Table 2.
Adverse events and laboratory abnormalities in the safety analysis population over a median of 86 weeks of follow-up
| Emtricitabine and tenofovir alafenamide group (n=2694) | Emtricitabine and tenofovir disoproxil fumarate group (n=2693) | ||
|---|---|---|---|
| Participants with any adverse event | 2498 (93%) | 2494 (93%) | |
| Discontinuation of study drug because of adverse event | 36 (1%) | 49 (2%) | |
| Serious adverse event* | 169 (6%) | 138 (5%) | |
| Treatment-related serious adverse event† | 545 (20%) | 630 (23%) | |
| Death‡ | 1 (0·04%) | 1 (0·04%) | |
| Common adverse events (≥10% in either group) | |||
| Rectal chlamydia | 770 (29%) | 792 (29%) | |
| Oropharyngeal gonorrhoea | 740 (27%) | 722 (27%) | |
| Rectal gonorrhoea | 693 (26%) | 671 (25%) | |
| Exposure to a communicable disease | 465 (17%) | 441 (16%) | |
| Diarrhoea | 430 (16%) | 422 (16%) | |
| Nasopharyngitis | 350 (13%) | 355 (13%) | |
| Upper respiratory tract infection | 356 (13%) | 310 (12%) | |
| Syphilis | 342 (13%) | 321 (12%) | |
| Urethral chlamydia | 280 (10%) | 259 (10%) | |
| Grade 3 or 4 laboratory abnormality (≥1% in either group) | |||
| Any | 196 (7%) | 206 (8%) | |
| Increased alanine aminotransferase§ | 39 (1%) | 40 (2%) | |
| Increased amylase§ | 34 (1%) | 46 (2%) | |
| Increased aspartate aminotransferase§ | 63 (2%) | 51 (2%) | |
| Hyperglycaemia, fasting§ | 12 (<1%) | 17 (1%) | |
| Increased LDL, fasting§ | 51 (2%) | 18 (1%) | |
| Glycosuria§ | 19 (1%) | 32 (1%) | |
Data are n (%).
The most common serious adverse events in the emtricitabine and tenofovir alafenamide group were appendicitis (n=8, 0·3%), suicidal ideation (n=7), acute kidney injury (n=5), hepatitis A (n=5), cellulitis (n=4), pneumonia (n=4), depression (n=4), suicide attempt (n=4), and road traffic accident (n=4); the most common serious adverse events in the emtricitabine tenofovir disoproxil fumarate group were appendicitis (n=9), suicidal ideation (n=5), cellulitis (n=4), pneumonia (n=4), atrial fibrillation (n=4), chest pain (n=4), anal abscess (n=3), and diverticulitis (n=3).
Serious adverse events considered to be associated with emtricitabine tenofovir alafenamide included nephrotic syndrome (n=1), chest pain and loss of consciousness (n=1), and agranulocytosis and pyrexia in the same participant (n=1); serious adverse events considered to be associated with emtricitabine tenofovir disoproxil fumarate included acute kidney injury (n=2), migraine (n=1), pneumonia (n=1), urinary calculus (n=1), and renal tubular necrosis (n=1).
Reasons for death included one traffic accident in the emtricitabine and tenofovir alafenamide group, and one unknown cause in the emtricitabine and tenofovir disoproxil fumarate group.
Threshold values for the defined concentrations are in the appendix (p 10).