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Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety assessment of VITEKTA is primarily based on data from a controlled clinical trial, Study 145, in which 712 HIV-1 infected, antiretroviral treatment-experienced adults received VITEKTA (N=354) or raltegravir (N=358), each administered with a background regimen consisting of a fully active protease inhibitor coadministered with ritonavir and with other antiretroviral drug(s) for at least 96 weeks.

The proportion of subjects who discontinued study treatment due to adverse events, regardless of severity, was 3% in the VITEKTA group and 4% in the raltegravir group. The most common adverse reaction (all Grades, incidence greater than or equal to 5%) in subjects receiving VITEKTA in Study 145 was diarrhea. See also Table 2 for the frequency of adverse reactions occurring in at least 2% of subjects in any treatment group in Study 145.

Table 2 : Selected Adverse Reactions (All Grades) Reported in ≥ 2% of HIV-1 Infected Treatment-Experienced Adults in Either Treatment Group in Study 145 (Week 96 Analysis)a

Diarrhea 7% 5%
Nausea 4% 3%
Headache 3% 3%
aFrequencies of adverse reactions are based on all adverse events attributed to study drugs.

Less Common Adverse Reactions Observed in Treatment-Experienced Studies

The following adverse reactions occurred in < 2% of subjects receiving VITEKTA combined with a protease inhibitor and ritonavir. These reactions have been included because of their seriousness, increased frequency on VITEKTA compared with raltegravir, or investigator's assessment of potential causal relationship.

Gastrointestinal Disorders:abdominal pain, dyspepsia, vomiting

General Disorders and Administration Site Conditions: fatigue

Psychiatric Disorders:depression, insomnia, suicidal ideation and suicide attempt ( < 1%, most in subjects with a pre-existing history of depression or psychiatric illness)

Skin and Subcutaneous Tissue Disorders: rash

Laboratory Abnormalities

The frequency of laboratory abnormalities (Grades 3–4), occurring in at least 2% of subjects in either treatment group in Study 145, is presented in Table 3.

Table 3 : Laboratory Abnormalities (Grades 3–4) Reported in ≥ 2% of HIV-1 Infected Treatment-Experienced Adults in Either Treatment Group in Study 145 (Week 96 Analysis)

Laboratory Parameter Abnormality VITEKTA
Total Bilirubin ( > 2.5 x ULN) 6% 9%
Hematuria ( > 75 RBC/HPF) 6% 7%
Serum Amylasea ( > 2.0 x ULN) 6% 6%
Creatine Kinase ( ≥ 10.0 x ULN) 6% 4%
Total Cholesterol ( > 300 mg/dL) 5% 5%
Total Triglycerides ( > 750 mg/dL) 5% 4%
Hyperglycemia ( > 250 mg/dL) 5% 3%
Urine Glucose (4+) 4% 3%
GGT ( > 5.0 x ULN) 3% 7%
3 Neutrophils ( < 750/mm ) 3% 3%
ALT ( > 5.0 x ULN) 2% 5%
AST ( > 5.0 x ULN) 2% 6%
aFor subjects with serum amylase > 1.5 x upper limit of normal, lipase test was also performed. The frequency of increased lipase (Grades 3–4) occurring in VITEKTA (N=66) and raltegravir (N=58) treatment groups was 14% and 7%, respectively.