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. Author manuscript; available in PMC: 2016 Jun 3.
Published in final edited form as: N Engl J Med. 2015 Jul 21;373(8):705–713. doi: 10.1056/NEJMoa1501315

Table 3.

Adverse Events and Discontinuations, According to Antiretroviral Regimen.*

Event EFV–FTC–TDF
(N = 160)
RAL–FTC–TDF
(N = 146)
RPV–FTC–TDF
(N = 29)
All Patients
(N = 335)
number (percent)
Discontinuation of treatment owing to
    adverse event
0 0 0 0
Death 0 1 (1) 0 1 (<1)
Any adverse event 125 (78) 114 (78) 18 (62) 257 (77)
Common adverse events
  Headache 41 (26) 38 (26) 4 (14) 83 (25)
  Fatigue 41 (26) 26 (18) 4 (14) 71 (21)
  Diarrhea 19 (12) 13 (9) 4 (14) 36 (11)
  Nausea 17 (11) 13 (9) 3 (10) 33 (10)
  Arthralgia 11 (7) 9 (6) 2 (7) 22 (7)
  Upper respiratory tract infection 6 (4) 11 (8) 1 (3) 18 (5)
  Vomiting 6 (4) 6 (4) 2 (7) 14 (4)
  Muscle spasms 2 (1) 5 (3) 4 (14) 11 (3)
  Constipation 5 (3) 3 (2) 2 (7) 10 (3)
  Dysgeusia 5 (3) 1 (1) 2 (7) 8 (2)
  Sinusitis 3 (2) 2 (1) 2 (7) 7 (2)
Serious adverse events
  Any 4 (2) 3 (2) 1 (3) 8 (2)
  Hepatocellular carcinoma 1 (1) 1 (1) 0 2 (1)
  Portal-vein thrombosis 1 (1) 1 (1) 0 2 (1)
  Arthralgia 1 (1) 0 0 1 (<1)
  Azotemia 1 (1) 0 0 1 (<1)
  Clostridium difficile colitis 0 1 (1) 0 1 (<1)
  Cough 1 (1) 0 0 1 (<1)
  Diarrhea 0 0 1 (3) 1 (<1)
  Ileus 1 (1) 0 0 1 (<1)
  Bacterial peritonitis 1 (1) 0 0 1 (<1)
  Respiratory tract infection 0 1 (1) 0 1 (<1)
  Sepsis 0 1 (1) 0 1 (<1)
  Substance abuse 1 (1) 0 0 1 (<1)
*

EFV denotes efavirenz, FTC emtricitabine, RAL raltegravir, RPV rilpivirine, and TDF tenofovir disoproxil fumarate.

Listed are adverse events that were reported in at least 5% of patients in any group. Patients could have more than one adverse event or serious adverse event.