Nausea
1%
1%
<1%
3%
Diarrhea
<1%
<1%
<1%
2%
Skin and Subcutaneous Tissue
Rasha
0
<1%
<1%
6%
Ear and Labyrinth
Vertigo
0
<1%
0
2%
aIncludes pooled terms: rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, and drug eruption.
In addition, Grade 1 insomnia was reported by 1% and <1% of subjects receiving TIVICAY and raltegravir, respectively, in SPRING-2; whereas in SINGLE the rates were 7% and 3% for TIVICAY and ATRIPLA, respectively. These events were not treatment limiting.
Treatment-Experienced, Integrase Strand Transfer Inhibitor-Naïve Subjects: In an international, multicenter, double-blind trial (ING111762, SAILING), 719 HIV‑1‑infected, antiretroviral treatment-experienced adults were randomized and received either TIVICAY 50 mg once daily or raltegravir 400 mg twice daily with investigator-selected background regimen consisting of up to 2 agents, including at least one fully active agent. At 24 weeks, the rates of adverse events leading to discontinuation were 2% in subjects receiving TIVICAY 50 mg once daily + background regimen and 4% in subjects receiving raltegravir 400 mg twice daily + background regimen.
The only treatment-emergent ADR of moderate to severe intensity with ≥2% frequency in either treatment group was diarrhea, 1% (5/354) in subjects receiving TIVICAY 50 mg once daily + background regimen and 2% (6/361) in subjects receiving raltegravir 400 mg twice daily + background regimen.
Treatment-Experienced, Integrase Strand Transfer Inhibitor-Experienced Subjects: In a multicenter, open-label, single-arm trial (ING112574, VIKING-3), 183 HIV‑1‑infected, antiretroviral treatment-experienced adults with virological failure and current or historical evidence of raltegravir and/or elvitegravir resistance received TIVICAY 50 mg twice daily with the current failing background regimen for 7 days and with optimized background therapy from Day 8. The rate of adverse events leading to discontinuation was 3% of subjects at Week 24.
Treatment-emergent ADRs in VIKING-3 were generally similar compared with observations with the 50-mg once-daily dose in adult Phase 3 trials.
Less Common Adverse Reactions Observed in Treatment-Naïve and Treatment-Experienced Trials: The following ADRs occurred in <2% of treatment-naïve or treatment-experienced subjects receiving TIVICAY in a combination regimen in any one trial. These events have been included because of their seriousness and assessment of potential causal relationship.
Gastrointestinal Disorders: Abdominal pain, abdominal discomfort, flatulence, upper abdominal pain, vomiting.
General Disorders: Fatigue.
Hepatobiliary Disorders: Hepatitis.
Musculoskeletal Disorders: Myositis.
Renal and Urinary Disorders: Renal impairment.
Skin and Subcutaneous Tissue Disorders: Pruritus.
Laboratory Abnormalities:Treatment-Naïve Subjects: Selected laboratory abnormalities (Grades 2 to 4) with a worsening grade from baseline and representing the w |
