Renal dysfunction in chronic hepatitis B patients treated with adefovir dipivoxil.
Renal dysfunction has been reported in patients treated with adefovir dipivoxil (ADV); however, its incidence and clinical importance may be underappreciated given the lack of long-term follow-up and data outside of a clinical trial setting. Our goal was to examine the severity and incidence of renal dysfunction in a real-life setting for patients treated with ADV and whose baseline estimated glomerular filtration rate (eGFR) was >50 mL/minute. We performed a cohort study of 290 chronic hepatitis B patients: 145 patients treated with 10 mg ADV and 145 patients unexposed to ADV at two community clinics, who were matched for age (+/-10 years), sex, and baseline eGFR. The exposed and unexposed populations were well-matched with a similar mean age (46-47 years), proportion of male patients (76.5%), baseline serum creatinine (0.97-0.99 mg/dL), and baseline creatinine clearance (85.0-85.4 mL/minute). The incidence density for renal dysfunction defined by treatment termination and/or development of eGFR < or =50 mL/minute was five cases per 100 patient-years in the exposed group compared with 1.36 cases per 100 patient-years in the unexposed group (P = 0.02). The relative risk of exposed to unexposed was 3.68 (95% confidence interval 1.1-19.3). On Cox proportional hazard analysis also inclusive of sex, ADV was a significant predictor of significant renal dysfunction (hazard ratio [HR] 3.94, P = 0.03). There were also significant trends for age >50 years (HR 3.49, P = 0.087), mild renal impairment at baseline (HR 4.49, P = 0.073), and hypertension and/or diabetes mellitus (HR 2.36, P = 0.074).


CONCLUSIONS
ADV is an independent predictor for significant deterioration of renal function. Patients on ADV should be monitored, especially patients who are older, have baseline renal insufficiency, or have hypertension and/or diabetes mellitus.
Ha
Nghi B
NB
Pacific Health Foundation, San Jose, CA, USA.
Ha
Nghiem B
NB
Garcia
Ruel T
RT
Trinh
Huy N
HN
Vu
Andrew A
AA
Nguyen
Huy A
HA
Nguyen
Khanh K
KK
Levitt
Brian S
BS
Nguyen
Mindie H
MH
D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use; D015331:Cohort Studies; D003404:Creatinine / Q000097:blood; D005260:Female; D005919:Glomerular Filtration Rate; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000139:chemically induced*; D007677:Kidney Function Tests; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000009:adverse effects* / Q000627:therapeutic use; D012189:Retrospective Studies
D000998:Antiviral Agents; D063065:Organophosphonates; D003404:Creatinine; D000225:Adenine; C106812:adefovir dipivoxil