Toronto Centre for Liver Disease, Toronto General Hospital, Toronto, ON, Canada.
North Shore University Hospital, Manhasset, NY, USA.
Liver Int. 2018 Sep;38(9):1571-1575. doi: 10.1111/liv.13708. Epub 2018 Mar 14.
BACKGROUND & AIMS: Some individuals with hepatitis C virus infection treated with direct-acting antivirals require ribavirin to maximize sustained virological response rates. We describe the clinical management of ribavirin dosing in hepatitis C virus-infected patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin.
We performed a post hoc analysis of patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin for 12 or 24 weeks in six phase 3 trials. Multivariate stepwise logistic regression models assessed predictors associated with ribavirin dose adjustments and with developing anaemia.
Of 1548 patients, 100 (6.5%) modified ribavirin dose due to haemoglobin declines, of which 99% achieved sustained virological response at 12 weeks post-treatment. Median time to first ribavirin dose reduction was 37 days. Low baseline haemoglobin was significantly associated with an increased risk of requiring ribavirin dose modification (odds ratio: 0.618 [0.518, 0.738]; P < .001) and developing anaemia (odds ratio: 0.379 [0.243, 0.593]; P < .001).
Ribavirin dose reductions were infrequent, occurred early in treatment, and did not impact sustained virological response at 12 weeks post-treatment. Patients with low baseline haemoglobin should be monitored for on-treatment anaemia.
部分接受直接作用抗病毒药物治疗的丙型肝炎病毒感染者需要利巴韦林来最大限度地提高持续病毒学应答率。我们描述了接受奥比他韦/帕利瑞韦/利托那韦和达萨布韦联合利巴韦林治疗的丙型肝炎病毒感染者的利巴韦林剂量的临床管理。
我们对 6 项 3 期临床试验中接受奥比他韦/帕利瑞韦/利托那韦和达萨布韦联合利巴韦林治疗 12 或 24 周的患者进行了事后分析。多变量逐步逻辑回归模型评估了与利巴韦林剂量调整和贫血发生相关的预测因素。
在 1548 例患者中，由于血红蛋白下降，有 100 例（6.5%）调整了利巴韦林剂量，其中 99%的患者在治疗后 12 周时达到持续病毒学应答。首次降低利巴韦林剂量的中位时间为 37 天。基线血红蛋白低与需要调整利巴韦林剂量的风险增加显著相关（比值比：0.618[0.518, 0.738]；P<0.001）和发生贫血（比值比：0.379[0.243, 0.593]；P<0.001）。
利巴韦林剂量减少的情况并不常见，发生在治疗早期，并且不会影响治疗后 12 周的持续病毒学应答。基线血红蛋白低的患者应监测治疗中的贫血情况。
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