nd can occur many months after initiation of treatment.
6 ADVERSE REACTIONS
The following adverse drug reactions (adverse events assessed as causally related by the investigator or ADRs) are discussed in other sections of the labeling:
•
Hypersensitivity reactions [see Warnings and Precautions (5.1)].
•
Effects on serum liver biochemistries in patients with hepatitis B or C co-infection [see Warnings and Precautions (5.2)].
•
Fat Redistribution [see Warnings and Precautions (5.3)].
•
Immune Reconstitution Syndrome [see Warnings and Precautions (5.4)].
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
6.1 Clinical Trials Experience in Adult Subjects
Treatment‑Emergent Adverse Drug Reactions (ADRs):Treatment-Naïve Subjects: The safety assessment of TIVICAY in HIV‑1‑infected treatment-naïve subjects is based on the analyses of 48-week data from 2 ongoing, international, multicenter, double-blind trials, SPRING-2 (ING113086) and SINGLE (ING114467).
In SPRING-2, 822 subjects were randomized and received at least 1 dose of either TIVICAY 50 mg once daily or raltegravir 400 mg twice daily, both in combination with fixed-dose dual nucleoside reverse transcriptase inhibitor (NRTI) treatment (either abacavir sulfate and lamivudine [EPZICOM®] or emtricitabine/tenofovir [TRUVADA®]). There were 808 subjects included in the efficacy and safety analyses. The rate of adverse events leading to discontinuation was 2% in both treatment arms.
In SINGLE, 833 subjects were randomized and received at least 1 dose of either TIVICAY 50 mg with fixed-dose abacavir sulfate and lamivudine (EPZICOM) once daily or fixed-dose efavirenz/emtricitabine/tenofovir (ATRIPLA®) once daily. The rates of adverse events leading to discontinuation were 2% in subjects receiving TIVICAY 50 mg once daily + EPZICOM and 10% in subjects receiving ATRIPLA once daily.
Treatment-emergent ADRs of moderate to severe intensity observed in ≥2% of subjects in either treatment arm are provided in Table 2. Side-by-side tabulation is to simplify presentation; direct comparisons across trials should not be made due to differing trial designs.
Table 2. Treatment-Emergent Adverse Drug Reactions of at Least Moderate Intensity (Grades 2 to 4) and ≥2% Frequency in Treatment-Naïve Subjects in SPRING-2 and SINGLE Trials (Week 48 Analysis) System Organ Class/ Preferred Term
SPRING-2
SINGLE
TIVICAY 50 mg Once Daily + 2 NRTIs
(N = 403)
Raltegravir
400 mg Twice Daily + 2 NRTIs
(N = 405)
TIVICAY 50 mg + EPZICOM Once Daily
(N = 414)
ATRIPLA Once Daily
(N = 419)
Psychiatric
Insomnia
<1%
<1%
3%
2%
Abnormal dreams
<1%
<1%
<1%
2%
Nervous System
Dizziness
<1%
<1%
<1%
5%
Headache
<1%
<1%
2%
2%
Gastrointestinal
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