Adherence to chronic hepatitis B treatment guideline recommendations for laboratory monitoring of patients who are not receiving antiviral treatment.
BACKGROUND
Hepatitis B virus (HBV) DNA and alanine aminotransferase (ALT) levels predict future complications in chronic hepatitis B (CHB) patients. To determine when to initiate antiviral therapy, treatment guidelines recommend monitoring of HBV DNA and ALT levels at least annually. This study aimed to assess adherence to treatment guideline-recommended monitoring of CHB patients not receiving antiviral treatment and to identify predictors of laboratory monitoring and subsequent initiation of antiviral therapy.


METHODS
This retrospective cohort study used data from a large US health care claims database over a 5-year period (January 1, 2003 to December 31, 2007). The study population included patients 18-65 years of age with at least two paid medical claims with an ICD-9 code for CHB, at least one positive hepatitis B surface antigen test, and at least 12 months of continuous health plan enrollment after initial diagnosis. Descriptive statistics assessed the proportion of patients with claims for ALT and/or HBV DNA monitoring. Multivariate logistic regression models were used to determine predictors of monitoring and subsequent antiviral therapy.


RESULTS
The study included 1,168 CHB patients, with a mean follow-up of 728 days (median = 696 days). The proportion monitored at least every 12 months was 53.3% for ALT, 39.0% for HBV DNA, and 35.1% for both. Significant predictors of monitoring were a higher Deyo-Charlson Comorbidity Index (DCCI) score for ALT (OR 1.90, p < 0.001), male gender for HBV DNA (OR 1.49, p < 0.01), and a higher DCCI score (OR 1.10, p < 0.05) and male gender (1.46, p < 0.01) for both. Significant predictors of subsequent initiation of antiviral treatment were HBV DNA monitoring (OR 2.08, p < 0.001), a higher DCCI score (OR 1.24, p < 0.001), and male gender (OR 1.53, p < 0.01).


CONCLUSIONS
Laboratory monitoring of CHB patients not receiving antiviral treatment is below guideline recommendations, suggesting that initiation of antiviral therapy may also be delayed, leaving patients at risk for disease progression.
Research & Development, Bristol-Myers Squibb Co., 777 Scudders Mill Road, Plainsboro, NJ 08536, USA. Timothy.juday@bms.com
Timothy
T
Juday
Hong
H
Tang
Melissa
M
Harris
Annette Z
AZ
Powers
Edward
E
Kim
George J
GJ
Hanna
D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D019411:Clinical Laboratory Techniques / Q000592:standards; D015331:Cohort Studies; D004279:DNA, Viral / Q000302:isolation & purification; D005260:Female; D005500:Follow-Up Studies; D019983:Guideline Adherence / Q000592:standards*; D006514:Hepatitis B Surface Antigens / Q000302:isolation & purification*; D017325:Hepatitis B Vaccines / Q000627:therapeutic use; D006515:Hepatitis B virus / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000175:diagnosis* / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017410:Practice Guidelines as Topic / Q000592:standards*; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines