RVIR 400mg twice-daily + saquinavir 400 mg twice-daily. Overall the most frequently reported clinical adverse events, other than asthenia, among adult patients receiving NORVIR were gastrointestinal and neurological disturbances including nausea, diarrhea, vomiting, anorexia, abdominal pain, taste perversion, and circumoral and peripheral paresthesias. Similar adverse event profiles were reported in adult patients receiving ritonavir in other trials.
Table 7. Percentage of Patients with Treatment-emergent Adverse Events1 of Moderate or Severe Intensity Occurring in ≥ 2% of Adult Patients Receiving NORVIR Adverse Events Study 245
Naive Patients2 Study 247
Advanced Patients3 Study 462
PI-Naive Patients4
NORVIR + ZDV
n = 116 NORVIR
n = 117 ZDV
n = 119 NORVIR
n = 541 Placebo
n = 545 NORVIR + Saquinavir n= 141
1 Includes those adverse events at least possibly related to study drug or of unknown relationship and excludes concurrent HIV conditions.
2 The median duration of treatment for patients randomized to regimens containing NORVIR in Study245 was 9.1 months.
3 The median duration of treatment for patients randomized to regimens containing NORVIR in Study247 was 9.4 months.
4 The median duration of treatment for patients in Study 462 was 48 weeks.
Body as a Whole
Abdominal Pain 5.2 6.0 5.9 8.3 5.1 2.1
Asthenia 28.4 10.3 11.8 15.3 6.4 16.3
Fever 1.7 0.9 1.7 5.0 2.4 0.7
Headache 7.8 6.0 6.7 6.5 5.7 4.3
Malaise 5.2 1.7 3.4 0.7 0.2 2.8
Pain (unspecified) 0.9 1.7 0.8 2.2 1.8 4.3
Cardiovascular
Syncope 0.9 1.7 0.8 0.6 0.0 2.1
Vasodilation 3.4 1.7 0.8 1.7 0.0 3.5
Digestive
Anorexia 8.6 1.7 4.2 7.8 4.2 4.3
Constipation 3.4 0.0 0.8 0.2 0.4 1.4
Diarrhea 25.0 15.4 2.5 23.3 7.9 22.7
Dyspepsia 2.6 0.0 1.7 5.9 1.5 0.7
Fecal Incontinence 0.0 0.0 0.0 0.0 0.0 2.8
Flatulence 2.6 0.9 1.7 1.7 0.7 3.5
Local Throat Irritation 0.9 1.7 0.8 2.8 0.4 1.4
Nausea 46.6 25.6 26.1 29.8 8.4 18.4
Vomiting 23.3 13.7 12.6 17.4 4.4 7.1
Metabolic and Nutritional
Weight Loss 0.0 0.0 0.0 2.4 1.7 0.0
Musculoskeletal
Arthralgia 0.0 0.0 0.0 1.7 0.7 2.1
Myalgia 1.7 1.7 0.8 2.4 1.1 2.1
Nervous
Anxiety 0.9 0.0 0.8 1.7 0.9 2.1
Circumoral Paresthesia 5.2 3.4 0.0 6.7 0.4 6.4
Confusion 0.0 0.9 0.0 0.6 0.6 2.1
Depression 1.7 1.7 2.5 1.7 0.7 7.1
Dizziness 5.2 2.6 3.4 3.9 1.1 8.5
Insomnia 3.4 2.6 0.8 2.0 1.8 2.8
Paresthesia 5.2 2.6 0.0 3.0 0.4 2.1
Peripheral Paresthesia 0.0 6.0 0.8 5.0 1.1 5.7
Somnolence 2.6 2.6 0.0 2.4 0.2 0.0
Thinking Abnormal 2.6 0.0 0.8 0.9 0.4 0.7
Respiratory
Pharyngitis 0.9 2.6 0.0 0.4 0.4 1.4
Skin and Appendages
Rash 0.9 0.0 0.8 3.5 1.5 0.7
Sweating 3.4 2.6 1.7 1.7 1.1 2.8
Special Senses
Taste Perversion 17.2 11.1 8.4 7.0 2.2 5.0
Urogenital
Nocturia 0.0 0.0 0.0 0.2 0.0 2.8
Adverse events occurring in less than 2% of adult patients receiving NORVIR in all phaseII/phase III studies and considered at least possibly related or of unknown relationship to treatment and of at least moderate intensity are listed below by body system.
Body as a Whole
Abdomen enlarged, accidental injury, allergic reaction, back pain, cachexia, chest pain, chills, facial edema, facial pain, flu syndrome, hormone level altered, hypothermia, kidney pain, neck pain, neck rigidity, pelvic pain, photosensitivity reaction, and substernal chest pain.
Cardiovascular System
Cardiovascular disorder, cerebral ischemia, cerebral veno
