Fernández-Rodríguez Conrado M, Morillas Rosa María, Masnou Helena, Navarro José María, Bárcena Rafael, González José Manuel, Martín-Martín Leticia, Poyato Antonio, Miquel-Planas Mireia, Jorquera Francisco, Casanovas Teresa, Salmerón Javier, Calleja José Luis, Solà Ricard, Alonso Sonia, Planas Ramón, Romero-Gomez Manuel
Hospital Universitario Fundacion Alcorcon, Unit of Gastroenterology and Hepatology, Madrid, Spain.
Hospital Universitario Fundacion Alcorcon, Unit of Gastroenterology and Hepatology, Madrid, Spain.
Gastroenterol Hepatol. 2014 Jan;37(1):1-8. doi: 10.1016/j.gastrohep.2013.10.005. Epub 2013 Dec 17.
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).
To assess the impact of high doses of RBV on SVR in patients with G3 and HVL.
Ninety-seven patients were randomized to receive peginterferon α-2a+RBV 800 mg/day (A; n=42) or peginterferon α-2a+RBV 1600 mg/day+epoetin β 400 IU/kg/week SC (B; n=55). Patients allocated to group B who achieved RVR continued on RBV (800mg/day) for a further 20 weeks (B1; n=42) while non-RVR patients received a higher dose of RBV (1600 mg/day)+epoetin β (B2; n=13).
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 -2.5% (-21.8% 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%.
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 β were safe and well tolerated (Clin Trials Gov NCT00830609).
慢性丙型肝炎基因3型（G3）且病毒载量高（HVL）且无快速病毒学应答（RVR）的患者，在接受聚乙二醇干扰素联合利巴韦林（RBV）治疗时，不到一半的患者能实现持续病毒学应答（SVR）。
评估高剂量RBV对G3和HVL患者SVR的影响。
97例患者被随机分为接受聚乙二醇干扰素α-2a+800毫克/天RBV组（A组；n = 42）或聚乙二醇干扰素α-2a+1600毫克/天RBV+皮下注射促红细胞生成素β 400国际单位/千克/周组（B组；n = 55）。分配到B组且实现RVR的患者继续接受RBV（800毫克/天）治疗20周（B1组；n = 42），而非RVR患者接受更高剂量的RBV（1600毫克/天）+促红细胞生成素β（B2组；n = 13）。
A组64.3%的患者和B组76.4%的患者观察到RVR（p = 0.259）。意向性治疗（ITT）分析显示SVR率分别为64.3%（A组）和61.8%（B组），降低了-2.5%（-21.8%至16.9%）（p = 0.835）。B1组的SVR率为61.9%，B2组为61.5%。未报告严重不良事件，中度不良事件发生率<5%。
G3且病毒载量高且无RVR的患者未从更高剂量的RBV中获益。更高剂量的RBV加促红细胞生成素β安全且耐受性良好（临床试验注册号NCT00830609）。
