Gane Edward J, Hyland Robert H, An Di, Svarovskaia Evguenia S, Brainard Diana, McHutchison John G
Auckland Clinical Studies, Auckland, New Zealand.
New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand.
Antivir Ther. 2016;21(7):605-609. doi: 10.3851/IMP3066. Epub 2016 Jul 1.
Currently there are no all-oral treatment regimens for HCV in patients coinfected with HBV. In this pilot study, we evaluated whether ledipasvir and sofosbuvir therapy can suppress HCV infection in patients coinfected with HBV.
Patients with HBV and genotype-1 HCV received 90 mg ledipasvir and 400 mg sofosbuvir daily for 12 weeks. The efficacy end point was sustained virological response (HCV RNA <15 IU/ml) 12 weeks after the end of treatment.
Of the eight patients enrolled, six (75%) were male, five (63%) were Polynesian, seven (88%) had the CC IL28B genotype and two (25%) had cirrhosis. All eight patients (100%; 95% CI 63%, 100%) reached the primary end point of HCV RNA <15 IU/ml 12 weeks after treatment. In seven of eight patients (88%), serum HBV DNA levels increased during treatment, but none of the increases were greater than 20,000 IU/ml, and none were associated with clinical HBV flares or required treatment. The most common adverse events were viral infection (63%), fatigue (25%) and upper respiratory tract infection (25%). No patients had serious adverse events and none discontinued treatment for any reason.
In this small sample, 12 weeks of ledipasvir/sofosbuvir was a safe and effective treatment for genotype-1 HCV infection in patients coinfected with HBV. Larger studies with longer follow-up are warranted.
目前对于合并感染HBV的丙肝患者尚无全口服治疗方案。在这项初步研究中，我们评估了来迪派韦索磷布韦疗法能否抑制合并感染HBV患者的丙肝病毒感染。
合并感染HBV和基因1型丙肝的患者每天接受90毫克来迪派韦和400毫克索磷布韦治疗，持续12周。疗效终点为治疗结束后12周的持续病毒学应答（丙肝病毒RNA<15国际单位/毫升）。
入组的8例患者中，6例（75%）为男性，5例（63%）为波利尼西亚人，7例（88%）为CC型IL28B基因型，2例（25%）有肝硬化。所有8例患者（100%；95%置信区间63%，100%）在治疗后12周达到了丙肝病毒RNA<15国际单位/毫升的主要终点。8例患者中有7例（88%）在治疗期间血清乙肝病毒DNA水平升高，但升高幅度均未超过20,000国际单位/毫升，且均未伴有临床乙肝发作或需要治疗。最常见的不良事件为病毒感染（63%）、疲劳（25%）和上呼吸道感染（25%）。无患者发生严重不良事件，也无患者因任何原因停药。
在这个小样本中，12周的来迪派韦/索磷布韦治疗对于合并感染HBV的基因1型丙肝病毒感染患者是一种安全有效的治疗方法。有必要开展更大规模、随访时间更长的研究。
