Page 271 - SAHCS HIVMed Journal Vol 20 No 1 2019

Page 7 of 10 Original Research

between the two arms, except for Division of AIDS (DAIDS) abnormalities (total cholesterol: 0 in the TDF/FTC/RPV arm
grade 3 or 4 AEs which were more commonly reported in vs. 4 [1.9%], low-density lipoprotein [LDL] cholesterol: 2
patients receiving TDF/FTC/EFV compared with TDF/ [0.9%] vs. 11 [5.2%], triglycerides: 0 vs. 1 [0.5%]).
FTC/RPV (56 [26.5%] vs. 40 [18.8%], respectively). Regardless
of NNRTI at screening, the incidence of treatment-emergent Adverse events leading to discontinuation were reported in
DAIDS grade 3 or 4 AEs was lower in the TDF/FTC/RPV seven (3.3%) patients switched to TDF/FTC/RPV and in one
arm compared with TDF/FTC/EFV. For patients who (0.5%) patient receiving TDF/FTC/EFV. All AEs leading to
switched from EFV at baseline, the incidence was 15.7% permanent discontinuation were observed in at most one
(18/115) in the TDF/FTC/RPV arm versus 24.1% (28/116) in patient in any treatment arm, except for alanine
the TDF/FTC/EFV arm; for those patients who switched aminotransferase increases and ECG QT prolongation, which
from NVP at baseline, the incidence was 22.4% (22/98) versus both occurred in two (0.9%) patients in the TDF/FTC/
29.5% (28/95), respectively. RPV arm.

The most frequently reported AEs at least possibly related In the TDF/FTC/EFV group, a lower rate of treatment-
to the study drugs were vertigo (5 [2.3%] in the TDF/FTC/ emergent neuropsychiatric events of interest was seen in the
RPV arm vs. 11 [5.2%] in the TDF/FTC/EFV arm), headache subgroup of patients who were receiving EFV at screening
(10 [4.7%] vs. 6 [2.8%]), dizziness (2 [0.9%] vs. 8 [3.8%]), (20/116 patients, 17.2%) compared with the rate in patients
increased appetite (8 [3.8%] vs. 1 [0.5%]) and nightmares (0 receiving NVP at screening (39/95 patients, 41.1%). This
vs. 8 [3.8%]) (Table 3). difference between the subgroups within the TDF/FTC/EFV
group was seen consistently for most individual
neuropsychiatric events recorded.
More patients in the TDF/FTC/EFV arm than in the TDF/
FTC/RPV arm experienced grade 3 or higher lipid
In the subgroup switched from NVP-based regimens, 41.1%
TABLE 3: Clinical adverse events and laboratory abnormalities. (39/95) of patients in the TDF/FTC/EFV arm experienced a
Adverse event TDF/FTC/RPV (n = 213) TDF/FTC/EFV (n = 211) neuropsychiatric event of interest, compared with only 30.6%
n % n % (30/98) of the patients who switched to the TDF/FTC/RPV
Any adverse event 178 83.6 174 82.5 arm (Table 4).
Drug-related adverse events 65 30.5 53 25.1
(all grades) TABLE 4: Treatment-emergent neuropsychiatric events of interest in the
Drug-related adverse events (all grades) in ≥ 1% of patients in either treatment arm subgroup of patients switching from NVP and the full ITT population.
Headache 10 4.7 6 2.8 Adverse event TDF/FTC/RPV TDF/FTC/EFV
Dizziness 2 0.9 8 3.8 NNRTI at All patients NNRTI at All patients
Vertigo 5 2.3 11 5.2 screening: (n = 213) screening: NVP (n = 211)
Insomnia 5 2.3 1 0.5 NVP (n = 98) (n = 95)
Nightmares - - 8 3.8 n % n % n % n %
Peripheral neuropathy 4 1.9 2 0.9 Any treatment- 30 30.6 59 27.7 39 41.1 59 28.0
Generalised pruritus 2 0.9 3 1.4 emergent
Increased amylase 5 2.3 - - neuropsychiatric
event of interest
Nausea 5 2.3 2 0.9 Nervous system disorders
Diarrhoea 1 0.5 4 1.9 Headache 17 17.3 37 17.4 16 16.8 28 13.3
Increased appetite 8 3.8 1 0.5
Renal and urinary disorders 1 0.5 5 2.4 Dizziness 3 3.1 7 3.3 11 11.6 13 6.2
Grade 3–4 adverse events 40 18.8 56 26.5 Somnolence 6 6.1 11 5.2 2 2.1 2 0.9
Drug-related grade 3–4 adverse 13 6.1 4 1.9 Hypersomnia - - - - 1 1.1 1 0.5
events Head discomfort - - - - - - 1 0.5
Drug-related grade 3–4 adverse events in ≥ 1% of patients in either treatment arm Memory impairment - - - - - - 1 0.5
Amylase increased 5 2.3 - - Psychiatric disorders
Alanine aminotransferase 3 1.4 - -
increased Nightmare 4 4.1 4 1.9 6 6.3 9 4.3
Serious adverse events 16 7.5 11 5.2 Insomnia 5 5.1 10 4.7 2 2.1 4 1.9
Drug-related serious adverse events 3 1.4 1 0.5 Depression 1 1.0 1 0.5 1 1.1 2 0.9
Deaths 1 0.5† - - Abnormal dreams - - - - 1 1.1 1 0.5
Discontinuations because of 7 3.3‡ 1 0.5§ Anxiety - - - - 1 1.1 1 0.5
adverse events Libido decreased - - - - 1 1.1 1 0.5
Select grade 3–4 laboratory abnormalities Libido increased - - - - 1 1.1 2 0.9
Amylase 6 2.8 11 5.3 Mood swings - - - - 1 1.1 1 0.5
Alanine aminotransferase 4 1.9 2 0.9 Stress - - 1 0.5 1 1.1 2 0.9
Aspartate aminotransferase 1 0.5 1 0.5 Restlessness - - 1 0.5 - - - -
Total cholesterol - - 4 1.9
LDL cholesterol 2 0.9 11 5.2 Ear and labyrinth disorders
Triglycerides - - 1 0.5 Vertigo 6 6.1 11 5.2 12 12.6 16 7.6
Hyperglycaemia 3 1.4 - - Eye disorders
ALT, alanine aminotransferase; EFV, efavirenz; FTC, emtricitabine; LDL, low-density Photophobia - - 1 0.5 2 2.1 2 0.9
lipoprotein; RPV, rilpivirine; TDF, tenofovir disoproxil fumarate. Vision blurred 1 1.0 1 0.5 2 2.1 2 0.9
†, Myocardial infarction, unrelated to study medication; ‡, Elevated ALT grade 3 (n = 2),
QT prolongation grade 3 (n = 2), increased creatinine (n = 1), tachycardia (n = 1), tuberculosis EFV, efavirenz; FTC, emtricitabine; NVP, nevirapine; RPV, rilpivirine; TDF, tenofovir disoproxil
(n = 1); §,Lipoatrophy. fumarate.

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