Table 3.
Frequency of adverse events by treatment group, EPICOS randomized trial
| TDF/FTC + HCQ (n = 220) | TDF/FTC (n = 233) | HCQ (n = 231) | Placebo (n = 223) | |
|---|---|---|---|---|
| Severity of adverse event | ||||
| Mild | 78 (35.5) | 77 (33.0) | 63 (27.3) | 63 (28.3) |
| Moderate | 37 (16.8) | 33 (14.2) | 36 (15.6) | 29 (13.0) |
| Severe | 1 (0.5) | 1 (0.4) | 1 (0.4) | 2 (0.9) |
| Adverse event classified as serious | 1 (0.5) | 0 | 0 | 4 (1.8) |
| Adverse event classified as related to study drug | 49 (22.3) | 51 (21.9) | 46 (19.9) | 37 (16.6) |
| Effect of adverse event on study treatment | ||||
| Treatment was interrupted | 28 (12.7) | 27 (11.6) | 14 (6.1) | 19 (8.5) |
| Treatment was delayed | 4 (1.8) | 4 (1.7) | 7 (3.0) | 3 (1.3) |
| Concomitant treatment was prescribed | 23 (10.5) | 26 (11.2) | 23 (10.0) | 21 (9.4) |
| Adverse events by system organ classa | ||||
| Gastrointestinal disorders | 68 (30.9) | 73 (31.3) | 56 (24.2) | 47 (21.1) |
| Blood and lymphatic system disorders | 1 (0.5) | 0 | 0 | 1 (0.4) |
| Cardiac disorders | 1 (0.5) | 2 (0.9) | 1 (0.4) | 3 (1.3) |
| Ear and labyrinth disorders | 1 (0.5) | 2 (0.9) | 0 | 3 (1.3) |
| Eye disorder | 3 (1.4) | 1 (0.4) | 2 (0.9) | 4 (1.8) |
| General disorders | 11 (5.0) | 17 (7.3) | 9 (3.9) | 10 (4.5) |
| Immune system disorder | 0 | 1 (0.4) | 0 | 0 |
| Infections | 4 (1.8) | 0 | 5 (2.2) | 3 (1.3) |
| Injuries | 2 (0.9) | 0 | 1 (0.4) | 2 (0.9) |
| Investigations | 2 (0.9) | 6 (2.6) | 3 (1.3) | 3 (1.3) |
| Metabolism and nutrition disorders | 2 (0.9) | 2 (0.9) | 1 (0.4) | 1 (0.4) |
| Musculoskeletal/connective tissue disorders | 9 (4.1) | 9 (3.9) | 6 (2.6) | 6 (2.7) |
| Nervous system disorders | 22 (10.0) | 31 (13.3) | 26 (11.3) | 19 (8.5) |
| Psychiatric disorders | 3 (1.4) | 3 (1.3) | 4 (1.7) | 8 (3.6) |
| Renal and urinary disorders | 0 | 1 (0.4) | 0 | 1 (0.4) |
| Reproductive system disorder | 1 (0.5) | 0 | 1 (0.4) | 1 (0.4) |
| Respiratory disorders | 1 (0.5) | 3 (1.3) | 3 (1.3) | 2 (0.9) |
| Skin disorders | 14 (6.4) | 6 (2.6) | 6 (2.6) | 4 (1.8) |
| Vascular disorders | 0 | 0 | 1 (0.4) | 3 (1.3) |
More than one adverse event per participant could occur. Data are presented as n (%).
AbbreviationsHCQ, hydroxychloroquine; FTC, emtricitabine; TDF, tenofovir disoproxil fumarate.
a
See supplementary methods for a list of the observed adverse events in each system organ class.