Study Number INTRON A 3 million IU 24 weeks of treatment INTRON A 3 million IU 72 or 96 weeks of treatment† Difference
(Extended - 24 weeks)
(95% CI)‡
*
Intent to treat groups.
†
Study 1: 72 weeks of treatment; Study 2: 96 weeks of treatment.
‡
Confidence intervals adjusted for multiple comparisons due to 3 treatment arms in the study.
ALT response at the end of follow-up
1 12/101 (12%) 23/104 (22%) 10% (-3, 24)
2 9/67 (13%) 21/80 (26%) 13% (-4, 30)
Combined Studies 21/168 (12.5%) 44/184 (24%) 11.4% (2, 21)
ALT response at the end of treatment
1 40/101 (40%) 51/104 (49%) - -
2 32/67(48%) 35/80 (44%) - -
TABLE 3 VIROLOGIC RESPONSE* IN CHRONIC HEPATITIS B PATIENTS Treatment Group† - Number of Patients (%)
Study Number INTRON A 5 million IU QD INTRON A 10 million IU TIW Untreated Controls P‡ Value
*
Loss of HBeAg and HBV DNA by 6-months posttherapy.
†
Patients pretreated with prednisone not shown.
‡
INTRON A treatment group vs untreated control.
§
Untreated control patients eva luated after 24-week observation period. A subgroup subsequently received INTRON A therapy. A direct comparison is not applicable (NA).
17 15/38 (39%) - - - - 3/42 (7%) 0.0009
2 - - - - 10/24 (42%) 1/22 (5%) 0.005
38 - - - - 13/24§ (54%) 2/27 (7%)§ NA§
All Studies 15/38 (39%) 23/48 (48%) 6/91 (7%) - -
TABLE 4 ALT RESPONSES* IN CHRONIC HEPATITIS B PATIENTS Treatment Group - Number of Patients (%)
Study Number INTRON A
5 million IU QD INTRON A
10 million IU TIW Untreated Controls P† Value
*
Reduction in serum ALT to normal by 6-months posttherapy.
†
INTRON A treatment group vs untreated control.
‡
Untreated control patients eva luated after 24-week observation period. A subgroup subsequently received INTRON A therapy. A direct comparison is not applicable (NA).
1 16/38 (42%) - - - - 8/42 (19%) 0.03
2 - - - - 10/24 (42%) 1/22 (5%) 0.0034
3 - - - - 12/24‡ (50%) 2/27 (7%)‡ NA‡
All Studies 16/38 (42%) 22/48 (46%) 11/91 (12%) - -
INDICATIONS AND USAGE
Hairy Cell Leukemia
INTRON® A is indicated for the treatment of patients 18 years of age or older with hairy cell leukemia.
Malignant Melanoma
INTRON A is indicated as adjuvant to surgical treatment in patients 18 years of age or older with malignant melanoma who are free of disease but at high risk for systemic recurrence, within 56 days of surgery.
Follicular Lymphoma
INTRON A is indicated for the initial treatment of clinically aggressive (see Clinical Experience) follicular Non-Hodgkin's Lymphoma in conjunction with anthracycline-containing combination chemotherapy in patients 18 years of age or older. Efficacy of INTRON A therapy in patients with low-grade, low-tumor burden follicular Non-Hodgkin's Lymphoma has not been demonstrated.
Condylomata Acuminata
INTRON A is indicated for intralesional treatment of selected patients 18 years of age or older with condylomata acuminata involving external surfaces of the genital and perianal areas (see DOSAGE AND ADMINISTRATION).
The use of this product in adolescents has not been studied.
AIDS-Related Kaposi's Sarcoma
INTRON A is indicated for the treatment of selected patients 18 years of age or older with AIDS-Related Kaposi's Sarcoma. The likel
