Real-life persistence and adherence in ETV treated chronic hepatitis b patients: results of a German prospective multicenter observational study
|Real-life persistence and adherence in ETV treated chronic hepatitis b patients: results of a German prospective multicenter observational study|
|Autor||Petersen J, Thomas Wilke, Mauss S, Heyne R, Herold C, Wiese M, Boeker K, Pichl T, Hueppe D|
|In:||Journal of Hepatoloy|
Entecavir (ETV) is a very effective and safe treatment option in chronic hepatitis B (CHB) patients. However, some patients show only a partial virologic response. The most reasonable explanation is non-persistence/non-adherence. Persistence and adherence measurement is underrepresented in clinical trials. Therefore, the extent of non-persistence (NP), non-adherence (NA) and clinical outcomes of any NA/NP were measured in ETV-treated patients in a real-life study.
In a prospective observational multicenter study, persistence and adherence were measured based on documented prescriptions within a 12 month period. A patient was defined as NP if he missed all treatment doses in [gt]30 subsequent days. Adherence was measured based on medication possession ratio (MPR) between first and last documented prescription (NA if MPR[lt]80%). Proportion of patients reaching undetectable HBV-DNA levels ([lt]69IU/mL) was determined.
112 CHB patients were analysed, baseline characteristics and results are presented in table 1. 26.8% of patients (n=30) missed treatment doses in [gt]30 subsequent days (NP group), 30% of patients in the NP group (n=9) and none of the persistent patients were classified as non-adherent. Mean MPR for all patients was 95.3%. 84.4% of persistent/adherent patients and 63.0% of patients in the NP group reached undetectable HBV-DNA levels (p=0.022). So far no significantly correlating factors for NP/NA could be detected.
This study highlights the importance of persistence/adherence in CHB treatment to achieve a sustained virologic response. Further analysis of risk factors for non-persistence/non-adherence needs to be performed in a larger patient population with a longer observational period.