IMS Health Economics & Outcomes Research, Milan, Italy. email@example.com.
HBeAg-negative chronic hepatitis B (CHB) is the most frequent and difficult to treat viral hepatitis worldwide. HBV-DNA and HBsAg serum levels, which help the early identification of non-responders to peg-interferon (PEG-IFN), prompt more flexible individualized therapeutic strategies exploiting the benefits of both PEG-IFN and nucleos(t)ide analogs (NAs). We assessed the cost-effectiveness of week-12 HBV-DNA\HBsAg stopping rule for early interruption and switch to currently most effective NAs treatments (entecavir-ETV or tenofovir-TDF).
A decision-analytic Markov model was developed in health-related states: CHB, compensated and decompensated cirrhosis, hepatocarcinoma, liver transplant, post-liver transplant, death and virologic response, relapse, HBsAg clearance. Simulated strategies were: 1) ETV/TDF in CHB; 2) ETV/TDF delayed until compensated cirrhosis (CC); 3) first-line-PEG-IFN followed by switch to ETV/TDF for either patients meeting week-12 stopping rule or week-48 null-responders/relapsers ; 4) first-line PEG-IFN followed by switch to ETV/TDF delayed until CC. ETV and TDF were considered alternatively for a total of 8 strategies. A lifetime simulation horizon was applied.
Early treatment strategies using NAs with or without first-line PEG-IFN provided the highest results (about 22-life-years and 15-QALYs). Delayed treatments until cirrhosis development resulted in poorer outcomes. The average per-patient lifetime costs ranged from €33,500 (TDF in CC) to €68,900 (TDF in CHB). Costs using ETV were 20-50% higher. First-line-PEG-IFN strategies resulted ranging from dominant (i.e. more effective and less costly) to highly cost-effective, even though differences in QALY were always very narrow.
The cost-effectiveness of antiviral therapy of HBeAg-negative CHB could be improved significantly using first-line PEG-IFN followed by a switch to NAs in either patients meeting week-12 HBV-DNA/HBsAg stopping rule or week-48 non responders/relapsers.