PREZCOBIX® Safety/Tolerability
PREZCOBIX®: Established Tolerability Profile With a Low Discontinuation Rate1
ADRs (≥GRADE 2) WERE INFREQUENT*1
|
Study 130 24 Weeks |
Study 130 48 Weeks |
ARTEMIS 192 Weeks |
|
|
Once-Daily PREZCOBIX® 800/150 mg + OBR (n=313) |
Once-Daily PREZCOBIX® 800/150 mg + OBR (n=313) |
Once-Daily DRV/r 800/150 mg + TDF/FTC (n=343) |
|
| Drug exposure (weeks) | 31.4† | 58.4† | 162.5‡ |
| Abdominal pain | 1.3 | 1.3 | 5.8 |
| Diarrhea | 5.1 | 5.4 | 8.7 |
| Flatulence | 1.0 | 1.0 | <1.0 |
| Nausea | 3.2 | 3.5 | 4.1 |
| Vomiting | 1.6 | 1.9 | 2.0 |
| Fatigue | 0.6 | - | <1.0 |
| (Drug) Hypersensitivity | 1.6 | 1.9 | - |
| Anorexia | - | - | 1.2 |
| Headache | 1.6 | 2.9 | 6.5 |
| Rash | 5.8 | 5.4 | 6.0 |
| Discontinuation due to ADRs | 3.8 | 3.8 | 2.3 |
Direct comparisons should not be made between data from separate clinical trials.
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Selected ADRs (≥Grade 2) occurring in <1% of patients with PREZCOBIX® at Week 24 of Study 130 included fatigue, immune reconstitution syndrome, diabetes mellitus, hypercholesterolemia, hypertriglyceridemia, myalgia, abnormal dreams, pruritus, and dyspepsia. There were no differences observed at Week 481
*Excluding laboratory abnormalities as ADRs. ADRs in ≥1% of patients are shown.
†Median exposure.
‡Mean exposure.
ADRs=adverse drug reactions; OBR=optimized background regimen.
Reference: 1. Data on file. Janssen Therapeutics, Division of Janssen Products, LP.