- 作者：Conrado M. Fern谩ndez-Rodr铆guez ; Rosa Mar铆a Morillas ; Helena Masnou ; Jos茅 Mar铆a Navarro ; Rafael B谩rcena ; Jos茅 Manuel Gonz谩lez ; Leticia Mart铆n-Mart铆n ; Antonio Poyato ; Mireia Miquel-Planas ; Francisco Jorquera ; Teresa Casanovas ; Javier Salmer贸n ; Jos茅 Luis Calleja ; Ricard Sol脿 ; Sonia Alonso ; Ram贸n Planas ; Manuel Romero-Gomez
- 关键词：Chronic hepatitis C ; HCV ; Genotype 3 ; Ribavirin ; Sustained virological response ; Rapid virological response
- 刊名：Gastroenterolog铆a y Hepatolog铆a
- 出版年：January, 2014
- 年：2014
- 卷：37
- 期：1
- 页码：1-8
- 全文大小：851 K
Introduction
Less than half of patients with chronic hepatitis C genotype 3 (G3) and high viral load (HVL) without a rapid virological response (RVR) achieve a sustained virological response (SVR) when treated with peginterferon plus ribavirin (RBV).Objectives
To assess the impact of high doses of RBV on SVR in patients with G3 and HVL.
Methods
Ninety-seven patients were randomized to receive peginterferon 伪-2a + RBV 800 mg/day (A; n = 42) or peginterferon 伪-2a + RBV 1600 mg/day + epoetin 尾 400 IU/kg/week SC (B; n = 55). Patients allocated to group B who achieved RVR continued on RBV (800 mg/day) for a further 20 weeks (B1; n = 42) while non-RVR patients received a higher dose of RBV (1600 mg/day) + epoetin 尾 (B2; n = 13).
Results
RVR was observed in 64.3% of patients in A and in 76.4% in B (p = 0.259). Intention-to-treat (ITT) analysis showed SVR rates of 64.3% (A) and 61.8% (B), with a reduction of 鈭?.5% (鈭?1.8% to 16.9%) (p = 0.835). The SVR rate was 61.9% in arm B1 and 61.5% in arm B2. No serious adverse events were reported, and the rate of moderate adverse events was < 5%.
Conclusions
G3 patients with high viral load without RVR did not obtain a benefit from a higher dose of RBV. Higher doses of RBV plus epoetin 尾 were safe and well tolerated (Clin Trials Gov ).