ho were previously untreated) eva luated the use of VICTRELIS in combination with PegIntron/REBETOL with or without a four-week lead-in period with PegIntron/REBETOL compared to PegIntron/REBETOL alone. SPRINT-2 (subjects who were previously untreated) and RESPOND-2 (subjects who had failed previous therapy) eva luated the use of VICTRELIS 800 mg three times daily in combination with PegIntron/REBETOL with a four-week lead-in period with PegIntron/REBETOL compared to PegIntron/REBETOL alone [see Clinical Studies (14)]. The population studied had a mean age of 49 years (3% of subjects were >65 years of age), 39% were female, 82% were white and 15% were black.
During the four week lead-in period with PegIntron/REBETOL in the VICTRELIS-containing arms, 28/1263 (2%) subjects experienced adverse reactions leading to discontinuation of treatment. During the entire course of treatment, the proportion of subjects who discontinued treatment due to adverse reactions was 13% for subjects receiving the combination of VICTRELIS with PegIntron/REBETOL and 12% for subjects receiving PegIntron/REBETOL alone. Events resulting in discontinuation were similar to those seen in previous studies with PegIntron/REBETOL. Only anemia and fatigue were reported as events that led to discontinuation in >1% of subjects in any arm.
Adverse reactions that led to dose modifications of any drug (primarily PegIntron and REBETOL) occurred in 39% of subjects receiving the combination of VICTRELIS with PegIntron/REBETOL compared to 24% of subjects receiving PegIntron/REBETOL alone. The most common reason for dose reduction was anemia, which occurred more frequently in subjects receiving the combination of VICTRELIS with PegIntron/REBETOL than in subjects receiving PegIntron/REBETOL alone.
Serious adverse events were reported in 11% of subjects receiving the combination of VICTRELIS with PegIntron/REBETOL and in 8% of subjects receiving PegIntron/REBETOL.
Adverse events (regardless of investigator's causality assessment) reported in greater than or equal to 10% of subjects receiving the combination of VICTRELIS with PegIntron/REBETOL and reported at a rate of greater than or equal to 5% than PegIntron/REBETOL alone in SPRINT-1, SPRINT-2, and RESPOND-2 are presented in Table 3.
Table 3 Adverse Events Reported in ≥10% of Subjects Receiving the Combination of VICTRELIS with PegIntron/REBETOL and Reported at a Rate of ≥5% than PegIntron/REBETOL alone Adverse Events Previously Untreated
(SPRINT-1 & SPRINT-2) Previous Treatment Failures
(RESPOND-2)
Percentage of Subjects Reporting Adverse Events Percentage of Subjects Reporting Adverse Events
Body System Organ Class VICTRELIS + PegIntron + REBETOL
(n=1225) PegIntron + REBETOL
(n=467) VICTRELIS + PegIntron + REBETOL
(n=323) PegIntron + REBETOL
(n=80)
Median Exposure (days) 197 216 253 104
Blood and Lymphatic System Disorders
Anemia 50 30 45 20
Neutropenia 25 19 14 10
Gastrointestinal Disorders
Nausea 46 42 43 38
Dysgeusia 35 16 44 11
Diarrhea 25 22 24 16
Vomiting 20 13 15 8
Dry Mouth 11 10 15 9
General Disorders and Administration Site Conditions
Fatigue 58 59 55 50
Chills 34 29 33 30
Asthenia 15 18 21 16
Metabolism and Nutrition Disorders
Decreased Appetite 25 24 26 16
Musculoskeletal and Connective Tissue Disorders
Arthralgia 19 19 23 16
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