Table 4.
Adverse Events Through Week 48
| Adverse Event | B/F/TAF (n = 284) | DTG + F/TAF (n = 281) |
|---|---|---|
| Any AE | 236 (83%) | 243 (86%) |
| Grade 3 or 4 AE | 23(8%) | 13(5%) |
| Serious AEb | 30 (11%) | 19 (7%) |
| Study drug–related AE | 41 (14%) | 28 (10%) |
| Study drug–related serious AE | 0 | 1 (<1%) |
| Any AE leading to study drug discontinuationa | 6 (2%) | 6 (2%) |
| Death | 1 (<1%) | 1 (<1%) |
| AE ≥5% in either arm | ||
| Nasopharyngitis | 32 (11%) | 28 (10%) |
| Diarrhea | 23 (8%) | 32 (11%) |
| Upper respiratory tract infection | 20 (7%) | 30 (11%) |
| Headache | 13 (5%) | 23 (8%) |
| Arthralgia | 16 (6%) | 17 (6%) |
| Influenza | 16 (6%) | 14 (5%) |
| Fatigue | 21 (7%) | 8 (3%) |
| Insomnia | 18 (6%) | 11 (4%) |
| Back pain | 15 (5%) | 11 (4%) |
| Bronchitis | 14 (5%) | 11 (4%) |
| Pain in extremity | 12 (4%) | 11 (4%) |
| Cough | 6 (2%) | 16 (6%) |
Data are presented as no. (%).
Abbreviations: AE, adverse event; B/F/TAF, bictegravir/emtricitabine/tenofovir alafenamide; DTG + F/TAF, dolutegravir plus emtricitabine/tenofovir alafenamide.
aAEs leading to study drug discontinuation in the bictegravir group included fatigue (n = 1), device-related infection (n = 1), dyspepsia (n = 1), fatigue, nightmare, and hyperhidrosis (n = 1), abnormal dreams (n = 1), and agitation (n = 1); all events were considered by the investigator to be related to study drug except device-related infection. AEs leading to study drug discontinuation in the dolutegravir group included insomnia, fatigue, headache, nausea, and anxiety (n = 1), generalized rash (n = 1), maculopapular rash and conjunctival hyperemia (n = 1), asthenia and flatulence (n = 1), yolk sac tumor (site unspecified) (n = 1), and abnormal dreams and sleep disorder (n = 1); all events were considered by the investigator to be related to study drug except anxiety, generalized rash, and yolk sac tumor (site unspecified).
bSerious AEs in the bictegravir group included diverticulitis (n = 2) and biliary dyskinesia, bronchospasm, cardiorespiratory arrest, cellulitis, chest pain, cholecystitis, chronic obstructive pulmonary disease, clavicle fracture, concussion, coronary artery disease, device-related infection, drug abuse, dyspnea, foreign body in gastrointestinal tract, gastroenteritis, infectious diarrhea, large intestine perforation, ligament rupture, lumbar spinal stenosis, malignant lung neoplasm, overdose, perirectal abscess, pneumonia, pneumonitis, pneumothorax, postprocedural infection, pyelonephritis, rebound psychosis, rhabdomyolysis, seizure, sinus tachycardia, tendon rupture, and ventricular tachycardia (n = 1 each). Serious AEs in the dolutegravir group included abdominal pain, angina pectoris, ankle fracture, appendicitis, increased blood glucose, cholecystitis, acute cholecystitis, diverticulitis, dyspnea, inguinal hernia, lisfranc fracture, myocardial infarction, osteonecrosis, pyelonephritis, subdural hemorrhage, vertebral artery dissection, viral upper respiratory tract infection, vomiting, and yolk sac tumor site unspecified (n = 1 each).