Chronic Hepatitis B

Adults
In patients with chronic hepatitis B, some type of adverse reaction occurred in 98% of the 101 patients treated at 5 million IU QD and 90% of the 78 patients treated at 10 million IU TIW. Most of these adverse reactions were mild to moderate in severity, were manageable, and were reversible following the end of therapy.

Adverse reactions classified as severe (causing a significant interference with normal daily activities or clinical state) were reported in 21% to 44% of patients. The severe adverse reactions reported most frequently were the "flu-like" symptoms of fever (28%), fatigue (15%), headache (5%), myalgia (4%), rigors (4%), and other severe "flu-like" symptoms, which occurred in 1% to 3% of patients. Other severe adverse reactions occurring in more than one patient were alopecia (8%), anorexia (6%), depression (3%), nausea (3%), and vomiting (2%).

To manage side effects, the dose was reduced, or INTRON A therapy was interrupted in 25% to 38% of patients. Five percent of patients discontinued treatment due to adverse experiences.

Pediatrics
In pediatric patients, the most frequently reported adverse events were those commonly associated with interferon treatment: flu-like symptoms (100%), gastrointestinal system disorders (46%), and nausea and vomiting (40%). Neutropenia (13%) and thrombocytopenia (3%) were also reported. None of the adverse events were life threatening. The majority were moderate to severe and resolved upon dose reduction or drug discontinuation.

Abnormal Laboratory Test Values by Indication  Dosing Regimens
Percentage (%) of Patients
 MALIGNANT MELANOMA FOLLICULAR LYMPHOMA HAIRY CELL LEUKEMIA CONDYLOMATA ACUMINATA AIDS-RELATED KAPOSI'S SARCOMA CHRONIC HEPATITIS C  CHRONIC HEPATITIS B
 Adults Pediatrics
 20 MIU/m2 Induction (IV)
10 MIU/m2 Maintenance (SC) 5 MIU
TIW/SC 2 MIU/m2
TIW/SC 1 MIU/lesion 30 MIU/m2
TIW/SC 35 MIU
QD/SC 3 MIU
TIW  5 MIU
QD 10 MIU
TIW 6 MIU/m2
TIW
LABORATORY TESTS N=143 N=135 N=145 N=352 N=69–73 N=26–28 N=140–171 N=96–101 N=75–103 N=113–115
NA - Not Applicable- Patients' initial hematologic laboratory test values were abnormal due to their condition.
*
Decrease of ≥2 g/dL; 20% 2–<3 g/dL; 6% ≥3 g/dL
†
Decrease of ≥2 g/dL
‡
Decrease of ≥2 g/dL; 14% 2–<3 g/dL; 3% ≥3 g/dL
§
White Blood Cell Count was reported as neutropenia
¶
Decrease to <3000/mm3
#
Decrease to <70,000/mm3
Þ
Neutrophils plus bands 
Hemoglobin 22 8 NA - - 1 15 26* 32† 23† 17‡
White Blood Cell Count § - - NA 17 10 22 26¶ 68¶ 34¶ 9¶
Platelet Count 15 13 NA - - 0 8 15# 12# 5# 1#
Serum Creatinine 3 2 0 - - - - - - 6 3 0 3
Alkaline Phosphatase 13 - - 4 - - - - - - - - 8 4 0
Lactate Dehydrogenase 1 - - 0 - - - - - - - - - - - - - -
Serum Urea Nitrogen 12 4 0 - - - - - - - - 2 0 2
SGOT 63 24 4 12 11 41 - - - - - - - -
SGPT 2 - - 13 - - 10 15 - - - - - - - -
Granulocyte Count 
Total
 92 36 NA - - 31 39 45Þ 75Þ 61Þ 70Þ
1000–<1500/mm3
 66 - - - - - - - - - - 32 30 32 43
750–<1000/mm3
 - - 21 - - - - - - - - 10 24 18 18
500–<750/mm3
 25 - - - - - - - - - - 1 17 9 7
<500/mm3
 1 13 - - - - - - - -