病毒性肝炎示教材料.pptVIP

9 Section 2: Overview Updated preparation date: November 2008 686HQ08PM125 10 Section 2: Overview Updated preparation date: November 2008 686HQ08PM125 Logically, there are 3 solutions to resistance management on-treatment. It has become very feasible to take an aggressive approach to monitoring clinical metrics on-treatment in recent years: PCR-assays for viral load are becoming more accessible The cost of hybridization assays (which have greater sensitivity for quantification at higher viral loads 10^6 copies/ml) is dropping Serum ALT levels are easily measured This has increased options for on-treatment management of resistance. Resistance prediction and resistance prevention represent the most preferable solutions. 11 Section 2: Overview Updated preparation date: November 2008 686HQ08PM125 The US hepatologists Consensus Guidelines and AASLD Guidelines do give recomemndations on the frequency of ALT and viraemic testing on-treatment. However, this is given as a purely passive objective, to monitor virologic effectiveness and identify an appropriate time to withdraw therapy for HBeAg(+) patients. Where the clinical need for a predictive strategy of resistance management is accepted, recommendations are needed for on-treatment management that provide consensus on the following practical issues: What clinical on-treatment metric(s) should be monitored as a predicator for resistance emergence? What are the time points for making a decision based on these? What are the thresholds for decision making? What should those decisions be (action points)? The Roadmap Concept was born of the longstanding hypothesis that ongoing viraemia is probably the most potent on-treatment predictor of resistance emergence, given the balance of cost, technological access and effectiveness. On-treatment resistance-mutation sequencing may be more effective, but at the current time is not a viable option for the physician in the clinic. A workshop was convened to investigate this roadm