SUSTIVA (Page 4 of 10)

Nervous System Symptoms

For 1008 patients treated with regimens containing SUSTIVA and 635 patients treated with a control regimen in controlled trials, Table 4 lists the frequency of symptoms of different degrees of severity and gives the discontinuation rates for one or more of the following nervous system symptoms: dizziness, insomnia, impaired concentration, somnolence, abnormal dreaming, euphoria, confusion, agitation, amnesia, hallucinations, stupor, abnormal thinking, and depersonalization [see Warnings and Precautions (5.5) ]. The frequencies of specific central and peripheral nervous system symptoms are provided in Table 3.

Table 4: Percent of Patients with One or More Selected Nervous System Symptomsa,b
Percent of Patients with: SUSTIVA 600 mg Once Daily(n=1008) Control Groups(n=635)
% %
a Includes events reported regardless of causality.
b Data from Study 006 and three Phase 2/3 studies.
c “Mild” = Symptoms which do not interfere with patient’s daily activities.
d “Moderate” = Symptoms which may interfere with daily activities.
e “Severe” = Events which interrupt patient’s usual daily activities.
Symptoms of any severity 52.7 24.6
Mild symptomsc 33.3 15.6
Moderate symptomsd 17.4 7.7
Severe symptomse 2.0 1.3
Treatment discontinuation as a result of symptoms 2.1 1.1

Psychiatric Symptoms

Serious psychiatric adverse experiences have been reported in patients treated with SUSTIVA. In controlled trials, psychiatric symptoms observed at a frequency of >2% among patients treated with SUSTIVA or control regimens, respectively, were depression (19%, 16%), anxiety (13%, 9%), and nervousness (7%, 2%).

Rash

For 1008 adult and 57 pediatric patients treated with regimens containing SUSTIVA and 635 patients treated with a control regimen in controlled trials, the frequency of rash by NCI grade and the discontinuation rates as a result of rash in clinical studies are provided in Table 5 [see Warnings and Precautions (5.7) ].

Table 5: Percent of Patients with Treatment-Emergent Rasha,b
Percent of Patients with: Description of Rash Gradec SUSTIVA 600 mg Once Daily Adults(n=1008) SUSTIVAPediatric Patients(n=57) Control GroupsAdults(n=635)
% % %
a Includes events reported regardless of causality.
b Data from Study 006 and three Phase 2/3 studies.
c NCI Grading System.
Rash of any grade 26.3 45.6 17.5
Grade 1 rash Erythema, pruritus 10.7 8.8 9.8
Grade 2 rash Diffuse maculopapular rash, dry desquamation 14.7 31.6 7.4
Grade 3 rash Vesiculation, moist desquamation, ulceration 0.8 1.8 0.3
Grade 4 rash Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, necrosis requiring surgery, exfoliative dermatitis 0.1 3.5 0.0
Treatment discontinuation as a result of rash 1.7 8.8 0.3

As seen in Table 5, rash is more common in pediatric patients and more often of higher grade (ie, more severe) [see Warnings and Precautions (5.7) ].

Experience with SUSTIVA in patients who discontinued other antiretroviral agents of the NNRTI class is limited. Nineteen patients who discontinued nevirapine because of rash have been treated with SUSTIVA. Nine of these patients developed mild-to-moderate rash while receiving therapy with SUSTIVA, and two of these patients discontinued because of rash.

Laboratory Abnormalities

Selected Grade 3-4 laboratory abnormalities reported in ≥2% of SUSTIVA-treated patients in two clinical trials are presented in Table 6.

Table 6: Selected Grade 3-4 Laboratory Abnormalities Reported in ≥2% of SUSTIVA-Treated Patients in Studies 006 and ACTG 364
Study 006 LAM-, NNRTI-, and ProteaseInhibitor-Naive Patients Study ACTG 364 NRTI-experienced, NNRTI-, and ProteaseInhibitor-Naive Patients
Variable Limit SUSTIVAa + ZDV/LAM(n=412) SUSTIVAa + Indinavir(n=415) Indinavir+ ZDV/LAM(n=401) SUSTIVAa + Nelfinavir+ NRTIs(n=64) SUSTIVAa + NRTIs(n=65) Nelfinavir+ NRTIs(n=66)
180 weeksb 102 weeksb 76 weeksb 71.1 weeksb 70.9 weeksb 62.7 weeksb
a SUSTIVA provided as 600 mg once daily.
b Median duration of treatment.
c Isolated elevations of GGT in patients receiving SUSTIVA may reflect enzyme induction not associated with liver toxicity.
d Nonfasting.
ZDV = zidovudine, LAM = lamivudine, ULN = Upper limit of normal, ALT = alanine aminotransferase,AST = aspartate aminotransferase, GGT = gamma-glutamyltransferase.
Chemistry
ALT >5 x ULN 5% 8% 5% 2% 6% 3%
AST >5 x ULN 5% 6% 5% 6% 8% 8%
GGTc >5 x ULN 8% 7% 3% 5% 0 5%
Amylase >2 x ULN 4% 4% 1% 0 6% 2%
Glucose >250 mg/dL 3% 3% 3% 5% 2% 3%
Triglyceridesd ≥751 mg/dL 9% 6% 6% 11% 8% 17%
Hematology
Neutrophils <750/mm3 10% 3% 5% 2% 3% 2%

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