. Treatment discontinuation was more frequent in group B (36%) than in group A (18%) ( P = .0004). SVR rates in groups C and D were 79% and 64%, respectively. Conclusions: Extension of treatment with peginterferon-alfa2a plus ribavirin from 48 to 72 weeks significantly increases the rate of SVR in patients with detectable viremia at week 4 of treatment.