编者按：2016年4月16日，欧洲肝脏研究协会（EASL）丙型肝炎小组、丙型肝炎指南修订委员会对外举行发布会。该小组主要负责人、法国巴黎东区大学亨利蒙度医院Jean-Michel Pawlotsky教授主持了会议，并发表了关于《EASL 2016丙型肝炎治疗推荐意见》的专题报告。作为第51届EASL年会的压轴大戏，该推荐意见的更新即将在今年9月正式公布。《国际肝病》记者对Pawlotsky教授进行了独家专访。

 

　　《国际肝病》：应用新型直接抗病毒药物（DAA）方案，慢性丙型肝炎患者可获得95%以上的持续病毒学应答（SVR）率。在临床实践中，是否没有必要再考虑基于干扰素的方案？

 

　　Pawlotsky教授：新型DAA非常有效，目前的DAA联合治疗慢性HCV感染患者可获得95%以上的SVR率，可以治愈绝大多数患者。因此，目前欧洲已不再将包含聚乙二醇干扰素的方案作为一线治疗。不过，含聚乙二醇干扰素方案还有一个应用指征，即作为挽救治疗策略，用于既往无干扰素方案治疗失败的基因3型患者的再治疗，例如索非布韦（sofosbuvir）和达拉他韦（daclatasvir）治疗失败的基因3型患者。总而言之，丙型肝炎的治疗已经进入无干扰素方案的时代。

 

　　Prof. Pawlotsky: The new direct-acting antiviral drugs are very effective. We are using treatment regimens that yield rates of SVR that are >95%, so we are curing the vast majority of patients. Currently, in Europe, there is no longer an indication for first-line therapy with a peg-interferon-containing regimen. We are not using it anymore. There remains one indication for these regimens with peg-interferon, which is a rescue strategy in patients with genotype 3 who have received sofosbuvir and daclatasvir and have failed. So the only option for treating patients with a peg-interferon-based regimen would be the retreatment of patients with genotype 3 infection who had failed a treatment without interferon. Otherwise, we are not using peg-interferon anymore and have arrived in the era of interferon-free regimens.

 

　　《国际肝病》：对于应用新型DAA方案治疗失败的患者该如何管理？

 

　　Pawlotsky教授：应用基于新型DAA的无干扰素方案，患者不能获得SVR的失败率非常低，不同人群的失败率通常仅为2%~5%。对于这些患者，EASL推荐应用索非布韦和一种或两种DAA联合治疗，后者尽可能与之前应用的方案无交叉耐药，并加用利巴韦林。如果患者存在肝硬化，则治疗疗程延长为24周。目前，我们应用索非布韦与之前未用过的一种药物联合，有时与两种药物联合（例如索非布韦联合一种蛋白酶抑制剂、一种NS5抑制剂加利巴韦林），用于这些患者的再治疗。应用这些方案，患者可获得非常满意的治疗结果，但仍然有一些患者发生复发，对这些少数患者，目前尚不能治愈感染，暂无其他选择。

 

　　Prof. Pawlotsky: The rate of failure to achieve SVR with the new DAA-based interferon-free regimens is very low, between 2% and 5% in general depending on the population. For these patients, the recommendation made by the EASL is to treat with sofosbuvir, one or two other direct-acting antivirals that have no cross-resistance if possible with a previously administered regimen, and add ribavirin. If the patient has cirrhosis, treatment is for 24 weeks. What we are doing to retreat these patients is when we use sofosbuvir, we combine with a drug that was different from the one that was given previously, sometimes two drugs (for instance, sofosbuvir, one protease inhibitor, one NS5 inhibitor plus ribavirin). With these regimens we achieve reasonably good results, but there are some patients who still relapse and in whom we are unable to cure infection. For these patients, we don’t have any other options, but they are the minority.

 

　　《国际肝病》： 2016年EASL丙型肝炎治疗推荐意见有哪些主要更新点？

 

　　Pawlotsky教授：2015年4月，在第50届EASL年会上，我们发布了新版丙型肝炎治疗推荐意见。今年，鉴于新型DAA grazoprevir/elbasvir以及sofosbuvir/velpatasvir的联合方案正在等待欧盟批准（预计将于今年夏季之前获批）。因此，我们计划于2016年9月召开的“EASL巴黎丙型肝炎主题会议”上发布最新版的EASL丙型肝炎治疗推荐意见。

 

　　随着新型DAA方案的批准，EASL指南可能会进行再一次更新，我们将关注ABT-493和ABT-530等第二代DAA药物的联合方案，这些联合将于2017年中期得到批准。之后可能还有其他药物的联合方案。我们预计在未来3年内将实现丙型肝炎治疗的标准化，从而可以制定出明确的丙型肝炎治疗指南。

 

　　Prof. Pawlotsky: The last EASL recommendations for the treatment of hepatitis C were published a year ago in April 2015 and we have decided to not update them for this meeting because grazoprevir/elbasvir, the new combination, and the other new combination, sofosbuvir/velpatasvir, have not yet been approved in Europe. They will be approved probably before the summer, so there will be an update of the EASL recommendations in September 2016 that will be presented in Paris at the EASL Special Conference on Hepatitis C. The next updates will probably come with new treatments as they are approved. The next update will concern the second-generation drug combination from AbbVie of ABT-493 and ABT-530. These combinations should be approved by mid-2017 and eventually another couple of combinations will be approved later on. We are getting to the stage where, in the next three years, we should have standardization of the field and we will be able to write definitive guidelines.

 

　　最后，Pawlotsky教授表示非常期待2017年在中国上海召开的亚太肝脏研究协会（APASL）年会，他非常高兴地接受了大会的邀请。他期待与中国同道共襄盛举，并预祝会议取得巨大成功！

 

　　I think the next APASL meeting in Shanghai, China will be a success. I have been invited to attend that meeting and have gladly accepted, so I will see you in Shanghai very soon.